DeLancey AUGS Pres 2008

ABSTRACTS
Oral Paper Presentations

Presentation Number: Paper 1 Effect of Weight Change on Natural History of Pelvic Organ Prolapse B. Kudish,* C. B. Iglesia,* S. L. Hendrix, B. Cochrane, H. Richter, G. S. McNeeley, J. Larson, and R. J. Sokol *Washington Hospital Center, Washington, DC, Detroit Medical Center, Detroit, MI, University of Washington, Seattle, WA, University of Alabama, Birmingham, AL, Womens Health Initiative, Seattle, WA, Wayne State University, Detroit, MI Objective: According to the National Center for Health Statistics, an estimated 66% of U.S. adults are either overweight or obese, the majority being female. The purpose of this secondary analysis was to evaluate the relationship between change in weight and pelvic organ prolapse (POP) progression/regression in postmenopausal women over a 5-year period. Methods: Women with a uterus (N 16,608), ages 50 to 79, enrolled in the Womens Health Initiative Estrogen plus Progestin Clinical Trial between 1993 and 1998 were included in the study. Demographic, medical history, and clinical data on age, race, body mass index, waist circumference, parity, major medical morbidities, and Baden-Walker classification (Grades 0 3), assessing for uterine prolapse, cystocele, and rectocele, were extracted from baseline and yearly examinations and questionnaires. Descriptive statistics, ordinal and logistic regression methods were used to identify factors associated with POP. Results: Over the 5-year time period, the majority of women (55.7%) gained weight (mean 4.43 kg, 5.95 kg), while the overall rate of prolapse (Grades 13) increased by 4%, from 40.9% at baseline to 44.7% at year 4 of evaluation. After controlling for age, parity, race, and other health/physical variables, being overweight (BMI 25, 30 kg/m2) and obese (BMI 30 kg/m2) at baseline was associated with progression in cystocele, rectocele, and uterine prolapse (Table 1) compared to women with normal BMI of 25 kg/m2 over the average follow-up of 5.6 years. We then adjusted for prolapse at baseline and baseline BMI to evaluate an effect of weight change on POP. A 10% weight change was associated with minimal change in POP. For example, a 10% weight loss was associated with a borderline worsening of uterine prolapse (OR 1.08, 95% CI 1.031.11) and a minimal regression of cystocele (OR 0.97, 95% CI 0.951.00) and rectocele (OR 0.96, 95% CI 0.93 0.99). Conclusions: Being overweight or obese is highly associated with progression of POP. However, regression of POP does not appear to be significantly associated with weight loss, suggesting that damage to the pelvic floor, related to weight gain, might not be reversible. Therefore, avoidance of weight gain may prevent progression of POP. Disclosures: B. Kudish, None; C.B. Iglesia, None; S.L. Hendrix, None; B. Cochrane, None; H. Richter, None; G.S. McNeeley, None; J. Larson, None; R.J. Sokol, None. Presentation Number: Paper 2 The Association of Urethral Sphincter Morphology in Magnetic Resonance Images with Urethral Function D. M. Morgan,* W. Umek, K. Guire,* H. K. Morgan,* and J. O. DeLancey* *University of Michigan, Ann Arbor, MI, University of Vienna, Vienna, Austria Objective: We recently reported that maximum urethral closure pressure (MUCP) is 42% lower in cases than a group of matched controls.1 This study analyzes the relationship between anatomical measures of the urethral sphincter using magnetic resonance (MR) images and urethral function. Methods: Women with SUI symptoms and daily demonstrable stress incontinence (n 103) were recruited from outpatient urogynecology and urology clinics and from local advertisements. Asymptomatic continent controls (n 108) were recruited by advertisement to match for age, race, parity and hysterectomy status using group matching. The testing protocol included determination of urethral axis with Q-tip testing, MUCP and Kegel augmentation of urethral closure pressure (KUCP). Axial proton-density MR images were obtained at 5 mm intervals. The lengths of the striated urethral sphincter (SUS) and vesical neck (VN) (from internal urinary meatus to the top of the striated sphincter) were determined by multiplying the number of images in which these structures were identified by the 5 mm slice interval. The inner and outer diameters of the SUS were measured, and the difference between them was calculated as SUS thickness. The inner diameter represents the region containing urethral smooth muscle layers, submucosa, and lumen. Spearman correlation coefficients were used on pooled data from the two groups to evaluate the relationship between anatomical and physiological data. Comparisons between cases and controls were performed with t-tests. Results: SUS thickness is associated with higher MUCP (r 0.14, p .036) and better elevation of the urethral axis during Q-tip testing (r .17, p .016). A longer SUS is associated with a higher MUCP (r 0.18, p .014) and a higher KUCP (r 0.21, p .004). VN length is associated with lower MUCP (r . 16, p.017). Aging correlates with a shorter SUS length (r .26, p .001) and increasing VN length (r .19, p .006). Stress incontinent and continent women did not differ significantly in SUS thickness (2.9 1.6 mm v 3.3 1.8 mm, p .079), SUS length (13.2 3.4 mm v. 14.0 3.8 mm, p .114) and inner urethral diameter (12.3 1.71 mm v 11.8 1.5 mm, p .085). Conclusions: The associations of striated urethral sphincter thickness and length with MUCP and aging are in the expected directions and are physiologically consistent. However, the differences in MR imaged measurements of urethral anatomy are not as remarkable for cases and controls as are those reported for MUCP. Comment: Differences in urethral anatomy do not fully account for the differences in function observed amongst women with and without stress incontinence. Disclosures: D.M. Morgan, None; W. Umek, None; K. Guire, None; H.K. Morgan, None; J.O. DeLancey, None. The support of ORWH and NICHD P50 HD 044406 is gratefully acknowledged.
TABLE. Effect of Baseline BMI on Change in Pelvic Organ Prolapse BMI Normal Overweight Obese Cystocele (OR) 1.0 1.31 (1.221.41) 1.46 (1.321.6) Rectocele (OR) 1.0 1.37 (1.251.49) 1.57 (1.41.76) Uterine Prolapse (OR) 1.0 1.42 (1.291.57) 1.67 (1.451.91)
(J Urol April 2008 e-pub).
Presentation Number: Paper 3 The Minimum Important Differences for the Urinary Scales of the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire M. D. Barber, for the Pelvic Floor Disorders Network Cleveland Clinic, Cleveland, OH
Journal of Pelvic Medicine & Surgery Volume 14, Number 4, July/August 2008
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TABLE. MID of UDI, UDI-Stress and UIQ using Anchor- and Distribution-Based Methods Change from Baseline to 3 Months after Treatment in UDI UDI-Stress UIQ 6.4 22 11 4.6 16 7.5 Baseline UDI-Stress 18.2 24.4 6.5 17 16
Anchor-Based methods PGI-I, patient global impression of improvement Change in UIE, urinary incontinence episodes Incontinence Severity Index
Criteria Difference in scores between patients reporting Better and those reporting About the Same Difference in scores between patients with 25% improvement and those with no change* Difference in scores between patients with one level of improvement on ISI and those with no change
Distribution-based methods Effect size Standard error of Measurement (SEM)

* No change defined as
0.5 SD (standard deviation) 1 SEM
UDI 20.3 15.6
UIQ 19.4 7.9
25% change from baseline to 3 months in UIE.
Objective: To determine the minimum important difference (MID) for the urinary scales of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). Methods: 444 subjects enrolled in a multi-center randomized trial comparing behavioral therapy to an incontinence pessary for stress urinary incontinence completed baseline and 3 month follow-up visits. Eligibility criteria included: age 18 years, stress-predominant urinary incontinence, 2 stress incontinence episodes on a 7-day bladder diary, and patient desire for non-surgical treatment. At baseline and 3 month follow-up, subjects completed the 7-day diary, the Incontinence Severity Index (ISI), PFDI, and PFIQ. The Patients Global Impression of Improvement (PGI-I) was completed at 3-months. The MID of the Urinary Distress Inventory (UDI), the UDI-stress subscale of the PFDI, and the Urinary Impact Questionnaire (UIQ) of the PFIQ were assessed using anchor- and distribution-based approaches. Higher scores on these measures indicate more distress/impact. Anchors included the PGI-I, ISI, and incontinence episodes on the bladder dairy. Distribution-based measures included effect size and standard error of measurement. Treatment assignment remained blinded and was not assessed in these analyses. Results: Mean (SD) changes from baseline to 3 months after treatment in UDI, UDI-stress and UIQ scores were 33 (39), 19 (22), and 33 (44) points, respectively. The MID based on the PGI-I (difference in scores between subjects who indicated they were better vs. those who responded about the same) was 6.4, 4.6 and 6.5 for the UDI, UDI-stress and UIQ, respectively. MID determined by the other anchor-based methods (ISI and bladder diary) were greater than those for the PGI-I and similar to the distributionbased findings (Table). Conclusion: The MID of the urinary scales of the PFDI and PFIQ are smaller from a patients perspective than when objective criteria are used. While differences in scores of the UDI, UDI-stress and UIQ greater than 11, 7.5, and 16 points respectively should be considered clinically important, incontinent women may be able to perceive smaller differences. The impact of these smaller differences on quality of life improvement requires further study. Disclosures: M.D. Barber for the Pelvic Floor Disorders Network, American Medical Systems, Grant/Research Support.
Presentation Number: Paper 4 The Anal Continence Trial: A Randomized Comparison of Overlapping vs End to End Repair of 3rd Degree Obstetrical Lacerations S. A. Farrell, D. Gilmour, G. Turnbull, M. Schmidt, G. Flowerdew, T. F. Baskett, and C. Fanning Dalhousie University, Halifax, NS, Canada Objective: To compare rates of flatal and fecal incontinence in the two surgical groups; to correlate symptoms with external anal sphincter anatomy (endoanal ultrasound) and function (anal manometry). Methods: 62 women in each group were required to detect a difference in flatal incontinence rates of 25%. Vaginally primparous women who suffered 3rd or 4th degree tears of the external anal sphincter (EAS) were randomized. Women and evaluators were blinded to intervention. Standardized and validated questionnaires were administered at baseline and repeated at 6 months. At 6 months participants were evaluated using endoanal U/S and anal manometry. The primary outcome measure was the rate of flatal incontinence at 6 months. Longer term follow-up continues. Appropriate statistical analysis was used. Results: Follow-up at 6 months included questionnaires, anal ultrasound and anal manometry. 127 vaginally primiparous patients completed the 6 month follow-up, 65 in the end to end group and 62 in the overlapping group. Baseline demographic and obstetrical variables were not different in the groups. The flatal incontinence rate was higher in the overlapping group (60%) compared to the end to end group (37%) (OR 2.5, CI 1.2, 5.2). Obstetrical factors didnt influence outcome. Fecal incontinence rates were overlapping 15% and end-to-end 8% which did not achieve statistical significance (OR 2.04, CI .64, 6.5) Poor sustained voluntary contraction of EAS on anal manometry was associated with higher rates of flatal incontinence. There was no association between symptoms and endoanal ultrasound findings. Conclusions: The end to end repair of a 3rd or 4th degree obstetrical laceration in primiparous women results in lower rates of flatal incontinence at 6 months.
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Disclosures: S.A. Farrell, Canadian Institutes of Health Research, Grant/Research Support; D. Gilmour, None; G. Turnbull, None; M. Schmidt, None; G. Flowerdew, None; T.F. Baskett, None; C. Fanning, None.
Presentation Number: Paper 5 Significant Linkage Evidence of a Predisposition Gene for Pelvic Floor Disorders on Chromosome 9 P. Norton, K. Allen-Brady, and L. Cannon-Albright University of Utah School of Medicine, Salt Lake City, UT Objective: Pelvic floor disorders (PFDs), including pelvic organ prolapse (POP), stress urinary incontinence (SUI), and hernias are common, multifactorial conditions with possible heritable contributions. Linkage analysis of affected sibling pairs has been used widely to identify genetic components in other common disorders such as diabetes, obesity, and Alzheimers disease. The aim of this study was to identify linkage evidence for a predisposition gene for pelvic floor disorders in a set of affected sister pairs. Methods: Women who underwent surgical repair of PFDs at our University from 1996 2006 were invited to participate. Sisters of probands were surveyed for surgical repair of PFDs or evidence of PFDs on standardized questionnaires (PFDI). Those sisters who were likely affected with PFDs diagnosed in probands (POP, SUI, or mixed) were seen and examined along with the probands for phenotyping (POP-Q) and blood sampling for genotyping. Medical reports were obtained to confirm surgeries. For this analysis, a strict phenotype was used: individuals requiring surgery or repeat surgery for PFDs were defined as affected, and over 90% of individuals so defined had stage III or IV POP documented. Genotyping was performed for the POP phenotype using the Illumina 1 million SNP market set, and linkage analysis was tested by the log10 of the odds for linkage, or lod score, calculated by computer using the McLINK analysis package. Results: Of the 553 women contacted, 297 had surgery for POP and 256 had surgery for both SUI and POP at our University. Of these 553, 140 could not be contacted, had died, or did not respond, 94 declined or withdrew or did not have a sister who agreed to participate, and 195 had no living sisters. One hundred twenty-two probands provided information on 1 to 8 sisters. Sisters were identified as probably affected and were recruited for study if there was 1) evidence of moderate to severe PFDs, usually surgery for the condition 2) high homogeneity with the type of PFD in the proband and 3) in a few families, less affected sisters were included if there was a large pedigree. A total of 209 women were evaluated and phenotyped with collection of blood for DNA testing. After prioritizing for the most affected pairs of proband and sister/s, genotyping was performed on 96 total women from 38 families, representing 35 sets of sisters and 3 extended pedigrees. Of these 96 women, 75 were surgically treated POP cases, 65% were also affected with surgically treated SUI, and 8% with surgically treated hernia. Significant genome-wide evidence for linkage was identified on chromosome 9q21 with a lod score of 3.51 (p 0.000037) under the recessive model. Seventeen of our 38 pedigrees had evidence for linkage. Conclusions: Using linkage analysis, we have found significant evidence for a predisposition gene for PFDs on chromosome 9. Increased understanding of the genetic predisposition for PFDs may help localize the gene of interest and provide insight into the pathogenesis, prevention, and intervention of these conditions. Disclosures: P. Norton, None; K. Allen-Brady, None; L. CannonAlbright, None.
Presentation Number: Paper 6 Allogenic Myoblast Transplantation in the Rat Anal Sphincter J. B. Craig, F. Lane, G. Nistor, S. Motakef, K. Noblett, and H. Keirstead University of California-Irvine, Orange, CA Objective: The purpose of this study is to determine the feasibility of injecting myoblasts into the anal sphincter complex as a potential treatment for anal incontinence. Anal Incontinence (AI) affects 215% of the general population. Both surgical and non-surgical treatments for AI show limited long-term effectiveness. Muscle progenitor cells or myoblasts have been used in the urethral sphincter as a treatment for urinary incontinence. Studies have shown these cells to stimulate increases in muscle volume and regeneration of injured muscle fibers. The aim of this study is to determine if rat myoblasts will propagate within the sphincter complex. Methods: A three-phase study using non-pregnant female Sprague Dawley rodents of approximately 8 10 weeks of age has been initiated. Phase I involved 16 rodents randomly assigned to receive injections of either human or rodent myoblasts. Four animals received Green Fluorescent Protein (GFP) labeled rat myoblasts. A 1 mm 2 mm 2 mm biopsy of skeletal muscle was harvested from a study animal. Recovered myoblasts were expanded in vitro over 10 days, then tagged with GFP using Cytomegalovirus as a viral vector. Under general anesthesia, a 10 micro liter Hamilton syringe with a 33-gauge needle was used to inject the cell aspirate into the anal sphincter. In animals receiving GFP-labeled cells, two animals received 1.5 106 microliter of 6 cells and two animals received a dose of 4.5 10 . The cells were injected into the external anal sphincter using direct visualization and EMG identification, dividing the dose between three injection sites. Remaining myoblasts were plated and remained viable at 21 days post harvest. Results: Euthanasia was performed on day 10 and the anal sphincter complex was surgically extracted, fixed, cryoprotected and cut in 20 m sections. The tissue was quantified for the presence of transplanted cells by identifying the presence of fluorescence. The bioluminescence of the GFP permitted confirmation that GFP-labeled myoblasts were present in the external anal sphincter and had fused with host tissue. In Phase II myoblasts will be injected into rodents with surgically-induced anal sphincter rupture. Functional studies will be performed to establish regeneration of the sphincter complex following myoblast transplantation. Phase III will evaluate safety and migration. Conclusions: Rodent myoblasts incorporated into the anal sphincter as evidenced by the presence of GFP-labeled cells in the external anal sphincter. This demonstrates that myoblasts can successfully be introduced and fuse with host tissue. Disclosures: J.B. Craig, None; F. Lane, None; G. Nistor, None; S. Motakef, None; K. Noblett, Medtronics, Paid Instructor; H. Keirstead, None.
Presentation Number: Paper 7 Fibrillar Collagen Degrading Matrix Metalloproteinases are Increased in Vaginal Connective Tissue of Women with Prolapse W. Zong, S. E. Stein, and P. A. Moalli University of Pittsburgh, Pittsburgh, PA Objective: Collagen III has been shown to be elevated in vaginal connective tissue of women with advanced prolapse independent of hormonal status (Obstet. Gynecol 2005; 106: 953). Here we sought to determine whether this increase, indicative of tissue remodeling, is associated with quantitative differences in the fibrillar collagen
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degrading enzymes MMPs-1 and -13, and whether the expression of these enzymes is impacted by hormonal status. Methods: Following IRB approval and informed patient consent, 65 full-thickness vaginal biopsies were procured at time of surgery from premenopausal control women with stage II prolapse (N 16) and women with prolapse (N 49). The latter were divided into 3 groups - premenopausal (N 16), postmenopausal not on hormone therapy (HT, N 16), and postmenopausal on HT for 1 year (N 17). The epithelium was excised leaving the subepithelium, muscularis and advendtitia for biochemical analysis. The amount of MMP-1 and -13 was determined for each sample in duplicate by Western immunoblotting and quantitated by densitometry. The values were expressed as arbitrary units relative to an internal control (1 unit). Equal loading was insured by normalizing to the same blot stained with Coomassie blue. Data were analyzed using the Kruskal-Wallis test and post hoc analysis using the Mann-Whitney U test. Results: Premenopausal women with and without prolapse had similar age, gravidity, parity and BMI. These parameters were also similar in the menopausal women with prolapse on and off HT. Among the women with prolapse, the median stage of prolapse was III. Relative to control, active MMP-1 and active MMP-13 were increased in all prolapse groups (p 0.001) while the amount of the proenzyme forms was not different (p 0.23, 0.15, respectively). Analysis of the independent effect of hormones in tissues from women with prolapse showed no impact on either the proenzyme or active form of MMP-1 or MMP-13 (p 0.05). Conclusion: Active MMP-1 and MMP-13 are increased in the vagina of women with advanced prolapse relative to controls indicating a rapid remodeling of these tissues with prolapse progression. The absence of an impact of hormones suggests that hormones are not effective in delaying prolapse progression in women with advanced prolapse.
TABLE. Median (Interquartile Range) Active MMP-1 a Preb Post-, no HT c Post-, HT Active MMP-13 PrePost-, no HT Post-, HT 0.53 (0.32, 0.65) 0.76 (0.66, 0.88) 0.36 (0.26, 0.49) 0.857 0.17 (0.15, 0.20) 0.21 (0.12, 0.24) 0.20 (0.14, 0.22)
Overall p 0.001
Post-hoc p 0.003 (a vs b) 0.001 (b vs c) 0.085 (a vs c)
Disclosures: W. Zong, None; S.E. Stein, None; P.A. Moalli, R01HD045590, Grant/Research Support.
(HT) relative to premenopausal women and post menopausal women on HT (Am J Obstet Gynecol 2004; 190: 620). The aim of this study was to determine whether the decreased collagen I is associated with an increased amount of the proteolytic (active) form of the fibrillar collagen degrading matrix metalloprotienases (MMPs)-1 and -13. Methods: Following IRB approval and informed patient consent, 45 biopsies were procured from an intact portion of the ATFP in patients undergoing a surgical repair of prolapse. Patients were divided into 3 groups-premenopausal (N 15), postmenopausal not on HT (N 15), and postmenopausal on HT for 1 year (N 15). The expression of MMPs-1 and -13 was determined by Western immunoblotting, using monoclonal antibodies recognizing both proenzyme and active forms. The antibodies were validated with appropriate positive and negative controls prior to the tests. The immunoreactive bands were quantified by densitometry. The values were expressed as arbitrary units relative to an internal control (1 unit) loaded in duplicate on each gel. Equal loading was insured by normalizing to the same blot stained with 0.2% Coomassie brilliant blue. The test was performed at least in duplicate for each sample. Data were analyzed at 0.05 level of significance using Kruskal-Wallis test and post hoc analysis using Mann-Whitney U test. Results: Subjects in the 3 groups had similar gravidity, parity, BMI and stage of prolapse. Although premenopausal women were younger, there was no difference in age in the postmenopausal women on and off hormones. Proezyme forms of MMP-1 and MMP-13 were not adequately detected in all specimens, therefore, only the active forms were included in the final analysis. Active MMP-1 was higher in specimens from postmenopausal not on HT relative to those from both premenopausal women and postmenopausal women on HT. The amount of active MMP13 was not different among the 3 groups. Conclusion: Menopause in the absence of HT is associated with an increase in active MMP-1 and a decrease in collagen I in ATFP. This may compromise the integrity of ATFP and contribute to the onset of prolapse in menopausal women. Disclosures: W. Zong, None; S.E. Stein, None; P.A. Moalli, R01HD045590, Grant/Research Support.
Presentation Number: Paper 8 The Collagen Degrading Matrix Metalloproteinase-1 is Increased in the Arcus Tendineous Fasciae Pelvis of Menopausal Women W. Zong, S. E. Stein, and P. A. Moalli University of Pittsburgh, Pittsburgh, PA Objective: Collagen I is decreased in the arcus tendineous fasciae pelvis (ATFP) of postmenopausal women with prolapse not on hormone therapy
Presentation Number: Paper 9 Changes in Sexual Function in Women 2 Years After Sling or Burch Colposuspension: Results from the Sister Trial L. Brubaker,* A. Stoddard, H. Johnson, H. Zyczynski, J. Shaffer, D. Kalinoski, S. Chiang,** J. Kusek, W. Steers, and Urinary Incontinence Treatment Network *Loyola University Chicago, Maywood, IL, New England Research Institute, Boston, MA, University of Maryland, Baltimore, MD, University of Pittsburgh,
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TABLE. Success N, mean (sd) Overall outcome (includes stress test, pad test, diary, re-treatment and symptoms) Stress-specific outcome (includes stress test, re-treatment and symptoms) Stress test Pad test Diary Re-treatment Urodynamic stress incontinence 118, 5.77 (6.16) 175, 5.32 (6.08) 248, 5.07 (5.94) 261, 4.90 (5.81) 180, 5.33 (6.19) 280, 4.92 (5.85) 28, 5.89 (6.72) Failure N, mean (sd) 153, 3.79 (5.54) 112, 3.67 (5.82) 45, 2.09 (5.64) 32, 2.31 (6.96) 113, 3.48 (5.48) 9, 3 (6.16) 262, 4.48 (5.9) p-value (t-test) 0.006 0.02 0.002 0.02 0.01 .0001 0.23
Pittsburgh, PA, University of Texas Southwestern, Dallas, TX, University of California San Diego, San Diego, CA, **University of Washington, Seattle, WA, NIDDK, Bethesda, MD, University of Virginia, Charlottesville, VA Objective: To describe changes in sexual function and correlates of change 2 years after surgery for stress urinary incontinence (SUI). Methods: We report this planned secondary analysis of women who were randomized to Burch or fascial sling for predominant SUI. The methods of this trial have been previously described, including the sexual function assessment at baseline and at 2 years post surgery, or prior to SUI re-treatment by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ). All analyses were carried out using SAS software Ver. 9.1 (SAS Institute, Inc, Cary, NC). Statistical significance was defined by a pvalue 0.05. Results: Of 655 women enrolled, 450 reported sexual activity with a partner at baseline and answered 10 of 12 PISQ items. At baseline sexually active women were younger (49.5 vs. 57.4 yrs, p 0.001), and had a significantly lower body mass index (BMI 29.2 vs. 31.6, p 0.001), lower total MESA scores (25.4 vs. 26.7, p 0.05), lower MESA urge subscale scores (6.2 vs. 7.1, p 0.007) and lower pad weights (38.2 vs. 55.3 grams, p 0.04) than women who reported they were not sexually active. In women reporting activity at 2 years, the mean PISQ total score increased from 32.23 6.85 to 36.85 5.89. Compared to baseline, fewer sexually active subjects reported incontinence (53% vs. 9%, p 0.0001), restriction of sexual activity due to fear of incontinence (52% vs. 10%, p 0.0001), avoidance of intercourse because of vaginal bulging (24% vs. 3%, p 0.0001) or negative emotional reactions during sex (35% vs. 9%, p 0.0001) at 2 years. There was no significant change in frequency of orgasm, or sexual desire, excitement, or satisfaction after surgery. Improvement was associated with surgical success (Table) and did not differ by surgical group assignment, baseline POP-Q stage or concomitant POP surgery (p 0.05). PISQ Score Change (Two Years - Baseline) by Outcome (Higher score improved function). Conclusion: Sexual function in women undergoing either a Burch colposuspension or fascial sling with a successful surgical outcome improved by two years post-operatively. Disclosures: L. Brubaker, Pfizer, Grant/Research Support; Allergan, Grant/Research Support; A. Stoddard, None; H. Johnson, None; H. Zyczynski, None; J. Shaffer, None; D. Kalinoski, None; S. Chiang, None; J. Kusek, None; W. Steers, None; &. Urinary Incontinence Treatment Network, None.
Presentation Number: Paper 10 Relationships of Anterior Vaginal Wall to the Vaginal Apex After Apical Prolapse Procedures L.A. McGuire*, I. Wilkinson-Ryan, and K. Strohbehn* *DartmouthHitchcock Medical Center, Lebanon, NH, Dartmouth Medical School, Hanover, NH Objective: To determine the relationship between the anterior and apical Pelvic Organ Prolapse Quantification (POP-Q) values before and after isolated apical vaginal support procedures. Methods: Following IRB approval, 244 patients undergoing apical vaginal suspensions (sacral colpopexy; transvaginal intraperitoneal or extraperitoneal colpopexy) without anterior support procedures from January 1, 2004 through December 31, 2006 were retrospectively identified. A chart review was performed to extract preoperative and postoperative POP-Q values, age, parity, prior surgeries, BMI, primary surgeon and POP-Q examiner. Twenty-nine subjects were excluded due to concomitant surgeries on the anterior wall, including 22 paravaginal repairs, six pubovaginal slings and one anterior colporrhaphy. One patient was excluded as her apical suspension was performed prophylactically. Two other patients were excluded, one patient with didelphis uterus and duplicate vagina, and one patient with a clearly erroneous medical record that could not be rectified. Correlations between POP-Q values, both pre and post-operatively, for the remaining 212 patients were then analyzed. Results: 212 patients were analyzed using linear regression with a Pearson correlation coefficient. Preoperative vaginal apex support (point C) correlated with the most prolapsed portion of the anterior vaginal wall (point Ba) with a linear relationship. A linear regression analysis yields an equation of: Y 0.87 3.47 with a correlation coefficient of 0.58 (p-value 0.0001). Postoperative vaginal apex and anterior wall values were less linear, Y 0.24 7.5 with a correlation coefficient of 0.17 (p-value 0.0199), with most Point C values clustered at 8. The post-operative changes in C and Ba again correlate well, Y 0.91 2.42 with a correlation coefficient of 0.55 (p-value 0.0001) (Fig.1). Conclusions: This study corroborates previous findings of a linear relationship between the vaginal apex and the anterior vaginal wall in women with pelvic organ prolapse. Furthermore, it demonstrates that a linear relationship remains postoperatively when evaluating the change of the vaginal apex and anterior vaginal wall in women undergoing an isolated apical support procedure.
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Disclosures: L.A. McGuire, None; I. Wilkinson-Ryan, None; K. Strohbehn, DuraMed, Grant/Research Support.
2004 (p .001). In women 50 years, the proportion castrated increased from 26% in 1979 to 37% in 2004. In women 50 years, the proportion castrated nearly doubled, increasing from 43% in 1979 to 93% in 2004. After initial results from WHI were released in 2002, a decrease in castration of 28 women per 100,000 women occurred in 20032004. Women undergoing castration at hysterectomy were older (47.4 years) than women who had at least one ovary preserved (41.7 years, p .001). Castration at hysterectomy was associated with higher incidence of cardiovascular, respiratory, gastrointestinal, organ injury, and postoperative infection complications (all p-values .01). Conclusions: While the age-adjusted rate of prophylactic castration decreased from 1979 to 2004, the actual proportion of women undergoing castration at hysterectomy increased. The largest increase was in women 50 years old. There was a decrease in the rate of prophylactic castrations performed between 1979 2002 and 20032004, consistent with the release of the WHI results. Disclosures: J.L. Lowder, None; L.J. Burrows, None; S. Oliphant, None; L. Meyn, None.
Presentation Number: Paper 11 Prophylactic Castration at the Time of Hysterectomy in the United States, 1979 2004 J. L. Lowder*, L. J. Burrows, S. Oliphant, and L. Meyn *Division of Urogynecology, Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, PA, The Center for Vulvovaginal Disorders, Washington, DC, Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, PA, Division of Infectious Diseases, Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, PA Objective: To describe the national rates and trends of prophylactic castration (bilateral oophorectomy or removal of remaining ovary) at the time of hysterectomy in women without ovarian or other gynecologic pathology. To determine if a change in trend for castration occurred after the release of the Womens Health Initiative (WHI) in 2002. Methods: Data from the National Hospital Discharge Survey (NHDS), a federal database that samples inpatient hospitals in the United States, were analyzed from 1979 to 2004 for diagnosis and procedure codes using the ICD-9-CM classification system. After excluding women with diagnoses of ovarian pathology (benign and malignant) and gynecologic diagnoses that usually warrant ovarian removal (e.g., endometriosis, upper genital tract cancer), two groups of women were created: (1) hysterectomy with bilateral oophorectomy or removal of remaining ovary (castration); and (2) hysterectomy with or without other procedures with at least one ovary remaining. Ageadjusted rates were calculated using 2000 census population data and compared for change over time with the score for linear trend. ANOVA with Dunnetts post-hoc analysis was used to evaluate change in trend between 1979 2002 and 20032004. Results: The estimated number of hysterectomies with castration performed from 1979 to 2004 was 3, 686, 785 and ranged per year from a low of 111, 504 in 1989 to a high of 177, 112 in 2002. The age-adjusted rate of hysterectomy with castration was comparatively stable during this period, from lows of 1 per 1,000 women in 1989, 2003, and 2004 to a high of 1.5 per 1,000 in 1980. In comparison, the number of hysterectomies without castration was 5, 461, 078 and ranged per year from a low of 153, 513 in 1997 to a high of 309, 327 in 1981. The rate of hysterectomy without castration decreased significantly, from 2.9 per 1,000 women in 1979 1981 to 1.1 per 1,000 women in 2001 and stabilized at 1.2 per 1,000 women through
Presentation Number: Paper 12 Cesarean Section Delays the Development of Pelvic Organ Prolapse When Compared to Spontaneous Vaginal Delivery in Lysyl Oxidase like-1 Knockout Mice A. M. Gustilo-Ashby*, U. Lee*, D. Vurbic, D. Sypert*, F. Daneshgari*, M. D. Barber*, and M. S. Damaser* *The Cleveland Clinic, Cleveland, OH, Louis Stokes Cleveland VA Medical Center, Cleveland, OH Objective: Female pelvic floor dysfunction (FPFD) is a complex group of conditions which include urinary incontinence, voiding dysfunction, pelvic organ prolapse (POP), and rectal prolapse. Pregnancy and childbirth are well documented risk factors for FPFD, yet it is unclear whether this is due to the effects of pregnancy, delivery or both. Mice lacking the protein Lysyl Oxidase Like-1 (LOXL1 KO) have abnormal elastic fiber homeostasis and frequently develop FPFD after vaginal delivery. This finding suggests that elastic fiber defects underlie the primary pathophysiology of FPFD. The objective of this study was to test the hypothesis that tissue trauma resulting from vaginal delivery leads to FPFD as a result of abnormal elastic fiber homeostasis in this mouse model. Methods: Age-matched primigravid female LOXL1 KO mice were allowed to have a spontaneous vaginal delivery (SVD) at term or were delivered by cesarean section (CS) at 18 20 days gestation. After delivery, mice were observed weekly for the development of POP using the Mouse Pelvic Organ Prolapse Quantification (MOPQ) system. KaplanMeier time to prolapse curves were created to describe the development of POP. At 12 weeks post-partum, lower urinary tract function was assessed by conscious cystometry (CMG) and leak point pressure (LPP) testing. Statistical analysis was performed using the two-way ANOVA test. Pairwise comparisons were performed with the Tukey-Kramer adjustment. Urethrovaginal cross-sections were stained for elastin and analyzed semiquantitatively using a histological grading scale to assess extent of elastin fiber disorganization and fragmentation. Results: Thirty-nine mice were delivered by SVD and 36 delivered by CS. Twelve weeks after SVD or CS, 23 (59%) and 11 (31%) mice had developed Grade 2 or 3 POP, respectively. The mean time to develop POP was 7.2 weeks after SVD and 10.5 weeks after CS (log rank, p 0.0008). The Cox proportional hazard ratio was 0.55 (95% CI: 0.38 0.79). Mice with POP had increased bladder contractility as evidenced by a significant increase in nonvoiding contractions during CMG (p 0.02). Neither POP nor route of delivery were associated with
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differences in voided volume, voiding pressure, voiding time or leak point pressure. POP, but not mode of delivery, was associated with a significant increase in disorganization and fragmentation of elastic fibers. Conclusions: Cesarean section delays, but does not prevent, the development of POP when compared to SVD in LOXL1 KO mice. POP is associated with increased bladder contraction frequency and increased elastic fiber fragmentation and disorganization in the urethra and vagina. SVD leads to an increased incidence of POP in the setting of abnormal elastic fiber homeostasis. The mechanisms underlying the role of elastin and mode of delivery in FPFD warrants further investigation. Disclosures: A.M. Gustilo-Ashby, None; U. Lee, None; D. Vurbic, None; D. Sypert, None; F. Daneshgari, None; M.D. Barber, None; M.S. Damaser, None.
acute phase lasting 4 5 years that slows subsequently. These studies in ovariectomized mice suggest that a similar phenomenon may occur in the vaginal wall after menopause with an acute phase of remodeling followed by reduced basal levels of vaginal extracellular matrix. Estrogen withdrawal, therefore, may lead to symptomatic pelvic organ prolapse in the perimenopausal years especially in women with borderline or compromised pelvic organ support. Disclosures: S.M. Roshanravan, None; P. Keller, None; J.F. Acevedo, None; R.A. Word, None.
Presentation Number: Paper 13 Remodeling of the Vaginal Muscularis During Estrogen Withdrawal S. M. Roshanravan, P. Keller, J. F. Acevedo, and R. A. Word UT Southwestern Medical Center, Dallas, TX Objective: Epidemiologic evidence indicates that menopause is an independent risk factor for pelvic organ prolapse. Symptomatic pelvic organ prolapse commonly develops in the perimenopause. The biologic mechanisms that lead to loss of pelvic organ support during this time are not well understood. The goal of this study, therefore, was to test the hypothesis that estrogen withdrawal disturbs homeostatic pathways that maintain extracellular matrix in the vaginal wall. Methods: Ovariectomized (OVX) mice were used as a model system to study the effects of estrogen withdrawal on elastic fiber homeostasis in the vaginal wall. Mice (C3B6 at 6 8 wks, n 70) in metestrous were ovariectomized, and sham procedures were conducted on a subset of mice (n 25). After removal of epithelium, vagina was collected at 9 time points (0, 6, 24, 48, 72 h, and 5, 7, 14, and 28 d). Real time PCR, quantitative zymography, and immunoblot analyses were conducted to assess levels of MMP2, MMP9, LOX and LOXL1. Results: Zymography revealed dramatic time-dependent changes in protease activation in the vaginal wall with a burst of pro- and active MMP9 after OVX. Increases in both forms of MMP9 began within 24 h, peaked at 48 72 h (4 6-fold, p 0.01), falling below baseline levels 28 d after OVX. Pro and active MMP2 remained constant gradually decreasing to below baseline from 14 28 d post OVX. Messenger RNA levels of both MMP2 and MMP9 progressively decreased 5-fold in the vaginal wall after OVX, suggesting that the post-OVX burst in protease activity was due to posttranscriptional mechanisms. Expression of LOX mRNA decreased dramatically as a function of time after OVX to levels 8- (LOX, p 0.01) and 5-fold (LOXL1, p 0.01) less than shams. These changes were fully reversed by estrogen replacement. Increased protease activity, together with decreased LOX and LOXL1, was accompanied by marked loss of vaginal weight (from 70.4 4.9 to 37.0 1.0 mg) and protein content (from 1852 149 to 613 116 g/vagina) at 48 h decreasing to 18.7 2.1 mg and 241 51 g/vagina 14 d after surgical-induced estrogen withdrawal. Immunoblot analysis of LOXL1 indicated that pro LOXL1 was maintained at steady state levels from 6 h to 5 d before a sharp decline at 714 d. Interestingly, disappearance of proLOXL1 was accompanied by increased expression of mature LOXL1 at 14 d. Conclusions: Estrogen withdrawal results in dramatic, rapid, and progressive disruption of the balance between matrix degradative and synthetic components in the vaginal wall. Numerous studies have shown that bone loss increases at the time of menopause with the
Presentation Number: Paper 14 Effect of Estrogen on Processing of Procollagen and Lysl Oxidases in the Vaginal Wall S. M. Roshanravan, P. Keller, P. G. Drewes, and R. A. Word UT Southwestern Medical Center, Dallas, TX Objective: Bone morphogenic protein-1 (BMP1) has been identified as procollagen C proteinase, a secreted metalloprotease needed for bone formation. BMP-1 and tolloid like-1 (TLL1) are crucial for processing fibrillar collagen precursors by cleaving the C-terminal propeptides of procollagen I, II, and III. BMP1 and TLL1 are also important in processing precursors of lysyl oxidases to mature enzymes that cross-link both collagen and tropoelastin in the extracellular matrix. The goal of this study was to determine the effect of ovariectomy and estrogen replacement on BMP1, TLL1, lysyl oxidases, and collagen and elastin metabolism in the vaginal wall. Methods: Mice (C3B6 at 6 8 wks, n 70) in metestrous were ovariectomized. Sham procedures were conducted on a subset of mice (n 25). After removal of epithelium by sharp dissection, vaginal muscularis was collected at 9 time points after ovariectomy (0, 6, 24, 48, 72 h, and 5, 7, 14, and 28 d). For some experiments, fullthickness tissues were used. For estrogen reversal experiments, ovariectomized mice (14 d) were treated with vehicle or estradiol (E2) for 14 d (n 510 for each group). Real time PCR was used to quantify relative mRNA levels of LOX, LOXL1, MMP-3, procollagen 1 , BMP-1, and TLL1. The housekeeping gene 2-microglobulin (B2M) was used as an endogenous control for RNA input. Immunoblotting was performed to compare protein levels and processing of LOX and LOXL1. Results: Ovariectomy, but not sham operation, resulted in significant time-dependent decreases in the procollagen peptidases BMP-1 and TLL1 (1.0 0.27 compared with 0.18 0.03 units/B2M at 14 d, BMP-1; 1.0 0.3 vs 0.35 0.08 TLL1, both p 0.05). Further, LOX and LOXL1 mRNA and protein were also decreased significantly after ovariectomy. Procollagen 1 mRNA was decreased in the postmenopausal vagina whereas the major mouse collagenase (MMP3) was increased after ovariectomy compared with sham-operated controls (0.65 0.28 compared with 0.18 0.03, p 0.05). All of these negative effects of ovariectomy on collagen and elastin metabolism were reversed fully by physiological estrogen replacement (15 g/kg/d). Moreover, estrogen therapy suppressed MMP3 activity 16-fold. Conclusions: Ovariectomy has negative consequences on collagen and elastin homeostatic pathways in the vaginal wall. Furthermore, estrogen therapy fully reverses these effects. Although long term effects of estrogen replacement on the vaginal matrix are not known, these experiments suggest that estrogen improves collagen and elastin synthesis by inhibiting the collagenase MMP3 and increasing procollagen peptidases, procollagen 1 , and lysyl oxidases in the fibromuscular layer of the vaginal wall. These results may thereby contribute to our understanding of the mechanisms by which menopause and antiestrogens adversely affect pelvic organ support.
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Disclosures: S.M. Roshanravan, None; P. Keller, None; P.G. Drewes, None; R.A. Word, None.
Presentation Number: Paper 15 Discontinuation Rates in Women Treated with Anticholingeric Medications M. Gopal, K. Haynes, S. Bellamy, and L. Arya University of Pennsylvania, Philadelphia, PA Objective: To determine the discontinuation rates of anticholingeric medications used for the treatment of lower urinary tract symptoms. Methods: The Health Improvement network (THIN), an electronic medical record database containing 4.77 million patient records from the United Kingdom was analyzed. Women 18 years old who were prescribed anticholingeric medications between January 1991 and December 2005 were included in the study. An episode of drug therapy represented the time from initial prescription to drug discontinuation. Medication discontinuation was defined as when no anticholingeric prescriptions were issued within 90 days following the end of the last anticholingeric drug prescription. An overall discontinuation rate for all anticholingeric medications was determined. A class specific discontinuation rate was also determined for nine different types (classes) of anticholingeric medications. For the class specific analysis, the cumulative incidence of discontinuation was adjusted for age, number of prior episodes, number of anticholingeric drug classes used, switch status (drug therapy switched to another medication) and year of initiation. Kaplan-Meier method was used to determine an overall discontinuation rate. A Cox multivariable regression was performed for the class-specific analysis. Results: There were 49,419 episodes (contributing a total of 530, 498 person-time months) of anticholingeric therapy available for analysis from 29, 369 women. The mean age of women prescribed anticholingeric medication was 63.9 16. The average number of treatment episodes and number of drug classes prescribed per patient was 1.6 1.3 and 1.5 0.57 respectively. The median time for overall anticholingeric drug discontinuation was 4.8 months. The percentage of episodes where women switched to another medication was 16%. The overall cumulative incidence of discontinuation increased with duration of prescription use. The discontinuation rate was 41.6% (95%CI: 41.2, 42.1) at 4 months, 58.8% (95%CI: 58.4, 59.3) at 6 months, 77.2% (95%CI: 76.8, 77.6) at 12 months and 87.5% (95%CI: 87.3, 87.9) at 24 months. The median time for drug discontinuation was highest for Tolterodine Tartrate and Tropsium (5.5 months each). The drugs with the shortest median time to discontinuation were Teroldine and Flavoxate (4 months each). At 6 months, the adjusted cumulative incidence of discontinuation were as follows: extended release Oxybutynin 57% (95%CI: 55.1, 59.4), extended release Tolterodine Tartrate 54% (95%CI: 52.3, 57.7), Oxybutynin 71% (95%CI: 68.4,73.5) and Tolterodine Tartrate 61% (95%CI: 59.4, 64.3). By 24 months, the adjusted cumulative incidence of discontinuation was 90% for all nine drug classes. Conclusion: Discontinuation rates for anticholingeric medications are high. Disclosures: M. Gopal, None; K. Haynes, None; S. Bellamy, None; L. Arya, None.
W. Kusek, and L. L. Subak *The Miriam Hospital, Providence, RI, University of Arkansas Medical School, Little Rock, AR, University of California, San Francisco, San Francisco, CA, Brown University, Providence, RI, University of Alabama at Birmingham, Birmingham, AL, NIDDK, Bethesda, MD Objective: To determine the effect of weight loss on urinary incontinence (UI) among obese and overweight women at 18 months. Methods: The Program to Reduce Incontinence by Diet and Exercise (PRIDE) is a multi-center, randomized clinical trial in 338 overweight and obese women experiencing 10 UI episodes per week at screening on a 7-day voiding diary. Women were randomized to either an intensive 6-month weight loss program including diet, exercise, and behavior modification followed by a 12-month weight maintenance program (intervention; N 226) or to a structured education program (control; N 112). Number and type of incontinent episodes was determined by voiding diary. The primary analysis used GEE negative binomial models for repeated measurements to estimate the effect of weight change on change of weekly frequency of incontinent episodes. Results: Mean ( SD) age (53 11 years), weight (97 17 kg), BMI (36 6 kg/m2) and weekly number of UI episodes (24 18) were similar for both groups at baseline. Overall, 86% of the women completed the 18-month trial. The mean weight loss at 18 months in the intervention and control groups was 6.5 kg and 1.7 kg, respectively (p 0.001). Despite large differences in weight loss and improvement in UI within each group (p 0.01 vs. baseline for all), there were no significant differences between the intervention and control groups in decreased total (61% vs. 55%), stress (70% vs. 64%) or urge (55% vs. 50%) incontinent episode frequency at 18 months. However, when the treatment groups were combined, there was a strong dose-response relationship between magnitude of weight loss and UI improvement. Comparisons of women who gained weight from baseline to 18 months, lost 0 to 5%, 5 to 10% or 10% of initial body weight, showed a significant association between weight loss category and decreased total, stress and urge incontinent episodes (all p 0.002). This effect was independent of treatment group or initial BMI. Compared to women who gained weight (reference group), the odds of having at least 70% improvement in overall total UI episode frequency was 1.8 (95% CI 1.1, 3.1) in women who lost 0 5%, 2.0 (95% CI 1.0, 4.0) in women who lost 510% and 2.6 (95% CI 1.5, 4.6) in women who lost 10% (p .05). Conclusions: There is a strong and continuous dose-response relationship between weight loss and decreased frequency of UI among overweight and obese women. Even modest weight loss appears to have significant benefits for UI through 18 months of follow-up. Thus, weight loss should thus be considered as a first-line treatment for overweight/obese women with UI. Disclosures: R.R. Wing, None; D. Smith West, None; D. Grady, None; J.M. Creasman, None; D. Myers, None; K.L. Burgio, Pfizer, Inc., Grant/Research Support; Astellas: ; Ortho McNeil; GlaxoSmithKline, Consultant; F. Franklin, None; A.A. Gorin, None; E. Vittinghoff, None; J. Macer, None; J.W. Kusek, None; L.L. Subak, Pfizer, Inc., Grant/Research Support.
Presentation Number: Paper 16 Weight Loss Improves Urinary Incontinence in Overweight & Obese Women Through 18 Months R. R. Wing*, D. Smith West, D. Grady, J. M. Creasman, D. Myers, K. L. Burgio, F. Franklin, A. A. Gorin*, E. Vittinghoff, J. Macer, J.
Presentation Number: Paper 17 A Randomized Controlled Trial Comparing Traditional Pelvic Muscle Rehabilitation to a Pilates Exercise Program for Strengthening Pelvic Floor Muscles P. Culligan*, J. Scherer*, K. Dyer*, J. Priestley, G. Guingon-White, D. DelVecchio, and M. Vangeli *Atlantic Health Division of Urogynecology, Morristown, NJ, Kennesaw State University Dept of
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Math and Statistics, Kennesaw, GA, Atlantic Rehab Institute, Morristown, NJ, Bodies in Balance, Madison, NJ Objective: To compare pelvic floor muscle strength between groups of women participating for 12 weeks in either in a structured Pilates exercise program or a pelvic muscle rehabilitation (PMR) program. Methods: Adult women with POP-Q stage 1 were eligible for enrollment. A blocked random assignment technique was used to determine the allocation sequence, and opaque sealed envelopes were used to conceal the group assignments. After randomization, baseline pelvic floor muscle strength (our main endpoint) was measured via a computerized vaginal pressure sensor (PathwayTM CTS 2000, The Prometheus Group, Dover NH). Muscle strength measurements were repeated after participants had completed a total of 24 one-hour sessions (i.e. twice weekly for 12 weeks) in either the Pilates or PMR program. Both exercise programs were standardized, and all sessions were conducted in a one-on-one fashion by either a certified pelvic floor Physical Therapist or a certified Pilates instructor. The Pilates instructors led participants in a full body program emphasizing core muscles including the pelvic floor muscles. These instructors used only verbal cues while the Physical Therapists used computerized biofeedback and invasive vaginal manipulation techniques to focus training solely on the pelvic floor. PFDI and PFIQ scores were secondary endpoints. Baseline group characteristics and outcome measures were compared using 2, Mann-Whitney U tests or t-tests as appropriate. A prospective sample size calculation called for 24 patients in each group to have 80% power for detecting a 25% difference in muscle strength between groups. Results: 62 women were enrolled (30 and 32 in Pilates and PMR groups respectively). There was a differential dropout rate between groups-leaving 28 and 24 participants in the Pilates and PMR groups respectively. There were no differences between either the original randomized groups or the subsets of those groups who actually completed the study in terms of age, BMI, parity, pre-treatment muscle strength, PFDI scores or PFIQ scores. Mean pre-treatment muscle strength for the Pilates and PMR groups were 14.9 12.5 cmH2O and 12.5 10.4 cmH2O respectively (p 0.43). Both groups demonstrated improved strength at the end of the study. Mean improvement in the Pilates group was 6.6 7.5 cmH2O (p 0.0001); and in the PMR group was 6.1 7.5 cmH2O (p .001). However, comparison of these improvements between groups failed to demonstrate significance (p 0.8). Improvements in PFIQ scores approached significance in both groups (p-values 0.053 and 0.082). These differences were not significant between groups (p 0.86). The PFDI scores, however, did improve significantly in both groups (p-values 0.001 and 0.0001). These PFDI improvements were not significant between groups (p 0.93). Conclusions: There was no difference in pelvic muscle strength improvement or PFDI score improvement between women who completed a full body Pilates exercise program and women who underwent a focused, invasive PMR program. Disclosures: P. Culligan, CR BARD; Solace; Novasys, Grant/Research Support; CR BARD; Ethicon Womens Health & Urology; Intuitive Surgical, Consultant; Enturia, Speakers Bureau; CR BARD; Intuitive Surgical, Paid Instructor; J. Scherer, None; K. Dyer, None; J. Priestley, None; G. Guingon-White, None; D. DelVecchio, None; M. Vangeli, None.
Objective: The objective of this study was to assess the prevalence of nocturia and degree of bother from night-time urinary frequency in a community-based population of women, and to propose evidence based definitions of normal and abnormal night-time urinary frequency. Methods: The voiding habits of 4,061 women from a communitybased sample recruited for an epidemiologic study were analyzed. The validated questionnaire to identify pelvic floor disorders included questions related to nocturia and night-time frequency. Nocturia was assessed with the question: Do you awaken during your normal sleeping hours to urinate? Night-time urinary frequency was assessed with the question: How many times on average do you need to empty your bladder during sleeping hours? Degree of bother related to each category of night-time voiding frequency was assessed using a 100 mm visual analog scale (VAS). We defined frequent night-time voiding as 2 voids per night. Degree of bother was compared using ANOVA and Students t-tests. Associations with a two-sided p-value of 0.05 were considered significant. Results: The mean age of the subjects in the study was 56.5 15.8 years, 72% reported nocturia and 33% had 2 or more episodes per night ( frequent night-time voiding). Degree of bother increased with each interval increase in night-time frequency (Figure, p 0.001). Mean VAS was 27.3 26.3 for 1 time vs. 57.3 28.5 for 2 times per night, p 0.001. Conclusions: In this cohort of women from a community-dwelling sample, nearly three quarters reported nocturia, suggesting that it is very common and not pathologic. One third of women reported night-time voiding frequency of 2 or more times and these women were more than twice as bothered by their frequency than those with only one episode per night. Based on these findings, for epidemiologic research, increased night-time frequency should be defined as 2 or more voids per night.
Presentation Number: Paper 18 Epidemiology of Nocturia and Night-Time Urinary Frequency in Women: What is Normal? E. S. Lukacz,* E. L. Whitcomb,* J. M. Lawrence, C. W. Nager,* and K. M. Luber *UCSD, La Jolla, CA, Kaiser Permanente Southern California, Pasadena, CA, Kaiser Permanente San Diego, San Diego, CA
Disclosures: E.S. Lukacz, Pfizer Inc, Consultant; Medtronic Corp., Consultant; Novartis Pharmaceuticals, Speakers Bureau; Proctor & Gamble Pharmaceuticals, Speakers Bureau; Intuitive Corp., Speakers Bureau; E.L. Whitcomb, None; J.M. Lawrence, None; C.W. Nager, None; K.M. Luber, Pfizer Inc., Consultant; Watson Pharmaceuticals, Consultant; Astellas, Consultant; Pfizer, Inc, Speakers Bureau; Watson Pharmaceuticals, Speakers Bureau; Astellas, Speakers Bureau.
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Presentation Number: Paper 19 Incidence and Remission of Urinary Incontinence in a Community Based Population of Women 50 Years and Older Y. M. Komesu, R. G. Rogers, R. M. Schrader, and C. Lewis Univ of New Mexico Health Sciences Center, Albuquerque, NM Objectives: To determine incidence and remission rates of urinary incontinence (UI) and predictors of severe UI, in women 50 years enrolled in a community based population. Methods: We analyzed data collected between 19932006 in the Health and Retirement Study (HRS), a NIH funded publicly available database. Respondents are retirees and their spouses who were queried regarding sociologic, economic and health issues every two years. UI questions were asked in 1993, 1995, 1996 and every 2 years thereafter. For incidence we evaluated women who initially reported no UI and for remission we evaluated women who initially did report UI. All women had at least 4 years of follow-up and were 50 years at enrollment. We tracked risk factors previously associated with severe UI; age, Basal Metabolic Index (BMI), parity, ethnicity, medical co-morbidities (hypertension, diabetes, lung disease, heart disease, cancer, stroke, arthritis), current history of smoking, and history of psychiatric illness (including depression). UI was defined as any urinary leakage in the last year, and severe UI was defined as urinary leakage 15 days in the last month. Identified variables were used in a repeated measures logistic regression model to determine which were most closely associated with severe UI using GEE analysis (PROCGENMOD, SAS version 9.1). Results: 14,246 women reported UI status and met our study criteria. Of these, 5293 (37.2%) were in their 5th decade at initial evaluation, 3376 (23.7%) in their 6th, 3920 (27.5%) in their 7th, 1441 (10.12%) in their 8th and 216 (1.52%) were in their 9th decade of life. The 4 year incident rate of UI increased from 13.8% for women in their 5thdecade to 41.2% in their 9th decade of life. Severe UI incidence was lower, but also increased with each decade; from 4.5% in the 5th to 29.4% in the 9th decade of life. Factors most closely associated with incident severe UI were age (9th compared to 5th decades OR 14.8, 95% CI 8.8 24.9), ethnicity (Blacks compared to Whites OR 0.6, CI 0.6 0.7), history of psychiatric illness (OR 1.4, CI 1.31.6), increased BMI (BMI 35 OR 2.3, CI 1.73.1), and increasing number of medical co-morbidities (3 co-morbidities OR 2.2, CI 1.6 3.1). In contrast to incidence, UI remission rates fell with increasing age, decreasing from 37.6% in the 5th to 24.3% in the 9th decade. Remission rates for severe UI were also age dependent, 54.6% for patients in the 5th and declining to 36.9% in the 9th decade. Conclusions: In this community based population of women, UI and severe UI incidence rates increased with age. Predictors of severe UI include age, high BMI, ethnicity, history of psychiatric illness, and presence of medical co-morbidities, but did not include parity. Remission rates of both UI and severe UI are high, particularly in younger patients. Disclosures: Y.M. Komesu, None; R.G. Rogers, None; R.M. Schrader, None; C. Lewis, None.
Methods: This is a nested case control study within a statewide post partum fecal incontinence symptom survey. From a total of 5,491 subjects who participated and agreed to further participation, seventy six participants who lived within 30 miles of the exam site were selected for a longitudinal clinical examination study. Cases were defined as a positive response to one of 3 questions regarding fecal incontinence following delivery. All subjects underwent a comprehensive pelvic examination including POPQ, pelvic muscle strength testing using the Brink scale, rectal examination, and endoanal ultrasound in both 2-D and 3-D modalities by a blinded examiner trained in these examinations. Results: In total, 48 cases and 28 asymptomatic controls participated. Subjects were seen between six and nine months postpartum (mean 7.8 months 0.7). Of the 48 cases, 31 (65%) had FI to flatus only. Cases were older (31.5 vs. 28.4 years, p 0.02) and had higher Body Mass Index (26.2 vs. 23.6, p 0.01). Seven cases had 4th degree lacerations compared with no controls. Otherwise, baseline characteristics did not differ between groups for infant weight, duration of 2nd stage, assisted delivery, episiotomy, cesarean delivery, or smoking. The total Brink score was 9.1 (SD 2.6) in cases and 9.6 (SD 2.2) in controls (p 0.41). Though not statistically significant, cases comprised the majority of the none/weak Brink scores for pelvic floor muscle duration (71%), pressure (69%), and displacement (71%). An absent bulbocavernosous reflex was seen in 6 cases and was present in all 28 controls. A total of ten women had sphincter disruptions seen on 2D ultrasound, nine of them in the case group (19.2% vs. 3.6%, p 0.08). Paradoxically, 3-D ultrasound revealed increased external anal sphincter volume in cases (8.2 cc 4.3) compared with controls (6.3 cc 2.6, p 0.04). Conclusions: Results from this small case-control study suggest that childbirth may disrupt multiple functional areas of the pelvic floor and potentially contribute to postpartum fecal incontinence. These results suggest a potential opportunity for multiple modalities of early intervention and further evaluation to decrease the long-term impact of the physical and neurological insult. Disclosures: M.A. Denman, Spouse is a paid Instructor for Depuy Spine., Other (please specify type of relationship and company name); T. Gregory, Intuitive Surgical, Consultant; P. Osterweil, None; H. Li, None; J. Guise, None.
Presentation Number: Paper 20 Post Partum Fecal Incontinence: Exam & Ultrasound Characteristics M. A. Denman, T. Gregory, P. Osterweil, H. Li, and J. Guise Oregon Health Sciences University, Portland, OR Objective: To compare physical exam and ultrasound findings of recent post partum primiparous women complaining of fecal incontinence (FI) with a similar cohort of primiparous women without complaints of FI.
Presentation Number: Paper 21 Bowel Symptoms in a Longitudinal Cohort of Women During Pregnancy and Postpartum C. A. Brincat, C. Lewicky-Gaupp, D. Patel, C. Sampselle, J. Miller, and D. E. Fenner University of Michigan, Ann Arbor, MI Objective: The aim of this secondary analysis is to assess the prevalence of fecal incontinence (FI) at various time points during pregnancy and at one year post partum, and to determine associations with demographic and birth variables. Methods: We conducted a secondary analysis of a randomized controlled trial of 240 primiparous women during pregnancy and one year post-partum. The primary aim of the parent study was to determine the effect of pelvic floor exercises in conjunction with spontaneous pushing with or without perineal massage (intervention group) or directed pushing with or without perineal massage (control group) on pelvic floor function at several time points. Inclusion criteria were the following: 18 years of age or older, negative history of genitourinary pathology, plans to remain in the region for at least one year after the birth of the infant and ability to read and understand English. Women were queried at the following time points: 20 and 35 weeks gestation and 6 weeks, 6 months and 1 year postpartum. At each
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of these time points, women were asked if they had lost control over stool or bowel movements, and if they were practicing Kegel exercises. Associations of bowel symptoms with demographic and birth data were determined using Fishers exact tests for categorical variables and Students t-tests for continuous variables. Results: Most participants were Caucasian (87%), with a median age of 30 years (range 18 42). Of the initial 240 women, at one year postpartum, 151 were available for follow-up. 5.3% (8/151) answered affirmatively to the question, Have you lost control over your stools or bowel movements, that is, have you had any bowel accidents? However, at 20 weeks of pregnancy, there was a self-reported fecal incontinence rate of 1.3% (3/240). FI was most common at 6 weeks post-partum (6.4%11/173). At one year, there was no difference in the number of patients who reported fecal incontinence in the control group 5.3% (4/76) and the intervention group 5.3% (4/75). Additionally, there were no statistically significant differences in patient demographics (age, bodymass index) and infant data (weight, head circumference) between those who reported FI at one year post-partum and those who did not. Also, there was no significant association between practicing Kegel exercises or delivery data (mode of delivery, episiotomy or laceration, and the presence or absence of FI at one year post-partum. Conclusions: Women should be reassured that the prevalence of bowel accidents is low after delivery whether or not pelvic floor exercises are performed. We found no predictors for fecal incontinence in this low-risk cohort of primiparous women. Disclosures: C.A. Brincat, None; C. Lewicky-Gaupp, None; D. Patel, None; C. Sampselle, None; J. Miller, None; D.E. Fenner, None.
Presentation Number: Paper 22 Prevalence of Fecal Incontinence in Overweight and Obese Women with Urinary Incontinence and Effect of Dietary Fiber Intake A. D. Markland,* H. E. Richter,* K. L. Burgio,* C. Bragg,* A. Hernandez, and L. L. Subak *University of Alabama at Birmingham, Birmingham, AL, University of California, San Francisco, San Francisco, CA Background: Obesity is a risk factor for both urinary incontinence (UI) and fecal incontinence (FI). Stool consistency may play an important role in the development of FI. Increasing dietary fiber intake is often used to improve stool consistency. Objectives: To evaluate the prevalence of monthly FI in obese and overweight women with UI and to compare dietary fiber intake levels in subjects with and without FI. Methods: Baseline data from 336 overweight and obese women with 10 UI episodes per week who were enrolled in the Program to Reduce Incontinence by Diet and Exercise (PRIDE) study were analyzed. PRIDE is a multi-center, randomized, clinical trial that evaluated the effect of weight reduction on UI. FI was defined as the loss of mucous, liquid, or solid stool at least monthly as reported on the Fecal Incontinence Severity Index (FISI). The Block Food Frequency Questionnaire (FFQ) was used to quantify total energy (kcal), fat, cholesterol, protein,
carbohydrate and dietary fiber intake. Low fiber intake was defined as 10 gm fiber/day. Potential confounding variables were assessed by self-report questionnaires and examination, including sociodemographic factors, medical history, body mass index (BMI), UI severity (Sandvik Severity Scale), lower urinary tract symptoms (American Urologic Association Symptom Index (AUASI) score), depression (Beck Depression Inventory (BDI) score), and quality of life (MOS SF-36). Multivariable logistic regression analysis was used to identify independent risk factors for FI. Results: Complete data on the FFQ and the FISI were obtained in 336 (99%) women. They had a mean ( SD) age of 53 10 years, BMI 36 6, and 19% were African American. Overall prevalence of FI was 16%. Compared to women without FI (n 281), women with FI (n 55) had a significantly higher prevalence of severe UI (p .013) and flatal incontinence (p .001), higher mean AUASI (p .001), and BDI scores (p .009), and lower mean SF-36 mental component score (p .001). More women with FI had low fiber intake than women without FI (29% vs. 15%, p 0.01) yet no differences were seen in other dietary intake variables. In multivariable analyses, the prevalence of FI increased significantly with low fiber intake (OR 2.5, 95% CI 1.3, 5.1), higher BDI scores (OR 2.1 per 10 point increase in score, 95% CI 1.3, 3.4), and increased AUASI scores (OR 1.9 per 10 point increase in score, 95% CI 1.1, 3.3). Conclusions: Overweight and obese women report a high prevalence of FI at least monthly (16%) compared to population-based rates of FI in women (5 6%). An increase in fiber intake may improve FI in overweight and obese women with urinary incontinence. Disclosures: A.D. Markland, None; H.E. Richter, None; K.L. Burgio, Pfizer, Astellas, Consultant; C. Bragg, None; A. Hernandez, None; L.L. Subak, Pfizer, Grant/Research Support.
Presentation Number: Paper 23 Constrictor and Elevator Functions of the Pelvic Floor are Distinct: Evidence from Studies in Patients with Fecal Incontinence V. Raizada, M. M. Weinstein, V. Bhargava, D. H. Pretorius, J. Wan, and R. K. Mittal Pelvic Floor Function & Disease Group, San Diego, CA Objective: Pelvic floor muscles provide elevator function (support to pelvic organs) and constrictor function (continence to anal canal/ urethra) to the pelvic viscera. We hypothesize that fecal incontinence patients (FI) have normal elevator but impaired constrictor function. Methods: Ultrasound (US) measurements were validated using MRI in 5 subjects. Vertical and horizontal movements of the Anorectal angle (ARA) were used as surrogate for elevator and constrictor function respectively. Patients with fecal incontinence (FI) and age as well as parity matched asymptomatic controls (C) were studied. Images were acquired at rest (R) and sustained squeeze (S) using Philips 3D US system. For constrictor function, the horizontal distances between a fiducial point on pubic symphysis and ARA, and for elevator function the vertical distances between the perineal skin and the ARA were measured.
TABLE. Table Shows the Horizontal and Vertical Measurements Obtained from US Images Horizontal (mm) Rest C FI 51.0 54.5 9.2 12.6 Squeeze 39.8 47.1 8.8* 12.0
0.01; n
Delta 11.1 7.4 5.0* 5.1
Vertical (mm) Rest 26.7 25.7 7.3 8.9
Squeeze 32.4 30.2 6.8 9.1
Delta 5.7 4.5 2.8 3.2
* unpaired t-test with unequal variances vs FI: p
26 in each group.
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Results: Vertical distances at R, S, and their difference ( ) were similar in the C and FI groups. Horizontal distance at R was also similar in C and FI groups. During S horizontal distance was smaller in FI than C. for horizontal distance in C was larger than FI. This indicates a stronger constrictor function in asymptomatic C compared to FI patients. Conclusions: Our data support the hypothesis that constrictor but not the elevator function of the pelvic floor muscles is compromised in fecal incontinence patients. We propose that elevator and constrictor functions are due to different components of the pelvic floor muscle.
maximum squeeze pressures and were hypersensitive to rectal distention with decreased tolerable rectal volumes and urges to defecate at lower volumes (Table). FISI scores were higher in OI group compared to both OC and YC group; no difference was found between OC and YC groups (total patient scores: OI 34.8 4.7, OC 8.2 2.2, YC 8.11 3.7, p 0.001). Similarly, FIQOL scores in all scales were significantly lower in the OI group compared to the OC and YC groups, but no difference was found between OC and YC groups (data not shown). Conclusion: Structural changes (increased thickness) of the IAS smooth muscle occur with aging, regardless of continence status. Fibrosis of the smooth muscle may explain the increased thickness and decreased resting pressures. Thinning of the striated EAS and a corresponding drop in squeeze pressure correlated with FI, but not with aging. Rectal hypersensitivity appears associated with FI symptoms rather than aging and may play a role in the mechanism of fecal incontinence. Disclosures: C. Lewicky-Gaupp, None; Q. Hamilton, None; M. Huebner, None; J. Ashton-Miller, Johnson & Johnson, Consultant; J.O. DeLancey, Johnson & Johnson, Consultant; D.E. Fenner, None.
Disclosures: V. Raizada, None; M.M. Weinstein, None; V. Bhargava, None; D.H. Pretorius, None; J. Wan, None; R.K. Mittal, None.
Presentation Number: Paper 24 Anal Sphincter Structure and Function Relationships in Aging and Fecal Incontinence C. Lewicky-Gaupp*, Q. Hamilton*, M. Huebner, J. Ashton-Miller*, J. O. DeLancey*, and D. E. Fenner* *University of Michigan Hospital, Ann Arbor, MI, University of Tuebingen, Tuebingen, Germany Objective: To determine the extent to which age and incontinence status affect the structure and function of the external (EAS) and internal (IAS) anal sphincters. Methods: Young women (YC) aged 20 41 years and older women (OC) aged 60 88 years without fecal incontinence (FI) were compared to older women aged 63 85 years with fecal incontinence (OI). Continence was defined as a Wexner score of 4, and women were considered incontinent if they had a score 8. Women were excluded if they had: prior sphincter or posterior vaginal wall surgery, IBS, pelvic radiation, pregnancy within the past year, or neuromuscular disease. Patients completed the Fecal Incontinence Quality of Life scale (FIQOL) and the Fecal Incontinence Severity Index (FISI) and had anorectal manometry (ARM) as well as transanal ultrasound. Results: 9 YC, 9 OC, and 8 OI women were studied. Median vaginal parity was significantly higher in the older women compared to the young (OC 2, OI 3 v. YC 0, p 0.001). The number of bowel movements per week was similar among the groups (range 710/week). The IAS was thicker in older women compared to younger but similar in the two older groups. Resting pressure was lower in women with FI. The EAS was thinner in the OI group. These women (OI) also had decreased
Presentation Number: Paper 25 Urinary Peptides Differentiate Interstitial Cystitis Subjects from Asymptomatic Controls M. P. Canter*, C. A. Graham, M. H. Heit, L. S. Blackwell, D. W. Wilkey, J. B. Klein, and M. Merchant *Urogynecology and Pelvic Surgery Center, Arlington, VA, Urogynecology Specialists of Kentuckiana, Louisville, KY, Clinical Proteomics Center, University of Louisville, Louisville, KY Objective: To identify differences in urinary peptides between interstitial cystitis (IC) subjects and asymptomatic controls (AC). Methods: Eighteen women with IC (mean voiding frequency 10 times/day, mean nocturnal voids 1, and bladder pain for six months) were recruited with age, race, and sex matched AC. Subjects volunteered a first morning void urine specimen and completed the Urge Urogenital Distress Inventory, the Urge Incontinence Impact Questionnaire, the IC Symptom and Problem Questionnaire, the Pelvic Pain and Urinary/Frequency Patient Symptom Scale and Short Form 36. Urine specimens were dialyzed and separated into low and high molecular weight protein fractions using a 10,000 Dalton molecular weight cut-off membrane. The low molecular weight protein fraction was
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used in this study. These peptides were concentrated and desalted using solid phase extraction methods and then separated using High Profile Liquid Chromatography and robotically spotted onto MS target plates; an approach useful for low abundant peptides. Positive ion MALDI-TOF MS mass spectra were data acquired with a mass to charge ratio (m/z) of 700 to 4000 m/z and evaluated using, Principal Component Analysis, PCA. Urine peptide samples that sorted into two groups by PCA were compared by statistical ttest techniques to discern peptides that were present at levels statistically different between the two groups. Peptides with a t-test probability 95% were considered candidates. Candidates underwent peptide fragmentation with MALDI-TOF-TOF MS. The resulting peptide fragments were compared to potential parent protein amino acid sequences in the Swiss-Prot database. Peptides with a total ion score 20 were considered homologous. Peptide concentrations were correlated to IC severity using disease specific and general health questionnaires. Results: Five urinary peptides were significantly greater in IC subjects; their presence positively correlated with IC severity. Two of the five peptides were identified as unique fragments of alpha-2 (IX) collagen and histone deacetylase 9. Nine peptides were significantly greater in the AC; their presence negatively correlated with IC severity. Six of the nine peptides were identified as unique fragments from alpha-2 (IX) collagen, histone deacetylase 7, MAPK/ERK kinase 3, CUB and Sushi multiple domains 3 isoform 1, a E3 ubiquitin ligase and type-II adenylate cyclase. Conclusion: Fourteen urinary peptides differentiate IC subjects from AC. The peptides found in a greater concentration in IC subjects positively correlated with worsening IC severity which may indicate break down of protective proteins or up-regulation of inflammationmediated proteins. The dysregulated presentation of alpha-2 (IX) collagen peptides may reflect altered activity of matrix metalloproteases. The urinary peptides found in a greater concentration in AC negatively correlated with worsening IC severity which may indicate a loss of protective proteins in IC subjects. Disclosures: M.P. Canter, None; C.A. Graham, None; M.H. Heit, None; L.S. Blackwell, None; D.W. Wilkey, None; J.B. Klein, None; M. Merchant, None.
Active electrode site 1 cm) were applied over the sacral (S1) region. An amplitude-modulated waveform was applied and voiding contractions were counted again, every 30 minutes. Results: 5/8 test animals (63%) responded to the treatment (Defined as reduction in contractions in test animals Mean reduction in contractions in control animals Standard Error). Analysis of the data demonstrated a statistically significant decrease in the number of contractions after the application of stimulation (P 0.05) (Figure 1(b)). Conclusion: The novel amplitude-modulated waveform, applied transcutaneously, was able to reduce the frequency of voiding contractions in a hyper-reflexive bladder model. The results indicate the potential utility of this transcutaneous neuromodulation device in the clinical treatment of urge incontinence.
Presentation Number: Paper 26 Reduction in Voiding Frequency in a Constant Infusion Rodent Model Using a Novel Amplitude-Modulated Waveform Through Transcutaneous Sacral Neuromodulation A. K. Monga*, S. Wahlgren, A. R. DiUbaldi, M. R. Tracey, M. Hoffman, B. Patel, D. Stoloff, L. Hodgson, and R. Toddywala *BUPA Hospital Southampton, Southampton, United Kingdom, Ethicon, Inc., Somerville, NJ, Nostrum Pharmaceuticals, Inc., Edison, NJ Background: Sacral neuromodulation is an effective but invasive option to treat detrusor overactivity. The Selective Nerve Stimulation (SNS, known as Project SyNapSe) device provides non-invasive, transcutaneous neurostimulation through a controlled, amplitudemodulated waveform. This carrier waveform is designed to be of sufficient frequency to overcome tissue impedance. The pulse envelope contains specific pulse width, amplitude, and shape information designed to stimulate specific nerves. Objective: This work aims at demonstrating the feasibility of a transcutaneous neuromodulation approach to treat bladder overactivity. Methods: A neurogenic bladder overactivity model was developed in rodents through constant infusion of a noxious agent (0.25% acetic acid at 2 mL/h) into the bladder (n 8). The experimental design is schematically represented in Figure 1(a). Baseline hyperactivity was established by counting the number of voiding contractions every 30 minutes. Commercial Ag/AgCl electrodes (Noraxon Dual Electrode,
Disclosures: A.K. Monga, Ethicon, Inc., Consultant; S. Wahlgren, Employee; Ethicon, Inc., A.R. DiUbaldi, Employee; Ethicon, Inc.; M.R. Tracey, Employee; Ethicon, Inc., Other; M. Hoffman, Employee; Ethicon, Inc., Other; B. Patel, Employee; Ethicon, Inc., Other; D. Stoloff, Employee; Ethicon, Inc., Other; L. Hodgson, Employee; Ethicon, Inc., Other; R. Toddywala, Employee; Nostrum Pharamceuticals, Inc., Other.
Presentation Number: Paper 27 Pregnancy and Delivery Induced Changes in Rat Vagina Persist Postpartum M. Alperin*, A. Feola, R. Duerr*, S. Abramowitch, and P. Moalli* *Magee-Womens Research Institute, University of Pittsburgh, Pittsburgh, PA, Musculoskeletal Research Center, University of Pittsburgh, Pittsburgh, PA
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Objective: Vaginal birth is considered to be the greatest risk factor for pelvic organ prolapse. However, the exact impact of pregnancy and delivery on the vagina and supportive tissues has not been well defined. We sought to determine the impact of vaginal delivery on the biomechanical behavior of the vagina using an in vivo testing protocol. Methods: 25 Long-Evans virgin, pregnant and 4 week postpartum rats were utilized to measure vaginal distensibility (VD) in vivo. Under sedation, a custom-made balloon contiguous with a pressure transducer was inserted into the vagina. The balloon was distended with water in 0.2 cc increments via an infusion pump. Pressurevolume curves were generated and the slopes were used to characterize VD (higher slope less distensible). Measurements of the genital hiatus (GH) and total vaginal length (TVL) were recorded before the experiment. Results are represented as mean SD. Statistical analyses were performed using one-way ANOVA with posthoc testing at a significance of 0.05. Results: Based on TVL and the volumes required to achieve 10 mmHg, initial vaginal diameters were not significantly different between the 3 groups with the mean of 0.78 0.05 cm in virgin, 1.01 0.16 cm in pregnant, and 1.00 0.11 cm in postpartum rats (p 0.08). TVL did not differ in virgin and postpartum animals (p 0.14). Virgins generated a mean pressure of 106 mmHg at 1 cc, while pregnant and postpartum rats demonstrated much lower pressure at the same volume (p 0.001 please, click Figure). To achieve pressures similar to the virgins, postpartum rats required instillation of 2cc. VD, derived from the slope of the pressure-volume curves, was increased in pregnant vs. virgin rats as demonstrated by the lower slope 11.4 7.12 mmHg/mL vs. 195.36 50.22 mmHg/mL (p 0.001) . Postpartum rats did not recover to the virgin state and demonstrated significantly higher distensibility with a much lower slope of 95.5 36.51 mmHg/mL when compared to the slope of virgin rats (p 0.01). Conclusions: This testing protocol affords measurement of VD in vivo using clinically relevant loading conditions. The continual increase in VD in the late postpartum period defines a persistent change in biomechanical behavior of the vagina related to spontaneous vaginal delivery.
vaginal wall involves crosslinking of elastin monomers in the extracellular matrix predominantly by lysyl oxidase (LOX) and LOXL1. Elastic fibers are degraded by matrix metalloproteases and cysteine proteases. The goal of this investigation was to determine the incidence of pelvic organ prolapse, rectal prolapse, and hernia formation in LOXL1-deficient mice as a function of age. Further, we sought to test the hypothesis that MMP2 and MMP9 is increased in pelvic or abdominal fascia from old wild type (WT) or LOXL1-/- mice with prolapse or hernia formation compared with young WT or agematched knockout mice without evidence of disease. Methods: Mouse Pelvic Organ Quantification (MOPQ) exams were used to serially measure the degree of vaginal, perineal, and rectal prolapse in 176 LOXL1-/- for 22 months. Quantitative gelatin zymography was conducted in vaginal muscularis from young (n 7) and old (n 7) wild type mice and old LOXL1-/- mice with (n 7) or without (n 7) prolapse. MMP2 and MMP9 was also assessed in LOXL1-/- mice with (n 4) or without (n 4) abdominal hernias. Statistical analysis was conducted using 2 and Students t tests. Results: In this study, young mice (10 36 wk, n 117) were compared with old (3752, n 29 and 53 63 wk, n 83) and elderly mice (64 90 wk, n 64). The prevalence of advanced prolapse (Stage 23) in LOXL1-/- increased progressively from 7.7% in young animals to 14, 16.8, and 20.3% in old and elderly mice irrespective of parity status. Rectal prolapse increased from 10% in young mice to 22% in elderly animals. Hernias were absent in young females but occurred in 6% of old (37 63 wks) and 16% of elderly LOXL1-/- mice (p 0.01). Hernia formation occurred through fascial defects at the myopectineal line independent of pelvic organ prolapse. Pro- and active MMP2 and MMP9 were readily identified in vaginal muscularis. In contrast, MMP2 and MMP9 were not detectable in abdominal fascia from WT or LOXL1-/- animals with or without hernias. Active MMP2 and MMP9 were increased 8- and 6.8-fold in vaginal muscularis from LOXL1-/- with prolapse compared with agematched WT mice (both p 0.02), but were not altered during aging in WT animals. MMP2 fluorimetric assays confirmed significant increases in MMP2 activity in tissues from knockouts (p 0.004). Conclusions: This is the first report of abdominal hernias in LOXL1-/mice. Hernia formation was similar to that observed in fibulin-3 deficiency, another mouse model of pelvic organ prolapse. Thus, pelvic organ prolapse and hernia formation are linked in certain genetic defects involving defects in elastic fiber assembly. Although increased MMP2 and MMP9 activity was associated with prolapse of the pelvic organs, herniation through the abdominal fascia was not. Taken together, the results suggest that fibulin-3 or LOXL1 function may be impaired in women with co-morbidities of pelvic organ prolapse and hernias during aging. Disclosures: J.F. Acevedo, None; D.D. Rahn, None; S. Roshanravan, None; R.A. Word, None.
Disclosures: M. Alperin, None; A. Feola, none; R. Duerr, None; S. Abramowitch, None; P. Moalli, None.
Presentation Number: Paper 28 Pelvic Organ Prolapse and Hernias J. F. Acevedo, D. D. Rahn, S. Roshanravan, and R. A. Word UTSW MC, Dallas, TX Objectives: Elastic fiber integrity is maintained by a delicate balance between synthesis and degradation. Synthesis of elastic fibers in the
Presentation Number: Paper 29 Inherited Pelvic Organ Prolapse in the Mouse: Preliminary Evaluation of a New Murine Model A. R. McNanley, A. M. Johnson, M. K. Flynn, R. W. Wood, S. D. Kennedy, and J. E. Reeder University of Rochester, Rochester, NY Objective: To describe preliminary anatomic, radiographic, and genetic observations in a population of mice with inherited, spontaneous pelvic organ prolapse (S-POP). Methods: University Committee on Animal Resources protocols were followed. While monitoring bladder tumor growth in UPII-SV40T
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transgenic mice for studies on bladder cancer, S-POP was observed in males and nulliparous females. Additional S-POP mice were identified by visible phenotype and euthanized using carbon dioxide. Necropsies were performed which confirmed prolapsed pelvic organs. To assess extent of POP without disrupting in vivo anatomic relationships, specimens were studied using magnetic resonance imaging (MRI) microscopy. Mice were immersed in 10% formalin containing MRI gadolinium contrast agent prior to imaging. Voxel dimensions of 117 58 117 `m were obtained from the upper thorax to the lower extremities. Images were reconstructed using Image J and Amira software. Breeding records between affected mice and wild type mice were analyzed to determine inheritance patterns. Results: CT in a male with a profoundly enlarged scrotum showed the bladder prolapsed into the scrotum (Fig 1). Additional affected mice were identified. Subsequent necropsy and MRI microscopy in these mice showed bowel and bladder prolapsed through the pelvic floor. In females, the uterus was displaced distally and compressed by bladder and bowel. The appearance of the POP appears similar to that seen in the human female phenotype. Analysis of breeding colony records suggested that S-POP was inherited independent of the UPII-SV40T transgene in both males and females and appeared to be a dominant trait. Conclusions: This mouse model is distinct from previously described models, in that POP does not require parturition as a precipitating event. This suggests a different, perhaps more severe, form of S-POP than has been previously described, making this a potentially robust animal model for further study. Identification of the gene(s) responsible for this phenotype may offer greater insight into the pathophysiology of POP in humans.
Presentation Number: Paper 30 Regional Heterogeneity in the Expression Pattern of the Sphingosine-1-Phosphate (S1P) Signaling Pathway in the Rat Lower Urinary Tract (LUT) K. S. Sandhu, R. G. Chua, S. Collins, N. Kanika, M. Mikhail, A. Melman, and M. E. DiSanto Albert Einstein College of Medicine, Bronx, NY Objective: Proper storing and emptying of the bladder requires coordinated contractility of the bladder and urethral smooth muscle (SM). Alteration in SM contractility is associated with urinary dysfunction such as overactive bladder and incontinence. The bioactive lipid S1P is a master regulator of SM phenotype, and is present in serum at levels ( 1 M) which is consistent with SM contraction. S1P interacts with three G-protein-coupled receptors termed S1P1, S1P2, and S1P3 that activate many signal transduction pathways including the RhoA/Rho-kinase pathway. The goal of this study was to investigate the existence and relative expression of the S1P receptors, as well as the major enzymes that regulate the metabolism of S1P throughout the LUT. Methods: Four female middle-aged Sprague-Dawley rats were sacrificed. Serum was obtained and bladder tissue was divided into bladder dome (BD), mid-bladder (MB), trigone (TRI), and urethra (URE). Total RNA was extracted and quantitated via nanodrop absorbance. Real-Time RT-PCR was performed with primers specific to the S1P receptors (S1P1, S1P2, and S1P3), the S1P synthesizing enzymes, sphingosine kinases 1 and 2 (SK-1 and SK-2), and the S1P degrading enzymes, S1P phosphatases 1 and 2 (SPP1 and SPP2). Expression levels were normalized to -actin and GAPDH. The S1P serum levels were determined by HPLC. Results: Chloroform extraction of serum followed by derivatization of sphingolipids with 9-fluorenylmethyl chloroformiate (FMOC-Cl) and subsequent HPLC separation on a reverse-phase C-18 column revealed significant levels of S1P in the low micromolar range. All three S1P receptors and both isoforms of SK and SPP were expressed throughout the LUT. However, S1P receptor expression varied between bladder regions and URE. Most notably, S1P1 expression was significantly higher ( 2-fold) in the URE compared to each bladder region (BD, MB, and TRI) while the expression of S1P2 was 2-fold greater in the BD compared to the TRI and URE. While there were no significant differences in the expression of SPPs throughout the LUT, the expression of SK-2 was 2-fold higher in the URE compared to the MB and TRI, and SK-1 expression was highest in the BD. Conclusions: We demonstrate for the first time that the major components of the S1P signaling pathway exist throughout the rat LUT. The higher expression of the S1P1 receptor in the URE compared to the bladder may be functionally relevant as the S1P1 receptor can activate nitric oxide synthase (NOS), which is known to play a distinct role in urethral SM relaxation. Enhanced relative expression of the S1P2 receptor in the BD may be important for sustained force generation necessary for bladder emptying. Higher relative expression of SK isoforms in the BD and URE suggests increased local S1P production in these areas of high contractility and tone, respectively. In summary, our study suggests an important role of S1P signaling in the LUT and identifies this pathway as a possible therapeutic target for voiding dysfunction.
Disclosures: A.R. McNanley, None; A.M. Johnson, None; M.K. Flynn, None; R.W. Wood, None; S.D. Kennedy, None; J.E. Reeder, None.
Disclosures: K.S. Sandhu, None; R.G. Chua, None; S. Collins, None; N. Kanika, None; M. Mikhail, None; A. Melman, None; M.E. DiSanto, None.
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Presentation Number: Paper 31 Visibility of the Perineal Membrane Structure in Living Women on Mr Imaging C. Brandon, C. Lewicky-Gaupp, K. Larson, and J. L. DeLancey University of Michigan Hospital, Ann Arbor, MI Objective: The perineal membrane (PM) is an often discussed, yet rarely studied, pelvic organ support structure. Recent cadaver resear1ch1 demonstrates the different ventral and dorsal portions of the perineal membrane (PM) and its close relationship to the levator ani muscle. This study seeks to evaluate MR imagings ability to visualize these relationships in living women. Methods: MR images from 20 nulliparous women were examined. All subjects (aged 23 to 55 years) denied incontinence or prolapse symptoms and had pelvic organ prolapse quantification (POP-Q) exams. Proton density MR images were acquired with a combination of Philips 1.5T and 3T scanners (4 mm slice, 1 mm gap). The location of known attachment points, structural connections and anatomical relationships from previous cadaver studies were examined in each scan plane. 3-D models were made of selected exemplars to assist with anatomical relationships. Results: In the coronal plane (Figure; top row) at the level of the urethra (U), the PMs ventral portion is part of a densely grouped and interconnected series of structures including the compressor urethrae (CU), vestibular bulb (VB), and pubic portion of the levator ani (LA-p). This complex is immediately adjacent to the ischiopubic ramus (IPR) with no visible interposing space or structures. In contrast, the membranes dorsal part at the level of the vagina (V) has a clear, membranous, lateral portion between vagina and IPR. At this level, the PM connects medially with the levator ani, lying cephalad to the vestibular bulb. The close relationship with the LA-p is seen dorsally. The iliococcygeal portion of the levators (LA-i) is also seen. In the sagittal plane (Figure; bottom row), the medial section shows the parallel course and adjacent positions of the PM and LA-p. Lateral sections show the more dorsal membranous portion. Note the clitoral crus (CC) can also be seen. Conclusion: MR images of nulliparous volunteers reveal that the anatomical features of both the ventral and dorsal perineal membrane can be seen in living women. The close relationship between the perineal membrane and levator ani is evident.
Disclosures: C. Brandon, None; C. Lewicky-Gaupp, None; K. Larson, None; J.L. DeLancey, Johnson & Johnson, Consultant.
Stein TA, DeLancey JOL. Structure of the perineal membrane in females: gross and microscopic anatomy. Obstet Gynecol 2008; 111(3):686 93.
Presentation Number: Paper 32 Quantifying the Accuracy of ICD-9 Codes in Identifying Perioperative Complications as Compared to Chart Review C. A. Heisler, A. L. Weaver, L. J. Melton, III, and J. B. Gebhart Mayo Clinic, Rochester, MN Objective: To quantify the ability of ICD-9 codes to identify perioperative complications as compared to chart review. Methods: Medical records of women who underwent vaginal hysterectomy were reviewed from index surgery through 9-weeks post-operation for the following perioperative complications: cardiac or respiratory arrest, congestive heart failure (CHF), pulmonary embolism, pulmonary edema, urinary tract infection, ureteral obstruction, hemorrhage, delirium. Documentation reviewed included surgical consultation, operative note, inpatient and anesthesia records, direct patient communications and postoperative evaluation. Billing records were utilized to identify ICD-9 codes corresponding to the specific complications. Chart review served as the gold standard for
TABLE. Sensitivity, Specificity, PPV and NPV of ICD Code Identification of Perioperative Complications As Compared to Chart Review (Gold Standard) Complication Cardiac Arrest Respiratory Arrest CHF Pulmonary Embolism Pulmonary Edema Urinary Tract Infection Ureteral Obstruction Hemorrhage Delirium Sensitivity 1/1 1/1 0/2 2/2 1/5 24/108 9/12 6/25 1/2 100% 100% 0% 100% 20% 22% 75% 24% 50% PPV 1/1 1/1 0/0 2/2 1/1 24/26 9/9 6/7 1/1 100% 100% 100% 100% 92% 100% 86% 100% Specificity 711/711 711/711 710/710 710/710 707/707 602/604 700/700 686/687 710/710 100% 100% 100% 100% 100% 99.7% 100% 99.9% 100% NPV 711/711 711/711 710/712 710/710 707/711 602/688 700/703 686/705 710/711 100% 100% 99.7% 100% 99.4% 87.5% 99.6% 97.3% 99.9%
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determination of perioperative complications. Records that were identified as having a complication through chart review or ICD-9 codes were re-abstracted to verify clinical information. Sensitivity, specificity, positive predictive values (PPV) and negative predictive values (NPV) were calculated for ICD code identification of perioperative complications. Results: 712 women were evaluated for perioperative complications after vaginal hysterectomy. For cardiac arrest, respiratory arrest and pulmonary embolism, ICD codes identified all instances and failed to identify none (see table). However, ICD codes missed other types of complications, which caused sensitivity to vary from 0% to 75%. ICD codes were least likely to identify congestive heart failure and pulmonary edema, and only slightly more likely to detect postoperative hemorrhage and urinary tract infections. Conclusion: ICD codes accurately and completely captured major complications such as cardiac arrest, respiratory arrest and pulmonary embolism. However, some complications would have been underestimated or missed entirely if ICD codes were the only means of assessment. Therefore, depending on the definition of morbidity, chart review is imperative for accurate ascertainment of complications. Disclosures: C.A. Heisler, None; A.L. Weaver, None; L.J. Melton, III, None; J.B. Gebhart, Bard, Grant/Research Support.
for laparoscopic and robot-assisted sacral colpopexy, thus off-setting the higher initial costs. A more comprehensive cost-analysis from a prospective comparison of these three modalities including these other factors is warranted. Disclosures: M. Patel, None; D. OSullivan, None; P. Tulikangas, None.
Presentation Number: Paper 33 A Comparison of Costs for Abdominal, Laparoscopic and Robot-Assisted Sacral Colpopexy M. Patel*, D. O. Sullivan, and P. Tulikangas* *University of Connecticut, Hartford Hospital, Hartford, CT, Hartford Hospital, Department of Research Administration, Hartford, CT Objective: To review the hospital based costs associated with abdominal, laparoscopic and robot-assisted sacral colpopexy. Methods: Cases with the following three procedures were identified for further analysis: open abdominal sacral colpopexy, laparoscopic sacral colpopexy or robot-assisted sacral colpopexy. We excluded those with a concurrent hysterectomy. The estimated total charges, estimated total costs, estimated direct and indirect costs were computed based on International Statistical Classification of Diseases and Related Health Problems 9 codes and adjusted for inflation using the Consumer Price Index from the US Department of Labor Bureau of Labor statistics. The operating room time, surgical time, estimated blood loss and demographics were also reviewed. Results yielding p 0.05 were considered statistically significant. Results: There were no difference in age, BMI, stage of prolapse, estimated blood loss, operating room time and length of procedure among the three groups. Comparing the inflation-adjusted estimated hospital charges, the robot-assisted and laparoscopic approaches were more expensive than the open abdominal sacral colpopexy, $24,161.48, $19,308.94 and $13,149.99 respectively (p 0.0004). There was no difference between mean adjusted estimated total charges for the laparoscopic approach and the robot-assisted approach. The estimated direct costs were significantly higher for robot-assisted as compared to open sacral colpopexy, but not different between robot-assisted and laparoscopic sacral colpopexy. All charges and cost comparisons are in Figure 1. Conclusion: Robot-assisted sacral colpopexy produces the highest estimated hospital charges and is more expensive than open sacral colpopexy. The least expensive surgical approach from the hospital perspective is the open abdominal sacral colpopexy. Economic gains from reduced recovery time and loss of productivity may be higher
Presentation Number: Paper 34 Comparison of Short-Term Outcomes of Robotic Sacrocolpopexy Versus Abdominal Sacrocolpopexy E. J. Geller*, N. Y. Siddiqui, J. M. Wu, and A. G. Visco *UNCChapel Hill, Chapel Hill, NC, Duke University, Durham, NC Objective: To compare short-term outcomes in patients undergoing robotic sacrocolpopexy versus abdominal sacrocolpopexy for advanced pelvic organ prolapse. Methods: We conducted a retrospective cohort study comparing robotic sacrocolpopexy to abdominal sacrocolpopexy with placement of permanent mesh. Data were collected between January 2004 and March 2008 from two university hospitals regarding demographics and peri-operative outcomes. The primary outcome was apical support on 6-week post-operative POP-Q examination. Secondary outcomes included estimated blood loss, operative time, length of stay, blood transfusion, bowel or bladder injury, urinary retention, post-operative fever, wound infection, pneumonia, pulmonary embolus, ileus, bowel obstruction, and mesh erosion. Results: The analysis included 178 patients (73 robotic and 105 abdominal sacrocolpopexy). There were no differences in age, race or BMI between groups. Women in the robotic group had more significant prolapse than the abdominal group on preoperative POP-Q examination: C ( 3 vs. 1, p 0.002), Ba ( 4 vs. 3, p 0.001) and Bp ( 2.5 vs. 0, p 0.005). They were also more likely to undergo hysterectomy (47.9% vs. 29.5%, p 0.02) and less likely to undergo other concomitant procedures for prolapse (5.5% vs. 65.7%, p 0.001) than women in the abdominal group. There was no difference in the rate of anti-incontinence surgery (50.7% vs. 40.0%, p 0.17). Postoperatively, robotic sacrocolpopexy was associated with a slight improvement in C point ( 9 vs. 8, p 0.008), but no difference in Ba or Bp when compared to abdominal sacrocolpopexy.
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Robotic sacrocolpopexy was also associated with less blood loss (103 96 mL vs. 255 155 mL, p 0.001), longer total operative time (328 55 min vs. 225 61 min, p 0.001), shorter length of stay (1.3 0.8 days vs. 2.7 1.4 days, p 0.001) and a higher incidence of postoperative fever (4.1% vs. 0.0%, p 0.04). There were no significant differences in the other secondary outcome measures. Operative time remained significantly greater in the robotic group (p 0.001) when controlling for BMI, hysterectomy, other concomitant prolapse surgery, anti-incontinence surgery and lysis of adhesions. Estimated blood loss remained significantly lower in the robotic group (p 0.001) when controlling for the same variables. Conclusions: Robotic sacrocolpopexy demonstrated similar apical support at 6 weeks compared to abdominal sacrocolpopexy, with less blood loss and shorter length of stay. Operative time was longer but may decrease as the learning curve for this new procedure improves. There were similar outcomes between the two groups in terms of peri-operative complications. Long-term data are needed in order to assess the durability of this new minimally invasive approach to prolapse repair. Disclosures: E.J. Geller, None; N.Y. Siddiqui, None; J.M. Wu, None; A.G. Visco, Intuitive Surgical, Consultant; Intuitive Surgical, Paid Instructor.
an elongated cervix. Intra-operative complications included 18 cystotomies (5%), 3 ureteral injuries (1%), and 1 rectal injury for an overall visceral injury rate of 6.6%. Out of 112 women who did not report stress urinary incontinence (SUI) or demonstrate SUI during preoperative urodynamics, 27 reported it post-operatively for a de novo SUI rate of 24%. Of these patients 3 underwent interval mid-urethral sling and 2 underwent periurethral bulking. Fifty-three women (16%) complained of pelvic muscle dysfunction (new onset dyspareunia or vaginal pain) postoperatively. In 39 (74%) of these women the symptoms largely resolved within 6 months with medications and physical therapy. One woman with continued vaginal pain underwent surgery to revise the mesh. Five (1.4%) women had recurrent symptomatic prolapse, all in the apical compartment. Fourteen (4%) cases of mesh exposure where identified; 3 were asymptomatic and managed expectantly and 11 were excised with complete resolution of mesh exposure symptoms. Conclusions: Over a 2.7 year period of performing vaginal reconstruction utilizing the PROLIFT System, surgeons can expect a low rate of recurrent prolapse and mesh exposure. However, pelvic muscle dysfunction and de novo SUI will be encountered postoperatively in some women. Disclosures: M. Aungst, None; E. Friedman, None; W. von Pechmann, None; N. Horbach, None; J. Welgoss, Ethicon, Consultant; Medtronics, Consultant.
Presentation Number: Paper 35 Stress Incontinence and Pelvic Muscle Dysfunction after Total Vaginal Mesh M. Aungst*, E. Friedman, W. von. Pechmann, N. Horbach, and J. Welgoss *Walter Reed Army Medical Center, Washington, DC, George Washington University, Washington, DC, Northern Virginia Pelvic Surgery Associates, Annandale, VA Objective: To determine the post operative rates of stress urinary incontinence, pelvic muscle dysfunction, recurrent prolapse, and mesh exposure after vaginal mesh reconstructive surgery using the PROLIFT System (Gynecare, Somerville, N.J). Methods: This was a retrospective review of women who underwent vaginal reconstruction with polypropylene mesh using the PROLIFT system between July 7, 2005 and Jan 31, 2008. Utilizing billing records (CPT codes), 337 consecutive cases were identified from a single practice. Complete office records for 335 women were available and comprise this series. Surgical procedures were performed by three fellowship trained urogynecologists, generally assisted by urogynecology fellows and residents. Results: Follow-up ranged from 132 months with a mean follow-up of 8 months. Patient age ranged from 33 87; average was 62. Maximum prolapse stage ranged from II-IV, with 35% having stage II, 63% stage III, and 2% stage IV. Two-hundred forty-four women underwent combined anterior and posterior PROLIFT (71%), 66 underwent anterior PROLIFT (20%), and 23 (8%) underwent posterior PROLIFT. Two planned PROLIFT surgeries did not undergo mesh placement. One case was converted to a uterosacral ligament suspension, Burch, and anterior repair after ureter injury passing the deep anterior trocar, and the second was converted to a LeFort after cystotomy during dissection for anterior mesh placement. Various concomitant procedures were performed including 160 mid-urethral slings, 16 vaginal hysterectomies, 3 laparoscopic supracervical hysterectomies, 37 posterior colporrhaphies, and 23 perineorrhaphies. Eleven women underwent concomitant cervical conization to shorten
Presentation Number: Paper 36 Complication and Reoperation Rates Following Surgical Repair for Apical Vaginal Prolapse: A Meta-Analysis G. B. Diwadkar*, M. D. Barber*, B. Feiner, C. Maher, and J. E. Jelovsek*, *Cleveland Clinic, Cleveland, OH, Wesley Hospital, Brisbane, QLD, Australia Objective: To compare postoperative complication and reoperation rates for surgical procedures correcting apical vaginal prolapse, including traditional procedures, sacral colpopexy, and vaginal mesh kits. Methods: A literature search was conducted for original articles published or presented between 1985 and January 2008 addressing apical prolapse repair and associated complication, recurrence, or reoperation rates. Exclusion criteria included: 50 subjects, nonEnglish articles, case reports, and follow-up 3 months. Procedures were separated into 3 groups: Traditional vaginal procedures (uterosacral ligament, sacrospinous ligament, and iliococcygeus fascial suspension, and McCalls culdoplasty), sacral colpopexy (open or laparoscopic), and vaginal mesh kits. Complications were classified using the Dindo Grading System. Weighted averages and confidence intervals were calculated for each Dindo grade, specific complications, reoperations for recurrence, and total reoperations (Dindo IIIb and prolapse recurrence). Results: 111 studies including 16,891 subjects met criteria for inclusion. Dindo grade I (antiemetic, antipyretic, or analgesic use) and II (other pharmacological treatment or blood transfusion) rates were greatest in the traditional procedure group. The mesh complication rate in the traditional group represented erosions from concomitant procedures. Visceral injury and wound complication rates were greatest in the sacral colpopexy group. Dindo grade IIIa (surgery not requiring general anesthesia) and Dindo IIIb (requiring general anesthesia) rates were highest in the vaginal mesh kit group, likely due to higher rates of mesh erosion
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and fistulas. Reoperation rates for prolapse recurrence were highest in the traditional group. The total reoperation rate was greatest in the mesh kit group (8.5%) despite the shortest mean follow-up of 17.1 months. Conclusions: Overall complication rates are similar for traditional surgeries, sacral colpopexies, and vaginal mesh kits for treatment of apical prolapse. However, the rate of reoperations due to complications and total reoperation rate are highest for vaginal mesh kits, in spite of fewer reoperations for prolapse recurrence and shorter overall follow-up.
Disclosures: G.B. Diwadkar, None; M.D. Barber, American Medical Systems, Grant/Research Support; B. Feiner, None; C. Maher, None; J.E. Jelovsek, None.
milder and more uniform response than PS, with lower scores for inflammation (p 0.007, Mann-Whitney Rank Sum test) and good host tissue incorporation between PP fibers. PS induced a more variable response, with PS grafts missing in 6/20 vaginal sites (but in no abdominal sites) at 9 months. Some PS grafts in the vagina and abdomen appeared intact with minimal inflammation and poor host tissue infiltration, while a severe foreign body reaction was observed in other animals in which the grafts appeared to be undergoing digestion. Paired analysis (n 28) revealed that vaginal grafts had higher scores for inflammation (p 0.005) and neovascularization (p 0.001), and had lower scores for fibroblastic proliferation (p 0.001) than abdominal grafts. Vaginal grafts from ovariectomized rabbits (n 12) and those with intact ovaries (n 17) had similar scores for inflammation (p 0.32), neovascularization (p 0.51), and fibroblastic proliferation (p 0.83). Conclusions: Synthetic and biologic grafts evoke different foreign body reactions that may have implications for surgical outcomes in women. Polypropylene mesh induces a milder, more uniform response than porcine dermis, whereas porcine dermis elicits a more variable response and may degrade in the vagina by 9 months. Because vaginal implantation elicits a different tissue response than abdominal implantation, vaginal models are most appropriate for investigations of host responses to graft materials used in vaginal surgery. Disclosures: L.M. Pierce, None; A. Rao, None; S.S. Baumann, None; J.E. Glassberg, None; T.J. Kuehl, None; T.W. Muir, None.
Presentation Number: Paper 37 Long-Term Histological Response to Synthetic and Biologic Graft Materials Implanted in the Vagina and Abdomen of a Rabbit Model L. M. Pierce, A. Rao, S. S. Baumann, J. E. Glassberg, T. J. Kuehl, and T. W. Muir Scott and White Hospital, Temple, TX Objective: To evaluate the effects of graft type (synthetic versus biologic), site of implantation (vagina versus abdomen), and ovariectomy on the histological response to graft materials used in pelvic reconstructive surgery. Methods: Forty-five female New Zealand White rabbits were randomly assigned to undergo ovariectomy or sham laparotomy and were surgically implanted with polypropylene mesh (PP; Gynemesh, Ethicon; n 23) or porcine dermis (PS; PelviSoft, C.R. Bard; n 22) into the posterior vaginal wall and abdomen. The same graft type was implanted at both sites in each animal. Grafts with surrounding host tissues were harvested 9 months after implantation. Serial full thickness sections were processed with routine histological stains to evaluate the host inflammatory response and degree of tissue incorporation within the grafts. Inflammation, neovascularization, and fibroblastic proliferation were scored by a pathologist on a scale of 0 to 4 (0 none, 1 minimal, 2 mild, 3 moderate, 4 severe). Results: Erosion occurred in the vagina of 8/45 rabbits 5/23 (22%) rabbits implanted with Gynemesh (2 with and 3 without ovaries) and 3/22 (14%) rabbits implanted with PelviSoft (2 with and 1 without ovaries) . Erosion did not occur at abdominal sites. Grafts available for histological analysis included 37 PP samples 15 vaginal (9 with and 6 without ovaries); 22 abdominal (12 with and 10 without ovaries) and 33 PS samples 14 vaginal (8 with and 6 without ovaries); 19 abdominal (10 with and 9 without ovaries) . Overall, PP induced a
Presentation Number: Paper 38 Biomechanical Properties of Synthetic and Biologic Graft Materials Following Long-Term Implantation in the Rabbit Abdomen and Vagina L. M. Pierce*, M. A. Grunlan, Y. Hou, S. S. Baumann*, T. J. Kuehl*, and T. W. Muir* *Scott and White Hospital, Temple, TX, Texas A&M University, College Station, TX Objective: To evaluate the effects of anatomical location and ovariectomy on biomechanical properties of synthetic and biologic grafts following long-term implantation in a rabbit model. Methods: Thirty-five New Zealand White rabbits were randomly assigned to undergo ovariectomy or sham laparotomy and were surgically implanted with polypropylene mesh (PP; Gynemesh, Ethicon; n 17) or porcine dermis (PS; PelviSoft, C.R. Bard; n 18) into the posterior vaginal wall and abdomen. Grafts were harvested 9 months after implantation and measured with electronic calipers. Static mechanical properties of grafts were determined with an RSAIII mechanical analyzer by investigators blinded to treatment. Results were compared to baseline (before implantation) values (n 5). For PS grafts, testing was performed on abdominal sites only. Results: Thirty-four PP samples (17 vaginal and 17 abdominal grafts from 9 rabbits without and 8 with ovaries) and 18 PS samples (18 abdominal grafts from 9 without and 9 with ovaries) were tested. At baseline, PP grafts were weaker (force required for rupture 8.3 N 1.1SE PP; 16.3N 0.5 PS; p 0.001) and less resistant to tensile forces (i.e., less stiff; 3.0 N/mm 0.1 PP; 6.8 N/mm 0.4 PS; p 0.008) than PS. At 9 months after implantation, PP grafts increased in elasticity indicated by increased maximal elongation before rupture (41% 4 baseline; 87% 7 vagina, p 0.003; 73% 7 abdomen, p 0.02) and decreased stiffness (baseline 3.0 N/mm 0.1; 1.6 N/mm 0.2 vagina, p 0.003; 2.4 N/mm 0.3 abdomen,
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p 0.03). PP grafts tended to increase in strength after implantation (8.3 N 1.1 baseline; 12.2 N 1.8 vagina, p 0.28; 15.7 N 2.0 abdomen, p 0.06) although statistical significance was not achieved. In contrast, PS grafts decreased in maximal elongation (55% 4 baseline; 36% 4 abdomen, p 0.02) and did not change significantly in strength (16.3 N 0.5 baseline; 13.6 N 2.5 abdomen, p 0.28) or stiffness (baseline 6.8 N/mm 0.4; 5.3 N/mm 1.2 abdomen, p 0.15) from baseline. At abdominal sites, PS grafts were more resistant to tensile forces than PP (5.3 N/mm 1.2 PS vs. 2.4 N/mm 0.3 PP; p 0.04) and maximal elongation was half that of PP (36% 4 PS vs. 73% 7 PP; p 0.001), but PS and PP were similar in strength (p 0.52). Vaginal PP grafts showed significant (p 0.001) shrinkage from baseline (20% mean decrease in surface area), while the surface area of abdominal grafts did not change (p 0.16). Abdominal PP grafts were stiffer than vaginal PP grafts (p 0.049) but were not significantly different in strength (p 0.19) or maximal elongation (p 0.15). Ovariectomy had no effect on the mechanical properties of PP or PS grafts compared to grafts from rabbits with intact ovaries (p 0.05 for all comparisons). Conclusions: Changes in biomechanical properties of synthetic and biologic graft materials occur following long-term implantation. Vaginal PP grafts shrink more and are less stiff than abdominal grafts. At 9 months, PS is similar in strength but is twice as stiff as PP and has a maximal elongation only half that of PP. Disclosures: L.M. Pierce, None; M.A. Grunlan, None; Y. Hou, None; S.S. Baumann, None; T.J. Kuehl, None; T.W. Muir, None.
was more pronounced at larger diameter probes. Women with most severe injury of PRM ( 75%) had significantly lower rest and squeeze pressures at higher probe sizes (10, 20, 30 mm). Only 4/45 (9%) were in injured EAS and IAS group and their anal pressures at rest and squeeze were lower compared to women with no defects, but not statistically significant (fANOVA p 0.45). Conclusion: In asymptomatic parous women PRM defects are more common than EAS and IAS defects. Women with PRM defects have lower vaginal pressure and abnormal length tension muscle characteristics.
Disclosures: M.M. Weinstein, None; D.H. Pretorius, Equipment Loan, Grant/Research Support; S. Jung, None; J.J. Wan, None; C.W. Nager, None; R.K. Mittal, None. Presentation Number: Paper 39 Anal Sphincter Complex Muscle Anatomy and Function in Asymptomatic Parous Women M. M. Weinstein, D. H. Pretorius, S. Jung, J. J. Wan, C. W. Nager, and R. K. Mittal University of California, San Diego; Pelvic Floor Function and Disorder Group, San Diego, CA Objective: To assess the anatomy and function of the anal sphincter complex muscles: the puborectalis muscle (PRM), external anal sphincter (EAS) and internal anal sphincter (IAS) with threedimensional ultrasound (3DUS), vaginal and anal manometry in asymptomatic parous women (APW). We hypothesized: 1) APW have a high prevalence of the PRM injury and those with the PRM injury have impaired vaginal pressure compared to uninjured women. 2) APW with the IAS and EAS defects have impaired resting and squeeze pressures, respectively. Methods: Women with one prior vaginal delivery and no anal or urinary incontinence were studied with 3DUS to assess the PRM, EAS and IAS. The muscles were assessed with a semi-quantitative scoring system and grouped into injured and uninjured groups. Women in uninjured PRM group had 25% defect and injured group had 25% defect. The EAS and IAS were assessed for defects along the sphincters length; uninjured EAS and IAS group had 25% defect and injured 25% defect along the sphincter length. Vaginal and anal pressures were measured at rest and during a pelvic floor contraction with a sleeve sensor mounted on different diameter probes. We analyzed data with Student t-test, chi-square and factorial ANOVA (fANOVA) tests. Results: 45 women, mean age 50 (range 24 68) were assessed; 44 had adequate PRM images. In the uninjured group of 30, 22 had no PRM defects and 8 had 25% PRM defects. The 14 women (32%) in the PRM injured group had significantly lower vaginal pressures than uninjured group (fANOVA p 0.001) Figure 1 ; this difference
Presentation Number: Paper 40 Findings by MRI of Injury and Recovery of the Levator ANI Muscle and Surrounding Structures After High Risk Vaginal Birth J. Miller, C. Brandon, L. Kane Low, J. Ashton-Miller, and J. DeLancey University of Michigan, Ann Arbor, MI Objective: To use serial magnetic resonance (MR) imaging and established criteria from musculoskeletal radiology to classify severity, type, and resolution of birth related injury to the levator ani muscle (LA) and surrounding structures. Methods: We studied 21 women with factors associated with an increased risk of LA injury: first vaginal delivery, long 2nd stage, forceps delivery, or anal sphincter laceration (Kearney, 2006). MR was obtained at 2 6 weeks and 6 months post vaginal birth using multiplanar 3T proton density. In the last 11 women a fluid sensitive sequence was added to increase sensitivity to signal intensity changes indicative of edema. MR injury features noted were: 1) High signal intensity reflecting trauma-related edema. 2) Signal intensity pattern reflecting injury as diffuse or focal. 3) Muscle fiber discontinuity graded as partial or full tear. The figure shows an early and late scan example. PB pubic bone, R Rectum, U urethra. Note on early scan, high signal (lighter color) in the (R) LAs pubic portion (LA-p) but normal signal (dark) in adjacent obturator internus (OI). On the left (L) no LA-p is seen in the expected location (arrow) between the vagina and OI. At 6 months LA signal intensity has improved on the right, muscle absence persists on the left. Results: In 21/21 women high signal intensity was seen in the LA but not in the OI on early scan. Reduction of the signal intensity occurred in all late scans though in women with fluid-sensitive images
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there remained mildly increased signal in the LA compared to the unaffected OI. Partial or full LA tears were seen at the location of the pubic bone attachment point in 6/21 women on early scan; none showed reattachment on late scan. (One woman with tear dropped before f/u). None of the women showed a pattern of muscle atrophy from early to late scans, which would be expected if there were overt denervation. Of the 11 women with fluid sensitive scans 4 with LA tears and 4 without showed focal bone marrow edema (high signal). Conclusion: Results show feasibility of using MR to study birth related tissue injury and recovery. LA tears and focal bone marrow edema were seen. None of the LA tears observed in early scans resolved. Comment: Edema in the LA but not the OI is more consistent with stretch than compression injury.
Presentation Number: Paper 41 One-Year Anatomic and Functional Outcomes After Reconstructive Surgery with Prolift Pelvic Floor Repair System M. Alperin,* R. Ellison,* E. A. Frankman,* L. Meyn, and H. M. Zyczynski* *Magee-Womens Hospital, University of Pittsburgh, Pittsburgh, PA, Magee-Womens Research Institute and Foundation, University of Pittsburgh, Pittsburgh, PA Objective: To prospectively assess anatomic and functional outcomes 1 year after prolapse repair using Prolift (Gynecare/Ethicon, Somerville, NJ) pelvic floor repair system. Methods: Baseline and 1 year postoperative data were analyzed in 40 consecutive women enrolled in this IRB approved, prospective study assessing objective and subjective outcomes after prolapse repair using Prolift systems. Objective outcomes were measured by standardized Pelvic Organ Prolapse Quantification (POPQ) examination. Subjective analysis included assessment of symptoms, quality of life, and sexual function using validated Pelvic Floor Distress Inventory (PFDI), Pelvic Floor Impact Questionnaire (PFIQ), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ) self-questionnaires. Global satisfaction with the procedure was assessed using a Visual Analog Scale from 1 to 10, with the boundaries of very unsatisfied and very satisfied. Subjects were also asked if they would recommend the procedure to a friend. Paired Students t-tests were used to analyze pre- versus postoperative data. Results: Mean age at surgery was 65.8 9.7 (mean SD) years, body mass index was 26.7 3.9 kg/m2 and median parity was 3 (range 1 8). Six (15%) had previous prolapse surgery and 24 (60%) had a prior hysterectomy. Total Prolift was performed in 22 (55%), anterior Prolift with apical modification in 14 (35%), and posterior Prolift in 4 (10%). Concomitant procedures included 3 hysterectomies and 6 midurethral
Disclosures: J. Miller, None; C. Brandon, None; L. Kane Low, None; J. Ashton-Miller, None; J. DeLancey, None.
TABLE. Preoperative (mean SD) Anatomic Outcomes (POPQ) Stage Stage 0 Stage 1 Stage 2 Stage 3 Stage 4 Ba (cm) Bp (cm) C (cm) Genital Hiatus (cm) TVL Functional Outcomes PFDI (0-1000) UDI (0-300) CRADI (0-400) POPDI (0-300) PFIQ(0-1200) UIQ (0-400) CRAIQ (0-400) POPIQ (0-400) PSIQ (0-125)
Postoperative (mean SD) 3 17 20 0 0
p-value
0 0 6 32 2 2.7 0.5 1.2 5.0 8.8 255.4 71.1 82.9 101.4 203.6 71.7 57.8 74.1 82.5 2.3 3.2 4.4 1.3 1.2 151.9 46.3 73.8 58.6 188.9 64.2 85.4 86.9 17.9 1.7 1.8 6.4 3.1 7.5 109.2 30.6 43.6 35.0 53.1 23.4 16.6 13.1 100.2
1.0 1.2 1.2 0.9 2.8 148.7 38.7 56.2 51.2 83.5 32.8 34.3 35.5 16.1
0.001 0.001 0.001 0.001 0.008 0.001 0.001 0.001 0.001 0.001 0.001 0.004 0.001 0.001
Frequency.
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slings. At 1 year, POPQ measures of the anterior, apical, and posterior compartments were significantly improved from baseline as were quality of life and sexual function scores (see Table). All 22 women who were sexually active at baseline were sexually active at 1 year. Dyspareunia was similar at baseline and at 1 year follow up affecting 9 (41%) and 8 (36%) subjects respectively. Mesh exposure occurred in 2 (5%) subjects. The median patient global satisfaction with the procedure was 9.2 (range 2.310.0) and 95% would recommend it to a friend. Conclusion: Anatomic support and functional outcomes 1 year after transvaginal prolapse surgery with Prolift repair systems are promising with high patient satisfaction and an acceptable complication rate. Disclosures: M. Alperin, None; R. Ellison, None; E.A. Frankman, None; L. Meyn, None; H.M. Zyczynski, Contract researcher, Ethicon Womens Health and Urology, Other.
Conclusions: Anterior vaginal prolapse repair with polypropylene mesh reinforcement offers lower anatomic recurrence than anterior colporrhaphy at two years. However, quality of life and sexual symptoms scores improved in both groups. Disclosures: J.N. Nguyen, American Medical Systems, Grant/Research Support; American Medical Systems, Consultant; R.J. Burchette, None.
Presentation Number: Paper 42 Anatomy and Visceral Function After Anterior Vaginal Prolapse Repair: A Randomized Controlled Trial J. N. Nguyen,* and R. J. Burchette *Southern California Permanente Medical Group, Downey, CA, Kaiser Permanente Research and Evaluation, Pasadena, CA Objectives: To report 2-year outcomes of a randomized controlled trial comparing polypropylene mesh reinforced anterior vaginal prolapse repair to anterior colporrhaphy. Methods: Seventy-six patients, mean age 60 years and BMI 28 kg/m2, with stage II or greater anterior vaginal prolapse were recruited from the urogynecology clinic and randomly assigned to either anterior colporrhaphy (AC) or Perigee polypropylene mesh repair. Other surgical procedures were performed as indicated. The primary outcome was recurrent stage II anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, surgical time, blood loss, length of hospitalization, and adverse events. Vaginal support was considered optimal when both points Aa and Ba were at stage 0 ( 3 cm), and satisfactory when both points Aa and Ba were at stage I ( 2 cm) and improved from preoperative staging. Anatomic cure was defined as an optimal or satisfactory outcome, and unsatisfactory (failure) if either point Aa or Ba was at stage II or beyond ( 1 cm or lower). A research nurse and medical assistant, both blinded to the subjects group assignment, performed the annual POPQ staging exam administered the PFDI-20, PFIQ-7 and PISQ-12 questionnaires respectively. Results: Thirty-eight women had anterior colporrhaphy and 37 had polypropylene mesh repair. One patient allocated to mesh repair withdrew from the study prior to surgery. Clinical and demographic data did not differ significantly between the two treatment groups. Recurrent stage II anterior vaginal prolapse (primary outcome) at two years occurred in 20/38 (53%) of anterior colporrhaphy and 5/38 (14%) of the mesh group (p .004). Operative time and length of hospitalization were similar in both groups. Postoperative day one hemoglobin change was higher in the mesh group (2.4 vs 1.8 g/dl, p .02) but there was no difference in transfusion rates (3%). Quality of life (PFDI-20, PFIQ-7) symptom scores improved in both the AC (109 58 vs. 45 32, 82 54 vs. 23 34) and mesh (108 45 vs. 34 31, 82 54 vs. 14 23) groups two years after surgery (p .0001). Sexual symptom (PISQ-12) scores were similar between groups at baseline and did not change significantly after surgery. The rates of de novo dyspareunia were 4/26 (16%) and 2/22 (9%) in the colporrhaphy and mesh groups respectively. Two of 37 women (5%) had vaginal mesh extrusions and were treated without recurrence. Neither serious adverse events nor deaths occurred in either group.
Presentation Number: Paper 43 A Cost-Effectiveness Analysis of Botulinum Toxin a Injection Versus Anticholinergic Medications for the Primary Treatment of Idiopathic Urge Incontinence J. Wu, N. Y. Siddiqui, C. L. Amundsen, E. R. Myers, and A. G. Visco Duke University, Durham, NC Background: Anticholinergic medications are primary therapy for urge incontinence. Although anticholinergics are effective, these medications have bothersome side effects resulting in poor patient compliance. Botulinum toxin A injection has emerged as an effective treatment for refractory urge incontinence but it is associated with higher costs and limited duration of effect. Objective: To assess the cost-effectiveness of intradetrusor botulinum toxin A injection compared to anticholinergic medications for the primary treatment of idiopathic urge incontinence. Methods: A Markov decision analysis model was developed to compare the costs, in 2008 US dollars, and effectiveness, measured in quality-adjusted life-years (QALYs), of botulinum toxin A injection (BoNT-A) and anticholinergic medications. The probabilities of improvement and adverse events for each therapy and the quality of life (utility values) associated with continence and urge incontinence were derived from published studies. Costs were based on Medicare reimbursements and national physician fee schedules. Costs and QALYs were discounted at rate of 3% per year. The analysis was conducted from a societal cost perspective with a time period of two years using 3-month cycles. The primary outcome was the incremental cost-effectiveness ratio (ICER), which is defined as (BoNT-A cost-Medication cost)/(BoNT-A QALY Medication QALY). Sensitivity analyses were performed to assess the effect of varying estimates through their ranges. Results: While the botulinum treatment strategy was more expensive ($4,392 vs $2,563), it was also more effective (1.63 vs 1.50 QALYs) compared to the anticholinergic regimen. The calculated ICER was $14,377/QALY. Given a well-accepted definition for cost-effectiveness of an ICER $50,000/QALY, BoNT-A is cost-effective compared to anticholinergics. We also performed extensive one-way sensitivity analyses to determine whether varying estimates through their low and high values would impact the results. The probability of compliance with anticholinergics was 33% for the base-case. When compliance exceeded 75%, anticholinergic medications became cost-effective. Anticholinergics also became cost-effective if the cost of the botulinum procedure ($1690 in the base-case) exceeded $3875. For the remainder of the sensitivity analyses, BoNT-A remained costeffective. Changes in anticholinergic cost over 3 months ($110 to $570) and changes in efficacy (initial failure after BoNT-A: 8% to 40%; BoNT-A failure at 9 months: 25% to 75%; BoNT-A retention: 4% to 43%; and improvement with medications: 43% to 89%) did not change the cost-effectiveness of BoNT-A. Conclusions: Over a two-year period, botulinum toxin A injection was cost-effective compared to anticholinergic medications for the
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primary treatment of urge incontinence. Anticholinergics become cost-effective if patients are highly compliant with medications or if the botulinum procedure costs increase substantially. Disclosures: J. Wu, None; N.Y. Siddiqui, None; C.L. Amundsen, None; E.R. Myers, Merck, Precision Diagnostics, Grant/Research Support; Merck, Precision Diagnostics, Consultant; A.G. Visco, Intuitive Surgical, Consultant; Intuitive Surgical, Paid Instructor.
Presentation Number: Paper 44 Preemptive Local Analgesia in Vaginal Surgery J. B. Long, R. J. Eiland, J. G. Hentz, P. A. Mergens, P. M. Magtibay, R. M. Kho, and J. L. Cornella Mayo Clinic Arizona, Phoenix, AZ Objective: To assess the efficacy of preemptive paracervical block with long-acting local anesthestics on postoperative pain for patients undergoing vaginal hysterectomy with McCall culdoplasty. Methods: A prospective, randomized, double blinded trial of preemptive local analgesia (PLA) in 90 women undergoing vaginal hysterectomy (with and without concomitant vaginal procedures) was conducted. PLA consisted of a 10cc paracervical injection of 0.5% bupivicaine with 1:200,000 epinephrine at the start of the case, and an additional 10cc injected into the more proximal uterosacral ligaments just prior to placement of McCall culdoplasty sutures. Pain was recorded using a visual analog score (VAS) at 30 minutes, 3, 12, and 24 hours post-operatively. Additionally, total narcotic use was recorded at the same time points. All adverse events were tracked over a 6-week post-operative time period. Results: The mean pain VAS 30 minutes and 3 hours post-operatively was 43% (P 0.003) and 33% (P 0.02) lower, respectively, in the PLA group versus the placebo group. Mean pain VAS for the PLA treatment at 12 and 24 hours after surgery were equivalent to placebo treatment. Additionally, the mean total dose of narcotic at every time point post-operatively was significantly less in the PLA group versus the placebo group. Conclusion: PLA with bupivicaine prior to vaginal hysterectomy is associated with significantly lower pain scores and a reduction in narcotic use post-operatively. Disclosures: J.B. Long, None; R.J. Eiland, None; J.G. Hentz, None; P.A. Mergens, None; P.M. Magtibay, None; R.M. Kho, None; J.L. Cornella, None.
model of a resting vagina (A) and its 2-D representation (B). Manufacturer-specified anchoring points were reviewed for anterior wall mesh kits (Anterior Prolift , Anterior Avaulta, and Perigee) allowing identification of superior and inferior points along the ATFP. Axes (cranio-caudal and ventro-dorsal) were constructed through the superior suspension points and the percentage of anterior vaginal wall length superior and posterior to these axes were measured. Results: Vaginal position at rest and Valsalva varies among our 11 women. A portion of anterior vagina is above superior mesh attachment points in 100% (11/11) at rest and in 73% (8/11) during Valsalva. A portion of anterior vagina is posterior to superior mesh attachment points in 82% (9/11) at rest and in 100% (11/11) during Valsalva. Mean vaginal lengths at rest and maximal Valsalva were 9.3 0.7 cm (SD) and 8.6 1.2 cm respectively. The mean percentage of vaginal length above superior anchoring sites was 40 14% in the 11/11 at rest and 29 12% in the 8/11 at maximal Valsalva. The percentage of vaginal length posterior to or behind superior anchoring sites varied from 3% to 70% (mean percentage at rest (9/11) 15 6%, and Valsalva (11/11) 24 24%). Conclusion: The upper vagina lies above and behind superior suspension points in the majority of women with normal support.
Disclosures: K. Larson, None; Y. Hsu, None; J.O. DeLancey, Johnson & Johnson, Consultant.
Presentation Number: Paper 45 The 3-D Relationship Between Superior Attachment Points for Anterior Wall Mesh Operations and the Upper Vagina in Women with Normal Support K. Larson, Y. Hsu, and J. O. DeLancey University of Michigan, Ann Arbor, MI Objective: Some patients experience apical prolapse after anterior vaginal wall mesh kit operations. To understand why this may occur, we examined the 3-D structural relationships between the suspension points and normal anterior vaginal wall location. Methods: 11 Asymptomatic women with a uterus and normal support were identified from subjects recruited as controls for an ongoing study (all portions of the vagina 1cm above the hymen during Valsalva). Multi-planar MR imaging of the pelvis was performed in the supine position at rest and maximal Valsalva. 3-D reconstructions of the pelvic bones, uterus, and vagina at rest and maximal Valsalva were created using 3-D Slicer (Slicer2). Reconstructions were imported into IDEA-S modeling software. On each side of the pelvis, the line of the arcus tendineus fascia pelvis (ATFP) was constructed from its visible insertion in the pubis to the ischial spine (* on Fig. 1). Figure 1 shows a 3-D
Presentation Number: Paper 46 Elastin Metabolism is Increased in the Vagina of Women With Prolapse Relative to Controls W. Zong,* S. E. Stein,* B. Starcher, and P. A. Moalli* *University of Pittsburgh, Pittsburgh, PA, University of Texas Health Center, Tyler, TX Objective: Clinically, prolapse progression is associated with mechanical stretching of the vaginal wall. Stretch has been shown to alter the synthesis of extracellular matrix components including elastin (Am J Physiol 1997; 272: L452). The aim of this study was to compare elastin metabolism in the vagina of women with and without prolapse and to define the regulation of this process by hormones. Methods: Following IRB approval and patient consent, 87 histologically confirmed full-thickness vaginal biopsies were procured from patients at time of surgery. Vaginal tissue from premenopausal women with stage II prolapse and no self-reported incontinence served as controls (N 20). Women with prolapse were divided into 3 groups - premenopausal (pre, N 20), postmenopausal not on hormone therapy (post no HT, N 29), and postmenopausal on HT (post HT, N 18). The epithelium was excised leaving the subepithelium, muscularis and adventitia for biochemical analysis. The elastin degrading matrix metalloproteinase -9 (MMP-9) was detected by gelatin zymography and the elastin precursor, tropoelastin, by immunoblotting. Tropoelastin was quantified by densitometry and expressed as units relative to an internal control while MMP-9 values were arbitrary densitometry units. Mature elastin was measured via a desmosine crosslink radioimmunoassay (crosslinks/total
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TABLE. Tropoelastin (units) Control Prolapse a Preb Post-, no HT c Post-, HT Desmosine (pmol/mg) Control Prolapse a Preb Post-, no HT c Post-, HT ProMMP-9 (units) Control Prolapse a Preb Post-, no HT c Post-, HT Active MMP-9 (units) Control Prolapse a Preb Post-, no HT c Post-, HT N 15 14 14 15 15 18 28 17 16 15 16 16 16 15 16 16 Median (Interquartile Range) 0.8 (0.7, 1.4) 1.7 (1.1, 2.3) 7.2 (5.4, 13.8) 4.5 (3.0, 7.8) 386 (319, 609) 533 (319, 1160) 635 (464, 898) 511 (412, 972) 108511 (71716, 162138) 172148 (145340, 190155) 143005 (116047, 200158) 145612 (130673, 227104) 136971 (112787, 220212) 228557 (191745, 337239) 264108 (163303, 434441) 254731 (186555, 354290)
P-value 0.001* 0.001 (a vs b) 0.001 (a vs c) 0.013 (b vs c) 0.019* 0.99 (a vs b) 0.99 (a vs c) 0.99 (b vs c) 0.003* 0.99 (a vs b) 0.99 (a vs c) 0.99 (b vs c) 0.001* 0.99 (a vs b 0.99 (a vs c) 0.99 (b vs c)
* Overall P-value comparing control vs prolapse regardless of hormonal status;
Post-hoc P-value adjusted to a significance level of 0.017.
protein). Data were analyzed using Kruskal-Wallis test and post hoc analysis using the Mann-Whitney U test. Results: Premenopausal women with and without prolapse had similar age, parity and BMI. Subjects with prolapse had similar parity and BMI with a median stage of prolapse of III. Proenzyme and active forms of MMP-9, tropoelastin and mature elastin were uniformly increased in women with prolapse relative to controls (see Table). Only tropoelastin was significantly regulated by hormones with the highest amount in postmenopausal not on HT. Tropoelastin was suppressed by HT but not to premenopausal levels. Conclusion: Elastin and MMP-9 are increased in the vagina of women with prolapse relative to controls suggesting that this tissue is rapidly remodeling with mechanical stretch. Further studies are needed to provide insight into the increase in tropoelastin in menopausal women not on HT. Disclosures: W. Zong, None; S.E. Stein, None; B. Starcher, None; P.A. Moalli, R01HD045590, Grant/Research Support.
of surgeon characteristics including age, gender, experience, medical school attended, physical appearance and reputation on a 10 point scale ranging 0 not at all important to 10 completely important when making a decision to have surgery. Aids used to improve surgical consent understanding were similarly rated on a three point scale ranging from 1 not helpful to 3 very helpful as well as their preferred level of detail regarding a proposed surgical procedure on a three point scale ranging from 1 simple overview with no details to 3 very detailed. Women also reported on a 10-point scale their comfort with surgeons-in-training participation their surgical procedure. Data were analyzed using frequency tables and repeated measures Multivariate Analysis of Variance (MANOVA). Results: 198 women completed surveys. Mean age was 49 17 years. The majority of women were Caucasian (47%), completed high school (29%), and had undergone at least one prior surgery (89%). Women ranked the following surgeons attributes in descending order of importance (difference of 1.00 point reflect a significant difference with p 0.05); surgeon experience (9.14 1.73), reputation (8.15 2.53), medical school (5.18 3.27), physical appearance (4.84 3.32), age (4.49 3.05), and gender (2.90 3.42). Women ranked the following consent aids in descending order of helpfulness (difference of 0.11 points reflect a significant difference with p 0.05); pamphlets and brochures (2.74 0.49), easy access to a clinic nurse for questions about surgery (2.71 0.55), diagrams (2.69 0.54), and pictures (2.68 0.56). Women ranked their preferred level of detail provided regarding surgery in descending order (difference of 0.05 point reflect a significant difference with p 0.05); very detailed description of functional changes following surgery (2.92 0.32), risks (2.87 0.41), the course of recovery following surgery (2.87
Presentation Number: Paper 47 Womens Perspective on Important Surgeon Attributes and Aids to Improve Informed Surgical Consent H. Abed, P. Perera, and R. G. Rogers University of New Mexico, Albuquerque, NM Objective: To describe what patients consider important surgeon attributes and what improves their understanding when giving informed surgical consent. Methods: We surveyed women presenting for care to a womans health clinic. Data collected included patient age, race and education. Women were asked to rank the importance of a variety
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0.37), anatomic changes (2.86 0.39), alternatives to surgery (2.82 0.45), surgery benefits (2.82 0.45), who actually operates (attending surgeon or trainee) (2.72 0.54) and details about anesthesia (2.65 0.63). Women reported that they were somewhat comfortable with trainees being supervised while performing surgery (5.76 3.08), and not at all comfortable if trainees were not supervised throughout the entire surgical procedure (2.28 2.96). Conclusions: Women ranked surgeon experience and reputation as important in their decision making to have surgery. Patients prefer detailed information about functional and anatomic changes after surgery, as well as detailed description of risks associated with surgery. Disclosures: H. Abed, None; P. Perera, None; R.G. Rogers, Pfizer, Grant/Research Support; Pfizer, Consultant; Pfizer, Speakers Bureau.
part, the inconsistencies between incidence and prevalence data. These results suggest that the definition of cases in incidence studies may not fully account for prior periods of active symptom expression.
Presentation Number: Paper 48 Variation in Incontinence and Overactive Bladder W. F. Stewart,* A. G. Hirsch,* J. G. Blaivas, D. K. Newman, C. Payne, M. P. Fitzgerald, K. L. Burgio, G. Cundiff,** A. Dilley, and V. A. Minassian* *Geisinger Clinic, Danville, PA, Weill Medical College, Cornell Medical Center, New York, NY, University of Pennsylvania Medical Center, Berwyn, PA, Stanford University School of Medicine, Stanford, CA, Loyola University Health System, Maywood, IL, University of Alabama at Birmingham, Birmingham, AL, **Providence Health Care, Vancouver, BC, CANADA, GlaxoSmithKline, King of Prussia, PA Introduction: Studies report incidence estimates for overactive bladder (OAB) and incontinence that are inconsistent with prevalence estimates. This inconsistency may be explained by how studies define incidence (e.g. continent at baseline and incontinent at follow-up). It is possible that a portion of individuals thought to be non-cases at cross-section (baseline or follow-up) were actually in an inactive (symptom-free) period. We used data from the General Longitudinal Overactive Bladder Evaluation (GLOBE) to determine if variation in symptom expression, explains the inconsistencies between incidence and prevalence estimates. Methods: A random sample of 15,656 primary care patients, 40 years of age, was mailed the GLOBE Bladder Health Survey (BHS); 44% responded. A sub-sample of baseline respondents received the same survey 6 months later; 74% responded. The BHS uses a 4week recall period to assess urgency and incontinence. Occurrence was reported as never/rarely, a few times, about once a week, a few times a week, or every day. Composite scores for urgency and incontinence symptoms were derived as indicators of severity and occurrence. Change in symptom scores were modeled as categorical and continuous measures using logistic and linear regression. Covariates included age, BMI, duration, UTI, bladder problems, pelvic surgeries, BPH, births, hysterectomy, and symptom patterns. Active urgency and active incontinence were defined as symptoms at least a few times in the past 4 weeks. Results: Transition from active to inactive urgency and incontinence symptoms was higher for males, while females had higher transition rates from inactive to active (Figure 1). Age and duration of time with symptoms were associated with persistence of active symptoms for both genders. Conclusion: A high proportion of individuals transition between active and inactive symptom status over six months. Duration of time with symptoms is an indicator of persistence and possibly progression. The variation in symptom expression over short periods of time may explain, in
Disclosures: W.F. Stewart, GlaxoSmithKline, Grant/Research Support; AstraZeneca, Grant/Research Support; Roche, Grant/Research Support; Merck, Grant/Research Support; GlaxoSmithKline, Consultant; A.G. Hirsch, GlaxoSmithKline, Grant/Research Support; AstraZeneca, Grant/Research Support; J.G. Blaivas, GlaxoSmithKline, Consultant; D.K. Newman, Astellas, Grant/Research Support; Contura, Grant/Research Support; Coloplast, Consultant; P&G, Consultant; Bard, Consultant; Watson Pharma, Speakers Bureau; Novartis, Speakers Bureau; Astellas, Speakers Bureau; GlaxoSmithKline, Speakers Bureau; Allergan, Speakers Bureau; SCA, Speakers Bureau; C. Payne, Roche, Grant/Research Support; American Medical Systems, Consultant; Allergan, Consultant; Astellas, Consultant; BL Pharma, Consultant; Glaxo SmithKline, Consultant; NDI medical, Consultant; Pfizer, Consultant; Roche, Consultant; Curant, Shareholder; clinical trial Advanced Bionics, Other; Advisory Board Allergan, Other: clinical trial Celgene, Other; scientific advisory board Curant, Other; clinical trial Q-Med, Other; M.P. Fitzgerald, Pfizer, Grant/Research Support; Astellas, Grant/Research Support; Pfizer, Consultant; Astellas, Consultant; K.L. Burgio, Pfizer, Grant/Research Support; GlaxoSmithKline, Consultant; Astellas, Consultant; Ortho McNeil, Consultant; Pfizer, Consultant; G. Cundiff, GlaxoSmithKline, Consultant; A. Dilley, full time employee GlaxoSmithKline, Other; V.A. Minassian, GlaxoSmithKline, Grant/Research Support.
Presentation Number: Paper 49 Epidemiology of Daytime Urinary Frequency in CommunityDwelling Women E. S. Lukacz,* E. L. Whitcomb,* J. M. Lawrence, C. W. Nager,* and K. M. Luber *UCSD, La Jolla, CA, Kaiser Permanente Southern California, Pasadena, CA, Kaiser Permanente San Diego, San Diego, CA Objective: The objective of this study was to assess the prevalence and degree of bother from daytime urinary frequency in a communitybased population of women, and to propose evidence-based definitions of increased daytime urinary frequency. Methods: The voiding habits of 4,061 women from a communitybased sample recruited for an epidemiologic study were analyzed. The
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validated questionnaire to identify pelvic floor disorders included questions related to daytime urinary frequency and degree of bother related to daytime frequency using a 100 mm visual analog scale (VAS). Daytime urinary frequency was assessed with the question: During waking hours, how frequently do you need to empty your bladder? Responses were categorized into 1) less than every 6 hours, 2) every 5 to 6 hours, 3) every 3 to 4 hours, 4) every 1 to 2 hours, and 5) more than once per hour. We explored degree of bother for each interval of frequency of daytime voiding. Degree of bother was compared using ANOVA and Students t-tests. Associations with a twosided p-value of 0.05 were considered significant. Results: Median daytime frequency of voiding was every 3 to 4 hours. Overall, 6% of women voided less than every 6 hrs, 16% every 5 to 6 hours, 51% every 3 to 4 hours, 24% every 1 to 2 hours and 3% more than every hour. Each interval increase in daytime frequency was associated with significantly increased degree of bother as measured by VAS (Figure 1. p 0.001). The mean degree of bother for frequency of every 2 hours or more was twice that of the bother for less than every 2 hours (23.6 23.7 vs. 51.7 30.1 mm p 0.001).
Conclusions: In this cohort of community-dwelling women, most reported a daytime urinary frequency of every 3 to 4 hours. Nearly a third of women (27%) reported daytime urinary frequency of every 2 hours or more. These women were nearly twice as bothered by their frequency than those who voided less frequently than every 2 hours. The International Continence Society definition of increased daytime frequency is the complaint by the patient who considers that he/she voids too often by day. This appears to correlate well with a cutpoint of every 2 hours or more given the marked increase in degree of bother related to voiding more frequently than every 2 hours. Disclosures: E.S. Lukacz, Pfizer Inc, Consultant; Medtronic Corp, Consultant; Novartis Pharmaceuticals, Speakers Bureau; Proctor & Gamble Pharmaceuticals, Speakers Bureau; Intuitive Corp, Speakers Bureau; E.L. Whitcomb, None; J.M. Lawrence, None; C.W. Nager, None; K.M. Luber, Pfizer, Inc, Consultant; Watson Pharmaceuticals, Consultant; Astellas, Consultant; Pfizer, Inc, Speakers Bureau; Watson Pharmaceuticals, Speakers Bureau; Astellas, Speakers Bureau.
Objectives: To determine, in women without advanced pelvic organ prolapse with or without a uterus, 1) whether successful incontinence pessary fitting can be predicted by specific POP-Q measurements, and 2) whether POP-Q measures predict pessary size. Methods: In a multicenter study, 446 women with stress urinary incontinence (SUI) and POP-Q stage 2 were randomized to 1 of 3 treatment arms: 1) incontinence pessary, 2) behavioral therapy, or 3) combined. This analysis includes 252 women assigned to receive an incontinence pessary. Pessary fitting was typically performed by trained nurse practitioners, nurses, or physical therapists. Pessary fitting was considered unsuccessful if the provider obtained an inadequate fit after at least 3 attempts, the participant found the pessary painful, or the participant did not plan to use the pessary after fitting. The size and type of the pessary was used to obtain measures of the diameter of the ring or dish including the knob (bolster). Linear and logistic regression were used. Results: Mean age and body mass index were 49 years and 29 kg/m2, respectively. 94% were parous. 3% reported previous prolapse surgery, 5% previous UI surgery, and 22% previous total hysterectomy. 235 women (93%) were successfully fitted with an incontinence ring (n 122) or incontinence dish (n 113); 17 women (7%) were unsuccessfully fitted. The median number of pessaries attempted was 2. Hysterectomy, genital hiatus (GH, with or without strain) and GH/TVL (total vaginal length) ratios did not predict unsuccessful fitting (p 0.05). However, mean TVL was greater in women successfully fitted (9.6 cm compared to 8.8 cm in those unsuccessfully fitted; p 0.007). Neither total vaginal length (for women with and without a cervix,), point D in women with a cervix, or point C in women without a cervix, predicted final pessary diameter (p 0.05). Conclusions: The vast majority of women with SUI without advanced pelvic organ prolapse can be successfully fitted with an incontinence pessary by trained non-physicians. Women with a shorter vaginal length were less likely to be successfully fitted, but specific POP-Q measures were not helpful in determining incontinence pessary size. Our data suggest that the trial and error method of incontinence pessary fitting cannot be made more scientific with specific vaginal measures. Disclosures: C.W. Nager, None; ...for the Pelvic Floor Disorders Network, None.
Presentation Number: Paper 50 POPQ Measures do not Predict Incontinence Pessary Size C. W. Nager for the Pelvic Floor Disorders Network, UCSD, San Diego, CA
Presentation Number: Paper 51 Patient-Centered Goal Attainment for OAB and SUI E. R. Trowbridge, B. Tomney, V. E. Bovbjerg, K. L. Hullfish, and W. D. Steers University of Virginia, Charlottesville, VA Objective: Women with overactive bladder (OAB) and stress urinary incontinence (SUI) experience significant impairment in their quality of life. However, current outcome measures for treatment of OAB and SUI often do not directly identify or measure achievement of patient-centered goals. Our primary objective was to compare pre-treatment goals for women with OAB and SUI and quantify their attainment post-treatment. Secondary objective was comparing both quality of life and satisfaction measures. Methods: Prospective cohort of 54 women seeking care for OAB (predominant symptoms: urgency, frequency and urge incontinence) (n 27) and SUI (positive cough stress test, urodynamic SUI) (n 27) responded to open-ended questions about their personal treatment outcome goals. Women received nonsurgical therapy (bladder training, anticholinergic, pessary) or surgery (autologous fascia sling, prolapse surgery, botox). At 12-month follow-up, women reported their level of agreement that each goal had been met using a 5-point scale
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( 2 strongly disagree to 2 strongly agree). In addition, women completed: Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI-6), Patient Health Questionnaire PHQ-9 , and physical and mental health scales (SF-12). Overall satisfaction was measured on a 4-point scale (completely to not satisfied). Results: Both groups were similar in age (57.6 vs 54.4 yrs, p 0.27), race (96% Caucasian, p .98), parity (2.5 vs 2.3, p .78) and in duration of symptoms (5.2 vs 6.7 yrs, p .93). 63% of women with OAB also reported prolapse symptoms vs 41% with SUI (p 0.18). At 12 months follow-up, women with OAB reported greater goal attainment (p 0.01), despite both groups reporting similar satisfaction (satisfied/very satisfied) (p .89) with treatment. Types of goals differed significantly between women with OAB vs SUI. Women with SUI were significantly more likely than OAB women to report goals related to no longer leaking (48% vs 11%, p .006) and increasing their activity levels (19% vs 0%, p .05), whereas OAB women were more likely to report goals unrelated to pelvic floor symptoms (ie self-image/relationships) (19% vs 4%, p .08). There was no significant difference in the self-reported severity of urinary incontinence or the reported amount of urine loss between the two groups. Initial proportion of women receiving nonsurgical treatment did not differ between the groups (82% vs 78%, p .9) for OAB vs SUI women respectively. Similarly, there were no significant differences in the IIQ-7, UDI, SF-12 physical and mental health scores and depression scores between the two groups at baseline. Conclusions: Personal treatment goals differed between women with OAB and SUI but overall attainment of patient-centered goals at 1 year follow-up was similar for both groups. Our findings suggest that comprehensive treatment of PFD may benefit from identifying and specifically addressing patient-centered goals especially for women with outcome goals unrelated to pelvic symptoms. Disclosures: E.R. Trowbridge, None; B. Tomney, None; V.E. Bovbjerg, None; K.L. Hullfish, None; W.D. Steers, None.
in medical education. The number of women willing to be interviewed by a medical student or a resident (77% vs. 78%), examined in the office (41% vs. 49%) or examined under anesthesia (42% vs. 54%) were similar. Of the 49% of women willing to be examined in the office by a resident, 36% would only allow a female resident. Of the 54% of women willing to be examined under anesthesia by a resident, 84% would be agreeable to an exam by either gender. There were no women that agreed to care by a male resident but not a female resident. Women that were aware of their physicians involvement in teaching were significantly more likely to allow an interview by a medical student or resident regardless of gender (p 0.001). Additionally, being aware of this involvement in teaching was significantly associated with women allowing male (p 0.016) and female (p 0.002) residents to examine them in office but had no effect on examinations in the operating room. Women greater than 40 years old had increased odds of permitting office interviews by medical students or residents (OR 2.99, 95% CI 1.54, 5.83) in comparison to women younger than 40 years of age. Women older than 40 years also had increased odds of allowing an exam in the operating room by a female (OR 1.86, 95% CI 1.02, 3.41) or male resident (OR 2.52, 95% CI 1.30, 4.90) but not an exam in the office as compared to women less than 40 years old. The number of years that the women had been patients in the practice ( 4yrs vs. 4yrs) did not affect the decision to allow interviews or exams by any group, except for interviews by male medical students. Women in the practice 4 years had increased odds of allowing an interview by a male medical student (OR 1.66, 95% CI 1.03, 2.67). Conclusion: Prior awareness of a physicians involvement in teaching and age greater than 40 years old were associated with a patients decision to be interviewed or examined by a medical student or resident, regardless of gender. Disclosures: B.L. Robinson, None; E.K. Saks, None; M. Gopal, None; H. Harvie, None; W. Ronner, None; L. Arya, None.
Presentation Number: Paper 52 Willingness of Gynecologic Patients to be Interviewed and Examined by Female and Male Medical Students and Resident Physicians B. L. Robinson,* E. K. Saks, M. Gopal, H. Harvie, W. Ronner,* and L. Arya *Pennsylvania Hospital, Philadelphia, PA, Hospital of the University of Pennsylvania, Philadelphia, PA Objective: To assess the willingness of gynecologic patients to allow female or male medical students and residents to participate in their care in the office and operating room. Methods: A 6-item questionnaire was administered to 312 patients in a single-physician gynecology office. The willingness to be interviewed and examined in the office and operating room under anesthesia by female or male medical students and residents was determined. The following variables were collected: age, number of years as a patient in the practice and prior knowledge of their gynecologists involvement in medical education. Descriptive analysis was performed to determine the proportion of women agreeable to be interviewed and/or examined by gender. Univariable analysis was performed to determine if awareness of their physicians involvement with medical education impacted their willingness to have medical student and resident participation. Results: The mean age of the women was 50.9 15.3 years with a mean length of time of 6.6 6.4 years in the practice. Seventy-one percent of the patients were aware that their physician was involved
Presentation Number: Paper 53 Prophylactic Antibiotics to Prevent Urinary Tract Infection (UTI) During Clean Intermittent Self-Catheterization (CISC) for Management of Voiding Dysfunction After Prolapse/ Incontinence Surgery: A Decision Analysis G. Sutkin,* J. L. Lowder,* and K. Smith *Division of Urogynecology, Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, PA, Section of Decision Sciences and Clinical Systems Modeling, Department of Internal Medicine, University of Pittsburgh, Pittsburgh, PA Objective: To date, no randomized controlled trial (RCT) of prophylactic antibiotic use to prevent UTI during CISC for voiding dysfunction after prolapse/incontinence surgery has been performed. Prior to initiating a RCT to study this question, we sought to model this clinical situation using decision analysis (DA) methods. Methods: A decision tree model was constructed to evaluate risks and benefits of prophylactic antibiotic use during selfcatheterization for voiding dysfunction after prolapse/incontinence surgery in women. In this model, women requiring selfcatheterization were randomized to either prophylactic antibiotics or not. Probabilities for UTI after CISC with or without prophylactic antibiotics were obtained from published literature and from practice quality assurance reviews. Probabilities for sequelae from antibiotic use or UTI were obtained from published literature and expert consensus. The main outcome was the probability of experiencing no UTI or adverse event. Two clinical scenarios were modeled and were defined as: 1) True UTI - UTI
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symptoms and positive culture; 2) Bacteriuria - any positive urine culture with or without symptoms. Results: Under baseline assumptions, prophylactic antibiotics were favored in both models. In the True UTI model, prophylactic antibiotics had an 83.1% probability of no UTI or adverse events, 16.1% better than no prophylactic antibiotics. Prophylactic antibiotics were favored unless the probability of UTI without prophylaxis was 17% (base 33%) or the probability with prophylaxis was 32% (base 16%). Using 2-way sensitivity analysis for these two parameters, prophylaxis was favored unless the absolute risk of UTI was decreased 1% by prophylaxis (Graph 1). Results were not sensitive to variation of antibiotic adverse events within clinically plausible ranges. Similar findings were seen in the Bacteriuria analysis. Conclusions: Using decision analysis methods to evaluate risks and benefits, use of prophylactic antibiotics is favored for the prevention of UTI when CISC is used to manage voiding dysfunction after prolapsed/incontinence surgery.
were developed to identify risk factors associated with bacteriuria for each pathogen. Results: Four hundred women were included in this study. Mean ( SD) age of this cohort was 53 16 years with a range of 22 85 years. Urinary symptoms were reported by 77% of women. Thirty five percent of patients had a history of recurrent UTI. Forty two percent of women had some type of pelvic organ prolapse. Bacteruria defined as greater than 105 CFU/ml was noted in 16% (n 63) of women included in this study. The most prevalent single bacteria in this group was Escherichia coli at 43%. Thirty nine women had positive cultures with a variety of other organisms. Nitrites and leukocyte esterace were significantly associated with E. coli and Citrobacter in the urine (p 0.01). However, a significant association between urine dipstick results and other urinary pathogens was not seen. The sensitivity of positive urine nitrites or leukocyte esterase for E. coli was 0.48 (95% CI 0.31, 0.69) while the specificity for these tests were 0.97 (95 % CI 0.95, 0.99) and 0.85 (95% CI 0.81, 0.89), respectively. Similar results were noted for Citrobacter. Urine nitrites (AUC 0.73, CI 0.63, 0.82) was the most accurate single dipstick test for E coli but less so for Citrobacter (AUC 0.62, CI 0.47, 0.77). The addition of leukocyte esterase to the urine nitrite test demonstrated a trend towards improved accuracy for both E. coli (AUC 0.80, CI .71, 0.89) and Citrobacter (AUC 0.77, CI 0.61, 0.92). Urine leukocyte esterase and nitrites results were not useful for detecting bacteriuria from other pathogens in this population. After controlling for clinical factors, leukocyte esterase remained a significant predictor of bacteriuria for both E. coli (OR 2.9, CI 1.1, 7.8) and Citrobacter (OR 6.8, CI 1.7, 27.4) while the presence of urine nitrites was associated only with E. coli (OR 24, CI 8.3, 69.0). Conclusions: Although urine dipstick tests for nitrites and leukocyte esterase may be useful for screening women for the presence of E. coli and Citrobacter in the urine, other pathogens may be missed by these tests. Disclosures: G.M. Northington, None; H.S. Harvie, None; H. Adunuthula, None; L.A. Arya, None.
Disclosures: G. Sutkin, None; J.L. Lowder, None; K. Smith, None.
Presentation Number: Paper 54 The Sensitivity and Specificity of Urine Dipstick Results for Bacterial Pathogens G. M. Northington, H. S. Harvie, H. Adunuthula, and L. A. Arya University of Pennsylvania, Philadelphia, PA Objective: Although urine dipstick results for nitrites and leukocyte esterase have demonstrated good specificity for bacteriuria, the discriminatory power of these tests for specific pathogens is unknown. The primary objective of this study is to identify the predictive value of urine dipstick results for different types of pathogens detected in urine from women. Methods: We performed a retrospective chart review of all new patients reporting to the urogynecology clinic from April 2003 through May 2005. Charts were reviewed for leukocyte esterase, nitrites, bacterial counts, and pathogen identity. Demographic and clinical data were also recorded. Paired urinalysis and urine culture results were used to calculate the sensitivity and specificity of the urine dipstick for each pathogen identified. The accuracy of each test was estimated by calculating the area under its receiver operating characteristic curve (AUC). Multivariate logistic regression models
Presentation Number: Paper 55 The Association Between Regional Anesthesia and Acute Postoperative Urinary Retention in Women Undergoing Midurethral Slings K. J. Wohlrab,* N. B. Korbly,* E. A. Erekson,* C. D. Drimbarean, C. R. Rardin,* and V. W. Sung* *Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology; Alpert Medical School at Brown University, Providence, RI, Department of Anesthesiology; Women and Infants Hospital of Rhode Island, Providence, RI Objective: To estimate the association between regional anesthesia and acute postoperative urinary retention in women undergoing outpatient midurethral sling procedures. Methods: We performed a retrospective cohort study. Women undergoing outpatient midurethral sling procedures between January 2005 and December 2007 were included. Women were excluded if they underwent any concomitant procedure, or were admitted overnight following the procedure. All slings were performed under the supervision of a fellowship-trained urogynecologist at a tertiary care center. We recorded demographic, perioperative and surgical data and preoperative urodynamic results. Exposure was defined as
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the type of anesthesia, categorized as regional (spinal or combined spinal/epidural) or non-regional (general endotracheal, monitored anesthesia care with sedation, or local). Retrograde voiding trials were routinely performed on all women prior to discharge after anesthetic effects had clinically resolved and the woman was ambulatory. The retrograde voiding trial was performed by filling the bladder with 300 mL of normal saline and having the woman void within 20 minutes. Acute postoperative urinary retention was defined as a failed trial of void, or voiding less than 200 mL, for which a patient was discharged home with an indwelling catheter. Statistical analysis included descriptive statistics, chi-square, Fishers exact test, and two sample ttest, as appropriate. Multivariable logistic regression was used to estimate the effect of regional anesthesia on acute postoperative urinary retention. Variables with p-values less than 0.1 were retained in the final model. Results: A total of 130 women meet our inclusion criteria. Thirtynine (30%) women had regional anesthesia and 91 (70%) women had non-regional anesthesia. Women receiving regional anesthesia were older compared to women receiving non-regional anesthesia (57.3 vs. 50.5 years, p 0.01), but otherwise were similar in parity, previous pelvic surgery, preoperative urodynamic findings, and approach to midurethral sling (p-value greater than 0.05 for all). Overall, 49 (37.7%) women had acute postoperative urinary retention. More women who received regional anesthesia had acute postoperative urinary retention compared to women who received non-regional forms (66.7% vs. 25%, p .001). On multivariable analysis, women receiving regional anesthesia had an increased odds of acute postoperative urinary retention compared to women receiving nonregional anesthesia (OR 5.9, 95% CI 2.4, 14.0), after adjusting for age and approach to midurethral sling. Conclusions: Regional anesthesia is a risk factor for acute postoperative urinary retention following outpatient midurethral slings. Disclosures: K.J. Wohlrab, None; N.B. Korbly, None; E.A. Erekson, None; C.D. Drimbarean, None; C.R. Rardin, Boston Scientific, Consultant; V.W. Sung, None.
TABLE. Urethral Current Perception Thresholds Before and After Tolterodine Baseline CPT Median (25th-75th IQR) Urethra 2000 2.6 (1.35.4) Hz Urethra 250 Hz 1.3 (.692.1) Urethra 5 Hz 1.1 (11.9) Posttreatment CPT Median (25th-75th IQR) 1.7 (1.12.7) .75 (.4 1.2) .84 (.321.1)
P Value .92 .003 .06
Results: 17 women were enrolled and underwent baseline CPT testing. 4 of 17 (24%) discontinued medication due to side effects, did not have repeat testing, and were not included in the analysis. Participants had a mean SD age of 62 14, a median vaginal parity of 2 (range 0 4), and a median of 14 (1 40) UUI episodes per week on 7-day diary. Mean MESA urge subscale scores improved significantly from baseline after treatment (10 3.5 and 6.5 3.7, p .007). Table 1 shows baseline and post-treatment urethral CPTs. Urethral CPT at 250 Hz was significantly lower (improved sensation) after treatment with tolterodine, and urethral CPT at 5 Hz trended toward a significant decrease. Conclusion: Urethral sensitivity improves after 2 months of treatment with long-acting tolterodine. These findings suggest that this class of drugs may restore urethral sensory nerves to mediate uninhibited bladder contractions in addition to their known motor effects. Disclosures: K. Kenton, Pfizer, Grant/Research Support; L. Lowenstein, None; L. Brubaker, Pfizer, Grant/Research Support; Allergan, Grant/Research Support.
Presentation Number: Paper 56 Tolterodine Causes Measurable Restoration of Urethral Sensation in Women with Urge Urinary Incontinence K. Kenton, L. Lowenstein, and L. Brubaker Loyola University Stritch School of Medicine, Maywood, IL Objective: Antimuscarinic agents remain the mainstay of treatment for urge urinary incontinence (UUI). While the precise mechanism of benefit with antimuscarinic agents is unclear, it is likely that alterations in afferent nerve fibers play a role in treatment response. The aim of this study was to determine if tolterodine for UUI results in changes in bladder and/or urethral sensation. Methods: After IRB approval, women with 1 UUI episode per week on 7-day diary, seeking treatment were recruited. Participants were treated with 4 mg of long-acting tolterodine for 2 months. At baseline and 2 months after starting drug, all participants had Current Perception Threshold (CPT) testing and completed the validated Social Aspects of Aging Incontinence Questionnaire (MESA). CPT testing was done using a Neurometer device (Neurotron Inc, Baltimore, MD) connected to ring electrode on a 14 French catheter. CPTs were obtained in the urethra at 3 frequencies 2000 Hz, 250 Hz and 5 Hz corresponding to A- , A- , and C fibers. Baseline and post-treatment measures were compared using the Wilcoxon Signed Rank Test.
Presentation Number: Paper 57 Do Patients Want to be Involved in Treatment Decisions for Pelvic Floor Disorders? V. W. Sung,* C. A. Raker, and M. A. Clark *Alpert Medical School at Brown University, Providence, RI, Women and Infants Hospital, Providence, RI, Brown University, Providence, RI Objective: There has been an emphasis on patient involvement in medical decision making; however, patient preferences are not well studied in pelvic floor disorders (PFDs). Our objective was to validate the Autonomy Preference Index (API) and Control Preferences Scale (CPS) in women with PFDs and to identify variables associated with patient preferences for decision making and information seeking. Methods: The API and CPS have been validated in other fields. We adapted them for PFDs. The API consists of two scales: an 8-item information-seeking scale and a 6-item decision-making preference scale. Higher scores (range 0 100) indicate stronger preferences for participation. The CPS consists of one item with a 5-point scale on decision-making preferences. Patients are categorized as active, collaborative or passive, and lower scores indicate stronger preferences for involvement. We performed a cross-sectional study of women seeking care for PFDs at a tertiary care center from 10/06 10/07. Women completed the API and CPS at enrollment and 2 weeks later. Patient variables were collected. For validation, we used
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Cronbachs alpha and the intraclass correlation coefficient (ICC) to measure internal consistency and test-retest reliability. For construct validity, we hypothesized that the API decision making scale and CPS would be negatively correlated. Multiple linear regression was used to identify correlates of patient preferences in decision making and information seeking. For sample size, our null hypothesis was that ICC for the API would be moderate (ICC .5) and our alternative was that it would be good (ICC .7). At alpha .05 and beta .80, a sample of 63 women would be needed. To account for multiple comparisons and attrition, we aimed to recruit 110 women. Results: 110 women were recruited with baseline data, and 93 completed the surveys twice. Mean age was 60 18 years, 35% had prior surgery, 30% had prolapse symptoms and 70% had incontinence. The API had good psychometric properties (Cronbachs alpha .80, ICC .70). The CPS had moderate testretest reliability (ICC .50). The API and CPS were negatively correlated (r .3). The mean score for the API information seeking scale was 70 32, but the mean score for the decision making scale was 53.3 17, indicating that although women were neutral in their decision-making preference, they had a strong preference to be well informed. On the CPS, 44% preferred an active, 47% preferred a collaborative, and 9% preferred a passive role in their treatment decision. On multiple linear regression, prior physical therapy was associated with higher preferences for decision-making participation (p .05). No correlates were identified for information seeking. Age, race, symptom severity and duration were not associated with decision making or information seeking preferences. Conclusions: The API and CPS are valid in women with PFDs. Although most women prefer a collaborative role in decision-making, they have a strong preference for being well informed about their options. Disclosures: V.W. Sung, None; C.A. Raker, None; M.A. Clark, None.
nerve pierced the superficial surface of the external oblique muscle mean (range) 2.5 (1.15.1) cm medial and 2.4 (0 5.3) cm inferior to the anterior superior iliac spine (ASIS). The iliohypogastric nerve emerged 2.5 (0 4.6) cm medial and 2.0 (0 4.6) cm inferior to the ASIS. The line connecting left and right ASIS crossed midline 9 cm superior to the PS. The closest distance of the ilioinguinal and iliohypogastric nerves to a point 5 cm superior to PS and 8 cm from midline was 0.6 (0 1.6) cm and 1.3 (0 3.7) cm, respectively. At a point 2 cm superior to PS, the ilioinguinal and iliohypogastric nerves were 5.9 (4.0 8.3) cm and 3.8 (1.35.7) cm lateral from the midline, respectively. In all specimens, the width of the nerves in the anterior abdominal wall was 2 mm. Tracing from the external iliacs, the inferior epigastric vessels coursed medially toward the umbilicus. At the point 2 cm superior to the PS, they were 6.1 (4.8 7.9) cm from the midline. At the level of the ASIS, the vessels were 3.7 (2.6 5.5) cm from midline. Conclusions: Placement of lateral accessory trocars 5 cm superior to PS and 8 cm lateral to midline, as often recommended, does minimize the risk of inferior epigastric vessel injury but increases the likelihood of ilioinguinal and/or iliohypogastric nerve injury as both commonly course beneath this trocar site. To avoid injury to both nerves and vessels, lateral ports should be placed cephalad to the ASIS and 5 cm from midline. Pfannenstiel fascial incisions over 7 cm in total width may compromise the iliohypogastric nerves. The ilioinguinal nerve and inferior epigastric vessels, however, should be spared in fascial incisions narrower than 11 cm. Disclosures: D.D. Rahn, None; J.N. Phelan, None; A.B. White, None; M.M. Corton, None.
Presentation Number: Paper 58 Clinical Correlates of Anterior Abdominal Wall Neurovascular Anatomy in Gynecologic Surgery D. D. Rahn, J. N. Phelan, A. B. White, and M. M. Corton U.Texas Southwestern Medical Center, Dallas, TX Objective: The purpose of this study was to describe the relationships of relevant nerves and vessels of the lower anterior abdominal wall to common laparotomy and laparoscopic trocar incisions. Methods: Dissections were performed on 10 unembalmed female cadavers. The course of the ilioinguinal and iliohypogastric nerves was traced from the posterior abdominal wall to the lower portion of the anterior abdominal wall and labia majora. The deep inferior epigastric vessels were traced from the external iliacs to the level of the umbilicus. Measured relationships of nerves and vessels were made to a point 5 cm superior to the pubic symphysis (PS) and 8 cm lateral from midline, a commonly used landmark for accessory laparoscopic trocar insertion. Nerve and vessel positions were also measured relative to the midline 2 cm superior to the PS, a typical site for transverse incisions. Results: From their origin at L1, the ilioinguinal and iliohypogastric nerves coursed laterally toward the iliac crest, pierced the deep surface of transversus abdominus, and coursed in the plane between the transversus abdominus and internal oblique muscles. The nerves then passed medially and downward, pierced the internal oblique muscles, and traveled between the aponeuroses of the internal and external obliques. The ilioinguinal
Presentation Number: Paper 59 Episiotomy in the United States: Has Anything Changed? E. A. Frankman,* L. Wang, C. H. Bunker, and J. L. Lowder* *Magee-Womens Hospital, University of Pittsburgh, Pittsburgh, PA, Clinical and Translational Science Institute, University of Pittsburgh, Pittsburgh, PA Objective: To describe 1) episiotomy rates in the US following recommended changes in clinical practice; and 2) trends in cesarean delivery (CD) compared to trends in vaginal delivery rates, episiotomy usage, and anal sphincter laceration (ASL). Methods: The National Hospital Discharge Survey (NHDS), a federal dataset sampling inpatient hospitals, was used to obtain data based on ICD-9-CM diagnosis and procedure codes from 1979 2004. Age-adjusted rates (AAR) of term, singleton, vertex, liveborn spontaneous vaginal delivery (SVD), operative vaginal delivery (OVD), CD, episiotomy and ASL were calculated using 1990 census data for women 15 44 years of age. Results: Estimated annual deliveries (3,140,075 to 3,354,939) and AAR of SVD per 1000 women (38.1 to 36.7) remained stable from 1979 2004. AAR of OVD declined from 8.7 in 1979 to 4.6 in 2004 while CD rates increased from 8.3 in 1979 to 17.2 in 2004. Rate of episiotomy with all vaginal deliveries deceased from 51.6% in 1979 to 17.3% in 2004 with a sharp decline after 1997 from 31.0% (1998) to 17.3% (2004) (Figure 1). ASL and episiotomy trends are described in Figure 2. Conclusions: Routine episiotomy has declined since liberal usage has been discouraged. ASL rates with SVD have decreased, likely reflecting decreased usage of episiotomy. Rates of ASL with OVD have not changed and may reflect continued usage of episiotomy with OVD. Decline in OVD corresponds to a sharp increase in CD
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which may indicate practitioners are favoring cesarean delivery for difficult births.
to chronic low back pain inquiries showed a trend toward significance in favor of TAH (p 0.052). One participant from the SCH group ultimately underwent trachelectomy secondary to recurrent cervical dysplasia. Conclusion: No statistically significant differences were found with respect to lower urinary tract symptoms, prolapse or sexual function in patients undergoing TAH compared with SCH after nearly 10 years of follow up.
Disclosures: E.A. Frankman, None; L. Wang, None; C.H. Bunker, None; J.L. Lowder, None.
Presentation Number: Paper 60 Total or Supracervical Hysterectomy: Single-Site Long-Term Outcomes of the Tosh Trial W. J. Greer, T. L. Wheeler, H. E. Richter, R. E. Varner, and M. L. Mann University of Alabama at Birmingham, Birmingham, AL Objective: Two year outcomes from the Total Or Supracervical Hysterectomy (TOSH) trial were published in 2003, showing no difference in pelvic floor symptoms between groups. The purpose of this study was to characterize longer-term differences in outcomes. Methods: 54 original TOSH participants from one site were mailed the same questionnaires addressing pelvic symptoms, sexual function, and quality of life that had been previously completed. Medical and surgical histories were updated via questionnaire and medical records review. Further questions addressed any subsequent treatments for urinary incontinence, pelvic organ prolapse or other pelvic surgeries. Linear and logistic repeated measures for continuous and categorical variables were used to estimate differential improvements over time. Results: 37 of the 54 original TOSH participants (69%) at one site responded. Of these, 19 were TAH and 18 were SCH. There were no differences in baseline demographics, pelvic floor symptoms or vaginal exam findings between groups (P 0.05). Mean ( SD) follow up was 9.12 0.7 years (range 8.1 to 10.1). Within and between group results for selected outcomes are shown in the Table. No significant difference was found in any lower urinary tract or pelvic floor symptom, breast or menopausal symptoms, weight change, or need for treatment of urinary incontinence between the two groups. Within group analysis of sexual health questions showed a significant change in ability to have and enjoy sex in the TAH group (p 0.002). Two of the SCH patients (7.4%) reported a history of bleeding compared to none in the TAH group, but this was not statistically significant (p 0.05). Answers
Disclosures: W.J. Greer, None; T.L. Wheeler, None; H.E. Richter, None; R.E. Varner, None; M.L. Mann, None.
Presentation Number: Paper 61 Risk Factors that Predict Failure After Vaginal Repair of Obstetric Vesicovaginal Fistulas R. Nardos,* C. Chen, and M. Muletta* *Addis Ababa Fistula Hospital, Addis Ababa, Ethiopia, Cleveland Clinic, Cleveland, OH Objective: To identify fistula and bladder characteristics, and vaginal closure techniques which predict failures after vesicovaginal fistula repairs. Methods: A retrospective analysis of all patients with vesicovaginal fistulas that underwent vaginal repairs from January of 2006 to December of 2007. Results: Of the 1045 patients that underwent vaginal vesicovaginal fistula repair during the study period, the majority of these fistulas were mid-vaginal (26%), adjacent to one or both ureteral orifice (21%), or a combination of different locations (17%).
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TABLE. Characteristics Associated with Repair Failures Characteristics Complete urethral destruction Severe vaginal scarring Small bladder size Circumferential or urethral fistulas One layer closure Odds Ratio 8.37 4.58 3.80 2.81 1.61 95% Confidence Interval 3.2620.44 2.927.13 2.415.95 1.874.23 1.072.42
Circumferential fistulas accounted for 6% of cases and 9% of patients had either an absent urethra or a fistula that compromised the urethra. Despite the presence of a fistula, most patients still had a fair or good residual bladder size (84%) and had only minimal scarring of their vaginas (85%). Forty-eight percent of patients underwent a one layer closure of their fistulas while 52% underwent a two or more layer closure. The short-term cure rate was 74% with a 10% failure rate that required reoperation and a 15% stress incontinence rate. Bladder and fistula characteristics that were significantly associated with repair failures were bladders with complete urethral destruction, severe vaginal scarring, small bladders, and fistulas that were circumferential or involved the urethra (Table). Additionally, one layer fistula closures were also associated with fistula repair failures. However, as most small bladders were only amenable to one layer closure, after excluding small bladders (16%), one layer bladder closures were not significantly associated with repair failures. Conclusions: Risk factors for failure after vaginal repair of vesicovaginal fistulas include bladders that are small with complete urethral destruction, fistulas that involve the urethra or are circumferential, severe vaginal scarring, and one layer repair of fistulas. However, after excluding small bladders, one layer closures were not associated with repair failures. Disclosures: R. Nardos, None; C. Chen, None; M. Muletta, None.
validated with 100 women treated at the same institution who were not utilized in creating the original model. In this way, we could calculate expected and observed complications rates for validation. Results: The model was developed using 712 patients, of whom 139 (19.5%) had a non-UTI morbidity within 9 weeks following hysterectomy. The following variables were found to be significantly associated with increased morbidity: congestive heart failure (CHF) or prior myocardial infarction (MI) (OR 13.0, 95% CI 2.7 63.5), change (pre-post) in hemoglobin 3.1 g/dL (OR 2.4, 95% CI 1.63.8), preoperative hemoglobin 12.0 g/dL (OR 3.3, 95% CI 1.9 5.5), and prior thrombosis (OR 2.7, 95% CI 1.0-6.8). The c-index, summarizing the overall predictive ability of this model, was 0.68. The predicted probabilities of having a non-UTI morbidity as estimated by the model were similar to the observed rates in the validation sample. For example, among the patients with a decrease in hemoglobin as their sole risk factor, the predicted probability of a non-UTI morbidity was 26% (95% CI 20 32%) compared to an observed rate of 21% in the validation sample. Conclusion: We identified variables that predispose women undergoing benign vaginal hysterectomy to increased perioperative morbidity. Specifically, CHF or prior MI, change in hemoglobin 3.1 g/dL, preoperative hemoglobin 12.0 g/dL and prior thrombosis were associated with more complications. Determining risk-adjusted rates of complications allows providers to focus on areas where greater impact on patient care and quality improvement can be made. Disclosures: C.A. Heisler, None; A.L. Weaver, None; L.J. Melton, III, None; J.B. Gebhart, Bard, Grant/Research Support.
Presentation Number: Paper 62 Risk-Adjusted Perioperative Morbidity Model for Women Undergoing Vaginal Hysterectomy C. A. Heisler, A. L. Weaver, L. J. Melton, III, and J. B. Gebhart Mayo Clinic, Rochester, MN Objective: To develop and evaluate the utility of a risk-adjusted model for perioperative morbidity following vaginal hysterectomy. Methods: The medical records of all adult women who had a vaginal hysterectomy (VH) for benign indication at a single institution during 2004 2005 were reviewed for demographics, baseline medical status, peri-operative findings, surgical procedures and complications within 9 weeks post-surgery. Morbidity outcomes included hospital readmission, reoperation, unplanned ICU admission or any medical problem requiring intervention. Multivariate logistic regression models were fit, using stepwise and backward selection, to identify factors significantly associated with perioperative non-UTI morbidity. Since urinary tract infection (UTI) was considered to be a relatively minor complication that did not increase additional morbidity, the regression model was adjusted for it. Associations were summarized by calculating odds ratios (OR) and corresponding 95% confidence intervals (CI) using the parameter estimates from the model. This model was internally
Presentation Number: Paper 63 Incontinence Surgery is not Indicated as Prophylaxis in All Women Undergoing Abdominal Sacrocolpopexy D. M. Elser,* E. J. Stanford, M. D. Moen, K. Keil, and C. A. Matthews *Illinois Urogynecology, LTD, Oak Lawn, IL, University of Tennessee Memphis, Memphis, TN, Illinois Urogynecology, LTD, Park Ridge, IL, Keil Urogynecology, Denver, CO, Virginia Commonwealth University, Richmond, VA Objective: Based on recent literature, many gynecologists began to perform an incontinence procedure at the time of all pelvic organ prolapse (POP) surgery. The more common practice among pelvic reconstructive surgeons is to rely on urodynamic testing with and without prolapse reduction to determine if an anti-incontinence procedure is indicated. Our objective is to evaluate the utility of urodynamic testing in determining the need for anti-incontinence surgery in a cohort of women undergoing sacrocolpopexy (ASC). Methods: Records of 238 women who underwent Abdominal Sacrocolpopexy (ASC) by 9 surgeons during the time period 20052007, inclusive, in 5 university and private practice Urogynecology centers were identified through billing records & reviewed. Baseline demographics, pre-operative (pre-op) history and physical examination, pre-op urodynamics results, operative procedure, 6 week post op visit, and the last recorded visit were recorded and analyzed. Responses were considered positive if patient reported any episodes of incontinence, or urgency,without attempt to quantify frequency or severity. Results: Mean age was 60.9 (35 89). Pre-op urodynamics confirmed urodynamic stress incontinence (USI) in 106 (44%) women, 25 (10.5%) of whom were diagnosed with occult or potential stress incontinence. Sixty-eight (29%) women received a midurethral sling, while 44 (18%) women underwent a Burch procedure. Table I reports post op bladder function symptoms at 6 weeks & at last visit with a
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TABLE. Baseline N 238 6 weeks N 238 Long term visit (N 147)
Any symptoms of 23 (11%) 21 (14%) incontinence Any symptoms of urgency/ 35 (17%) 26 (18%) frequency Urgency/ frequency post op 13 (6%) 10 (7%) and DO pre op Urgency frequency both pre 10 (5%) 14 (9.5%) op and post op New urgency/ frequency 10 (5%) 14 (9.5%) post op No USI/ No occult USI/ No 115/124 (93%) 84/89 (94%) incontinence surgery & no incontinence post op No USI/ No occult USI/ No 9/124 (7%) 5/89 (6%) incontinence surgery & any incontinence post op
baseline diaries; at least some moderate bladder problems; and being sexually active and in a heterosexual relationship for 6 months. Subjects completed 5-day bladder diaries, the validated Overactive Bladder Questionnaire (OAB-q), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ), Sexual Quality of Life-Female questionnaire (SQOL-F), and the Hospital Anxiety and Depression Scale (HAD) at baseline and weeks 12 and 24. Data from women who received TOL ER during both the DB and OL phases were assessed. Results: Among 202 women randomized to TOL ER, 161 received TOL ER for the entire 24 weeks. Compared with baseline, women reported significant improvements in all endpoints at week 12 that were maintained during the OL phase (Table). Improvements in most endpoints became significantly larger from weeks 12 to 24, except UUI episodes per 24 h; nocturnal micturitions; and PISQ total, Behavioral/Emotive, and Partnerrelated scores. At week 12, subjects reported a 100% median reduction in UUI episodes vs baseline, with 57% of subjects reporting no UUI episodes in 5-day diaries at week 12. At week 24, subjects reported an additional 45% median reduction in UUI episodes, with 70% of subjects reporting no UUI episodes at week 24. Conclusion: TOL ER significantly improved OAB symptoms and HRQL of women within the 12-week DB phase of this study; these improvements were maintained or became significantly greater during the subsequent 12-week OL phase. The number of women reporting no UUI episodes on a 5-day diary also continued to improve from weeks 12 to week 24. These data suggest that longterm compliance with OAB pharmacotherapy is important for optimal treatment outcomes.
mean 41.8 weeks (range 8 96). At the remote visit, 10 patients requested further intervention for stress incontinence and 1 patient planned sacral neuromodulation for severe DO. There were 124 (52%) women who did not demonstrate USI or occult stress incontinence pre-operatively and who did not receive an incontinence procedure at the time of ASC. At 6 weeks, 9 (7%) of these women demonstrated any symptoms of incontinence. Conclusions: Using urodynamic evaluation of lower urinary tract function to determine whether or not to perform an incontinence procedure at the time of ASC appears to be a highly effective approach. Routinely performing incontinence procedures at the time of all POP surgeries, as suggested by some authors, is not supported by our data. Disclosures: D.M. Elser, Novasys Medical, Grant/Research Support; Ethicon, Consultant; Boston Scientific, Paid Instructor; E.J. Stanford, Coloplast, Consultant; M.D. Moen, Boston Scientific, Consultant; Ethicon, Consultant; Allergan, Speakers Bureau; Astellas, Speakers Bureau; K. Keil, Intuitive Surgical, Speakers Bureau; C.A. Matthews, Proctor and Gamble, Consultant; Pfizer, Consultant.
Presentation Number: Paper 64 Continued Improvement in Overactive Bladder Symptoms and Quality of Life in Sexually Active Women With Overactive Bladder And Urgency Urinary Incontinence Treated With Tolterodine Extended Release for 6 Months R. Rogers,* G. Bachmann, F. Sun, and J. D. Morrow *Univ of New Mexico School of Medicine, Albuquerque, NM, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, NJ, Pfizer Inc, New York, NY Objective: To assess improvements in overactive bladder (OAB) symptoms and health-related quality of life (HRQL) during a 24week study of tolterodine extended release (TOL ER) in sexually active women with OAB and urgency urinary incontinence (UUI). Methods: This study consisted of a 12-week, double-blind (DB), randomized, placebo-controlled phase immediately followed by a 12week open-label (OL) phase. Women reported OAB and UUI symptoms for 3 months; 8 micturitions, 3 micturition-related urgency episodes, and 0.6 UUI episodes per 24 hours in 5-day
Disclosures: R. Rogers, Pfizer Inc, Consultant; G. Bachmann, Pfizer Inc, Consultant; F. Sun, Employee-Pfizer Inc, Other (please specify type of relationship and company name); J.D. Morrow, EmployeePfizer Inc, Other.
Presentation Number: Paper 65 Impact On Variation in Symptoms V. A. Minassian,* D. Newman, J. Blaivas, M. P. Fitzgerald, C. Payne, G. Cundiff, K. Burgio,** A. Dilley, A. G. Hirsch,* and W. F.
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Stewart* *Geisinger Health System, Danville, PA, Penn Center for Continence and Pelvic Health, Berwyn, PA, Weill Medical College at Cornell University, New York, NY, Loyola University Medical Center, Maywood, IL, Stanford University School of Medicine, Stanford, CA, Providence Health Care, Vancouver, BC, Canada, **Director of UAB Continence Program, Birmingham, AL, GlaxoSmithKline, King of Prussia, PA Objectives: The relative impact of urgency, frequency and nocturia among overactive bladder (OAB) patients is debated. One test of the relative importance of urgency, frequency and nocturia is to determine their ability to predict changes in behaviors used to adapt to OAB. We used the General Longitudinal Overactive Bladder Evaluation (GLOBE) to determine the comparative validity of baseline symptom scores in predicting behavior change between baseline and six-month scores. Methods: The GLOBE Bladder Health Survey (BHS) was mailed to a random sample of 15,656 primary care patients, 40 years of age (response rate 44%, n 6856). A sub-sample of respondents received the same survey 6 months later, and 74% (n 2748) responded. The BHS used a 4-week recall to assess urgency, nocturia, frequency, incontinence and adaptive behaviors. Composite scores were derived for prevalence of urgency, nocturia, frequency, incontinence, and of general adaptive behaviors as indicators of severity/occurrence. Symptom specific behavior scores were derived for nocturia, urgency, and incontinence. Change in behavior scores between baseline and 6 months were modeled using linear regression. The independent variables were change in symptom scores. Covariates included age and time since onset. We used the partial r2 for each symptom to compare the relative strength of the association with change in adaptive behavior score. Results: The sample included 1537 women and 1182 men. Table 1 describes partial correlation coefficients to indicate the relative amount of variance in the outcome explained by the independent symptom variable. Change in symptoms status partially explained change in behavior, with the partial correlations consistently stronger in females. Change in urgency score had the strongest correlation with behavioral change scores. Conclusion: Among OAB symptoms and features, urgency is clearly the strongest predictor of change. Moreover, a comprehensive model that includes urgency, frequency and nocturia adds relatively little to the predictive validity above and beyond urgency alone.
Disclosures: V.A. Minassian, GlaxoSmithKline, Grant/Research Support; D. Newman, Astellas, Grant/Research Support; Contura, Grant/Research Support; Coloplast, Consultant; P&G, Consultant; Bard, Consultant; Watson Pharma, Speakers Bureau; Novartis, Speakers Bureau; Astellas, Speakers Bureau; GSK, Speakers Bureau; Allergan, Speakers Bureau; SCA, Speakers Bureau; J. Blaivas, GlaxoSmithKline, Consultant; M.P. Fitzgerald, Pfizer, Grant/Research Support; Astellas, Grant/Research Support; Pfizer, Consultant; Astellas, Consultant; C. Payne, Roche, Grant/Research Support; American Medical Systems, Consultant; Allergan, Consultant; Astellas, Consultant; BL Pharma, Consultant; GlaxoSmithKline, Consultant; NDI medical, Consultant; Pfizer, Consultant; Curant, Shareholder; clinical trial Advanced Bionics, Other; clinical trial Celgene, Other; clinical trial Q-Med; Advisory board Allergan, Other; scientific advisory board Curant, Other ; G. Cundiff, GlaxoSmithKline, Consultant; K. Burgio, Ortho McNeil, Grant/Research Support; GlaxoSmithKline, Consultant; Pfizer, Consultant; Astellas, Consultant; Ortho McNeil, Consultant; advisory board Astellas, Other; A. Dilley, full time employee GlaxoSmithKline, Other; A.G. Hirsch, GlaxoSmithKline, Grant/Research Support; AstraZeneca, Grant/Research Support; W.F. Stewart, GlaxoSmithKline, Grant/Research Support; AstraZeneca, Grant/Research Support; Roche, Grant/Research Support; Merck, Grant/Research Support; GlaxoSmithKline, Consultant.
Presentation Number: Paper 66 Association Between Urinary Incontinence And Depressive Symptoms In Overweight And Obese Women V. W. Sung,* A. L. Hernandez, T. L. Wheeler II, D. S. West, D. L. Myers,* and L. L. Subak *Alpert Medical School at Brown University, Providence, RI, University of California, San Francisco, CA, University of Alabama, Birmingham, Birmingham, AL, University of Arkansas for Medical Sciences, Little Rock, AR Objective: To estimate the association between urinary incontinence (UI) and depressive symptoms in overweight and obese women. Methods: A total of 338 incontinent and overweight women in the Program to Reduce Incontinence by Diet and Exercise (PRIDE) clinical trial were randomized to a 6-month lifestyle intervention (weight loss and exercise) or a structured education program. At baseline, women completed the Becks Depression Index (BDI) and were categorized as having no depressive symptoms (BDI score 9) or as having depressive symptoms (BDI score 10), according to standard BDI scoring. Number and type of UI episodes were determined by selfreport on a 7-day voiding diary. Effect of UI on quality of life was measured by the 30-item Incontinence Impact Questionnaire (IIQ). Multivariable logistic regression analysis was used to identify independent risk factors for depressive symptoms at baseline. Variables with p 0.1 were retained in the final multivariable model. Results: At baseline, the mean age of participants was 53 11 years, body mass index (BMI) was 36 6 kg/m2, weekly number of UI episodes was 24 18 episodes. Thirty percent (N 101) of women had BDI scores suggestive of some degree of depression. Compared to women without depressive symptoms, women with depressive symptoms were younger (mean age 51 vs. 54 years, p .03), less likely to have any college education (81% vs. 89%, p .05) and had minimally higher BMI (mean 37 vs. 36 kg/m2, p .06). In addition, women with depressive symptoms reported a higher number of UI episodes per week (mean 28 vs. 23 UI
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episodes, p .005), a higher number of stress incontinence episodes per week (11 vs. 9, p .05), and worse scores on the IIQ (136 vs. 97, p .001) than women without depressive symptoms. In separate multivariable analyses, we found the risk for having depressive symptoms increased with each 7-unit increase in UI episodes per week (OR 1.10, 95% CI 1.011.21) and each 50-point increase in IIQ (OR 1.43, 95% CI 1.20 1.70). Conclusions: Urinary incontinence and worse incontinencespecific quality of life measured by the IIQ were independently associated with depressive symptoms among overweight and obese women. Disclosures: V.W. Sung, None; A.L. Hernandez, None; T.L. Wheeler II, Pfizer, Speakers Bureau; D.S. West, None; D.L. Myers, None; L.L. Subak, Pfizer, Grant/Research Support.
Presentation Number: Paper 67 Prevalence And Degree of Bother From Pelvic Floor Disorders In Obese Women E. L. Whitcomb,* E. S. Lukacz,* J. M. Lawrence, C. W. Nager,* and K. M. Luber *University of California San Diego, La Jolla, CA, Kaiser Permanente Southern California, Pasadena, CA, Kaiser Permanente San Diego Medical Center, San Diego, CA Objective: To determine the prevalence and degree of bother from pelvic floor disorders (PFD) in obese women from a managed care population and to evaluate whether their prevalence is higher among women with greater degree of obesity. We hypothesized that the prevalence and degree of bother from PFD would increase among more obese women. Methods: A secondary analysis was performed on 1,155 obese (BMI 30 kg/m2) female members of a health maintenance organization enrolled in a large epidemiologic study of 4,458 women. A validated questionnaire identified women with pelvic organ prolapse (POP), stress urinary incontinence (SUI), overactive bladder (OAB), and anal incontinence (AI). Degree of bother from PFD was assessed using a 100 mm visual analog scale (VAS). The prevalence of PFD and degree of bother were compared across three categories of obesity (obese 30 kg/m2, super-obese 35 kg/m2 and morbidly obese 40 kg/m2). Chi-squared and Kruskal-Wallis analyses were used to compare the prevalence of PFD by degree of obesity. ANOVA was used to compare mean VAS scores across the three groups. Associations with a two-sided p-value 0.05 were considered significant. Results: The mean age SD of the obese cohort was 56.4 14.8 years, and the mean BMI 35.4 5.3 kg/m2. The prevalence of PFD was: POP 9%, SUI 24%, OAB 22%, AI 29%, and any one or more PFD 46%. The prevalence (%, CI) of any PFD was highest in morbidly obese women (57%, 49% 64%) compared to super-obese (53%, 47%58%) and obese women (44%, 41% 48%), p 0.05. A significant increase in the prevalence of POP, SUI, and any PFD was found in morbidly obese women compared to obese women, and in the prevalence of SUI in super-obese women compared to obese women. Although not statistically significant, a trend of increasing prevalence of OAB and AI was seen with higher degree of obesity. There were no significant differences in the prevalence of PFD between morbidly and super-obese women. Degree of bother for PFD did not vary by degree of obesity.
Conclusions: In this population, there was a consistent trend of increasing prevalence of PFD with higher degree of obesity, however degree of bother related to these conditions did not vary with increasing degree of obesity. Future study should explore PFD as an indication for weight reduction. Disclosures: E.L. Whitcomb, None; E.S. Lukacz, Pfizer Inc., Medtronic Corp., Consultant; Novartis Pharmaceuticals, Proctor & Gamble Pharmaceuticals, Intuitive Corp., Speakers Bureau; J.M. Lawrence, None; C.W. Nager, None; K.M. Luber, Pfizer Inc., Watson Pharmaceuticals, Astellas, Consultant; Pfizer Inc., Watson Pharmaceuticals, Astellas, Speakers Bureau.
Presentation Number: Paper 68 Optimism, Pessimism, And Female Sexual Function M. GOPAL,* T. Chua, and L. Arya* *University of Pennsylvania, Philadelphia, PA, Boston Univeristy School of Medicine, boston, MA Objective: Optimism and pessimism are two opposing outlooks on life that can affect all aspects of a womans life including her sexual function. The primary aim of this study was to determine the association between optimism and female sexual function. The secondary aim was to determine if there is an association between a womans perception of her partners sexual function and her own sexual function. Methods: 222 consecutive women reporting to a suburban gynecology clinic for their annual gynecologic examination participated in this cross-sectional study. Self-reported questionnaires were administered to the study participants. Female sexual dysfunction was measured by the Female Sexual Function Index (FSFI) and defined as an FSFI score of 27 or greater. The Life Orientation Test-Revised (LOT-R) was used to measure optimism and pessimism. The Center for Epidemiologic Studies Depression scale was used to determine depression. Other covariates of interest included: stress and urge incontinence, exercise, difficulty with sleep, BMI, age and number of prescribed medications. Questions measuring a womans perception of her partners sexual drive and recent sexual interaction were also administered. Associations predictive of female sexual dysfunction were determined by univariate analysis and multivariable logistic regression. Results: Seventy-six women with sexual dysfunction were compared to 146 women without sexual dysfunction. On univariate analysis, significant risk factors for female sexual dysfunction were age (OR 1.02, 95%CI: 1.00; 1.05), exercise (OR 0.34, 95%CI: 0.16; 0.74), and
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use of two or more prescription medications (OR 3.06, 95%CI: 1.30; 7.16). Women who perceived their partner as having a low sexual drive (OR 4.50, 95%CI: 2.04; 9.91) or those with partners that initiated sexual activity less than half the time (OR 6.63, 95%CI 2.01; 21.9) had increase odds of sexual dysfunction. Women in the sexual dysfunction group had lower optimism scores in comparison to women without sexual dysfunction (8.1 2.5 vs. 8.7 2.5, p 0.12). On multivariable regression, independent risk factors for female sexual dysfunction were age (OR 1.06, 95%CI 1.02; 1.10), intake of anxiety or depression medication (OR 5.41, 95%CI: 1.68; 17.43) and perception of her partners sexual function as being low (OR 6.67, 95%CI: 1.30; 33.33). Women who exercised (OR 0.18, 95%CI: 0.04; 0.75) and were optimistic (OR 0.73, 95%CI: 0.53; 0.99) had significantly decreased odds of sexual dysfunction. Conclusions: Optimistic women have decreased odds of sexual dysfunction. A womans perception of her partners sexual function is associated with her own sexual function. Disclosures: M. Gopal, None; T. Chua, None; L. Arya, None.
mean difference in total scores of the assessments was 0.1, SD 3.28, p-value 0.7094, indicating no statistical differences between scores of the modified vs. the unchanged PISQ-12. The correlation coefficient was 0.9217. Of note, there were no significant differences in PISQ-12 scores between women with different sexual preferences. Conclusions: This study showed a very strong significant correlation between the previously validated PISQ-12 and the modified PISQ-12, which includes a preliminary assessment of sexual activity and sexual preference. Based on these results the modified PISQ-12 can be reliably used in comparative studies assessing sexual function providing crucial information on baseline sexual-activity status and sexual preference of the participants. Disclosures: S.O. Aschkenazi, None; T. Gamble, None; A. Nguyen, None; R. Kuo, None; S.M. Botros, None; P.K. Sand, Indevus Pharmaceuticals, AMS, Astellas, Consultant; R.P. Goldberg, Boston Scientific., Consultant; Boston Scientific., Paid Instructor.
Presentation Number: Paper 69 Modification of the PISQ-12, the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, to Assess Sexual Activity and Sexual Preferences S. O. Aschkenazi, T. Gamble, A. Nguyen, R. Kuo, S. M. Botros, P. K. Sand, and R. P. Goldberg Northwestern University, Feinberg School of Medicine, Evanston, IL Objective: The short version of the PISQ questionnaire containing 12 selected questions from the long form was previously validated and found to predict long-form scores. It has good validity, reliability and is responsive to change in sexually active women. It is easily understood and rapidly completed. However, it does not assess the base-line sexual-activity status and sexual-preference of respondents. In view of its many attributes and familiarity among physicians treating pelvic-floor disorders, we aimed to test whether a modified version of the PISQ-12, which includes two preliminary questions regarding sexual-activity in the past 6 months and sexual preference (heterosexual/same-sex partner/both) would be as reliable, and could be used interchangeably, or complement the original PISQ-12. Methods: As part of a cross-sectional, multi-item, epidemiologic survey, 154 women volunteers completed a modified PISQ-12 questionnaire, which included the addition of two preliminary questions addressing sexual activity in the past six months and sexual preferences (heterosexual vs. same-sex partner). In addition, participants completed the un-modified PISQ-12 questionnaire, which included the12 questions assessing sexual function. In half the cases, the modified PISQ-12 was presented at the beginning of survey with the unaltered PISQ-12 at the end. This order was reversed for the remaining of the surveys. Mean PISQ-12 and individual PISQ-12 scores were compared between the modified PISQ-12 assessing sexual activity and sexual preference, and the unmodified questionnaire. The mean total and individual PISQ-12 item-scores, standard deviations (SD), range and P-values were calculated and compared using a nonparametric test (signed-rank test) for non-continuous variables graded by a Likert scale (0 4). Intraclass correlation coefficient between total/individual scores of the 2 questionnaires was calculated via oneway ANOVA, to assess the reliability/agreement between the two times measurements. An ICC 0.9 is considered as excellent reliability. Results: There were 148 pairs of modified and unaltered PISQ-12 questionnaires, which were complete and eligible for analysis. The
Presentation Number: Paper 70 Urinary Incontinence, Depression and PTSD in Women Veterans C. S. Bradley,* I. E. Nygaard, M. A. Mengeling, C. M. Kennedy,* J. C. Torner, and A. G. Sadler *University of Iowa, Dept. of Ob/Gyn, Iowa City, IA, University of Utah, Dept. of Ob/Gyn, Salt Lake City, UT, Veterans Affairs Medical Center, Iowa City, IA, University of Iowa, Department of Epidemiology, Iowa City, IA Objective: To measure associations between urinary incontinence (UI) symptoms, depression and post-traumatic stress disorder (PTSD) in women veterans. Methods: This cross-sectional study included women veterans 50 years of age who sought care at 2 Midwestern VA Hospitals and clinics in the preceding 5 years. Participants completed a computerassisted telephone interview assessing urogynecologic, medical and mental health disorders. We defined depression and PTSD using the short form Composite International Diagnostic Interview and Posttraumatic Diagnostic Scale, respectively, and used standardized epidemiologic items to identify UI type and frequency. Bi- and multivariable analyses compared characteristics and associated conditions between women with urge/mixed UI and no UI and between women with stress UI only and no UI. Results: 925 (62%) of 1493 eligible women enrolled and completed data collection. After excluding 32 with current/recent pregnancy, 893 were included in this study. Mean (SD) age and body mass index were 39.0 (8.6) years and 28.2 (6.2) kg/m2. Median parity was 2. 81% were Caucasian. 60% served in the regular military, 11% in the Reserves/National Guard, and 28% in both. 181 (20.3%) reported urge UI a few times monthly or more (Urge/Mixed UI). 140 (15.7%) reported stress (only) UI symptoms a few times monthly or more (Stress UI). 305 (34.2%) had no UI symptoms (No UI). Compared to those with no UI, women with any type of UI were older, more parous, heavier and had more chronic medical problems (p 0.001 each). Brain injury and sexual assault were more common in those with Urge/Mixed UI compared to no UI (p 0.001 for both). Women with Urge/Mixed UI had higher rates of depression and PTSD (p 0.0001 for both) and lower SF-12 mental component scores (p 0.0005) compared to women with no UI. Women with stress UI were similar to those with no UI in these parameters. After controlling for other factors, depression and PTSD remained significantly associated with Urge/Mixed UI (adjusted OR 95%CI 1.7 1.1, 2.7 and 2.0 1.2, 3.3 , respectively).
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TABLE. No UI (n 305) Age (y) SF-12 Mental Component History head/ brain injury History sexual assault Depression PTSD 35.6 47.6 29.2% 41.3% 23.6% 23.9% 9.2 7.8 Urge/Mixed UI (n 181) 42.6 44.8 44.2% 63.5% 42.5% 42.5% 6.6 8.9 Stress UI (n 140) 40.1 47.1 30.7% 47.1% 28.6% 24.3% 7.4 8.1
(Data not presented from women with infrequent UI (few times yearly)).
Conclusions: Unlike women veterans with stress UI only, those with urge/mixed UI symptoms are more likely to have depression, PTSD and poorer mental health-related QOL than those with no UI. Disclosures: C.S. Bradley, Pfizer, Speakers Bureau; Merck, Shareholder; I.E. Nygaard, None; M.A. Mengeling, None; C.M. Kennedy, Glaxo Smith Kline, Grant/Research Support; Merck, Grant/Research Support; Takeda, Grant/Research Support; J.C. Torner, None; A.G. Sadler, None.
Results: The most commonly used treatments were LAX and FS: 42.1% and 38.9% respectively at baseline, and 37.8% and 38.8% at 6 months. Among subjects who used LAX or FS at baseline, 68.7% and 67.8% continued with LAX or FS at 6 months. Significant predictors of LAX use at 6 months were baseline LAX use (p 0.008, OR 3.17) and CSI at 6 months (p 0.04, OR 1.09). Total variance explained was 12.8%. Baseline perceived effectiveness, SE severity and satisfaction with LAX did not predict whether subjects would use LAX at 6 months follow-up. None of the examined variables were identified by the regression analysis as predictors of LAX persistent use. Logistic regression analysis identified baseline FS use (p 0.003, OR 2.79) as the significant predictor of using FS at 6 months follow-up. Total variance explained was 11.3%. None of the examined variables were predictors of FS persistent use. Conclusions: LAX and FS are the most commonly and most persistently used treatments for CC. Approximately 2/3 of subjects persist in their use of these treatments for at least 6 months. Baseline LAX or FS treatment predicts the use of these treatments in 6 months. In addition, CSI at 6 months influences LAX use on follow-up. Surprisingly, baseline perceived effectiveness, SEs and satisfaction with LAX or FS are not predictors of use of these treatments at 6 months. No variable is identified as a predictor of persistent use of either LAX or FS. Disclosures: T. Nguyen, None; O. Palsson, None; M. Von Korff, None; A. Feld, None; R. Levy, None; M. Turner, None; W. Whitehead, Novartis Pharmaceuticals, Grant/Research Support; R24 DK67674, Grant/Research Support.
Presentation Number: Paper 71 Treatment Use In Patients With Chronic Constipation T. Nguyen,* O. Palsson,* M. Von Korff, A. Feld, R. Levy, M. Turner,* and W. Whitehead* *University of North Carolina, Chapel Hill, NC, Group Health of Puget Sound, Seattle, WA, University of Washington, Seattle, WA Objective: To determine a) which treatments are used most commonly and most persistently in patients with chronic constipation (CC) by Rome III criteria, b) what influences the use of these treatments at 6 month follow-up and c) what influences the persistent use of these treatments. Methods: HMO patients with a clinical diagnosis of CC (ICD-9CM code 564.0X) in the last year and subjects (matched by age and sex) without a CC diagnosis for the previous 5 years were invited to complete a postal survey. Participation rate was 66.2% (n 1707). Subjects from either sampling group meeting Rome III criteria for CC at baseline (n 936) were invited to complete a 6 month follow-up survey, and 789 of them (84.3%) did so. The analysis sample for the current study was 789 subjects with CC who completed the followup. The baseline and follow-up questionnaires included demographics, the Constipation History Questionnaire, Rome III Diagnostic Questionnaires, constipation treatments for the past three months, and ratings of treatment effectiveness, side-effect (SE) severity and satisfaction. Persistent use was defined as use of a treatment at baseline plus the 6-month follow up. Statistical analysis involved logistic regression using SPSS. Dependent variables in separate regression analyses were laxative (LAX) or fiber supplement (FS) use at 6 months, and persistence of LAX or FS use. Independent variables were demographics, the validated Constipation Severity Index (CSI) at baseline and at 6 months, baseline Rome III IBS diagnosis, baseline treatment use, and baseline perceived treatment effectiveness, SEs, and satisfaction.
Presentation Number: Paper 72 Patient-Centered Treatment Goals for Pelvic Floor Disorders: Association With PFD-Specific And General Quality of Life V. E. Bovbjerg,* E. R. Trowbridge,* M. D. Barber, T. E. Martirosian,* W. D. Steers,* and K. L. Hullfish* *University of Virginia School of Medicine, Charlottesville, VA, Cleveland Clinic, Cleveland, OH Objective: To determine the relationship of PFD patient-centered goals to PFD-specific and general quality of life and health status measures; patient-centered goals should be related to, but not identical to, PFD-specific and general measures of quality of life and well being, with stronger associations to PFD-specific measures. Methods: As part of a one year cohort study of patient-centered outcomes of PFD treatment, 143 women with PFD identified up to five goals for PFD treatment, and reported their level of goal attainment ( 2 worst possible outcome to 2 best possible outcome ) at 1.5, 3, 6, and 12 months. Mean goal attainment was calculated by summing individual goal attainment for each participant at each interval, and dividing by the number of goals, so that positive values indicated greater goal attainment and negative values relative lack of goal attainment (range 2 to 2). At those same intervals, participants completed brief measures of PFD-specific quality of life (Incontinence Impact Questionnaire IIQ-7 , Urogenital Distress Inventory UDI-6 , Incontinence Quality of Life I-QOL ), as well as general measures of depression (nine item Patient Health Questionnaire PHQ-9 ), and emotional and physical functional status (SF-12 physical PCS and mental health MCS scales). The associations of goal attainment to quality of life and health status were estimated using Pearson product moment correlation coefficients, such that positive coefficients indicated that greater goal attainment was associated with higher quality of life, better health status, and fewer depressive symptoms.
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Results: At 12 months, goal attainment was moderately correlated with IIQ-7 (r 0.32, p 0.01), UDI-6 (r 0.40, p 0.01), and I-QOL total (r 0.46, p 0.01), and avoidance (r 0.40, p 0.01), psychological (r 0.37, p 0.01), and social (r 0.55, p 0.01) subscales. Goal attainment was weakly correlated with PHQ-9 (r 0.27, p 0.02) and SF-12 mental health (r 0.28, p 0.02) scales, and not significantly associated with SF-12 physical (r 0.19, p 0.11) scale scores. Correlation patterns for follow-up visits at 1.5, 3, and 6 months showed similar associations, with no significant associations of goal attainment and PHQ-9 to SF-12 scores at either 1.5 or 3 months. Conclusion: Achievement of patient-identified goals for PFD treatment was consistently but moderately associated with PFDspecific measures of quality of life, suggesting that goal attainment is related to but not synonymous with condition-specific quality of life. The association of goal attainment to general QOL measures has not been previously reported: the lack of consistent associations suggests that goal attainment is not merely a reflection of the general health status of patients with PFD. Disclosures: V.E. Bovbjerg, None; E.R. Trowbridge, None; M.D. Barber, American Medical Systems, Grant/Research Support; T.E. Martirosian, None; W.D. Steers, Investigator, Astellis and Allergan, Grant/Research Support; K.L. Hullfish, None.
were unsure (attainment 0.3 1.1) or said they would not undergo the same treatment again (attainment 0.4 0.8; F 18.6, p 0.01). Similarly, those who reported they would recommend the treatment to others had significantly higher levels of goal attainment (attainment 0.9 1.0) than those who were unsure (attainment 0.1 1.3) or said they would not recommend the treatment (attainment 0.1 0.5; F 7.1, p 0.01). Results for follow-up visits at 1.5, 3, and 6 months showed similar associations. Conclusion: Attainment of patient-identified treatment goals was highly associated with patient satisfaction. Future work should determine whether treatment plans that explicitly address patientidentified goals result in greater patient satisfaction. Disclosures: V.E. Bovbjerg, None; E.R. Trowbridge, None; M.D. Barber, American Medical Systems, Grant/Research Support; T.E. Martirosian, None; W.D. Steers, Investigator, Astellis and Allergan, Grant/Research Support; K.L. Hullfish, None.
Presentation Number: Paper 73 Patient-Centered Treatment Goals for Pelvic Floor Disorders: Association With Patient Satisfaction V. E. Bovbjerg,* E. R. Trowbridge,* M. D. Barber, T. E. Martirosian,* W. D. Steers,* and K. L. Hullfish* *University of Virginia School of Medicine, Charlottesville, VA, Cleveland Clinic, Cleveland, OH Objective: To assess the association of patient-identified goals for pelvic floor disorder (PFD) treatment with measures of patient satisfaction with care. Methods: As part of a one year cohort study of patient-centered outcomes of PFD treatment, 143 women with PFD identified up to five goals for PFD surgical and non-surgical treatment, and reported their level of goal attainment ( 2 worst possible outcome to 2 best possible outcome ) at 1.5, 3, 6, and 12 months. Mean goal attainment was calculated by summing individual goal attainment for each participant at each interval, and dividing by the number of goals, so that positive values indicated greater goal attainment and negative values relative lack of goal attainment (range 2 to 2). At those same intervals, participants completed three survey items assessing their satisfaction with care: their overall level of satisfaction (completely satisfied, very satisfied, satisfied, not satisfied), whether they would have the same treatment again given the outcomes (yes, not sure, no), and whether they would recommend the treatment they had undergone to others (yes, not sure, no). The associations of goal attainment to satisfaction were assessed using oneway analysis of variance, treating satisfaction responses as categories which were compared on levels of goal attainment. Results: At 12 months, mean goal attainment differed significantly by satisfaction (F 24.2, p 0.01): participants who reported being completely (mean attainment 1.6 0.5) or very satisfied (attainment 1.2 0.6) with treatment reported higher goal attainment than those who were satisfied (attainment 0.4 1.0) or not satisfied (attainment 0.5 0.9). Those who reported they would undergo the same treatment again had significantly higher levels of goal attainment (attainment 1.1 0.9) than those who
Presentation Number: Paper 74 Urinary Incontinence-Related Costs Decrease With Improved Incontinence Following Treatment L. L. Subak,* R. R. Wing, A. M. Pinto, S. Nakagawa,* J. Creasman,* J. W. Kusek, M. Kuppermann,* and W. H. Herman *University of California, San Francisco, San Francisco, CA, The Miriam Hospital, Providence, RI, Baruch College/CUNY, New York, NY, NIDDK, Bethesda, MD, University of Michigan, Ann Arbor, MI Objective: To estimate the effect of a lifestyle intervention for urinary incontinence (UI) on UI management costs and health-related quality of life (QOL) and to identify predictors of these outcomes among overweight women with UI participating in a weight loss trial. Methods: A total of 338 incontinent and overweight women in the Program to Reduce Incontinence by Diet and Exercise (PRIDE) clinical trial were randomized to a 6-month lifestyle intervention (weight loss and exercise) or a structured education program. At baseline and 6 months, women quantified the number of supplies used for UI and additional laundry and dry cleaning required each week specifically due to UI. UI management costs (cost) were calculated by multiplying resources used by national resource costs ($2005). Healthrelated QOL was estimated with the Health Utilities Index (HUI3) and other QOL measured by the SF36, Incontinence Impact Questionnaire (IIQ) and Urogenital Distress Inventory (UDI). Potential predictors of changes in these outcomes were examined using generalized estimating equations controlling for age, ethnicity, parity, hysterectomy, baseline weight, change in weight and clinical site for change in cost and age, ethnicity, clinical site and change in UI frequency for change in HUI3. Results: The mean ( SD) age of participants was 53 10 years, BMI was 36 6 kg/m2, with reported annual household incomes of $40,000 (26%), $40,000 $99,999 (51%) and $100,000 (23%). Selfreported mean UI frequency was 24 18 episodes with 18% of women classified as stress only/predominant, 49% urge only/predominant and 34% mixed UI. At 6 months, the mean weight loss was 6 kg and weekly UI episodes decreased by 37%. Mean weekly cost was $7.76 $14 (median $3.79) at baseline and decreased to $4.61 $9.69 (median $1.97) at 6 months (p 0.001). In multivariable analyses, cost decreased by $1 per week for each decrease of 7 UI episodes per week (p 0.03) and was strongly associated with greater improvement in UDI and IIQ scores (p 0.006 for trend). Change in weekly cost was not associated with annual income, type of UI or change in weight. Mean HUI3 score was
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0.81 0.18 (median 0.85) at baseline and decreased to at 0.78 0.23 (median 0.85) at 6 months (p 0.02). In multivariable analyses, the HUI3 score increased by 0.04 for each 5 kg decrease in weight (p 0.001) and was strongly associated with greater improvement in SF36 Physical Component and Mental Component Summary scores (p 0.01 for trend). Change in HUI3 score was not independently associated with change in UI frequency. Conclusion: This is the first report of the change in UI management cost over time associated with change in UI frequency. At 6 months in PRIDE, cost decreased by over 55% and was strongly and independently associated with decreasing UI frequency. Improved health-related quality of life was strongly associated with weight loss but not with improved UI. A lifestyle intervention weight loss that improved UI frequency decreased UI management costs and improved health-related quality of life. Disclosures: L.L. Subak, Pfizer Pharmaceutical, Inc. (Subak), Grant/Research Support; R.R. Wing, None; A.M. Pinto, None; S. Nakagawa, None; J. Creasman, Pfizer, Inc., Grant/Research Support; J.W. Kusek, None; M. Kuppermann, Boehringer-Ingelheim Pharmaceuticals, Inc., Grant/Research Support; W.H. Herman, None.
I/V was 28% higher than the ratio of the non-treated group and similar to that of uninjured controls (p 0.11). Examination of the ratio of collagen I/III revealed no significant differences in virgins after simulated birth injury when compared to virgin controls (p 0.98). This ratio, however, was significantly higher in injured animals after treatment with SIS, even when compared to the uninjured controls, (p 0.001). For the postpartum animals, ratios of both collagen I/V and I/III were significantly lower (65% for I/V and 42% for I/III) after simulated birth injury followed by 4 weeks recovery than 4 week postpartum controls (p 0.001). SIS treatment increased these ratios by 59% and 35%, respectively, to levels which were similar to the postpartum controls (p 0.29 for I/V; p 0.57 for I/III). Conclusion: Collagen scaffold improves collagen ratios in the fibromuscular layer of the vagina following simulated birth injury. The data indicate that SIS treatment enhances the quality of tissue when applied at the time of injury. Disclosures: M. Alperin, None; A. Feola, None; R. Duerr, None; L. Meyn, None; S.F. Badylak, None; S. Abramowitch, None; P. Moalli, None.
Presentation Number: Paper 75 Collagen Scaffold Improves Healing After Simulated Maternal Birth Injury M. Alperin,* A. Feola, R. Duerr,* L. Meyn,* S. F. Badylak, S. Abramowitch, and P. Moalli* *Magee-Womens Research Institute, University of Pittsburgh, Pittsburgh, PA, Musculoskeletal Research Center, University of Pittsburgh, Pittsburgh, PA, McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, PA Objective: Damage to the vagina and its supportive tissues during childbirth contributes to significant morbidity later in life. Short of recommending a cesarean section prior to the onset of labor, little has been done to develop strategies to prevent or treat maternal birth injury. Our aim was to determine whether the use of an acellular collagen scaffold following traumatic vaginal delivery mitigates the impact of maternal birth injury in a rodent model. Methods: 58 Long-Evans virgin, immediate postpartum (0 2 hrs), and 4-week postpartum rats were utilized. Virgin rats served to account for factors associated with delivery that may impact recovery. 38 animals underwent simulated birth injury via balloon distension and recovered for 4 weeks. In 20 rats, either a strip or a liquid suspension of porcine small intestinal submucosa (SIS) was placed over the site of vaginal injury prior to closure, while the 18 remaining injured animals underwent a standard suture repair. 10 uninjured virgin and 10 uninjured 4-week postpartum rats served as controls. After sacrifice, the amount of fibrillar collagens I, III and V present in the subepithelium and muscularis of the mid vagina were assessed via quantitative fluorescence microscopy using a scanning laser confocal microscope and analyzed using custom software (MatlabTM). The ratio of collagen I/V and I/III was used as an indication of tissue biomechanical properties (higher ratio improved biomechanical properties) later to be confirmed by mechanical testing. Results are represented as mean pixel intensity ratios. Statistical analyses were performed using one-way analysis of variance with Sidaks multiple comparison post-hoc tests at the 0.05 significance level. Results: Immunofluorescent analyses demonstrated that the ratio of collagen I/V decreased 44% in virgin rats after simulated birth injury relative to virgin controls (p 0.001), indicating persistent injury after 4 weeks of recovery. After treatment with SIS, the ratio of collagen
Presentation Number: Paper 76 Co-Morbidities and Incontinence in an Elderly Long-Term Care Population B. Ridgeway, L. Chacko, M. D. Barber, and B. J. Messinger-Rapport Cleveland Clinic, Cleveland, OH Objective: Identify co-morbidities and medicines associated with urinary (UI) and fecal incontinence (FI) in a female, elderly long-term care population. Methods: Medical records of all female residents were reviewed in a privately-owned inner-city long-term care facility. Data were extracted from the in-patient physician and nursing notes, the most recent Minimum Data Set (MDS), and the Medication Administration Record. Demographics, medical conditions, and co-morbidities that may be associated with UI or FI, including age, diabetes (DM), congestive heart failure (CHF), dementia, depression, gait impairment, neurologic conditions, constipation, and number of daily medicines were recorded. Medications reported to be associated with UI including cholinesterase inhibitors, diuretics, glitizones, anti-hypertensives, antipsychotics, hormonal therapies and sedative-hypnotics were documented. Presence and severity of UI and FI was determined by the latest MDS evaluation. The relationships between incontinence and co-morbidities, medical conditions, and medications were evaluated using the Chi-square, Students t, and Wilcoxon signed-rank tests as appropriate. Multivariable logistic regression was used to evaluate the independent associations of co-morbidities and medications with UI and FI. This study was approved by the Cleveland Clinic IRB and the Fairfax Healthcare Center. Results: Sixty-seven (100%) female residents were evaluated during the 10 week study period. The mean SD (range) age was 86.4 8.6 (62101) years and the rates of incontinence were: UI 66%, FI 46%, and dual incontinence 42%. The following percentage of residents had the following diagnoses: DM 31%, CHF 30%, dementia 79%, depression 36%, and gait disorders 85%. On univariate analysis, the co-morbidities dementia (p .04), depression (p .02), and gait disorders (p .01) were significantly associated with UI while only dementia (p .01) was associated with FI. In multivariable analysis, dementia maintained independent relationships with UI and FI with odds ratios (95% confidence intervals) of 4.3 (1.3, 17.4) and 6.8 (1.6, 47.2) respectively while gait disorders maintained its relationship with
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UI with an odds ratio of 9.1 (2.0, 54.7). Dementia was the only comorbidity associated with severity of both UI (p .01) and FI (p .006). The total number of medicines and all medications individually were not associated with UI or FI except second generation anti-psychotics (ziprasidone, aripiprazole) which were associated with decreased UI (p 0.03). Of the 44 residents with UI, only 1 (2%) was treated with medicines approved for overactive bladder. Conclusions: UI and FI affect the majority of female long term care residents. Dementia and gait disorders are significantly associated with incontinence in this population. Medication treatment targeting incontinence type and therapeutic interventions for associated comorbidities such as gait disorders may decrease incontinence. Disclosures: B. Ridgeway, None; L. Chacko, None; M.D. Barber, American Medical Systems, Grant/Research Support; B.J. MessingerRapport, Novartis, Consultant; Pfizer, Speakers Bureau; Forest, Speakers Bureau.
vaginal wall from estrogen-treated animals (141 24 to 374 48 pmol des/vagina). Conclusions: Estradiol replacement results in robust increases in a novel isoform of LOXL1 in the ovariectomized mouse vaginal muscularis. Perhaps the most interesting finding is the dramatic increase in mature elastic fibers in vaginal tissues from adult animals treated with E2 suggesting that the vaginal wall is unique from other adult organs in which elastogenesis is limited to developmental time periods. Overall, these findings indicate that the beneficial effects of E2 extend beyond its effect on the epithelial layer of the vagina given that E2 enhances both elastogenesis and protein synthesis in the muscularis layer. Disclosures: S.M. Roshanravan, None; P.G. Drewes, None; P. Keller, None; J.F. Acevedo, None; B. Starcher, None; R.A. Word, None.
Presentation Number: Paper 77 Estrogen Regulates LOXL1 And Elastogenesis in The Vaginal Wall S. M. Roshanravan,* P. G. Drewes,* P. Keller,* J. F. Acevedo,* B. Starcher, and R. A. Word* *UT Southwestern Medical Center, Dallas, TX, UT Health Science Center, Tyler, Tyler, TX Objective: Although it is well established that estrogen improves the atrophic effects of menopause on vaginal epithelium, little is known regarding its effect on the supportive fibromuscular layer of the vaginal wall. Lysyl oxidase-like 1 (LOXL1) is a copper-dependent amine oxidase produced by smooth muscle and fibroblasts that, together with other family members, plays a vital role in cross-linking and stabilization of collagen and elastic fibers. LOXL1 knockout mice develop pelvic organ prolapse suggesting that this enzyme plays an important role in maintenance of pelvic organ support. The goal of this investigation was to determine the role of estrogen in regulation of LOXL1 and elastic fiber synthesis in the vaginal muscularis. Methods: Mice (6 8wks) were ovariectomized, and after 14 d, treated with vehicle, estradiol (E2) (physiologic dose, 15 ug/kg/d), or E2 (pharmacologic dose, 50 g/kg/d) for 3 or 14 d (n 16 for each group at each time point). Real time PCR and immunoblot analysis were used to assess LOXL1 mRNA and protein. N-glycosidase F, 23,6,8,9-neuraminidase, and endo- -N-acetylgalactosaminidase were used to assess the glycosylation status of LOXL1. Desmosine content and elastic fiber staining were used as indices of mature cross-linked elastic fibers. Results: LOXL1 mRNA was decreased significantly (9-fold) in vaginal tissues from ovariectomized mice compared with nonpregnant cycling controls. Treatment of ovariectomized mice with E2 resulted in significant upregulation of LOXL1 mRNA and protein (5-fold increase at 14 days, p 0.05). Interestingly, however, the molecular mass of pro-LOXL1 was decreased 8 kDa in vaginal tissues from E2-treated mice. Real time PCR studies using LOXL1-specific oligonucleotide primers to carboxy-teminal or first exons of LOXL1, together with deglycosylation experiments, indicated that E2 treatment induced expression of an alternatively spliced isoform of LOXL1 in the vaginal muscularis. E2-induced increased expression of LOXL1 was accompanied by significant increases in vaginal weight (from 14 1 to 134 10 mg, p 0.01) and protein content (364 40 compared with 3271 233 ug/vagina, p 0.001). Elastic fiber staining and desmosine assays revealed a marked increase in elastic fibers in the
Presentation Number: Paper 78 Incidence of Extrusion in Patients Treated with Type I Polypropylene Mesh KITS in Pelvic Organ Prolapse Repair J. C. Lukban* and R. Moore *Eastern Virginia Medical School, Norfolk, VA, Atlanta Urogynecology Associates, Alpharetta, GA Objective: To determine rate of mesh extrusion in patients receiving type I, polypropylene mesh in the repair of anterior, posterior, and/or apical or uterine descent. Methods: Data were pooled from two ongoing, multi-center, singlearm, prospective trials evaluating the efficacy and safety of the Perigee and Apogee Systems (American Medical Systems, Inc., Minnetonka, MN, USA) as part of the Perigee with IntePro Trial and the PROPEL Trial, respectively. The primary endpoint of each was anatomic cure (Stage I). A secondary endpoint was incidence of extrusion (vaginal exposure of mesh). Patients were followed postoperatively at 6 weeks, 3 months, 6 months and 12 months, and will be followed prospectively through 2 years. Nineteen academic and community urogynecologic, urologic or gynecologic practices in the United States contributed patients. Each patient underwent transvaginal placement of type I polypropylene mesh (IntePro, American Medical Systems, Inc., Minnetonka, MN, USA) by means of bilateral double transoburator trocars for anterior wall repair (Perigee) or bilateral transgluteal trocars for posterior wall repair with or without apical or uterine descent (Apogee). Reporting also includes patients who received Apogee or Perigee as a non-study (concomitant) repair in either of the two trials. Results: 262 women were enrolled for the surgical repair of prolapse ( Stage II) in the anterior (AC), posterior (PC), and/or apical compartments. Mesh was placed in AC and PC in 173 and 195 patients, respectively. Menopausal status of patients in the two subgroups was 87.8% for AC and 77.4% for PC. Prior hysterectomy was present in 49.1% of AC and 48.2% of PC. Rate of extrusion (vaginal exposure) was 6.9% (12/173) in the AC and 13.3% (26/195) in the PC. Of the anterior extrusions, 4.6% (8/173) required trimming of mesh ( 2 cm) with primary closure in the operating room while 2.3% (4/173) received non-invasive intervention in the form of inoffice trimming (0.6%, 1/173) or estrogen cream (1.7%, 3/173). Of the posterior extrusions, 7.7% (15/195) required trimming of mesh ( 2 cm) in the operating room while 6.2% (12/195) received non-invasive intervention in the form of in-office trimming (4.6%, 9/195) or estrogen cream (2/195, 1.0%). Patients experiencing extrusion had a mean follow-up time of 13.9 months (range 6.0 22.9) in the AC group and 12.6 months (range 5.123.8) in the PC group. Anatomic cure for patients experiencing extrusion was 91.7% for AC and for PC 88.0% (posterior) and 92% (apical) at stated mean follow-up.
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Conclusion: One must consider the risks and benefits of employing type I polypropylene mesh in the anterior and posterior compartments. Extrusions in our study required revision in the operating room in less than 5% and 8% of cases following Perigee and Apogee, respectively. Patients exhibiting vaginal exposure of mesh maintained a high rate of anatomic cure. Disclosures: J.C. Lukban, Pfizer, Glaxo-Smith-Kline, and AMS, Consultant; R. Moore, AMS, Allergan, Consultant.
significant bother was markedly increased 4 5 fold among women with a POP-Q Stage 2 and self-reported POP symptoms. This finding suggests that the addition of self-reported measures may provide more clinically relevant outcomes in studies using the POP-Q system. Disclosures: E.L. Whitcomb, None; G. Rortveit, None; J.S. Brown, NIDDK Cooperative Agreement DK 57136, DK 48489-08 NIDDK 5U01, K24 NIDDK, P50 DK 64538 ORWH NIDDK, Grant/Research Support; J.M. Creasman, None; D.H. Thom, None; S.K. Van Den Eeden, None; L.L. Subak, None.
Presentation Number: Paper 79 Racial Differences in the Prevalence of and Bother from Pelvic Organ Prolapse (POP) E. L. Whitcomb,* G. Rortveit, J. S. Brown, J. M. Creasman, D. H. Thom, S. K. Van Den Eeden, and L. L. Subak *University of California San Diego, La Jolla, CA, University of Bergen, Bergen, Norway, University of California San Francisco, San Francisco, CA, Kaiser Permanente Division of Research, Oakland, CA Objective: To compare the prevalence of, risk factors for and level of bother associated with subjectively reported and objectively measured POP in a racially diverse cohort of women. Methods: The Reproductive Risks for Incontinence Study at Kaiser II (RRISKII) is a population-based cohort study of 2,270 randomly selected middle-aged and older women. Symptomatic POP was selfreported as a feeling of a bulge, pressure or protrusion or a visible bulge from the vagina in the past 3 months. Women also reported if a healthcare provider ever told them that they have prolapse. Degree of prolapse was measured using the POP-Quantification System (POP-Q) in a subset of 1,137 women. Bother was quantified on a 5-point selfreported scale and we defined bother as moderate or great bother. Multivariable logistic regression analysis was used to identify independent association of POP and race while controlling for common risk factors for POP (age, BMI, parity, education, urinary tract infection, urinary incontinence and constipation, all p 0.2 after adjustment). Results: Mean ( SD) age was 52 10 years and 47% were white, 18% African-American, 17% Latina and 17% Asian. Symptomatic POP was reported by 74 (3%) women. In multivariable analysis, the risk of symptomatic POP was significantly higher in Latinas (OR 3.3, 95% CI 1.2 8.9) and white women (OR 3.2, CI 1.3 8.3) compared to AfricanAmerican women. Almost three times as many women with symptomatic POP reported moderate or great bother compared to women without symptoms but who had been told by a healthcare provider that they have prolapse (36% vs. 13%, respectively; p 0.001). After controlling for symptomatic POP, Latina women remained 3.4-times more likely to report bother compared to white women (p 0.02). Degree of prolapse by POP-Q Stage was similar across all racial groups (Stage 0: 6 8%, Stage 1: 24 29%, Stage 2: 64 69%, and Stage 3: 0 1%; p 0.80). Report of moderate or great bother increased with POP-Q Stage, and was reported by 10% of women with Stage 0 1, 26% Stage 2, 75% Stage 3 and 100% of women with Stage 4. POP-Q Stage was associated with degree of bother (Spearman correlation coefficient 0.36; p 0.001). Women with Stage 2 prolapse and self-reported POP symptoms were 4.6times more likely to report moderate or great bother than women with Stage 2 prolapse without self-reported symptoms (p 0.03). Conclusion: The prevalence of self-reported symptomatic POP was 3-fold greater for Latina and white women compared to other racial groups. Latina women were 3-fold more likely to be bothered by their POP than white women. Level of bother increased with self-report of POP symptoms and increasing POP-Q Stage. Of note, report of
Presentation Number: Paper 80 Environmental Factors Play a Dominant Role Over Genetics in Women with Stress Urinary Incontinence: A Large PopulationBased Classical Twin Study A. Nguyen, S. Aschkenazi, T. Gamble, R. Goldberg, P. Sand, A. Ching, P. Stibbe and S. Botros Evanston Incontinence Center, Northwestern University, Feinberg School of Medicine, Evanston, IL Objective: Both genetic and environmental factors are believed to impact the development of stress urinary incontinence (SUI) however, their relative contribution is unknown. The aim of this study is to use a classical twin analyses to explore the extent to which genetic and environmental factors influence the development of stress urinary incontinence in a large community based sample of monozygotic (MZ) and dizygotic (DZ) twins. Methods: This is a population-based classical twin study of 751 female MZ and DZ twin pairs. Structural equation models were fitted to data from anonymous surveys obtained from female twin pairs who attended the annual Twins Days Festival held in Twinsburg, Ohio from 20032007. Stress urinary incontinence was identified by an affirmative answer to the question, Do you leak urine with coughing, straining, laughing, physical activity or exercise? Concordance and correlation rates were calculated and structural equation models were used to estimate the contribution of genetic effects versus common and unique environmental factors on stress urinary incontinence. Results: Out of 751 twin pairs consisting of 652 MZ and 99 DZ pairs who volunteered to participate in the survey, there were 638 MZ and 99 DZ twin sister pairs with complete data pertaining to stress urinary incontinence. Mean age was 41.7 16.1 years (range 18 85), mean body mass index (BMI) was 26.1 6.4 (range 13.555.8), with race comprised of 89.5% white, 6.0% Black, 2.0% Hispanic, and 2% other ethnicities. There was no difference in general demographics: age, race, parity, BMI, menopausal status, mode of delivery or prior surgery between MZ and DZ twins. The overall prevalence was 42.3% and 49% in MZ and DZ twins, respectively. Concordance rates for SUI were 32% and 37.3% amongst MZ and DZ twins, respectively. The tetrachoric correlations were 0.789 in MZ, and 0.748 in DZ twins with largely overlapping 95% confidence intervals (MZ: 0.721 0.845; DZ: 0.536 0.882). The concordance rates and tetrachoric correlations were in agreement both indicating that genetic effects were not contributory. Sequential structural equation modelling of the categorical data revealed that the best fitting model of twin resemblance included the common and unique environmental factors with the common environment contributing 70.63% (95%CI: 27.95 83.50) of the variance and unique environmental factors contributing 21.1% (95%CI: 15.527.84) of the variance. Using this statistical model, the impact of genetics was not statistically significant 8.26% (95%CI: 0%52%). Conclusions: The results of this study indicate that environmental factors play a dominant role over genetics in women with stress urinary incontinence. Further longitudinal studies are warranted to
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confirm these findings in a more racially diverse sample and evaluate the impact of individual environmental factors on the development of SUI. Disclosures: A. Nguyen, None; S. Aschkenazi, None; T. Gamble, None; R. Goldberg, Boston Scientific, Consultant; P. Sand, Astellas, Indevus, Watson, Boston Scietntific, American Medical Systems, Pfizer, Ortho-McNeil and Allergan, Consultant; A. Ching, None; P. Stibbe, None; S. Botros, None.
Disclosures: M. To, None; D.M. Elser, Novasys Medical, Grant/ Research Support; Ethicon, Consultant; Boston Scientific, Paid Instructor; B. Hanna, None.
Video Presentations
Presentation Number: Video 1 The Transobturator Sling Procedure For Stress Urinary Incontinence S. B. Tate, anb R. D. Acland University of Louisville, Louisville, KY Clinical Problem: Stress Urinary Incontinence. Surgical Solution: Transobturator Sling. Methodology: Utilizing three dimensional videography of predissected specimens, this video demonstrates the clinical anatomy of the transobturator sling procedure. Excerpts of an educational video of the procedure being performed in an unembalmed cadaver illustrate the surgical techniques and correlation to previously mentioned surgical anatomy. Outcome: By watching this video describing the relevant clinical anatomy and transobturator sling procedure, the viewer will gain an understanding of the important anatomic considerations and the surgical procedure. Disclosures: S.B. Tate, Honoraria Bard, Other; R.D. Acland, None.
Presentation Number: Paper 81 Are Pessary Related Ulcers In Post Menopausal Women Associated With Bacterial Vaginosis (BV)? M. To*, D. M. Elser, and B. Hanna *University of Illinois at Chicago, Chicago, IL, Illinois Urogynecology, LTD, Oak Lawn, IL, Womens Health, Carol Stream, IL Objective: Women with advanced pelvic organ prolapse (POP) who opt for pessary use to manage symptoms often develop a vaginal discharge that is clinically similar to bacterial vaginosis (BV). Our objective was to determine if BV predisposes to development of vaginal ulcers in postmenopausal pessary users. Methods: Women with stage 3 or 4 POP opting for pessary use, were recruited between JanuaryNovember 2005. Each was followed for 1 year, or less if pessary use ceased. Power analysis prior to initiation of the study, using 10% as a clinically significant difference in ulcer formation determined that to achieve power of 80% and alpha of 0.05, 100 women needed to be enrolled. Patients were consented at time of pessary placement. Women were seen initially at 2 weeks and then every 3 months. At each visit, the pessary was removed and cleaned; vaginal speculum exam was performed; & the absence or presence of ulceration was noted. For all patients, a rapid test for presence of BV using the Proline Imino Peptidase (PIP) Activity Test (Quidel Corp., San Diego, CA) was performed. The physician & patient were blinded to the results.If an ulcer developed, pessary was removed and treatment was randomized to either metrogel or estrace. Re-examination was performed every 2 weeks until ulcer resolution. Results: One hundred fifteen patients were enrolled. Types of pessary used were ring: 68; donut: 28; gellhorn:37; gehrung: 4; cube:4 and incontinence ring:1. During this time, 5 patients changed pessary size & 19 changed pessary style. Sixteen patients opted for surgical management of prolapse during the study period. Of the 35 ulcer patients, 10 (29%) opted for surgery versus 8/80 (10%) who did not develop ulcers. Thirty-four patients developed 53 ulcerations requiring temporary pessary removal. Some patients developed vaginal ulceration on more than one occasion. Using chi-square analysis, there was a significant association between incidence of ulceration and type of pessary used (p 0.032). Ulcers occurred with the following frequencies: Donuts: 11; Gellhorn: 12, and Ring: 13. Most ulcers were resolved by the 2 week exam with a mode of 15 days (Range 7-106). One-way ANOVA found association between ulcer size and type of pessary worn (p 0.031). None of the BV tests were positive. There was no significant difference between time to ulcer resolution in women treated with topical estrogen cream vs. topical metronidazole vaginal gel (p 0.05). Conclusions: The majority of postmenopausal women with stage 3 or stage 4 prolapse can be managed safely and successfully long-term with a vaginal pessary. The discharge associated with pessary use does not appear to be due to BV. It is plausable that vaginal ulcers associated with pessary use are due to atrophy, pressure from a foreign object, or a combination of the two.
Presentation Number: Video 2 The Michigan 4-Wall Sacrospinous Ligament Supsension for Vaginal Vault Prolapse K. Larson, D. M. Morgan, and J. O. DeLancey University of Michigan, Ann Arbor, MI Clinical Problem: Vaginal vault prolapse. Surgical Solution: The Four-Wall Sacrospinous Ligament Suspension is a novel approach to sacrospinous suspension for treatment of vaginal vault prolapse. The procedure incorporates components critical to successful re-suspension of the vaginal apex in a minimally invasive, effective manner. It suspends all four vaginal walls to a single ligament through an apical incision, allowing direct healing between vagina and ligament. Methodology: The first step in the operation is to identify a point on each of the 4 vaginal walls that will reach the sacrospinous ligament without either undue tension or sagging. The intervening vaginal wall is then excised. Utilizing both sharp and blunt dissection, a pathway is developed along the peritoneum to the ligament. Two passes of looped, PDS suture in a Deschamps ligature carrier result in 4 strands of suture anchored in the ligament. These are sewn to the edges of the vaginal cuff and tied to bring the cut edge of the cuff into direct contact with the ligament. This allows the vagina to heal to the ligament directly, thus eliminating the need for permanent suture. If deemed necessary, an anterior repair would be performed prior to bringing the sutures through the vaginal cuff. A posterior repair, on the other hand, would be performed at the completion of the ligament suspension. Outcome: Our published results from 100 consecutive patients (almost 1/2 of whom had failed prior operations) reveal a 90% satisfactory treatment rate in a population consisting exclusively of stage III and IV post-hysterectomy prolapse.1 Subsequent, unpublished experience in over 1,000 cases reveals that introduction of PDS suture (to replace previously used chromic and Vicryl), results in apical
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failure rates less than our previously reported 4%. Attaching the anterior wall to the ligament minimizes both anterior enterocele and symptomatic cystocele formation (6% in published series). By attaching the left and right walls to one ligament, contralateral vaginal wall descent has been avoided; thus, there is no need for bilateral suspension which can increase complications associated with accessing both ligaments. This approach is also minimally invasive and avoids abdominal incisions and their complications including incisional hernias and infections), allowing for quicker recovery. In this surgery, there is minimal bowel manipulation, no foreign body to cause erosion or infection and no port site or port placement complications. Lastly, we have found this procedure is not significantly more difficult in obese patients. Disclosures: K. Larson, None; D.M. Morgan, None; J.O. DeLancey, Johnson & Johnson, Consultant.
1
exposure, resulted in sling removal. FIQOL data indicates an improvement in symptoms for all four categories addressed. Disclosures: P.L. Rosenblatt, American Medical Systems, Grant/Research Support; American Medical Systems, Consultant; Licensing agreement, American Medical Systems.
Am J Obstet Gynecol, Vol 158: 872-881. 1988.
Presentation Number: Video 3 Trans-Obturator Post Anal Sling (TOPAS) for Fecal Incontinence P. L. Rosenblatt Boston Urogynecology Associates, Cambridge, MA Clinical Problem: Fecal incontinence is a significant medical problem, as well as a socially debilitating issue. Several surgical procedures have been utilized in the past to treat this condition, including anal sphincteroplasty and the artificial anal sphincter, but none has borne out to be clearly superior. Surgical Solution: The Trans-Obturator Post Anal Sling (TOPAS) is a minimally invasive procedure that places a synthetic sling behind the anorectum to provide posterior support, in a manner similar to the natural support provided by the puborectalis muscle. The TOPAS procedure is performed as follows: local anesthetic is injected into the post anal area and medial thighs through the obturator foramen. Two small incisions 2 cm lateral and 3 cm posterior to the anus are made and a tunnel beneath the anorectum is developed. The 2 cm wide synthetic sling belly is passed from one side to the other and positioned under the anorectum. A curved introducer needle is placed through medial thigh incisions, around the ischiopubic ramus, and is directed posteriorly into the ischiorectal fossa. After the needle is passed through the ipsilateral buttock incision, the mesh is connected to the needle and brought up through the medial thigh incisions. Tension on the arms of the sling is then adjusted by gently elevating the sling arms while the surgeons index finger is placed in the rectum. The plastic sleeves are then removed from the sling. The post anal incisions are vigorously irrigated and closed with delayed absorbable suture. Methodology: A retrospective, IRB-approved analysis designed to assess the efficacy of TOPAS for the treatment of Fecal Incontinence was performed. For the evaluation of fecal incontinence, patients were asked to fill out intake questionnaires, bowel diaries and Fecal Incontinence Quality of Life Questionnaires (FIQOL) pre-operatively and post-operatively. Outcome: Fecal incontinence diary data were available from 8 patients, although a baseline diary was not submitted by 1 of these patients. The number of incontinent episodes and incontinent days decreased after surgery. At 6 weeks post-op, 2 patients reported complete continence and 1 additional patient reported a 50% decrease in incontinent episodes. One postoperative complication, a wound infection with separation of the postanal incision and mesh
Presentation Number: Video 4 Endoscopic Fibrin Sealant For the Treatment of Urogenital Injury and Fistula C. R. Rardin, D. L. Myers, K. J. Wohlrab, and R. Moore Alpert Medical School at Brown University, Providence, RI Clinical Problem: Urogenital injuries and fistulae can be distressing problems with a wide variety of sequellae; traditional surgical management carries significant risks of its own. Surgical Solution: Endoscopic use of two-component fibrin sealant. Methodology: cystoscopic application of fibrin sealant to the area of injury is described and demonstrated. Outcome: In one case of recurrent vesicovaginal fistula, and another case of non-healing iatrogenic vesicovaginal injury, successful resolution is demonstrated. Disclosures: C.R. Rardin, None; D.L. Myers, None; K.J. Wohlrab, None; R. Moore, None.
Presentation Number: Video 5 Posterior Vaginal Wall Support: How Does It Fail? C. Lewicky-Gaupp, R. U. Margulies, D. E. Fenner, and J. O. DeLancey University of Michigan Hospital, Ann Arbor, MI Clinical Problem: Support failures of the posterior vaginal wall, including rectocele and enterocele, are a distressing problem for many women. The specific mechanisms of posterior vaginal wall failure remain elusive. The objectives of this video are threefold. We plan to: (1) review the posterior compartment anatomy, (2) describe three proposed structural mechanisms of posterior wall failure including failure of the perineal body, the levator ani muscles and the vaginal portion of the uterosacral ligaments, and (3) show the relationship between failure mechanisms and surgical repair. Methodology: Using animation as well as conceptual anatomic drawings, the video begins by showing the normal posterior compartment anatomy. Normal anatomy is then compared to posterior vaginal wall support failure, specifically in the areas noted above. Individuals with posterior vaginal wall prolapse who have undergone static and dynamic MRI are shown as examples for this video. The video displays their clinical pelvic exams including Kegel and Valsalva maneuvers. While these individuals may have some degree of failure in multiple regions, each has a dominant site of failure which serves as an exemplar of one of the proposed mechanisms. Their dynamic (Valsalva and/or Kegel) and static MR images show the specific location and nature of the anatomic defects responsible for their type and extent of prolapse. Finally, we propose that, because each type of failure is associated with a specific anatomic defect, various surgical techniques can be employed to correct these defects. We present examples of three surgical techniques including distal repair of the perineal body, a more proximal repair of a gaping genital hiatus, and lastly a four-wall sacrospinous ligament suspension to address the most proximal site of failure.
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Outcome: This video will demonstrate examples of three specific mechanisms of posterior vaginal wall support failure (separation of the perineal body, levator ani muscle failure, and failure of the vaginal portion of the uterosacral ligaments) using both clinical and MRI examples. As clinicians, we know that these three types of failure can occur in varying combinations. The aim of this video, which focuses on the unique structural elements of each of these three areas of support, is to impart a better understanding of the basic structural failures leading to posterior wall prolapse as well as some of the surgical techniques that can be used to address these specific structural failures. We gratefully acknowledge the support of the Office for Research on Womens Health and NICHDs SCOR on Sex and Gender Factors Affecting Womens Health (1 P50 HD44406). Disclosures: C. Lewicky-Gaupp, None; R.U. Margulies, None; D.E. Fenner, None; J.O. DeLancey, Johnson & Johnson, Consultant.
Presentation Number: Video 6 Posterior Wall Prolapse Repair; Apical Fascial Defects P. A. Castillo*, M. Jean Michel*, L. M. Espaillat, and G. W. Davila* *Cleveland Clinic Florida, Weston, FL, Temple University Hospital, Philadelphia, PA Clinical Problem: To illustrate how restoring integrity of the endopelvic fascia in the posterior vaginal wall can resolve most posterior compartment prolapse. Surgical Solution: Rectocele repair represents a commonly performed procedure by pelvic surgeons. A rectocele is a herniation of the posterior vaginal wall resulting from a defect in the rectovaginal septum, not the vagina or rectum. It can be caused by either a discrete tear in the septum or by attenuation of these tissues. Rectovaginal defects vary considerably and discrete tears can occur in any location or direction along the rectovaginal septum. With careful surgical dissection defined tears can often be found. Specifically, transverse apical fascial defects often times may be the underlying cause for most posterior wall prolapse. Restoring continuity of the endopelvic fascia from the vaginal apex to the perineal body will restore anatomy and function as well as resolve symptoms often associated with a rectocele. Methodology: The posterior colporrhaphy and discrete fascial defect repair may be combined. Following careful dissection of the vaginal mucosa off of the closely adherent underlying rectovaginal fascia, an apical fascial tear is identified. The detached fascial edge is reapproximated to its apical attachment site at the cervical ring or cardinal-uterosacral ligament complex with interrupted permanent sutures thus restoring continuity of the endopelvic fascia. The fascia overlying the levator ani muscles can then be plicated in the midline, anterior to the rectovaginal fascia in an interrupted fashion using delayed absorbable suture. A perineorrhaphy is then performed to normalize the genital hiatus and provide vertical support to the lower vagina. Minimal if any vaginal mucosa is then resected and closed in a traditional fashion. Outcome: Correction of the discrete fascial defect at the time of posterior colporrhaphy re-establishes endopelvic fascial integrity from apex to perineum, levator plate integrity, anterior rectal wall support, normal vaginal caliber and length, and integrity of perineal body. Disclosures: P.A. Castillo, None; M. Jean Michel, None; L.M. Espaillat, None; G.W. Davila, AMS, Adamed, Synovis Astellas Watson Zuidex Protein Polymer Technologies Duramed, Grant/Research Support; AMS, Watson, Adamed, Consultant; Watson, AMS, Synovis, USSurgical, Pfizer, Astellas, Adamed, Other.
Presentation Number: Video 7 Surgical Principles in Obstetric Vesicovaginal Fistula Repair C. Chen*, R. Nardos&dagger, and A. Browning *Cleveland Clinic, Cleveland, OH, Addis Ababa Fistula Hospital, Addis Ababa, Ethiopia, Barhirdar Hamlin Fistula Centre, Barhirdar, Ethiopia Clinical Problem: Vesicovaginal fistulas from obstructed labor are a health crisis of epidemic proportions in non-industrialized nations with an estimated prevalence of 3.5 million. Fistulas that result from obstructed labor are often complex with evidence of diffuse tissue necrosis, which is very different from the fistulas encountered in industrialized countries. The objective of our video is to demonstrate basic surgical techniques in vaginal repair of circumferential vesicovaginal fistulas that result from obstructed labor. Surgical Solution: Vaginal repair of a circumferential vesicovaginal fistula with placement of a pubococcygeus sling. Methodology: For the vesicovaginal fistula repair, the vaginal epithelium is dissected off the proximal urethra. Both ureteral orifices are identified and ureteral stents placed. The bladder is mobilized circumferentially by dissecting the posterior bladder and fistula edge from the proximal anterior vaginal epithelium and anterior bladder and fistula edge from the paravesical attachments and the underside of the pubis. As the distal bladder defect is much larger than the proximal urethra opening, the anterior portion of the distal bladder is wrapped around the proximal urethra and sutures are placed at 12:00, 03:00 and 09:00. This will reconnect the anterior and lateral urethra to the anterior bladder. The posterior urethra is reattached to the posterior bladder with a purse-string suture. The remainder of the poster bladder defect is reapproximated vertically. A dye test is performed to check the integrity of the closure. The vaginal epithelium is reapproximated over the repaired bladder. For the pubococcygeus sling, the pubococcygeus muscle/ perineal membrane complex under the pubic rami is detached proximally and sutured in the midline under the mid-urethra. Outcome: In a published series addressing the short term outcomes of circumferential vesicovaginal fistula repairs, in 72 cases, 97% of patients had successful repair with 2 patients experiencing wound breakdowns requiring reoperations. The urinary retention rate was 8% with an incontinence rate of 47%, mostly secondary to stress provocations. In a published series addressing the short term outcome after pubococcygeus slings, in 27 cases, the continence rate was 81% with a retention rate of 15%. Disclosures: C. Chen, None; R. Nardos, None; A. Browning, None.
Tips & Tricks Presentations

Presentation Number: Tip and Trick 1 Modification of the Anterior Prolift Mesh for Reconstruction of Anterior and Apical Vaginal Prolapse J. A. Daucher*, M. Alperin, R. E. Ellison, L. A. Meyn, and H. M. Zyczynski *Reston Hospital Center, McLean, VA, Magee-Womens Hospital / University of Pittsburgh School of Medicine, Pittsburgh, PA Objective: To describe a modification to the shape and anchoring points of an anterior Prolift mesh (Gynecare/Ethicon, Somerville, NJ) that provides apical support in women with anterior and apical prolapse who do not require posterior wall graft reinforcement. Description: As much as 55% of the presentation of anterior vaginal prolapse can be attributed to loss of apical support 1 . Concurrent apical suspension during anterior vaginal prolapse repair is critical for
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durable outcomes while maintaining vaginal length. Currently, the three Prolift systems do not provide anterior and apical support without implanting posterior mesh. Total and posterior Prolift kits provide apical support with bilateral fixation to sacrospinous ligaments. The proximal anchoring points of the anterior Prolift mesh are the arcus tendineous at the ischial spine. This lateral support is insufficient for a prolapsing cervix or vaginal apex. We have devised a modification to the anterior Prolift mesh that provides simultaneous anterior and apical support with a reduced mesh load in the case of a well-supported posterior compartment. Experience: Mesh modification starts with the for 56 cm incision of the midline proximal tab of the anterior Prolift mesh. A suture is then secured to the end of each newly created mesh arm to extend its length. After cystoscopy confirms the absence of injury to the bladder, the surgeon removes the distal anterior cannulas and reuses them for the insertion through each sacrospinous ligament via the transgluteal, infracoccyeal approach typically employed with the posterior and total Prolift kits. Newly created mesh arms with attached sutures are then pulled through the sacrospinous ligaments. The sutures are removed leaving the mesh arms deep to the skin. The end result is a six point anchoring of the anterior mesh. To determine the safety and early anatomic support of our modification, we performed an IRB approved retrospective study. Demographic and anatomic measures (Pelvic Organ Prolapse Quantification (POPQ)) were recorded at baseline and 3 months as were peri-operative complications. Analysis: A total of 19 women with a mean age of 63 9 and BMI of 27 4 kg/m2 underwent an anterior Prolift with apical modification. Subjects were predominantly postmenopausal (86%) and Caucasian (100%). There were 2 trocar perforations of the bladder, no cystotomies and no rectal injuries. No women had an EBL 500 ml and there were no infections. Two mesh exposures were recorded. Preoperative and postoperative POP-Q measures were as follows: Ba: pre 2.2 1.6, post 2.3 0.8, (p 0.001); Bp: pre 1.7 1.2, post 1.8 , 1.0 (p 0.728); C: pre 3.3 2.3, post 7.0 1.1 (p 0.001), TVL: pre 8.8 1.2, post 8.3 1.4 (p 0.37). Conclusions: The proposed modification to the anterior Prolift mesh provides for apical support in women with an apical component to their anterior predominant prolapse without additional posterior mesh load. Disclosures: J.A. Daucher, None; M. Alperin, None; R.E. Ellison, None; L.A. Meyn, None; H.M. Zyczynski, Johnson & Johnson, Grant/Research Support.
deep to the mucosa on each side where it exited the urethra. Urethrotomy was unnecessary. Experience and Analysis: Traditional treatment of intraurethral mesh has been described, with urethral wall incision in order to remove the mesh followed by urethral closure. Others have described urethroscopy with attempted mesh excision using cystoscopic equipment. This approach proved difficult in one other case of urethral mesh erosion seen by the senior author, due to the distance of the instrumentation from the mesh with a poor fulcrum effect and lack of good visualization. In this case, we describe the use of a nasal speculum that assisted in visualization and excision of eroded mesh from within the urethra, thereby keeping the urethra intact and avoiding potential complications from urethral wall disruption. The patient returned to normal voiding but did have recurrent stress urinary incontinence. Disclosures: K. Strohbehn, DuraMed, Grant/Research Support; B.C. Young, None.
Presentation Number: Tip and Trick 3 Surgical Reconstitution of Unilaterally Detached Puborectalis Muscle A. Allen*, M. Nihira, and S. A. Shobeiri *OUHSC, Tulsa, OK, OUHSC, Oklahoma City, OK Objective: To present a novel surgical technique for repair of symptomatic detachment of the puborectalis muscle. Description: An avulsed puborectalis muscle is a known complication of vaginal delivery. This problem is most often asymptomatic. To develop a surgical approach, six fresh frozen pelves and 12 embalmed cadavers were dissected via a paramedian three cm incision, two cm lateral to the anococcygeal line into the ischioanal fossa. The following average measurements were obtained in fresh frozen pelves: anococcygeal body 3.6 cm, puborectalis arm 4.4 cm. The inferior rectal nerve was encountered in all specimens traveling lateral and caudad to the area of dissection. Deep transverse perineal muscle was seen more anteriorly in the same plane. Further dissection was performed to follow the puborectalis insertion into the pubic bone. A 3 5 cm autologous fascia lata graft was sutured to the levator raphe posteriorly and the ischiopubic rami anteriorly as a conduit to stabilize the contralateral arm of the puborectalis muscle. Experience and Analysis: We present the case of a 32 year old patient with dyspareunia and fecal incontinence since the vaginal birth of her child two years prior to presentation. The diagnosis of an avulsed right puborectalis was made by physical examination, and confirmed by MRI and 3-D ultrasound. The patient underwent reconstitution of the puborectalis muscle as described. Intraoperatively, no puborectalis remnant was identified. To our knowledge, no published report of surgical management of disrupted puborectalis muscle exists. The goals of this procedure were to alleviate the patients complaints of dyspareunia and fecal incontinence. The three month follow-up MRI confirmed stabilization of the puborectalis sling and return of the anus to a more anatomic position. At nine months, the patient was continent of stool and did not experience dyspareunia. The best time to repair a torn muscle would be immediately after the incident. In the case of the puborectalis muscle, the injury goes unrecognized, and may remain asymptomatic until later in life. We have described a novel technique that will benefit patients with symptomatic puborectalis injury. The dilemma remains on what to do with asymptomatic patients with known puborectalis injury. Disclosures: A. Allen, None; M. Nihira, None; S.A. Shobeiri, None.
Presentation Number: Tip and Trick 2 Nasal Speculum Retraction to Excise Urethral Mesh Erosion Following A TVT K. Strohbehn*, and B. C. Young *Dartmouth-Hitchcock Medical Center, Lebanon, NH, Beth Israel, Boston, MA Objective: To describe a technique to excise eroded mesh from the urethra without compromising the integrity of the urethra wall, utilizing a nasal speculum. Description: A 46 year old woman was referred from an outside hospital with continued problems of voiding dysfunction. She was ultimately diagnosed with intraurethral mesh erosion two months following a TVT procedure. Erosion of blue mesh in a mid-urethral posterior location was visualized on pre- and intraoperative cystourethroscopy. Following cystourethroscopy, a nasal speculum was introduced into the urethral meatus to gently retract the distal urethral walls. This facilitated excellent visualization of the mesh. The mesh was grasped and traction applied to it. It was then trimmed just
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Presentation Number: Tip and Trick 4 Making Pelvic Floor Ultrasound Images Clearer; Top Ten Instrumentation Tips for Improving Pelvic Floor Imaging Quality R. Hall, T. Omotosho, H. Abed, and R. Rogers University of New Mexico, Albuquerque, NM Objective: We present a clear demonstration of the top ten instrumentation tools that will enhance pelvic floor imaging using transperineal 2D and 3D diagnostic ultrasound. Description: Diagnostic imaging of the pelvic floor musculature and anal sphincter complex can be done using a wide variety of ultrasound transducers. One cannot assume that the ultrasound system obtains a high quality image by merely turning it on. Optimization of the ultrasound instrumentation makes a marked difference in image quality, but is operator dependent. The endovaginal transducer is the most commonly available transducer for practitioners; therefore, examples of all technique tips will be given using this mode. Using a Philips IU22 ultrasound system, images of the anal sphincter complex and pelvic floor will be altered by instrumentation options to compare differences in focal zone(See Figure 1), gain, TGC, read zoom, write zoom, sector width, mapping/post processing, color power angio, chroma, and 3D manipulation. A definition of each of the top ten knobs and comparative images of correct and incorrect use will be provided. Experience and Analysis: Refining instrumentation techniques improves ultrasound imaging of the pelvic floor, and are simple changes that are easy to incorporate into practice.
describing the specific gynecologic symptoms and management following this type of surgical procedure. We have treated a number of women following abdominoperineal resection and have identified a cluster of gynecologic signs and symptoms, including a posterior vaginal shelf, with steep posterior angulation of the vaginal apex toward the sacrum, copious foul vaginal discharge, which is frequently trapped at the apex of the vagina, and dyspareunia. Results: We have evaluated four patients who presented with copious vaginal (n 3) discharge and dyspareunia (n 2) following abdominoperineal resection (3 for ulcerative colitis, 1 for anorectal cancer). Median age was 52 (range 40 61). Median follow up time was 2 months (range 112 months). All of these women were found on exam to have steep posterior vaginal angulation and shelf likely caused by levator ani muscle plication at the time of their colorectal surgery. One was being followed for abnormal pap smears, and her primary gynecologist was having difficulty accessing the cervix due to the vaginal angle. We treated the two patients with dyspareunia surgically with a midline levator ani muscle transection (relaxing incision) and transverse pull down of the vaginal wall. Of those treated surgically, one had complete resolution of her dyspareunia, and the other is not sexually active because of partner issues but is using a vaginal dilator painlessly. The other two patients have been managed conservatively with vaginal clindamycin cream as well as douching assisted by manual retraction of the vaginal shelf to allow for drainage of secretions while showering. Of those treated conservatively, one remains sexually active without dyspareunia, and the other is not sexually active due to lack of a partner. Both have noted a significant decrease in their vaginal discharge. In short-term follow-up, both the conservative and surgical management strategies have resulted in decreased vaginal discharge and increased patient satisfaction. Conclusions: Excessive levator plication in the setting of anorectal resection may result in gynecologic complaints that can be effectively managed conservatively, with vaginal clindamycin and douching, or surgically with levator transaction and vaginal reconstruction. Disclosures: M.B. Berger, None; R.U. Margulies, None; D.E. Fenner, None.
Disclosures: R. Hall, None; T. Omotosho, None; H. Abed, None; R. Rogers, Pfizer, NIH, Grant/Research Support; Pfizer, Consultant; Pfizer, Speakers Bureau.
Presentation Number: Tip and Trick 5 Gynecologic Problems Following Abdominoperineal Resection of the Anus and Rectum M. B. Berger, R. U. Margulies, and D. E. Fenner University of Michigan, Ann Arbor, MI Objective: To describe the presenting gynecologic symptoms and treatment options for women who have previously undergone abdominoperineal resection of the anus and rectum for benign and malignant conditions. Methods: Since it was first described by Miles in 1908, the abdominoperineal resection has been a standard treatment for low rectal cancers and is also used as a surgical treatment for inflammatory bowel disease. In women, in order to close the vacant pelvic cavity, the levator ani muscles are plicated in the midline. Multiple studies have demonstrated sexual dysfunction, decreased subjective measures of body image, and decreased quality of life measures following abdominoperineal resection. However, there is a paucity of literature
Presentation Number: Tip and Trick 6 Surgical Approach to Vaginal Ulcers in the Setting of Advanced Pelvic Organ Prolapse C. A. Brincat, R. U. Margulies, and J. O. DeLancey University of Michigan, Ann Arbor, MI Objective: When a vaginal ulcer is present on a large prolapse, a decision must be made about delaying surgery until healing occurs versus excising the ulcer at the time of operation. This report concerns our operative technique and treatment outcomes with excising unhealed but not infected ulcers in a cohort of women with advanced pelvic organ prolapse at a Midwestern tertiary care facility. Description of the Technique: Ulcers are first evaluated for gross infection and atypical appearance suggesting malignancy. Infection is treated if present and the ulcer is biopsied if it has an unusual appearance. In this series all clean vaginal ulcers were excised at the time of surgery. A full thickness circumscribing incision is made through the epithelium and fascia at the junction between the indurated tissue and the normal vaginal mucosa. This situation occurred most often at the vaginal apex and the ulcer was included in that portion of the vagina excised during 4-wall sacrospinous ligament suspension. In the more severe cases, where mucosa is directly on the
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peritoneum, the area is excised including the attached peritoneum, using the knife to scrape the epithelium off of the fascia where no cleavage plane can be dissected. Once excised, the tissue is sent for histologic examination. Experience and Analysis: We reviewed the surgical billing records of a senior urogynecologic surgeon at our facility over a 10 year period (19972007) and identified 1605 cases. We then reviewed the 692 operative reports of transvaginal apical prolapse repairs, and included cases where the word vaginal ulcer appeared in the operative findings. Twenty-five patients with vaginal ulcers at the time of their prolapse repair were identified and their postoperative medical records were reviewed. None of these patients had postoperative wound infections or cuff dehiscence. None of the pathology reports described malignancy in the specimen. Conclusion: Excising vaginal ulcers at the time of surgical treatment for pelvic organ prolapse is an acceptable alternative to delaying surgery when infection is not present.
Disclosures: C.A. Brincat, None; R.U. Margulies, None; J.O. DeLancey, Johnson & Johnson, Consultant.
Poster Presentations
Presentation Number: Poster 1 Clinical Outcome after Lefort Colpocleisis Combined with Two Different Midurethral Slings in the Elderly Patients S. S. Badalian, St. Josephs Hospital Health Center, SUNY Upstate Medical University, Syracuse, NY Category: Surgery SUI. Objective: To compare the clinical outcome and the effectiveness of Lefort colpocleisis combined with two different midurethral slings (TVT-GYNECARE, and TOT-MONARC) for the treatment of complete prolapse with occult stress urinary incontinence in elderly patients. Methods: A retrospective chart review was performed from January of 2002 to December of 2007 on 27 elderly women (mean age 81 years, range: 76 88 years) who underwent a Lefort colpocleisis combined with midurethral sling procedure. All patients had multiple medical co-morbidities. Of the patients, 82% had prior Gelhorn pessaries for a few years, and 74% had a prior hysterectomy. Only one surgeon performed all the procedures. All the procedures were performed under spinal anesthesia. Results: Fourteen patients had a Lefort colpocleisis with a TVT procedure (mean age 80.7 years) and 13 patients had the Lefort with a TOT procedure (mean age 81.1 years). There were no differences in the mean blood loss and the mean hospital stay days. All the patients were discharged home after 24 48 hours. The mean operating time was 90 ( 23) minutes for the TVT group and 76 ( 12) minutes for the TOT group (p 0.05). There were no intraoperative or early postoperative complications. Preoperative complications of urinary retention, frequent urinary tract infections and intermittent urinary flow were resolved in all patients. No stress urinary incontinence was demonstrated after the surgery. De novo urge incontinence was seen in two patients in the TVT group. There were no cases of erosion or extrusion of the sling. All the patients were satisfied or extremely satisfied after the repair and did not feel regret for the loss of sexual function. Conclusion: In our patient population, both the TVT and TOTMONARC combined with the Lefort colpocleisis appears to be an effective treatment option for correcting a complete prolapse and occult stress urinary incontinence in elderly patients who desire to have an obliterative procedure and a quick recovery. We are in the process of collecting long-term data to assess the objective and subjective cure rates along with patient satisfaction rates after the combined procedures. Considering the similar results of the procedures, we favor the combination of Lefort colpocleisis with TOTMONARC because of its simpler technique of placement and shorter operating time for elderly patients with multiple co-morbidities. Disclosures: S.S. Badalian, Novartis, Algeran, P&G, AMS, Speakers Bureau.
Presentation Number: Poster 2 Is Burch or Mid-Urethral Sling Better With Abdominal Sacral Colpopexy? M. Patel*, D. OSullivan, and P. Tulikangas* *University of Connecticut, Hartford Hospital, Hartford, CT, Hartford Hospital, Department of Research Administration, Hartford, CT
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Category: Surgery SUI. Objective: To compare the post-operative rates of stress urinary incontinence (SUI), urgency and additional treatment for either stress or urge urinary incontinence after abdominal sacral colpopexy (ASC) with and without a concomitant anti-incontinence procedure. Methods: A cohort of women who had undergone ASC (n 150) either alone (27%) or with an anti-continence procedure (73%), were analyzed to determine the rates of post-operative SUI and urinary urgency symptoms. Review included demographics, preoperative symptoms of urgency, SUI, standard questionnaires, pelvic organ prolapse quantification exam, multichannel urodynamics (MUDS), post-operative complaints of SUI, urgency and treatment for either condition. Post-operative SUI, urgency and repeat treatment for SUI was compared between subjects who had either Burch, midurethral sling (tension-free vaginal tape TVT ) or no anti-incontinence procedure, stratified based on whether they had demonstrable preoperative SUI, potential SUI or no SUI. Odds ratios (OR) and 95% confidence intervals (CI) were generated with SPSS v. 14, with p 0.05 deemed significant. Results: A total of 110 women had SUI preoperatively (81 with genuine SUI and 29 with potential SUI). Median length of follow up was 8 months (range 1 61 months). Eighty-six subjects underwent a Burch, 24 had a TVT and 40 had no anti-incontinence procedure at the time of ASC. Post-operatively, 13% (20/150) of all subjects had SUI, 20% (4/20) with potential SUI, 45% (9/20) with genuine SUI and 35% (7/20) without preoperative SUI. Subjects with preoperative SUI who had a Burch were more likely to have post-operative SUI than those who had a TVT (13 versus 0, p 0.007). Of the subjects with post-operative SUI, 35% (7/20) had another operation. Among those who underwent a subsequent operation for SUI, the initial operation was a Burch in 85% (6/7) of the cases and 15% (1/7) had no prior anti-incontinence procedure. Pre-operatively, complaints of urinary urgency or detrusor overactivity on MUDS were noted in 56% (84/150) of subjects. Post-operatively 24% (36/150) of subjects had persistent symptoms of urinary urgency. Post-operative de novo urgency was seen in 18% (27/150) of patients. Subjects were more likely to have post-operative urgency if they had pre-operative SUI OR 3.90 (95% CI, 1.639.29) . Preoperative urgency was not associated with higher rates of post-operative urgency, regardless of type of antiincontinence procedure. Conclusions: Both Burch and TVT procedures improve SUI symptoms in patients undergoing ASC. Midurethral slings performed with ASC have lower rates of post-operative SUI. Urge symptoms are common in women both before and after surgery. Post-operative urinary urgency symptoms are not worsened by either Burch or TVT. Disclosures: M. Patel, None; D. OSullivan, None; P. Tulikangas, None.
Methods: This is a retrospective study of 76 patients with stress urinary incontinence who had received retropubic tension-free vaginal tape (TVT) or transobturator tension-free vaginal tape (TOT) from January 2005 to December 2006. Medical records were reviewed and clinical characteristics were compared according to operation procedures. Results: Twenty-four patients underwent TVT and 52 patients underwent TOT. There was no significant difference in the patients demographics and preoperative urodynamic study between the two groups. Mean operative time was significantly shorter in the TOT group (34 min and 17 min, p 0.05). The subjective cure rates (very satisfied, satisfied) were 91.7% in TVT and 98.1% in TOT. The age of 3 patients (1 TVT and 2 TOT) who showed incontinence after procedure ranged from 48 to 52 and all of them were perimenopausal. In the TOT group, 2 patients suffered from leg pain more than 1 week and 1 patient more than 4 weeks and there was no such complication in TVT group. Two cases of vaginal erosion were developed only in patients received TOT, and they had mild to moderate degree of cystocele. De novo urgency (frequency and urgency) was more frequent in the TVT group than in the TOT group (p 0.05, Fishers Exact test). In addition, 3 patients (1 TVT and 2 TOT) presented with voiding difficulty that was treated with an alpha1 adrenergic blocker; their ages were 40, 41, and 42, respectively. Conclusions: TVT and TOT are both effective and safe surgical managements for stress urinary incontinence. Perimenopausal women could be considered as having a risk factor of surgical failure after TVT or TOT. Physicians should be aware of possible leg pain after the TOT procedure. In a patient with cytocele who is scheduled for TOT, helical passer should be introduced carefully being cautious of possible vaginal erosion or perforation at lateral angle of vagina during the procedure. Disclosures: Y. Kim, None; H. Ahn, None; Y. Jeon, None; B. Jee, None; C. Suh, None.
Presentation Number: Poster 3 Factors Related with Failure and Complication after Retropubic Tension-Free Vaginal Tape and Transobturator Tension-Free Vaginal Tape Y. Kim, H. Ahn, Y. Jeon, B. Jee, and C. Suh Department of Ob&Gyn, Seoul National University Bundang Hospital, Seongnam, Republic Of Korea Category: Surgery SUI. Objective: The aim of the present study was to evaluate the factors predicting failure and complications in the surgical management of stress urinary incontinence.
Presentation Number: Poster 4 Outcomes of Mid-Urethral Synthetic Slings When Performed by Urogynecologists, Urologists, and General Gynecologists T. V. Deniseiko Sanses*, C. L. Grimes, K. A. Hoskey*, M. L. Russo, C. Melick, J. Blomquist*, and M. Ellerkmann* *Greater Baltimore Medical Center, Baltimore, MD, The Johns Hopkins Hospital, Baltimore, MD, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD Category: Surgery SUI. Objective: To describe the patient demographics, perioperative outcomes, surgeons experience and preferences in performing synthetic midurethral sling procedures at a private community hospital setting. Methods: This is a retrospective cohort study of mid-urethral synthetic slings performed at a community hospital between 2001 and 2007. Non-synthetic slings and slings performed with concurrent surgeries were excluded from analysis. All variables were stratified by surgeons specialty: urogynecology (URO-GYN), urology (URO), and general gynecology (GYN). Nominal variables were assessed with Pearson 2 test. ANOVA and Scheffe multiple comparison tests were used to compare continuous variables. The Pearson product-moment correlation coefficient was used to examine the relationship between years of surgeons experience and sling operating room (OR) time. Results: 639 out of 1324 mid-urethral slings were analyzed. 17 different types of synthetic sling procedures were performed. TVT (Gynecare) was the most prevalent type: 279 cases or 43.7% of all procedures.
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Compared to URO-GYN and URO, GYN less frequently operated on patients with a history of voiding dysfunction and/or prior incontinence surgery (19.1% vs 20.1% vs 12.3%, p 0.041 and 15.6% vs 15.8% vs 5.8%, p 0.001, respectively). Mean sling OR time in minutes was 38.9 9.1 for URO-GYN, 34.9 13.4 for URO, and 33.4 20 for GYN, p 0.003. Estimated blood loss and intra-operative complications (bladder, urethral, vaginal perforations) were similar among all specialties. In the postoperative period, readmission to hospital was more common by URO-GYN 4.3% than by URO 0.5% and GYN 1.0%, p 0.012. There was no difference in return to OR cases: 4.9% for URO-GYN, 2.2% for URO, and 4.1% for GYN, p 0.369. The tape release/removal frequency was similar 1.2% URO-GYN, 0.5% URO, and 2.4% GYN, p 0.265. URO-GYN was most likely to have a fellow present in 75.9% vs 2.7% vs 0.3% of cases (p 0.001). GYN attendings were in practice longer than URO-GYN and URO (19.7 8.6 vs 13.2 6.8 vs 10.5 4.9 years of experience; p 0.001). A slight inverse correlation (r .164, p 0.001) was found between surgeons years of experience and sling OR time. URO-GYN utilized the retropubic approach in 82.7% of cases vs URO 16.3% vs GYN 42%, p 0.001; URO preferred the suprapubic approach in 44.6% vs URO-GYN 3% vs GYN 0%, p 0.001; and GYN used the transobturator approach in 53.6% vs URO-GYN 14.8% vs URO 38.6%, p 0.001. Conclusions: Many types of minimally invasive synthetic mid-urethral slings are available. Although population demographic and surgical approaches vary, all three surgical specialties (urogynecologists, urologists, and general gynecologists) have similar major perioperative outcomes. Disclosures: T.V. Deniseiko Sanses, None; C.L. Grimes, None; K.A. Hoskey, None; M.L. Russo, None; C. Melick, None; J. Blomquist, None; M. Ellerkmann, None.
Presentation Number: Poster 5 Preliminary Results of Peri-Operative and 3-Month Outcomes from a World-Wide Observational Registry of Tension-Free Vaginal Tapes in Women With Stress Urinary Incontinence S. Khandwala*, V. Lucente, R. Kalbfleisch, K. Lee, D. Tincello, T. Botha , G. Buchsbaum**, and D. Grier *Advanced Urogynecology of Michgan, Dearborn, MI, The Institute for Female Pelvic Medicine & Reconstructive Surgery, Allentown, PA, McMaster University, Hamilton, ON, Canada, Samsung Medical Centre, Seoul, Republic of Korea, Leicester General Hospital, Leicester, United Kingdom, Arwyp Medical Centre, Arwyp, South Africa, **University of Rochester, Rochester, NY, Sound Urological Associates, Edmonds, WA Category: Surgery SUI. Objective: To obtain long-term clinical and patient reported outcomes on the use of GYNECARE TVT*, TVT*-Obturator and TVTSECUR* Systems in a worldwide prospective registry. Methods: 563 women from 24 sites in 7 countries, with confirmed SUI mixed incontinence, have been enrolled under IRB guidelines. Assessments are done at baseline, peri-operatively, and at up to 3, 6 & 12 months and then annually to 5 years. Peri-operative data are collected. Effectiveness evaluations include objective assessment by standing stress test at 12 months, subjective assessment using the Incontinence Quality of Life instrument (IQOL). Complications are collected. Results: 352 (62.5%) women have been TVT SECUR patients; 90 (16.0%) TVT-O and 121 (21.5%) TVT. In TVT SECUR patients, Hammock placement was used in 247 women (70.2%), and U placement in 105 women (29.8%).
Demographics and medical history of patients in the 3 groups appeared to be well balanced for age, weight, menopausal status, and previous gynecological surgeries. There were similar proportions of SUI (66.8%, 65.3%) to mixed incontinence (33.2%, 34.7%) in TVT SECUR and TVT groups, respectively. For TVT-O, the proportion was 55.6% with SUI and 44.4% with mixed. The proportion of patients with concurrent surgery was higher in the TVT-O group (44.4%) compared to TVT SECUR (17.9%) and TVT (21.5%). Here we report peri operative data excluding patients with concurrent surgeries. Median surgical duration was 15.5, 27 and 22 minutes for TVT SECUR, TVT and TVT-O, respectively. Use of local anaesthesia with sedation was higher in TVT SECUR group (73.5%) compared to 41.8% TVT and 45.5% TVT-O. Discharge from hospital on the day of surgery occurred in 85.5% TVT SECUR patients compared with 74.2% for TVT and 72.0% for TVT-O. Normal voiding at discharge was reported in 92.4% for TVT SECUR, 89.0% TVT and 96.0% TVT-O. Improvements in I-QOL mean changes from baseline were reported in all 3 groups. The proportion of patients with improvement greater than the minimal clinically important difference of 6.3 points at the 3 month visit were 86.3% TVT SECUR, 85.7% TVT-O and 90.0% TVT. Complications included: 1 bladder perforation (0.8%) during a TVT procedure; 1 vaginal laceration during a TVT SECUR procedure (0.3%); bleeding in excess of 200 ml was reported in 1 (0.3%) TVT SECUR patient; mesh exposure in 4 TVT SECUR (1.1%) and 3 TVT patients (2.5%); voiding dysfunction in 3 TVT SECUR (0.9%) and 1 TVT patient (0.8%); haematoma in 3 TVT SECUR (0.9%) and 1 TVT-O (1.1%); de novo urgency in 2 (0.6%) TVT SECUR patients; worsening urge incontinence in 1 (0.8%) TVT patient. Conclusions: These early results suggest that TVT SECUR is well tolerated and safe to use. Follow up continues to assess the long-term effectiveness of this novel single-incision sling. Dislcosures: S. Khandwala, Ethicon, Novartis, Astellas, Consultant; V. Lucente, Ethicon, Pfizer, Novartis, Astellas, Indevus, Bard, Consultant; R. Kalbfleisch, None; K. Lee, None; D. Tincello, Ethicon, Eli Lilly, Pfizer, Consultant; T. Botha, None; G. Buchsbaum, Ethicon, Consultant; D. Grier, None.
Presentation Number: Poster 6 Comparison of Surgical Outcome of TVT and TOT for SUI with POP S. Bai, H. Yang, H. Jung, M. Jeon, and S. Kim Department of Obstetrics and Gynecology, Seoul, Republic of Korea Category: Surgery SUI. Objectives: To compare tension-free vaginal tape and transobturator tape for surgical treatment of stress urinary incontinence associated with pelvic organ prolapse for postoperative complications and success rate. Methods: Two hundred ten women who underwent surgery for pelvic organ prolapse (stage II) and tension-free vaginal tape or transobturator tape for stress urinary incontinence were included in this study from March 2000 to May 2006 at Division of Female Pelvic Medicine and Reconstructive Surgery, Yonsei University Health System in Seoul. The patients were divided into two groups; 145 patients underwent tension-free vaginal tape and 133 patients underwent transobturator tape. Patients were examined in a supine and a 45 upright position using the Pelvic Organ Prolapse-Quantification system. Postoperative complications such as hemoglobin loss after surgery, hematoma, bladder and bowel injury, mesh erosion, urinary retention, de novo urgency, urinary tract infection were analyzed. Cure of stress urinary incontinence was defined as an absent subjective complaint of leakage and absent objective leakage on a cough stress test. This study was approved by
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the Institutional Review Board of Yonsei University Health System Center. The Students t-test and chi-square test were used for statistical analysis by using SPSS, version 12.0 (SPSS Inc., Chicago, IL, U.S.A.). p 0.05 was determined to be significant. Results: All patients were evaluated at the 12-month follow-up. The characteristics of patients showed no significant difference between the two groups. Postoperative complications were significantly less common after the transobturator tape than tension-free vaginal tape. (hemoglobin loss after surgery; tension-free vaginal tape (2.9 0.93 g/dL), transobturator tape (1.5 0.77 g/dL), p 0.04, urinary retention; tension-free vaginal tape (35.17%), transobturator tape (21.05%), p 0.0002, urinary tract infection; tension-free vaginal tape (11.72%), transobturator tape (3.75%), p 0.02) The groups did not differ significantly in cure rates. Conclusions: All techniques appear to be equally effective in the surgical treatment of stress urinary incontinence associated with pelvic organ prolapse. However, transobturator tape seems to be a safer procedure in postoperative complications. Disclosures: S. Bai, None; H. Yang, None; H. Jung, None; M. Jeon, None; S. Kim, None.
study is the small sample size. However this is to our knowledge the first study which examines tissue reaction of the vaginal wall initiated by explanted MPPM in the human female. Although the results are derived from tension-free vaginal tapes, in which erosion is rare and easy to control, future focus of this study may be in prolapse meshes, in which erosion of MPPM is a major problem, not yet resolved. Disclosures: T. Kavvadias, None; D. Kaemmer, None; U. Klinge, None; S. Kuschel, None; B. Schuessler, None.
Presentation Number: Poster 8 Impact of Body Mass Index on Outcome Of Transobturator Tape For The Treatment Of Stress Urinary Incontinence P. A. Castillo, V. C. Aguilar, and G. Davila Cleveland Clinic Florida, Weston, FL Category: Surgery SUI. Objective: To identify the impact of body mass index (BMI) on the efficacy of transobturator slings for stress urinary incontinence in women. Methods: 442 patients who underwent Monarc (AMS) trans-obturator tape for SUI at a tertiary care center. Patients with a minimum of 6 months postoperative follow-up were analyzed retrospectively. Postoperative outcomes among obese women, defined as BMI 27, were compared to non-obese women (BMI 27). Selection criteria for patients with stress urinary incontinence included positive cough stress test during filling cystometry, positive valsalva leak point pressure 60 cm H20 and maximal urethral closure pressure 20 cm H2O. Failure was defined as report of any leakage events, any pad usage, a positive empty supine stress test (ESST) or patient self assessment other than cured or greatly improved at last post-operative visit. Results: A total of 442 patients underwent a Monarc TOT procedure from March 2003 to Feb 2008. Records of 179 patients with a minimum of 6 months follow-up data were analyzed. Outcomes from 63 (35.2%) patients in the obese group were compared to 116 (64.8%) patients in the non-obese group. Conclusion: When correcting for disparity of group size, there was no significant difference in failure rate between groups. Preoperative obesity does not appear to be a risk factor for failure of transobturator sling. Disclosures: P.A. Castillo, None; V.C. Aguilar, None; G. Davila, AMS, Adamed, Synovis Astellas Watson Zuidex Protein Polymer Technologies Duramed, Grant/Research Support; AMS, Watson, Adamed, Consultant; Talks/honorarium:Watson, AMS, Synovis, USSurgical, Pfizer, Astellas, Adamed, Other
Presentation Number: Poster 7 Foreign Body Reaction in Vaginally Eroded and Non Eroded Polypropylene Tension Free Sub-Urethral Tapes in the Human Female: A Case Series T. Kavvadias*, D. Kaemmer, U. Klinge, S. Kuschel*, and B. Schuessler* *Cantonal Hospital of Lucerne, Lucerne, Switzerland, University Hospital Aachen, Aachen, Germany Category: Surgery SUI. Objective: The aim of this study was to establish the pattern of tissue reaction induced by macroporous polypropylene mesh (MPPM) at the vaginal wall and to compare this pattern in eroded and non eroded material. Methods: Ten women (mean age: 57 years, min. 43 max. 73) who were primarily treated for SUI with sub-urethral tapes (7 TOT-Safyre, 2 TVTs and 1 TOT-Monarc), were seen in our outpatient clinic between May 2004 and December 2006 with the following diagnoses: tapeerosion in five patients; voiding disorders with residual urine volume in three patients; dislocation of the tape with recurrent SUI in two patients. In all patients the tapes were removed. Mean time between surgical treatment and revision was 20 months (min. 1 max. 30). Explanted tissue and tape material was stained with 1% Hematoxylin/Eosin solution and foreign body reaction was tested by immunohistochemistry aiming at accumulation of macrophages (CD68), expression of matrix metalloproteinase (MMP) 2 and 13, cellular proliferation (Ki-67) and apoptosis (TUNEL) using a standard avidinbiotin complex and counterstaining with diaminobenzidine. Two investigators, blinded to the clinical data, scored the findings with a visual semi-quantitative scoring system; discrepancies were resolved under discussion. The collagen I/III quotient was also evaluated using cross-polarization microscopy after staining in picrosirius solution. Results: The inflammatory reaction consisted of fibrotic ingrowth between the pores following the length of the tape; eight out of ten explanted tapes were rolled up. The collagen I/III quotient was 7,05. Conclusions: Microscopic findings resemble results found in abdominal wall surgery and meshes explanted from animal models. The collagen I/III quotient was typical of fibrotic tissue. There were no major differences between the five eroded and the five non eroded tapes, indicating that the origin of erosion is not based on a different pattern of tissue reaction in the individual patient. Limitation of this
TABLE. OBESE (n 63) Failure Fail Rate Self assess Leak Pads ESST 16 19 14 6 25.40% 30.20% 22.20% 9.50% NON-OBESE (n 116) Failure Fail Rate 29 23 29 3 25% 19.80% 25% 2.60%
p Value 0.545 0.141 0.718 0.068
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Presentation Number: Poster 9 Body Mass Index as a Risk Factor for Cystotomy During MidUrethral Sling Placement G. C. Dunivan, A. Connolly, M. L. Jannelli, E. C. Wells, and E. J. Geller University of Noth Carolina, Chapel Hill, Chapel Hill, NC Category: Surgery SUI. Objective: To determine if body mass index (BMI) is a risk factor for cystotomy in women undergoing mid-urethral sling for stress urinary incontinence via the suprapubic approach. Methods: After IRB approval, a retrospective chart review was performed at an academic institution for all women undergoing a midurethral sling for stress urinary incontinence between June 2005 and October 2007 by the division of Urogynecology/Reconstructive Pelvic Surgery. All patients had a system placed which utilizes a suprapubic approach. Data collected included demographics, BMI, history of prior surgeries and preoperative POP-Q through electronic and paper medical records. There were no exclusions for clinical history, such as presence of mixed incontinence or prior pelvic surgery, nor for concomitant surgeries. The primary outcome was cystotomy at the time of sling placement. Data were analyzed with SPSS 15.0 (SPSS Inc., Chicago, IL). Students t-test, Chi-square, Wilcoxon rank sum and logistic regression were performed. Results: 198 women were identified through the operating room database: 69 women with a BMI 30 kg/m2 and 129 women with a BMI 30 kg/m2. Demographics were similar except for prior hysterectomy (58.0% vs 38.0%, p 0.007) and preoperative C point ( 6.0 vs 5.0, p 0.011), in the BMI 30 kg/m2 group versus the 2 BMI 30 kg/m group. The overall cystotomy rate was 10.6%. The cystotomy rate was lower in the BMI 30 kg/m2 group with 3 perforations (4.3%) versus 18 perforations (14.0%) in the BMI 30 kg/m2 group (p 0.04). In a logistic regression model controlling for BMI, age, race, prior anti-incontinence surgery, prior paravaginal repair, prior hysterectomy and prior cesarean delivery, a BMI 30 kg/m2 retained its association with an increased risk of cystotomy (OR 4.7, 95% CI 1.218.5) as did prior anti-incontinence surgery (OR 3.6, 95% CI 1.113.3). Conclusions: Women with a BMI 30 kg/m2 and those with a history of anti-incontinence surgery are at a higher risk of cystotomy during the placement of a mid-urethral sling utilizing the suprapubic approach. These data add to the existing literature which predominately reports on the transvaginal route and may aid the clinician in counseling patients on this minimally invasive procedure. Disclosures: G.C. Dunivan, None; A. Connolly, None; M.L. Jannelli, None; E.C. Wells, None; E.J. Geller, None.
2007. Operative notes and anesthesia records were reviewed for body mass index in kg/m2 (BMI), cystotomy, bowel injury, ureteral injury, estimated blood loss (EBL), retropubic hematoma, operative time (ORT), concurrent procedures, and product used. Obesity was defined as BMI 30. Data were divided into those with BMI 30 and 30. All cases without cystoscopy were excluded for intra-operative injury rate calculation. Intra-operative injury was determined by cystoscopy at time of procedure and repeat operation within one year. EBL and ORT were calculated from cases limited to mid-urethral sling alone. The data were subdivided into two groups consisting of those receiving a trans-obturator (TO) and those receiving a retropubic (RP) approach. NCSS system software (Kaysville, Utah) was used for statistical analysis. Means were compared using the Neuman-Keuls method for one-way analysis of variance with significance defined as p 0.05. Results: A total of 675 mid-urethral sling procedures were identified. All groups were similar in terms of age, race, and parity. Cystoscopy was not performed in 138 cases, leaving 537 for injury analysis. Additional procedures were performed in 394 cases leaving 281 for EBL and operative time analysis. Difference in cystotomy rate between BMI 30 and 30 of 1.6% and 4.8% (p 0.044) respectively, was statistically significant. Relative risk was 1.37 95% CI 0.96 1.57 . No bowel or ureteral injuries were identified. One retropubic hematoma occurred requiring re-operation in the BMI 30 group. Mean EBL was 53.0cc and 54.0cc and operative time was 65.2 minutes and 68.4 minutes for BMI 30 and 30 respectively. Neither difference was statistically significant. There was no significant difference between the BMI 30 and BMI 30 in the RP and TO sub-group analysis in regards to intra-operative injury, ORT, and EBL. In the TO group, no cystotomies occurred in those with BMI 30 and two occurred in those with BMI 30 (3.13%). Mean EBL for these two groups were 38.8cc and 45.4cc respectively. Mean ORT was 46.1 minutes and 49.8 minutes. There were no injuries in the RP group with BMI 30 and there were 14 cystotomies (5.4%) and one retropubic hematoma (0.24%) with BMI 30. Mean EBL was 69.2cc and 59.6cc respectively and mean operative time was 72.0 minutes and 71.3 minutes in this group. Conclusion: BMI 30 does not affect EBL or ORT and is associated with decreased risk of cystotomy in patients undergoing mid-urethral sling procedures. Disclosures: J.L. Woelk, None; C.S. Claydon, GlaxoSmithKline, Speakers Bureau; P. Brezina, None; S.M. Atkinson, Jr., Gynecare, Consultant; C. Hodson, None.
Presentation Number: Poster 10 Intra-Operative Complications of Mid-Urethral Slings in the Obese and Non-Obese J. L. Woelk, C. S. Claydon, P. Brezina, S. M. Atkinson, Jr., and C. Hodson East Carolina University, Brody School of Medicine, Greenville, NC Category: Surgery SUI. Objective: To determine the effect of obesity on intra-operative complication rates during mid-urethral sling procedures. Materials and Methods: After IRB approval, pre-operative, operative, and anesthesia records were reviewed on all mid-urethral sling procedures performed at our institution between January 2001 and April
Presentation Number: Poster 11 Early Versus Late Sling Lysis Results in Greater Improvement in Voiding Symptoms M. M. South,* J. M. Wu,* G. D. Webster, A. C. Weidner,* J. J. Roelands,* and C. L. Amundsen* *Duke University Urogynecology and Pelvic Reconstructive Surgery, Durham, NC, Duke University Urology, Durham, NC Category: Surgery SUI. Objective: Voiding dysfunction occurs anywhere from 5% to 20% after anti-incontinence procedures. The symptoms include urinary retention and obstructive and irritative voiding symptoms. The goal of this study was to determine if the time from sling placement to midline sling lysis affected overall improvement in patient symptoms. Methods: After IRB approval, we conducted a retrospective cohort analysis of 112 subjects undergoing midline sling lysis from January 1997 through September 2007. The inclusion criteria were subjects
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with a vaginal midline sling lysis for irritative and/or obstructive symptoms following a prior pubovaginal or midurethral sling. We excluded any subject with sling erosion without voiding symptoms and those who underwent a repeat sling at the time of lysis. We compared subjects who had an early sling lysis ( 1 year from sling to lysis) to a late sling lysis ( 1 year). The primary outcome was based on the subjects report of overall improvement in symptoms. We abstracted data on demographics, presenting symptoms, physical examination findings, date of anti-incontinence procedure, date of midline sling lysis, and post-operative symptoms. Statistical analysis consisted of Students t-test, chi-square, Fishers exact test and multivariate logistic regression. Results: Of 112 subjects, 74 (66%) had an early sling lysis and 38 (34%) had a late sling lysis. These two groups were similar in age, menopausal status, presence of preoperative irritative and obstructive symptoms, anterior colporrhaphy at the time of lysis and presence of an eroded sling. The early lysis group had a higher percentage of midurethral slings (36% vs. 8%, p .001), a lower rate of preoperative complete retention (70% vs. 89%, p .001), and a lower rate of prior urethrolysis (16% vs. 45%, p .003). No significant difference in follow-up time was found between early lysis compared to late lysis (49 months vs. 43 months, p .729). 10 (8.9%) subjects developed recurrent stress urinary incontinence after sling lysis which was independent of time to lysis. 94 (84%) subjects had improvement in their voiding dysfunction symptoms after midline sling lysis. Overall improvement occurred more often in the early sling lysis group compared to the late sling lysis group (91% vs. 71%, p 0.01). This finding retained significance in a multivariate logistic regression model that included age, prior urethrolysis, pre-operative complete retention and type of sling (OR 3.9, 95% CI 1.4 11.1). Conclusions: Based on this large cohort, we conclude that patients will benefit from earlier (within one year) midline sling lysis for voiding symptoms after a pubovaginal or midurethral sling procedure. The development of recurrent stress urinary incontinence after midline sling lysis is low and independent of time to lysis. Disclosures: M.M. South, None; J.M. Wu, None; G.D. Webster, None; A.C. Weidner, None; J.J. Roelands, None; C.L. Amundsen, None.
and at 1,4 and 8 hours postoperatively. Estimated blood loss, total office time, and return to normal activities were recorded. UDI-6 was filled out by patients preoperatively and collected at three months postoperatively. Results: VAS for the various aspects of the procedure : infiltration of local anesthetic(mean 0.8, range 1 4), incision (mean 0.05, range 0 1), dissection (mean 0.1, range 0 1), Device placement (mean 1.9, range 1 8), overall (1.55, range 13)., 1 hour (mean 1.9, range 0 8), 4 hour (mean 2.8, range 0 9), 8 hour (mean 2.5, range 0 8). Return to normal activities (mean 3.64 days, range 113 days. EBL (mean 18.6ccs, range 10 40ccs). Total Office Time (mean 52.95 minutes, range 2790 minutes).Return to normal activities (mean 3.64 days, range 0 13 days). UDI-6 results are pending at this time and will be available at time of presentation. Conclusions: It appears that single incision vaginal sling (TVT-Secur) is well tolerated in the office setting with the use of local anesthetic only. Long term results for this new technology are not yet available and we are unable to determine if there is a change in efficacy at different sites of service and this warrants further study. Disclosures: M.P. Woods, Ethicon Womens Health and Urology, Grant/Research Support; Ethicon Womens Health and Urology, Consultant.
Presentation Number: Poster 12 Vaginal Sling for Stress Urinary Incontinence Under Local Anesthetic in the Office Setting M. P. Woods Bellevue Obstetrics and Gynecology Associates, PC, Bellevue, NE Category: Surgery SUI. Objective: To assess feasibility of in office placement of a new vaginal sling procedure under local anesthetic, including patient comfort using a visual analog scale, resource utilization, and patient satisfaction. Secondary assessment on the patients life using UDI- 6 preoperatively and at 3 months postoperatively was also performed. Methods: 20 patients found on multichannel urodynamics to have genuine stress incontinence were recruited for an IRB approved study to assess tolerability and short term efficacy of TVT-Secur in the office setting. All procedures were placed in the hammock fashion, a standardized protocol for local anesthetic infiltration without sedation was utilized, all patients had intraoperative cystoscopy performed and received Ciprofloxin 500 mg by mouth 1 hour prior to procedure. A visual analog scale (110) was utilized on all patients at the time of local anesthetic injection, placement of device, over all procedure,
Presentation Number: Poster 13 Efficacy and Safety of Secur Tension Free Vaginal Tape Tvt Surgery in Stress Urinary Incontinence a Short Term FollowUp Study H. Yasmin, and M. L. Mokrzycki Saint Peters University Hospital, New Brunswick, NJ Category: Surgery SUI. Objective: SECUR TVT system is a new minimally invasive treatment for female urinary incontinence. The objective was to establish the safety and efficacy of Secur TVT. Methods: The Secur TVT features a small compact design that does not require exit incisions and uses the prolene polypropylene mesh. The mesh tape is inserted through the vagina and positioned without tension under the midurethra, creating the supportive sling. The study was done at Obstetrics & Gynecology Department, Saint Peters University Hospital, Drexel University, NJ, USA. A group of 60 patients with Stress urinary Incontinence SUI , i.e pure SUI in 57/60 women ; 3/60 women with mixed urinary incontinence from October 2006December 2007 were recruited to undergo SECUR TVT operation. The primary outcome was bladder perforation and secondary outcomes were cure rate of SUI symptoms, blood loss, voiding difficulty, and de-novo urgency. Preoperative evaluation consisted of complete clinical examination with urodynamic assessment. Results: The mean age was 60years range 34 88 , the median parity was 2.3 1 4 and the mean duration of urinary incontinence symptoms was 8weeks. The average BMI in this group of women was 27.1 range17.5 43.8 . The mean surgery time was 45 mins and mean estimated intraoperative blood loss was 100 ml. There were no cases of bladder perforation in all of the 60 cases, and no other major perioperative complications. The mean duration of hospital stay was only 1.5 days. 3/60 5% women with mixed incontinence had persistent urgency urinary incontinence; 3/60 5% women developed de-novo urgency. The mean follow up of these 60 patients to the office after the procedure was 8 weeks (range 220 wks). 3/60 (5%) women had voiding difficulties. There were no immediate post-operative complications like retropubic haematoma, vaginal haematoma or bowel
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obstruction. The cure rate of Secur TVT in stress urinary incontinence was reported to be 90% 54/60 women at short term followup. These 54 women reported complete resolution of stress urinary incontinence symptoms at their follow-up visits. There were five 5/60 reported failures and improvement of symptoms in one patient 1/60 . Conclusions: The Secur TVT shows a significant cure rate (90%) and appears to be simple, safe and effective sling procedure for SUI. It avoids major complication like bladder, vascular and intestinal injuries. Further follow-up is required to evaluate long-term complications and patient satisfaction. Disclosures: H. Yasmin, None; M. L. Mokrzycki, None.
Conclusions: Early data suggest that MiniArc can be performed under local anesthesia. Results of subjects under local anesthesia in comparison to those under general anesthesia showed shorter facility stay with minimal complications and little post-operative pain. Subjects in the MiniArc study continue to be followed for 24 months. Disclosures : M.J. Kennelly, American Medical Systems, Coloplast, Pfizer, NDI Medical, Allergan, Grant/Research Support; Bard, AMS, Ethicon Womens Health, Coloplast, Consultant; Pfizer, Watson, Astellas, GSK, Novartis, Allergan, Speakers Bureau; S. Pringle, American Medical Systems, Grant/Research Support; C. Klingele, American Medical Systems, Grant/Research Support; K. Keil, American Medical Systems, Grant/Research Support; AMS, Astellas, Consultant.
Presentation Number: Poster 14 An Early Clinical Evaluation of the Miniarc Performed Under General or Local Anesthesia for the Treatment of Stress Urinary Incontinence M. J. Kennelly,* S. Pringle, C. Klingele, and K. Keil *McKay Urology, Charlotte, NC, Southern General Hospital, Glasgow, United Kingdom, Mayo Clinic and Medical College, Rochester, MN, Keil Urogynecology, Denver, CO Category: Surgery SUI. Objective: To report intra and peri-operative data comparing general vs. local anesthesia from a single arm, multicenter, prospective trial utilizing the MiniArc sling system for the treatment of Stress Urinary Incontinence. Methods: The MiniArc procedure was performed on 103 femles with documented stress urinary incontinence. No other concomitant procedures were performed. Mean age of cohort was 50.8 years (range 3279 years), mean BMI was 27.9 kg/m2 (range 20 40 kg/m2), and parity 2 ( 1.1). 28.1% (29/103) were implanted under general anesthesia and 71.8% (74/103) under local (with or without sedation). A single incision (1.5 cm) was made at the mid-urethral level and the 8.5cm sling was placed with a single 3mm diameter needle along the transobturator trajectory into the obturator internus muscles. Intraoperative parameters included length of stay (LOS) defined as time from administration of first procedural medication to discharge, estimated blood loss (EBL), length of catheter placement, pain scores per Wong-Baker Faces Pain Scale 0 10 range at discharge, and complications. Data on voiding function and pain level were collected via phone interview at 7 days post-procedure. Results: LOS was 12.81 ( 26.06) hours with general anesthesia and 2.96 ( 4.59) hours with local. EBL under general anesthesia was 26.72 mL ( 27.65) and 29.86 mL ( 29.04) under local. At discharge, subjects reported a mean pain score of 0.86 ( 1.48) after general anesthesia and 0.59 ( 1.07) after local. 80/103 subjects (77.7%) were sent home without a catheter. 58.6% (17/29) subjects who went home with catheter were in the general group and 8.1% (6/74) were in the local group. 21/23 (91.3%) of subjects had a catheter placed for 24 hours or less. Two subjects delayed normal voiding until day 2 and day 3 post-procedure (local group). Post-procedure data were collected on 102 subjects at 7 days. 100% (102/102) of subjects reported voiding normally. Mean pain scores were 0.57 ( 1.07) for the general anesthesia group and 0.34 ( 1.01) for the local group. The median durations reported for taking prescription pain medications were 2 days and 1 day for the general and local anesthesia groups respectively. There were four device or procedure related adverse events reported: 1 intra-operative vaginal wall perforation (local group), 1 broncho spasm with bradycardia post procedure (general anesthesia), 1 mesh extrusion at 3 weeks postprocedure (local anesthesia), and 1 UTI (local anesthesia).
Presentation Number: Poster 15 The Short-Term Efficacy and Safety of the Miniarc; A Single Incision Sling System VS. the Tension-Free Vaginal Tape Secure System Procedure (TVT-S) in Women with Urodynamic Stress Incontinence Y. Asulin, E. Kulwa, and B. Hines Stamford Hospital, Department of Ob/Gyn, Stamford, CT Category: Surgery SUI. Objective: The purpose of this study is to compare the short-term efficacy and safety of the Tension Free Vaginal Tape Secur System (TVT-S) procedure with the MiniArc; a single incision Sling system in women with urinary stress incontinence. This study will compare the two procedures in regards to peri-operative morbidity such as rate of bladder injury, EBL, operative time and rate of return to normal bladder function. In addition, we will compare outcome symptomatology, quality of life as well as urodynamic outcome. Study design: IRB approved pilot Retrospective study. Methods: Sixteen women with urinary stress incontinence were treated surgically with either the TVT Secur (n 8) or with the MiniArc (n 8), Single-Incision Slings. Data was extracted from preoperative records, operative records, PACU records and progress notes from follow up visits. This study compared the two procedures in regards to the intraoperative and postoperative course and complications, rate of bladder injury, estimated blood loss, operative time and rate of return to normal bladder function. In addition, we compared outcome symptomatology and urodynamic outcome. Results: The mean age for the TVT S group was 66.25 years old and for the MiniArc group it was 46.4 years old. The mean BMI for the TVT S group was 23.07 and for the MiniArc group it was 25.5. Mean Parity for the TVT S was 2 and for the MiniArc it was 3. The mean preoperative post void residual for the TVT S was 25cc and for the MiniArc it was 29.4cc. The mean operative time for the TVT S was 21.6 minutes and for the MiniArc it was 29.1 minutes. EBL as well as recovery time in the PACU was minimal for both procedures. Intraoperative cystoscopy was done for all procedures and no bladder or vaginal wall injuries were noted. One patient in the TVT S group had urinary retention and eventually was able to void spontaneously after the cutting of the sling. Another patient in the TVT S group had persistent urinary incontinence in the six week follow up visit. The rest of patients in the TVT S group were dry in the six week post operative checkup. All patients in the MiniArc group were dry post operatively and no complications were recorded. Conclusions: Both the TVT S and the MiniArc single incision sling procedures appeared to be equally effective as surgical treatment of stress urinary incontinence in women. There appeared to be minimal
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complications as these procedures were proven to be relatively safe with good short term efficacy. The operating time was slightly longer in the MiniArc group than in the TVT S group; however, both procedures took longer to complete than the traditional Sling procedures. In addition, these single incision sling procedures were found to be technically more difficult to perform. Issues that require further investigation include whether or not these single incision sling procedures result in higher rates of urinary retention than traditional sling procedures, as well as the long term efficacy of these interventions. Disclosures: Y. Asulin, None; E. Kulwa, None; B. Hines, None.
Presentation Number: Poster 17 Preincision Lidocaine Versus Placebo for Prevention of Postoperative Groin Pain in Women Undergoing Midurethral Sling Placement Via the Obturator Space A. Mendenhall, and I. B. Addis University of Arizona College of Medicine, Tucson, AZ Category: Surgery SUI. Objective: To compare the effectiveness of lidocaine versus saline in relieving postoperative groin pain in patients who receive a midurethral sling via the obturator space (TOT). Methods: We conducted a randomized double blind placebo controlled trial at the University Medical Center from December 3rd 2007 until April 15, 2008. Patients were used as their own controls and were randomized to have lidocaine injected into the obturator space on either the right or left groin with saline injected into the opposing side during the sling procedure. Pain assessments were carried out using both a verbal and visual analog scale at the 1 and 2 hour marks as well as at 2 and 6 weeks post operatively. Univariate analysis was performed using t test and chi square where appropriate. Multivariate analysis was performed using linear regression with our primary outcome being results from the verbal and visual pain scale. Variables found to be significant in univariate analysis were included in the multivariate analysis. Stata 9.0 was used for all analysis. Results: 22 total patients have been enrolled in this study, which is ongoing. The mean age at the time of surgery was 52.2 years of age with a mean BMI of 33.2. 68% of enrolled patients had an additional operation at time of TOT placement. In general patients had relatively little pain post operatively from the TOT procedure on either the right or left groin. On a verbal scale from 0-10, average pain levels at 1 hour, 2 hours, 2 weeks and 6 weeks were 2.42, 2.38, 1.31 and 0.27 respectively. In multivariate analysis no statistically significant difference was found between lidocaine and saline in post operative groin pain levels. At one hour there was a significant association between pain and pre-op narcotic use, PACU pain meds and estimated blood loss. Conclusion: In patients undergoing the TOT procedure post operative groin pain is minimal. Of those patients who do have pain, there is no difference in pain levels with lidocaine or sterile saline. It is possible that any injection may have an effect in relieving groin pain during this procedure and further study may be beneficial. Disclosures: A. Mendenhall, None; I.B. Addis, None.
Presentation Number: Poster 16 Medium-Term Outcome Results and Surgical Complications of Inside-Out Transobturator TVT (TVT-O): A Prospective Study of 119 Consecutive Patients R. S. Gold, A. Groutz, and J. Hasson Lis Maternity Hospital, Tel Aviv, Israel Category: Surgery SUI. Objective: A prospective study to examine the surgical complications and medium-term outcome results of the transobturator Tension-free Vaginal Tape (TVT-O) procedure. Results were compared to a previous series of 313 consecutive retropubic TVT procedures carried out by our group. Methods: A total of 119 consecutive women who underwent TVT-O for urodynamically-proven stress urinary incontinence (SUI) were prospectively enrolled. Postoperatively the patients were scheduled for evaluation at 1, 3, 6 and 12 months, and annually thereafter. All underwent urodynamics at 3 months postoperatively. Main outcome measures were perioperative morbidity, postoperative urodynamicallyconfirmed persistent SUI (symptomatic,asymptomatic), persistent, or de novo overactive bladder (OAB) and bladder outlet obstruction (BOO). Results: The mean follow-up was 19.9 5.7 months (1230 months). Ten (8%) patients had postoperative voiding difficulties necessitating catheterization for 714 days. No loosening procedure of the tape was required. Twelve (10%) patients had protracted postoperative thigh pain, with spontaneous resolution within 3 6 months. Vaginal erosion of the tape was diagnosed in 2 (1.7%) patients. Ten (8%) patients developed recurrent urinary tract infections. Iatrogenic lower urinary tract injury was excluded by urethrocystoscopy. Subjectively, 8 (7%) patients had persistent postoperative SUI. However, urodynamic evaluation revealed asymptomatic sphincteric incontinence in 7 (6%) additional patients. Of the 65 patients who had preoperative OAB, 55 (85%) still had persisting symptoms after operation. Four other patients (7%) developed de-novo OAB symptoms, one of whom was found to have BOO by pressure-flow studies. Comparison of the TVT-O and retropubic TVT series is presented in Table. Conclusions: Medium-term outcome results of TVT-O procedure are comparable with TVT. The TVT-O procedure is associated with a short operation time and bladder injury is unlikely to occur. However, postoperative protracted thigh pain is a troublesome complication and patients should be informed accordingly. Longer follow up and further anatomical research are required before the TVT-O can be considered a valid alternative to the retropubic TVT procedure. Disclosures: R.S. Gold, None; A. Groutz, None; J. Hasson, None.
Presentation Number: Poster 18 Three-Year Clinical Trial of Nonsurgical, In-Office Transurethral Radiofrequency Collagen Denaturation for Treatment of Stress Urinary Incontinence: Interim Efficacy Results D. M. Elser,* G. K. Mitchell, J. R. Miklos, K. G. Mitchell, K. Cline, and W. Wells, *Illinois Urogynecology, LTD, Oak Lawn, IL, Atlanta Urogynecology Associates, Alpharetta, GA, SOGA, Houston, TX, Regional Urology, LLC, Shreveport, LA, Alabama Research Center, LLC, Birmingham, AL Category: Surgery SUI. Background: Transurethral radiofrequency collagen denaturation, a one-time treatment for women with stress urinary incontinence (SUI) due to bladder outlet hypermobility, is performed in an office setting in about 30 minutes using local anesthesia. This clinical trial aims to demonstrate its long-term effectiveness.
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Methods: A 3-year prospective study is conducting patient evaluations at baseline and at 3, 6, 12, 18, 24, and 36 months following treatment at 13 physician offices or ambulatory surgery centers in the US. This study includes women with SUI due to bladder outlet hypermobility for 12 months who failed prior conventional nonsurgical treatment. Women with urge or mixed urinary incontinence or who had prior incontinence surgery or bulking agent injections were excluded. Patients received pretreatment oral antibiotic, oral sedative if requested, and local periurethral lidocaine injection. Device was positioned in the bladder and radiofrequency energy was delivered in nine 1-minute increments, resulting in collagen denaturation of 36 circumferential sites from the bladder neck to the proximal urethral submucosa. Patients completed the Incontinence Quality of Life (I-QOL), Patient Global Impression of Improvement (PGI-I), and Urogenital Distress Inventory (UDI-6) instruments, and underwent a 1-h in-office stress pad weight test. Adverse events and responses to satisfaction questions were noted. Interim efficacy results are reported. Results: One hundred thirty-six women underwent transurethral collagen denaturation treatment. Most returned to normal daily activities within 1-2 days. At baseline, mean number of leaks due to activity was 2.9/d. Mean I-QOL and UDI scores were 51.3 and 52.7. At 12 months, 73 patients were evaluated. Mean number of leaks due to activity was 1.9/d. Additionally, 69% had 50% reduction in leaked volume (median reduction, 15.2g) on the stress pad weight test (P . 0001), which revealed that 45% of women evaluated were dry (29%, no leaks; 16%, 1 g leakage). Mean change in I-QOL scores from baseline was 19.6 points (P .0001), and 75.0% had improved UDI-6 scores. Mean UDI-6 improvement was 17.6 points (P .0001). On the PGI-I scale, 42.3% of patients reported their incontinence was very much or much better vs baseline. Additionally, 35.1% reported they would definitely or probably recommend transurethral collagen denaturation to a friend with SUI vs 14.2% who probably or definitely would not. No serious adverse events have been reported at any time point following treatment. Of note, intent-to-treat analysis showed no characteristic differences between patients lost to follow-up and those evaluable at 12 months. Eighteenmonth results will be presented. Conclusions: Transurethral collagen denaturation shows measurable durable improvement at least 12 months posttreatment. This treatment may allow SUI patients to avoid burdensome treatment and compliance requirements of other nonsurgical therapies. Disclosures: D.M. Elser, Novasys Medical, Grant/Research Support; G.K. Mitchell, Novasys Medical, Consultant; J.R. Miklos, Novasys Medical, Grant/Research Support; AMS, Paid Instructor; K.G. Mitchell, Novasys Medical, Grant/Research Support; K. Cline, Novasys Medical, Inc., Grant/Research Support; W. Wells, Novasys Medical, Inc., Grant/Research Support.
Presentation Number: Poster 19 The Adjustable Continence Therapy (Act) System: One Year Results of The North America Act Clinical Study Group S. E. Sutherland MD,* S. R. Aboseif MD, S. D. Nash MD, J. Slutsky MD, N. Baum MD, L. Tu MD, N. Galloway MD,** and P. Pommerville MD, *Metro Urology, Center for Continence Care and Female Urology, Mpls/St Paul, MN, Kaiser Permanente, Los Angeles, CA, Kansas City Urology Care, Leawood, KS, Urological Surgeons, Kankakee, IL, Neil Baum Urology, New Orleans, LA, CHUSFleurimont, Fleurimont, QC, CANADA, **Emory University School of Medicine, Atlanta, GA, Can-Med Clinical Research, Victoria, BC, Canada
Category: Surgery SUI. Objectives: Management of stress urinary incontinence (SUI) associated with intrinsic sphincter deficiency is challenging after prior failed therapies. The Uromedica Adjustable Continence Therapy (ACT) system is a novel device under FDA investigation that provides bulk at the bladder neck with adjustable silicone balloons for urethral coaptation and bladder neck support. We present preliminary results about the efficacy, safety, adjustability, and technical feasibility of the ACT system for treatment of recurrent female SUI. Materials/Methods: The study population involves female patients with recurrent SUI with or without urethral hypermobility. Baseline and follow-up tests were performed at 6 weeks, 3 months, 6 months, 9 months, 12 months and annually thereafter including urinalysis, a 3day voiding diary, provocative pad weight test, direct visual stress test, Stamey score and validated questionnaires to assess the degree of stress incontinence, voiding dysfunction, sexual function and quality of life. The surgical technique involves a small incision between the labia majora and minora at the level of the urethral meatus. A trocar is passed under fluoroscopic guidance to the urethrovesical junction. The device is delivered and the balloon filled with contrast. The injection port for balloon adjustment is placed into a subcutaneous pouch in the labia majora. Device adjustments were permissible when necessary beginning 6 weeks post-operatively. Results: There have been 161 patients implanted to date, with 107 subjects completing at least 12 months of follow-up. Mean age is 67.8 years (3194 years). 83.9% (N 115) had a previous anti-incontinence procedure, with 42.5%, 31.3%, 7.5% and 1.5% experiencing 1,2,3 and 4 prior failed procedures, respectively. Difficulty of ACT surgery was mild, moderate, or severe in 62%, 29%, and 9% of procedures, respectively. Improvement in Stamey score of at least 1 grade was achieved in 82 patients (76.6%). Mean provocative pad weight decreased from 49.7 grams at baseline to 11.9 grams at 1 year (p 0.001). Quality of life was assessed by the IQol, UDI and IIQ questionnaires and the results suggest improvements at 12 months (p 0.001); baseline score was 36.0 (SD 23.6) compared to 70.5 (SD 26.5) at 12 months for IQoL, 61.3 (SD 16.3) compared to 32.7 (SD 22.2) for UDI, and 54.2 (SD 27.6) compared to 23.4 (SD 27.3) for IIQ. The mean number of balloon adjustments through 1 year to achieve maximum continence was 2 (0 8). Device or procedure related adverse events (bladder perforation, intermittent retention, port or balloon erosion, migration, discomfort) were reported in 56.2% of subjects. Of these, 81% were considered mild in severity. Conclusion: Preliminary data suggest the Uromedica ACT system is an effective, simple, safe and minimally invasive treatment for recurrent female SUI. The balloons are easily adjusted percutaneously to enhance efficacy. Complications are usually of mild severity. Additional follow-up will determine the long-term durability of this device. Disclosures: S.E. Sutherland, MD, None; S.R. Aboseif, MD, None; S.D. Nash, MD, None; J. Slutsky, MD, None; N. Baum, MD, None; L. Tu, MD, None; N. Galloway, MD, None; P. Pommerville, MD, None.
Presentation Number: Poster 20 A Prospective Multi-Center Clinical Trial Evaluating the Apogee System for The Treatment of Posterior Vaginal Wall and Apical Prolapse: A Sub-Analysis of Apical Extrusions with or without Concomitant Hysterectomy J. C. Lukban,* M. Patel, D. Van Drie, S. Weprin, S. Zylstra, R. Vera, J. Nguyen,** T. Erickson, M. Virelles, J. Flaherty, R.
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Beyer, R. Moore, M. Hodroff,*** *Eastern Virginia Medical School, Norfolk, VA, Piedmont Urology Associates, Gastonia, NC, Grand Valley Gynecologists, PC, Grand Rapids, MI, Huey & Weprin Obstetrics & Gynecology, Englewood, OH, Milford Regional Medical Center, Milford, MA, Texas Tech University Health Science Center OB/GYN Department, El Paso, TX, **Southern California Permanente Medical Group, Downey, CA, Rosemark Womencare Specialists, Idaho Falls, ID, Institute for Womens Health & Body, Wellington, FL, Intermed, Portland, ME, Womens Health Care Specialists, Paw Paw, MI, Atlanta Urogynecology Associates, Alpharetta, GA, ***Fore River Urology, Portland, ME Category: Vaginal Prolapse Repairs with Grafts. Objective: To describe the incidence of apical extrusion (vaginal exposure of mesh) in patients receiving the Apogee System (AMS, Minnetonka, MN, USA) for pelvic organ prolapse repair with or without concomitant hysterectomy. Methods: In an ongoing, prospective, multi-center study involving 13 U.S. sites, women with posterior vaginal prolapse ( Stage II) and/or apical or uterine descent ( Stage II) were enrolled for primary posterior and/or apical mesh implant. Concomitant hysterectomy was performed at the discretion of the operating
TABLE. Apogee without Hysterectomy (n 97) Mean Age (range)* Menopause, n (%)* Estrogen Replacement 4 weeks preop., n (%) Prior Hysterectomy, n (%) Posterior Prolapse, % (n) Baseline ( Stage II) 6-mo ( Stage I) 12-mo ( Stage I) Apical Prolapse, % (n) Baseline ( Stage II)*0 6-mo. ( Stage I) 12-mo. ( Stage I) Extrusion Rate, % (n) Surgical Mgmt. Conservative Mgmt. Extrusion Site, % (n) Midline Incision/ Apex Distal Vagina 61.0 (33.090.0) 92 (95.8) 47 (48.5) 66 (68.0) Apogee with Hysterectomy (n 36) 53.2 (34.087.0) 19 (54.3) 13 (37.1)
surgeon. A sub-analysis was performed to determine extrusion rates in patients who received a concomitant hysterectomy versus those who did not receive hysterectomy at the time of transvaginal Intepro (type I polypropylene mesh) insertion employing bilateral transgluteal trocars. Primary endpoint for the parent study was the percent of patients with Stage I (cure) at follow-up, with clinical evaluations performed by an unblinded practitioner. Patients were seen postoperatively at 6 weeks, 3 months, 6 months and 12 months, and will be followed prospectively through 2 years. Continuous measurements were compared using a two sample t-test for difference of means. Frequency measurements were compared by Fishers exact test. Results: 133 women underwent the procedure with a mean followup of 10.0 months (range 2.314.6). Ninety-seven (73%) had Apogee alone and 36 (27%) had concomitant hysterectomy. Demographic data and outcomes are presented in the table below. Conclusions: Incidence of apical extrusion seems to be infrequent and independent of concomitant hysterectomy after repair with Apogee at a mean follow-up of 10.0 months. Page 1 of 2. Disclosures: J.C. Lukban, Pfizer, Glaxo-Smith-Kline, and AMS, Consultant; M. Patel, Medtronic, AMS, Consultant; D. Van Drie, Ethicon, AMS, Consultant; S. Weprin, None; S. Zylstra, Medtronic, AMS, Consultant; R. Vera, Encision, Shareholder; J. Nguyen, AMS, Grant/Research Support; AMS, Consultant; T. Erickson, AMS, Consultant; M. Virelles, None; J. Flaherty, None; R. Beyer, AMS, Consultant; R. Moore, AMS, Allergan, Consultant; M. Hodroff, AMS, Medtronic, Consultant.
99.0 (96/97) 90.8 (79/87) 93.3 (56/60) 23.7 (23/97) 94.3 (82/87) 91.7 (55/60) 9.3 (9/97) 3.1 (3/97) 6.2 (6/97) 4.1 (4/97) 1.0 (1/97) 4.1 (4/97)
94.1 (32/34) 96.9 (31/32) 93.3 (28/30) 50.0 (17/34) 96.9 (31/32) 90.0 (27/30) 8.3 (3/36) 5.6 (2/36) 2.8 (1/36) 2.8 (1/36) 2.8 (1/36) 2.8 (1/36)
*Statistical difference between treatment groups (p 0.05). Includes those who received local estrogen and/or trimming in the office or observed. Overall extrusion rates were similar in both groups, with 9 (9.3%) and 3 (8.3%) subjects exhibiting vaginal exposure of mesh in the Apogee only and concomitant hysterectomy groups, respectively (p 1.0). Apical extrusions were seen in 1 (1.0 %) patient receiving Apogee alone and in 1 (2.8%) receiving concomitant hysterectomy (p 0.47).
Presentation Number: Poster 21 A Tertiary Referral Centers Experience with Complications Arising from Transvaginal MESH KIT Procedures E. A. Hurtado, and R. A. Appell Baylor College of Medicine, Houston, TX Category: Vaginal Prolapse Repairs with Grafts. Objective: Due to the supposed high rate of failure associated with traditional vaginal prolapse repairs, many surgeons have turned to the use of transvaginal polypropylene mesh kits. Several case series describe excellent anatomic cure rates with few complications outside of minor mesh exposure. However as with any new procedure, further unexpected complications may arise. The purpose of this case series is to review a referral centers experience with complications from transvaginal mesh kits. Methods: In this case series, 12 patients presented to the senior authors practice with complications associated with transvaginal mesh kit procedures. All patients underwent complete surgical removal of the mesh to the level where the mesh arms attached to the body of the mesh for treatment of mesh exposure, pain, or vaginal bleeding/discharge followed by an anterior or posterior colporrhaphy of the remaining scar tissue. A chart review was performed to collect demographic data, operative notes, pathology, and post-operative follow-up. IRB approval was obtained. Results: All 12 patients underwent surgical removal of mesh with a mean follow-up time of 3.4 months. See table 1 for patient demographics. In surgery, 8 of 12 patients had mesh that had bunched together creating a fibrotic band which occurred in all groups listed in table 1. Six of 12 patients had complete resolution of pain. The other 6 patients had improvement of their pain though 3 patients described it as still bothersome. Of the 9 patients with mesh exposure, all required significant resection of the vaginal wall due to
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TABLE. All Number Age (years) Prior prolapse surgery Prior hysterectomy New onset pelvic/vaginal pain Vaginal bleeding/ discharge Mesh Exposure Prior exposure treatment Time to referral (months) 12 60.7 0 10 12 4 9 4 11.9 PerigeeTM 4 51.0 0 2 4 0 2 1 18.0 Perigee and ApogeeTM 1 77 0 1 1 1 1 0 23.0 Anterior ProliftTM 2 59.0 0 2 2 1 2 1 13.0 Total ProliftTM 5 65.8 0 5 5 2 4 2 5.4
mesh present within 1 mm of the epithelial layer. One patient required resection of a 5 5 cm area. After resection, no further mesh exposure occurred. Of 8 pieces of mesh sent for microscopic analysis, 2 had chronic inflammatory changes, 2 had giant cells present, and 3 had both giant cells with chronic inflammation. Conclusion: The use of transvaginal mesh kits may cause previously undescribed complications such as pelvic/vaginal pain or large extrusions requiring complete removal. Removal of all mesh except the arms may cure or significantly improve these complications. Additionally, these patients may have chronic inflammation and foreign body reaction to the mesh. Disclosures: E.A. Hurtado, None; R.A. Appell, None.
Presentation Number: Poster 22 Anterior Colporrhaphy and/or Sling at the Time of Vaginal Vault Suspension: Can Recurrence of Anterior Vaginal Wall Prolapse be Prevented? R. Lefevre,* L. M. Espaillat, V. C. Aguilar,* and G. W. Davila,* *Cleveland Clinic Florida, Weston, FL, Temple University Hospital, Philadelphia, PA Category: Vaginal Prolapse Repairs with Grafts. Objective: To evaluate the rate of recurrent cystocele following Apogee vault suspension performed with or without anterior colporraphy. Our secondary aim was to assess any additional effect of suburethral slings on cystocele recurrence. Background: Vaginal vault suspension may alter the vaginal axis and place excessive strain on the anterior vaginal wall predisposing it to prolapse recurrence. Performing an anterior colporrhaphy (AR) and/or suburethral sling at the time of vault suspension even in those with no significant anterior wall prolapse may prevent such cystocele recurrence.
Methods: Data was gathered on 179 patients who underwent an Apogee vault suspension. Demographic information, pre and postoperative pelvic examination, and surgical procedures performed were recorded. Cystocele recurrence was defined as a Grade 2 Baden-Walker and this was assessed at the last post-operative visit. Patients were grouped based on whether they had AR or sling at the time of Apogee vault suspension. The groups were adjusted for availability of follow-up weeks data. The cystocele recurrence rate was compared between the different groups and the corresponding impact of each procedure was analyzed using the SAS software version 9.1. A significance level of 0.05 was assumed for all tests. Results: Follow-up was available for a mean of 34.65 weeks (2 to 211 weeks). 95 (53.1%) patients underwent AR along with the vault suspension while 84 (46.9%) did not. Of those 95 patients from the former group, 71 (39.6%) had a concomitant sub-urethral sling while 24 (13.4%) did not. 48 (26.8%) patients out the group of 84 without an anterior repair had a concomitant sling while 37 (20.6%) did not. The overall cystocele recurrence rate was 19.5% (35/179) amongst the studied population. This was further subdivided for each of the above groups and comparisons were made. In those with a Grade 1 preoperative cystocele, similar lack of recurrence prevention was noted. Conclusion: Anterior colporrhaphy and/or performance of a suburethral sling at the time of vault suspension does not seem to affect the recurrence rate of cystoceles in our patient population. A well-designed randomized controlled trial would be helpful in proving or disproving this surgical concept. Disclosures: R. Lefevre, None; L.M. Espaillat, None; V.C. Aguilar, None; G.W. Davila, AMS, Adamed, Synovis Astellas Watson Zuidex Protein Polymer Technologies Duramed, Grant/Research Support; AMS, Watson, Adamed, Consultant; Talks/honorarium: Watson, AMS, Synovis, USSurgical, Pfizer, Astellas, Adamed, Other.
TABLE. Groups AR Sling No Yes No Yes No No Yes Yes Cystocele recurrence (%) 6 (16.7%) 6 (25%) 12 (25%) 11 (15.5) p 0.51 Recurrence RR p-value 1.00 1.86 1.94 0.9 0.37 0.27 0.86
N 36 24 48 71
Presentation Number: Poster 23 Pelvic Organ Proplapse Repair Using Perigee and Apogee System: A Retrospective Review of Complications and Efficacy J. A. Califano, G. Slobodov, and D. J. Culkin University of Oklahoma HSC, Oklahoma City, OK Category: Vaginal Prolapse Repairs with Grafts. Objective: It is estimated that half of women who have children will experience some form of prolapse in later life. Ideal intervention for pelvic organ prolapse would be minimally invasive, safe, and efficacious. We report the results of using Perigee and Apogee systems by AMS for cystocele and rectocele repair via a transvaginal approach.
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Methods: A retrospective chart review of patients undergoing treatment of pelvic organ prolapse with placement of the Perigee and Apogee system from January 2005 to July 2007. The data analyzed outcomes and complications. Results: A total of forty-one patients with a mean age of 61 (4179) underwent the procedure. Twenty-two patients had placement of Perigee with Apogee repair, eighteen had Perigee alone, and one patient has Apogee performed. Follow-up ranged from 1 month to 15 months (mean 5). The presenting symptoms were stress urinary incontinence (SUI) 34(83%), urge urinary incontinence (UUI) 4(10%), and mixed urinary incontinence (MUI) 3(7%). Four patients (10%) had intraoperative bladder perforations from passage of the trocar and were treated with primary repair and extended foley catheter placement. Four patients (10%) experienced urinary retention immediately following the procedure requiring clean intermittent catheterization. Denovo detrusor instability at two weeks follow-up was seen in eight patients (20%) all were treated with anticholinergics. Dyspareunia was noted in three patients (7%) postoperatively. Pudendal neuropathy, was seen in three patients (7%) at 2 months follow-up, however at 9 months only one patient had occasional symptoms of pudendal neuropathy with the other two cases completely resolving. Two patients required excision of mesh, one patient had exposed mesh, the second patient had pain due to an Apogee web causing dyspareunia and postcoital bleeding. Symptoms resolved in both patients after excision. Two patients had interstim sacral nerve stimulators placed for severe frequency and urgency. Conclusion: The use of the Perigee and Apogee systems for anterior and posterior repair is a safe, minimally invasive technique and is well tolerated. Detrussor instability, pudendal neuropathy, and dyspareunia were the most frequent post-operative complaints. Long-term results are needed to assess durability and efficacy, but initial findings are promising. Disclosures: J.A. Califano, None; G. Slobodov, None; D.J. Culkin, None.
Presentation Number: Poster 25 Bilateral, Graft-Augmented Sacrospinous Hysteropexy: 1-Year Anatomical and Functional Outcomes Following Surgery for Uterine Preservation T. L. Gamble,* S. O. Aschkenazi,* A. Nguyen,* Y. A. Liu, J. Beaumont, S. M. Botros,* P. K. Sand,* and R. P. Goldberg* *Evanston Northwestern Healthcare/Northwestern University Feinberg School of Medicine, Evanston, IL, Northwestern University, Evanston, IL, Center for Outcomes Research and Education/ Evanston Northwestern Healthcare, Evanston, IL Category: Vaginal Prolapse Repairs with Grafts. Objective: To evaluate the 1 year anatomic and functional outcomes of a bilateral anterior approach sacrospinous hysteropexy with allograft-reinforcement for uterovaginal prolapse. Methods: 39 consecutive women with Stage 2 uterine prolapse underwent a bilateral anterior approach sacrospinous hysteropexy with acellular dermal graft reinforcement to the anterior and apical compartments. Subjects self-selected uterine preservation as an alternative to vaginal hysterectomy. Surgical technique: Through a vertical anterior vaginal incision, and limited dissection within the paravaginal space, the ischial spine and sacrospinous ligament were identified by palpation. Single permanent 00 Gore Tex sutures were placed 1.5 cm medial to the ischial spines on both the right and left sacrospinous ligament (SSL), using a push and catch suturing device (Capio, Boston Scientific Corporation, Marlborough MA). Each SSL suture was secured to an acellular allograft (4 5 cm 710 cm) sized to patients dimensions. Arcus to arcus paravaginal support and reinforcement of the anterior colporraphy was obtained by securing the graft at three levels along the arcus tendineus fascia pelvis. These sutures were then secured to a fixation point on the ipsilateral vaginal apex located 1 cm lateral to the cervix on both sides. Once tied, these SSL sutures establish apical fixation of the graft and both vaginal apices. Anterior and posterior colporrhaphy repairs were performed in the usual fashion. Changes in pre- and post-operative POPQ staging were assessed using McNemars test. Paired t-tests were used to compare pre and post surgery PFDI and PISQ. Results: Mean age was 57(range) years (36 78), BMI 27 (18 39), and mean parity 3.0 (1 8). Mean operative time and estimated blood loss were 146 minutes and 203 ml (range: 75 400) respectively. All 39 women had anterior colporrhaphy, 97% had posterior repair and 85% had concurrent midurethral slings. Mean interval of 13.8 (525) months was obtained in 33/39 (83%) of subjects. No erosions or significant complications were observed. POPQ staging was improved for all compartments (p 0.05) : Aa 3.1, Ba 3.1, C 4.1, Ap 1.8, Bp 1.7, D 3.0. The risk of recurrent uterine prolapse as defined as Baden-Walker stage 3 4 after one year was: uterine prolapse 2.6%, cystocele 4% and, rectocele 4.3%. Post-operative mean total PFDI scores were significantly improved (25.9 vs. 77.1, p 0.043). Dyspareunia as measured by Likert scale {21% vs. 22% (p 0.706)} and mean total PISQ scores {27.9 vs 29.1 (p 0.732)} were not statistically different before and after surgery. Conclusion: Bilateral sacrospinous hysteropexy with anterior graftaugmentation provides effective support and improved self-reported QOL without adverse effects on female sexual function at one year among women who desire uterine preservation. Disclosures: T.L. Gamble, None; S.O. Aschkenazi, None; A. Nguyen, None; Y.A. Liu, None; J. Beaumont, None; S.M. Botros, None; P.K. Sand, Watson Pharmaceuticals,Inc;Indevus; Ortho-McNeil; Allergan, Grant/Research Support; Watson Pharmaceuticals,Inc;Indevus; Ortho-McNeil; Allergan, Consultant; Indevus; Ortho-McNeil;, Speakers Bureau; R.P. Goldberg, Boston Scientific, Consultant.
Presentation Number: Poster 24 Two Year Anatomical Outcome after Pelvic Organ Prolapse Repair with Prolift Transvaginal Mesh E. Kulwa, B. Hines, and A. Yitzhack Stamford Hospital, Stamford, CT Category: Vaginal Prolapse Repairs with Grafts. Objective: To investigate long term (two year) anatomical outcomes after pelvic organ prolapse repair with prolift. Methods: A retrospective chart review of 50 patients who underwent Prolift for repair of anterior and posterior compartments pelvic organ prolapse at one instituition between May 2005 and April 2006 with 2 years of follow up was done. Pre- op and post-op POP Q scores were obtained for each patient at 6 week, 6 month, 1 year and 2 year follow up periods. The Pre op and 2 yr post-op POPQ scores were analyzed. Wilcoxon matched pairs signed rank test was used to compare the pre and 2 year post-op POP Q scores at points Aa, Ba, C, Ap, Bp and D. Results: Prolift use was associated with statistically significant improvement in POP Q scores 2 years post-op at points Aa, Ba, Ap and Bp (Wilcoxon matched pair signed rank test p value 0.05). There was no difference in pre and post op POP Q scores at 2 year follow up at points C and D (Wilcoxon matched pair signed rank test p value 0.05). Conclusions: Prolift leads to good control of anterior and posterior prolapse in the long term but does not seem to have any effect on apical or uterine prolapse in the long term. Disclosures: E. Kulwa, None; B. Hines, None; A. Yitzhack, None.
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Presentation Number: Poster 26 Mesh Augmented Repair of Cystocele with Anterior Approach to Bilateral Sacrospinous Ligament Fixation P. Dramitinos, T. R. Ferzandi, K. J. Hanaway, and P. L. Rosenblatt Mount Auburn Hospital/Harvard Medical School, Cambridge, MA Category: Vaginal Prolapse Repairs with Grafts. Objective: To determine the safety and efficacy of bilateral sacrospinous ligament (SSL) fixation with mesh interposition via the anterior approach for anterior vaginal wall prolapse. Methods: The records of 18 patients who underwent prolapse repair utilizing mesh to augment bilateral SSL fixation through the anterior approach from June, 2004 to January, 2008 were reviewed. Preoperatively, all women had symptomatic anterior vaginal wall prolapse. The procedure involved a midline incision in the anterior vaginal wall from the bladder neck to the cervix (or vaginal cuff). The endopelvic fascia was dissected off the full thickness vaginal wall bilaterally until the ischial spines were identified. Any overlying tissue was dissected off the SSLs. Gore-Tex sutures were placed through the SSLs, bilaterally, approximately 3 cm medial to the ischial spine using the Capio needle driver. This suture was then passed through the corners of the wide part of a modified trapezoid-shaped piece of Gynemesh prolene mesh or through the proximal corners of the mesh from the Gynecare Prolift Anterior Pelvic Floor Repair System (where the proximal arms had been excised). The proximal portion of the mesh was sutured to the proximal pubocervical fascia. The distal portion of the mesh was affixed using several different methods: passage of permanent suture through the arcus tendineous fascia pelvis with the Capio needle driver, transobturator passage of the distal arms of the Prolift system, or suturing the mesh to the lateral/distal portion of the pubococcygeus. The sutures that had gone through the SSL were then tied down using pulley stitches, effectively elevating the apex of the vagina/cervix to the SSL, providing support to the bladder. The epithelium was reapproximated and the vagina was packed overnight. Results: All 18 patients underwent a successful procedure. Mean age was 63 years (46 78y). Mean follow-up was 6.5 months (1.2522 months). At last follow-up, 16 women (89%) had no recurrence of anterior vaginal wall prolapse (Ba 002d2). Preoperatively, the mean value for leading edge of the anterior wall with respect to the hymen (Ba) was 1.2 ( 1.5 to 5). The mean Ba at most recent postoperative follow-up was 2.4 ( 3 to 1). There were no significant intraoperative complications. Mean estimated blood loss was 147 ml (50 450 ml). Post-operatively, 5 patients required prolonged bladder catheterization (maximum 13 days). Post-operative complications included: 3 patients (17%) with pain/dyspareunia, 3 patients (17%) with urinary tract infection, 1 patient (6%) with mesh exposure, 3 patients (17%) with worse or de novo stress incontinence, 4 patients (22%) with worse or de novo symptoms of overactive bladder. Conclusions: This series demonstrates that mesh augmented repair of cystocele with anterior approach to bilateral SSL fixation is a safe procedure without significant intra- or post-operative complications, as well as an effective procedure, providing long-term support to the anterior vaginal wall. Disclosures: P. Dramitinos, None; T.R. Ferzandi, None; K.J. Hanaway, None; P.L. Rosenblatt, Ethicon Womens Health and Urology, Consultant; Bard Urological, Consultant; Boston Scientific Corporation, Consultant.
Presentation Number: Poster 27 Endofast Reliant System-A Novel Technique for Pelvic Organ Prolapse Repair M. Alcalay,* M. Livneh, M. Cosson, J. Lucot, and P. Von Theobald *Department of Obstetrics & Gynecology, Chaim Sheba Medical Center, Ramat Gan, Israel, Endogun Medical Systems Ltd., Kibutz Haogen, Israel, Departments of Obstetrics and Gynecology, CHRU de Lille, Lille, France, Departments of Obstetrics and Gynecology, CHRU de Lille, Lille, France, Departments of Obstetrics and Gynecology, CHU de Caen, Caen, France Category: Vaginal Prolapse Repairs with Grafts. Objective: To evaluate the efficacy of EndoFast Reliant system, a novel transvaginal technique for Pelvic Organ Prolapse (POP) repair, reinforcing the prolapsed organ with polypropylene mesh with softtissue fasteners. Methods: Between March and November 2007, a prospective multicenter study was carried out in 15 women with anterior and/or posterior POP, who underwent vaginal repairs with mesh reinforcement. The fasteners anchored the mesh into the soft tissue adjacent to the ischial spines and posterior symphysis for the anterior compartment, and at the ischial spines and puborectalis for the posterior compartment. Eleven patients (79%) underwent double compartment corrections. We excluded patients who needed hysterectomy or correction of stress urinary incontinence. All patients had preoperative evaluation including physical examination (using the POP-Q system), pelvic floor symptom evaluation using the PFDI questionnaire, and sexual function assessment using the FSFI questionnaire. Following surgery the physicians satisfaction with the system was documented, and the patients were followed at 2 weeks, 3 and 6 months post operatively, using the same measures that were evaluated at the preoperative visit. To follow possible migration of the fasteners, the patients had an X-ray examination of the bony pelvis immediately after the procedure and 3 months postoperatively. For statistical analysis we used SAS software. Results: The surgical procedure was performed under general or regional anesthesia. At time of writing, 15 patients had reached 3 month follow up, and 12 had reached 6-month follow up. Mean age was 63.6 years (range 34.279.2) and the mean BMI was 24.9 (range: 21.6 28.7). No intra-operative complications were observed. During follow up no mesh erosions were noted. No detachment or migration of fasteners have been observed. One case of misplacement of a single fastener was observed leading to dyspareunia; the fastener was duly removed under local anesthesia with no clinical consequences. Two cases of de - novo SUI occurred (14%), of which one was treated surgically. Prolapse was resolved in 100% of our patients at 3 months (Grade 0 or 1) and in 83.3% at 6 months (2 patients of 12 had grade 2 prolapse) as noted by physical examination. Consistent significant improvement in PFDI score related to prolapse, bladder and rectal symptoms were observed 3 and 6 months follow up. Sexual function did not change significantly during 6 months in the domains of satisfaction, arousal, lubrication, orgasm and satisfaction. Pain during intercourse improved significantly after surgery from a mean score of 0.6 at screening to a mean score of 2.7 (p 0.038) at 6 month. Conclusions: The low morbidity and the reduced dyspareunia of the EndoFast Reliant system make this procedure an attractive option for mesh use during prolapse repair. Longer follow up data is needed to strengthen these conclusions. Disclosures: M. Alcalay, Acting as a consultant to Endogun Medical Systems, Consultant; M. Livneh, Endogun VP Executive Clinical and Medical Affairs, Other; M. Cosson, None; J. Lucot, None; P. Von Theobald, None.
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Presentation Number: Poster 28 Anterior Repair With Mesh: with or without Prior Anterior Repair R. D. Moore,* R. Beyer, K. Jacoby, S. Freedman, K. McCammon, and M. Gambla *Atlanta Medical Research Institute, Alpharetta, GA, Womens Health Care Specialists, Paw Paw, MI, Integrity Medical Research, MountLake Terrace, WA, Sheldon J Freedman MD, Las Vegas, NV, Eastern Virginia Medical School, Norfolk, VA, Central Ohio Urolgy Group/Riverside Methodist Hospital, Columbus, OH Category: Vaginal Prolapse Repairs with Grafts. Objective: To compare outcomes of patients with primary versus recurrent cystoceles undergoing anterior repair with mesh via a transobturator route. Methods: In an ongoing, prospective, multi-center trial, 8 U.S. Sites implanted women with anterior vaginal wall prolapse ( Stage II). All sites received IRB approval prior to enrollment. Each patient underwent placement of Type I, polypropylene mesh (Perigee System with IntePro, American Medical Systems, Inc., Minnetonka, MN, USA) employing a transobturator approach. At the time of implant, the cystocele was not reduced nor repaired under the mesh. Additional reconstructive and incontinence procedures were completed as indicated. Exclusion criteria included concomitant hysterectomy or history of anterior wall graft. Intra- and post-operative data and complications were evaluated as well as QOL questionnaires (PFDI, PFIQ7, PISQ-12). Patients are being followed through 24 months. Surgical success was defined as Stage 1 anterior wall prolapse. Continuous measurements were compared using the two sample t-test for difference of means. Frequency measurements were compared by Fishers exact test or Chi-Square test. Results: 110 subjects were implanted; 25 had previous anterior repair PAR with recurrent cystocele and 85 had no previous anterior repair NPAR . There was no significant difference in demographics (age, bmi, gravidity, parity), but prior hysterectomy was significantly greater in the NPAR (p 0.0001). Average follow-up was 16.7 7.8 mos. Two intraoperative complications only occurred in NPAR_hematoma and bladder perforation. There was no significant difference on the 12 mo anterior staging success rates between the two groups (PAR: 95.2%; NPAR: 88.6%, p 0.253). Overall, 12 extrusions were seen for an overall extrusion rate of 10.9%. There was no significant difference in extrusions between the two groups (PAR: 20%; NPAR: 8.2%, p 0.097). Average onset of extrusions was 240.8 days (PAR, 38 124) and 177.6 days (NPAR, 48 426). There was no significant difference between other complication rates such as de novo urge with incontinence or pain. Conclusions: Anterior repair of cystocele with mesh graft via transobturator approach seems to be a safe and effective procedure both in patients with primary cystoceles and those with recurrent cystoceles that have had previous attempt at repair. In the current study there was no significant difference in the extrusion rate or the anterior success rate between these groups of patients. Patients with recurrent cystoceles are thought to be at a higher risk of complications and failure, however in the current study with the use of the Perigee procedure this was not found to be the case through medium term follow up. Disclosures: R.D. Moore, AMS, Allergan, Consultant; R. Beyer, AMS, Consultant; K. Jacoby, AMS, Grant/Research Support; AMS, Consultant; AMS, Shareholder; S. Freedman, AMS, Consultant; K. McCammon, AMS, Allergan, Astellas, Grant/Research Support; Honoraria: AMS, Allergan, Astellas, Other; M. Gambla, Lilly, AMS, GTX Inc, Pfizer, Bayer, Grant/Research Support; AMS, Boston Scientific, Lilly, Consultant.
Presentation Number: Poster 29 Safety and Efficacy of Vaginal Hysterectomy at the Time of Transvaginal Mesh Placement for Utero-Vaginal Prolapse M. Murphy,* R. Shrestha, R. Haff, H. van Raalte, S. Molden, and V. R. Lucente *Institute for Female Pelvic Medicine, North Wales, PA, Abington Memorial Hospital, Abington, PA, St. Lukes Hospital, Bethlehem, PA, Institute for Female Pelvic Medicine, Allentown, PA Category: Vaginal Prolapse Repairs with Grafts. Objective: Previous investigations have shown an increased risk of mesh exposure when vaginal hysterectomy is performed at the time of transvaginal reconstruction with mesh to treat uterovaginal prolapse. However, there may be times when concomitant hysterectomy is indicated. We therefore sought to assess the safety and efficacy of vaginal hysterectomy in this situation. Methods: This was a retrospective, repeated measures study of women with uterovaginal prolapse who underwent vaginal hysterectomy and pelvic reconstruction with the transvaginal mesh (TVM) technique between January 2005 and December 2007. Care was taken to keep the TVM incision(s) separate from the vaginal cuff, and mesh was never placed under the cuff closure. Patient demographics and perioperative outcomes were collected in a retrospective chart review. Preoperative values of the Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7), and Pelvic Organ Prolapse Quantitation (POPQ) were compared to postoperative values. Results: Of the 39 women meeting the study criteria, 16 underwent an anterior, 6 a posterior, and 17 a total TVM procedure at the time of vaginal hysterectomy. Midurethral slings were placed in 35 (89.7%). There were 2 (5.1%) operative complications; both cystotomies which were immediately recognized and repaired. All patients had at least 2 months of follow-up but 2 (5.1%) did not have postoperative POPQ measures. Median length of followup was 12 (range 238) months for the quality of life measures and 10 (238) months for the POPQ measures. Vaginal length was an average of 0.9 cm shorter postoperatively, but otherwise significant improvements were seen in all other measures (Table 1). Of the 37 patients with postoperative POPQ measures, there was 1 (2.7%) failure in a treated compartment and 5 (13.5%) in an untreated compartment. There were no apical failures and no mesh exposures. Conclusions: Incisions for transvaginal mesh placement should be kept separate from the vaginal cuff and mesh should not be tunneled behind the cuff. When these surgical principles were followed in this series of patients with close to one year of follow-up, transvaginal mesh reconstruction was safely and effectively performed with concomitant hysterectomy.
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Disclosures: M. Murphy, Ethicon Womens Health and Urology, Consultant; Boston Scientific, Consultant; R. Shrestha, None; R. Haff, None; H. van Raalte, Ethicon Womens Health and Urology, Consultant; S. Molden, Ethicon Womens Health and Urology, Consultant; V.R. Lucente, Ethicon Womens Health and Urology, Consultant.
Disclosures: N. Kohli, Coloplast, Consultant; Coloplast, Paid Instructor; R. Zipper, Coloplast, Grant/Research Support.
Presentation Number: Poster 30 Efficacy, Functional Outcomes and Adverse Effects of LowWeight Polypropylene Mesh for Pelvic Prolapse Repair N. Kohli,* and R. Zipper *Brigham and Womens Hospital, Boston, MA, Zipper Urogynecology, Melbourne, FL Category: Vaginal Prolapse Repairs with Grafts. Objective: To analyze the efficacy, functional outcomes, and adverse effects utilizing low weight polypropylene mesh in the surgical treatment of advanced pelvic prolapse (cystocele and rectocele) using a sacrospinous/arcus apical attachment. Methods: A retrospective chart review was conducted in order to identify patients undergoing low-density mesh augmentation of the anterior and/or posterior segment with or without concurrent vaginal hysterectomy. Preoperative information including demographic data, POP-Q exam, and pelvic floor dysfunction/functional assessment was collected. Patients were seen on a routine basis at 1 week, 6 weeks, and 6 months postop. They were also seen intermittently as needed. Postoperative data including POP-Q exam, pelvic floor dysfunction/functional assessment, and adverse effects was collected on follow-up. Results: 100 patients were included in the retrospective analysis with six-month follow-up. Average age of the patients was 67.3 13.5 yrs and parity was 3.2 1.2. Nineteen patients had grade 2 prolapse of at least 1 vaginal segment and the remaining patients had grade 3 or greater prolapse of either the anterior or posterior segment. Approximately 50% (55/100) of the patients had undergone previous hysterectomy and presented with post hysterectomy prolapse. 50 patients underwent anterior mesh placement, 37 underwent posterior mesh placement, and 13 patients underwent total vaginal mesh in both segments. 11 patients underwent concurrent vaginal hysterectomy. Average surgical time was 55.4 17.2 mins and EBL was 30.6 15.4 cc. Average length of stay was 1.5 0.6 days. There were no significant intraoperative complications reported. Using point Aa or Ap of 0.5 or greater to define surgical failure, cure rates for the mesh augmented segment were 100% (100/100) on 6 month follow-up. On 6 month follow-up, 19/42 (45%) patients with preoperative defecatory dysfunction reported improvement after surgery. 3 patients reported new onset defecatory dysfunction. The remainders were unchanged. For 6 (6%) patients, exposure of mesh was reported. The mesh exposure occurred between the 1 week post-op and the at the 6 week postop visit. Three patients underwent successful mesh revision and the remaining three patients were not sexually active and declined treatment. Of the 6 patients with mesh exposure 3 (50%) underwent concurrent vaginal hysterectomy. In sexually active women, sexual function improved in 4 patients while 4 patients reported on new onset dyspareunia. Conclusions: Surgical treatment of advanced prolapsed with lowweight polypropylene mesh is effective and associated with few complications. Surgical cure rates are significantly greater compared to previously reported traditional plication techniques. Functional outcomes for pelvic floor dysfunction improve in some patients following surgery. Mesh erosion is infrequent and may be higher in cases of concurrent hysterectomy.
Presentation Number: Poster 31 Erosion Rates of Transverse Vaginal Incisions for Pelvic Organ Prolapse Repairs Utilizing Various Types of Synthetic Mesh B. K. Jarnagin, L. Knoepp, and M. Adelman Vanderbilt University School of Medicine, Nashville, TN Category: Vaginal Prolapse Repairs with Grafts. Objective: To determine if using an initial transverse incision during a vaginal, mesh-utilizing approach for surgical correction of pelvic organ prolapse improves general healing and decreases typical meshrelated complications. Method: We performed a retrospective chart review of 65 patients who underwent surgical correction of pelvic organ prolapse with different mesh kits. All subjects who had a transverse incision rather than standard vertical incision for entry into the vagina were included. Data collected from the preoperative visit, operative report, and 6week and 3-month postoperative visits were used to provide general descriptive statistics of the study population, to evaluate the presence or absence of mesh erosion at postoperative visits, to and compare subjective and objective prolapse-related symptoms and exam findings pre- and postoperatively. Results: The average age of our study population was 65 years old, and the average BMI was 30. Of the 65 cases reviewed, there were 124 incisions (anterior and/or posterior vaginal). Evidence of erosion was noted at either the 6-week or 3-month post-operative visit for 6 (4.8%) patients. Four (3.2%) of these 6 mesh erosions/extrusions were identified and classified as minor, with resolution noted by the 3month postoperative exam. This left a total of 2 (1.6%) erosions that persisted and required surgical intervention after the 3-month visit. Both cases resolved after this intervention without further sequelae. No cystotomies, enterotomies, or rectal perforations were reported. The average preoperative POP-Q stage of the study population was 34, with objective improvement to an average POP-Q stage of 0 by the time of the final postoperative visit. Conclusion: The use of transverse vaginal entry incision results in a low rate of persistent mesh erosion/extrusion and potentially decreases the rate of other major surgical complications. Therefore, this incision type may be useful as an alternative to the standard, currently-used vertical vaginal incision, as current studies often imply significant erosion and surgical complication rates using these current techniques. Disclosures: B.K. Jarnagin, Bard, Inc.; Gynecare, Consultant; Bard, Inc.; Gynecare, Speakers Bureau; Bard, Inc., Paid Instructor; L. Knoepp, None; M. Adelman, None.
Presentation Number: Poster 32 Complications Associated with the Use of Transvaginal Mesh in Pelvic Organ Prolapse Repair F. A. Ganj,* R. R. Chesson, O. A. Ibeanu, and A. Bedestani *Louisiana State University, Metairie, LA, Louisiana State University, New orleans, LA Category: Vaginal Prolapse Repairs with Grafts. Objective: To determine the intraoperative and postoperative complications associated with the use of transvaginal polypropelene mesh in the repair of pelvic organ prolapse.
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Materials and Methods: Retrospective study of 127 cases of transvaginal repair of pelvic organ prolapse using synthetic mesh, performed from September 2005 to July 2007 in the Louisiana State University Medical system. The surgeries were performed by the same primary urogynecologist and involved synthetic mesh interposition between the sacrospinous ligament complex, arcus tendineus fascia pelvis, and vaginal apex, extending to the anterior and/or posterior vaginal wall for the repair of cystocele and/or rectocele and vaginal vault prolapse. The operative reports and patients charts were reviewed for intraoperative and postoperative complications, along with the type of intervention for the complications. Institutional Review Board approved the study. Statistical analysis was performed using SPSS version 11.5 for windows. Results: Mean age ( SD) was 63.5 10.16 years (range 26 to 79), mean body mass index ( SD) was 28.0 5.0, and median parity was 3 (range 0 to 8). Mean follow up period was 18.7 6.1 months (range 7 to 31). Mean post operative values ( SD) for POP-Q measurements Aa, Ap, and C were: 2.4 1.1 (cm), 2.4 0.9 (cm), and 7.7 1.2 (cm), respectively. The difference between preoperative and post-operative values of these points were statistically significant (p 0.0001). Mesh erosion rate was 10.2%, and significant correlation was observed between mesh erosion and concurrent vaginal hysterectomy (p 0.008, OR:5.65). There was also correlation between intraoperative bladder perforation and mesh erosion (p 0.028, OR:20.54). Parity and anterior vaginal mesh were risk factors for postoperative de novo urinary incontinence (p 0.05). Posterior vaginal mesh and parity were risk factors for the development of prolapse in the hitherto uninvolved pelvic compartment (p 0.05). Post-operative de novo urinary incontinence was seen less in patients with posterior vaginal mesh and patients with previous pelvic organ prolapse repair (p 0.05). Combined anterior and posterior vaginal mesh surgery increased the risk of intraoperative bleeding and need for blood transfusion (p 0.05). Conclusion: Surgical repair of pelvic organ prolapse using polypropylene mesh interposition with apical fixation is an effective procedure. Concurrent vaginal hysterectomy is associated with increased risk of vaginal mesh erosion. The performance of a combined anterior and posterior vaginal mesh repair is a risk factor for intraoperative bleeding and blood transfusion. Prolapse in another compartment and de novo urinary stress incontinence are a complication of the use of repair with use of mesh. Most mesh erosions were easy to resolve but there are occasional major complications. Disclosures: F.A. Ganj, None; R.R. Chesson, None; O.A. Ibeanu, None; A. Bedestani, None.
Presentation Number: Poster 33 Anatomic and Functional Outcomes of a New Rectocele Repair Technique Incorporating the Transvaginal Plication of the Rectal Muscularis Layer H. van Raalte,* M. Murphy, S. Molden,* E. Rogerson, R. Haff, and V. Lucente* *Institute for Female Pelvic Medicine, Allentown, PA, Institute for Female Pelvic Medicine, North Wales, PA, St. Lukes Hospital and Health Network, Bethlehem, PA Category: Other Surgery. Objective: To evaluate anatomic and quality of life outcomes following rectocele repair using a rectal plication technique compared a standard posterior colporrhaphy technique. Methods: A retrospective repeated measures study was used to evaluate patients that underwent surgery to treat posterior compartment prolapse from May 2004 to October 2007. Two techniques for repair were used, a standard posterior colporrhaphy and a rectal plication technique. The rectal plication technique was performed through a standard colporrhaphy incision extended to the level of the rectovaginal space. A running plication suture was placed through the rectal muscularis, and following rectal plication, the vaginal wall was closed with a routine posterior colporrhaphy closure. The techniques were compared using pre- and postoperative outcomes including colorectal symptoms, POP-Q measurements and CRADI-8 scores. Patients with posterior compartment graft use, concomitant abdominal surgery or incomplete pre-operative data were excluded. Results: 75 patients were included. Of these patients, 56 underwent a rectal plication repair and 19 underwent a posterior colporrhaphy. Median follow-up was 3.3 months (range 135 months). Baseline demographic data and time to follow-up were not significantly different between groups. Preoperative functional complaints were higher in the plication group, including manual stenting (55.4% versus 15.8%, p 0.004), incomplete emptying (66.1% versus 52.6%, p 0.42), fecal urgency (17.9% versus 10.5%, p 0.49) and fecal incontinence (39.3% versus 26.3%, p 0.38). Post-operative anatomical measures demonstrated a 97% cure (stage 2) with greater improvement in POP-Q measurements seen in the plication group compared to the colporrhaphy group (Table 1). Postoperative CRADI8 questionnaires were completed by 66 (88%) of patients. CRADI-8 scores were significantly improved in both groups, with the greatest change in CRADI-8 scores seen in the plication group. Conclusions: Our results suggest the rectal plication technique is anatomically as effective as a standard posterior colporrhaphy and may result in improved functional outcomes, particularly among patients with greater preoperative colorectal functional complaints.
TABLE. Anatomic and Functional Outcome Data Rectal Plication N 56 POP-Q Points Change in Point Ap Change in Point Bp p-value (within groups) CRADI-8 Scores Pre-operative CRADI Post-operative CRADI Change in CRADI scores p-value (within groups) 1.6 ( 1.5) 2.2 ( 1.98) 0.001 36.0 ( 22.4) 18.3 ( 16.10) 17.5 ( 19.9) 0.001 Posterior Colporrhaphy N 0.25 ( 0.87) 1.2 ( 2.3) 0.001 31.8 ( 22.8) 21.2 ( 13.0) 13.6 ( 24.5) 0.001 p value (Between Groups) 0.11 0.42 0.48 0.49 0.52
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Disclosures: H. van Raalte, Ethicon, Consultant; M. Murphy, Boston Scientific, Ethicon, Consultant; S. Molden, Ethicon, Consultant; E. Rogerson, None; R. Haff, Ethicon, Consultant; V. Lucente, Ethicon, Bard, Cook, AMS, Consultant.
Presentation Number: Poster 34 Which Layers are Plicated at the Time of Colporrhaphy? M. J. Wong, R. Urwitz-Lane, J. C. Felix, and B. Ozel University of Southern California Keck School of Medicine, Los Angeles, CA Category: Other Surgery. Objective: To determine which of the four layers of the vagina (epithelium, subepithelium, muscularis, adventitia) are plicated at the time of anterior and posterior colporrhaphy. Methods: We retrospectively reviewed the excised vaginal tissue from 23 women who had vaginal colporrhaphies; 14 anterior colporrhaphy and 19 posterior colporrhaphy specimens were collected. Each specimen was examined histologically with a pathologist to determine which layers were present. The surgical technique used in both the anterior colporrhaphy and the posterior colporrhaphy consisted of incising the vaginal epithelium in a sagittal fashion and dissecting the epithelium away from the underlying tissues using sharp dissection with scissors. The tissues that were left on the bladder or rectum were then plicated using delayed absorbable suture. Results: The median age of the subjects was 56. Median Ba and Bp were 1 and 0, respectively. The epithelium and subepithelium were present in all specimens. The muscularis layer was present in 7 (50%) of 14 specimens collected from the anterior vagina and 4 (21%) of 19 specimens collected from the posterior vagina. However, the muscularis was not present the entire length of the specimen in most cases. Conclusion: During anterior colporrhaphy and posterior colporrhaphy the tissues plicated at the time of repair consists of the adventitia and the muscularis in more than half the cases. Disclosures: M.J. Wong, None; R. Urwitz-Lane, None; J.C. Felix, None; B. Ozel, None.
period, and intra-operative and post-operative complications were also recorded. Patients were contacted by the investigator and were interviewed using a modified version of two previously validated and frequently used questionnaires; the Incontinence Impact Questionnaire, and the bowel function questionnaire. Patients were asked about recurrent urinary or bowel symptoms, patient satisfaction after the procedure, and the rate of surgical failure due to recurrent prolapse. Results: From January 2001 to December 2007, a total of 31 colpocleisis were performed. Among 31 patients evaluated, the mean age of the population was 71.5; with a mean BMI of 28.1. Comorbidities were: 61% with multiple medical disorders; 58% reported previous surgeries due to related pelvic disorders. Sixty one percent of the patients were multiparas and grand multiparas. Most of the patients (96%) had stage IV pelvic prolapse. Mean estimated blood loss was 278 ml; the mean operative time was 150 minutes with 83.8% percent of patients receiving spinal anesthesia. Mean hospital stay was 2.2 days. Only one readmission was reported due to an infected hematoma. Twenty patients (65%) were interviewed, there were 4 deaths non-related to the surgical procedure, and 7 patients could not be located. Ninety five percent of the patients interviewed, reported that their previous condition interfered with their usual activities and 100% report complete improvement after surgery (p 0.001). Nine patients referred having abdominal pain before the procedure and only 3 reported this symptoms after the procedure (p 0.05). All of the patients reported being satisfied with the surgery. Conclusions: Colpocleisis is a surgical procedure that can be offered to the non-sexually active elderly women, with medical comorbidities as a safe procedure. Our experience has shown that it can be performed with a short operative time, low rate surgical complications under regional anesthesia, and with a small amount of blood loss. It has also been shown to be associated with high rate patient satisfaction, marked improvement in their symptoms, thus improving quality of life. Disclosures: C.I. Marrero, None; A. Aponte, None; R. Torres, None; F. Santos, None; J. Rivera, None.
Presentation Number: Poster 35 Colpocleisis as Pelvic Reconstructive Surgery: Our Surgical Experience and Patient Satisfaction C. I. Marrero, A. Aponte, R. Torres, F. Santos, and J. Rivera Obstetric and Gynecology Department, Medical Sciences Campus University of Puerto Rico, San Juan, PR Category: Other Surgery. Objective: Describe the experience performing colpocleisis, evaluating surgical characteristics, patient co-morbidities, and patient satisfaction after the surgical procedure. Methods: A retrospective study was conducted using a departamental database to identify patients that had undergone total colpocleisis in the University Hospital at the Medical Center, Puerto Rico from 2001 to 2007. Data includes demographics such as age, parity, and body mass index, indications for surgery. Comorbidities were also evaluated such as history of systemic illnesses, toxic habits and number of previous pelvic related surgeries. Pelvic organ prolapse evaluation was recorded using the POP-Q system. Additional surgical procedures performed at the time of colpocleisis and surgical outcomes were described. Surgical related data description such as estimated blood loss, type of anesthesia, recovery
Presentation Number: Poster 36 Uterosacral Ligament Vaginal Vault Suspension in the Correction of Anterior and Apical Prolapse K. Y. Dyer,* K. M. Luber, and S. A. Menefee* *UCSD, La Jolla, CA, Kaiser Permanente, San Diego, CA Category: Other Surgery. Objective: Many surgeons have observed that stabilization of apical prolapse often corrects anterior vaginal wall descent. However, the efficacy of correcting apical support, without a procedure to
TABLE. Point Ba 3 2 1 0 1 2 3 4 10 (58.8%) 5 (29.4%) 2 (11.8%) 0 (0%) 0 (0%) Pre-op (n 17) Post-op (n 17) 1 (5.9%) 6 (35.3%) 4 (23.5%) 5 (29.4%) 1 (5.9%)
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specifically repair the anterior vaginal wall in women with combined apical and anterior prolapse is unknown. The objective of this study is to determine whether uterosacral ligament suspension (USLS) adequately addresses coexisting anterior vaginal wall descent in women with combined apical and anterior prolapse. Methods: We performed a retrospective observational study of women undergoing USLS for apical prolapse, who also had preoperative anterior vaginal wall descent and did not undergo a procedure to specifically address the anterior vaginal defect. In all subjects, intraoperative replacement of the apex corrected both the anterior and apical prolapse. Inclusion criteria were C 3, Ba 0 and eligible for vaginal support of the apex, with at least 6 months of follow-up. Objective failure was defined as Ba 0. Results: Seventeen women met our inclusion criteria. The mean patient age was 56 .3 ( 10.9) years, median parity 3 (range 1 6), and the median follow-up was 19.0 months (range 6 54). All patients underwent a concomitant vaginal hysterectomy and 59% had a posterior repair. Post operative Ba measurements demonstrated that 6 of the 17 patients met our objective criteria for failure. None of the patients with anterior vaginal wall failures were noted to have apical recurrence as defined by a point C value of 3. Conclusions: With an objective anterior vaginal wall failure rate of 35.2%, the use of USLS as a stand alone procedure for women with combined apical and anterior vaginal wall prolapse should be reconsidered. Further studies are needed to define the optimal anterior vaginal wall procedure for women meeting these criteria. Disclosures: K.Y. Dyer, None; K.M. Luber, None; S.A. Menefee, None.
Methods: Retrospective study evaluating 29 consecutive subjects undergoing a combined abdominal sacral colpopexy (ASC) and a rectopexy (Ripsteins, suture, or low anterior resection). Subjects were included if they were diagnosed with both uterovaginal prolapse by a Urogynecologist and internal rectal prolapse by a Colorectal surgeon. Surgical characteristics, and concomitant surgeries, subjective symptoms of frequency and urgency, diagnosis of urge and stress incontinence, abdominal pain, constipation, and pelvic organ prolapse quantification (POPQ) point C scores. Data was analyzed with SAS. McNemars test, stepwise multivariable analysis (linear and logistic), and generalized estimated equations were utilized with type I error set at 0.05. Results: All genitourinary symptoms significantly improved over time except stress incontinence at 1, 3, and 6 months and urge incontinence at 6 months (Table 1). The gastrointestinal symptoms of abdominal pain and constipation also significantly improved at 1, 3, and 6 months. The median POPQ C point was 4 at baseline and 7 at 3 and 6 months respectively, and significantly improved at 3 and 6 months compared to baseline (p 0.0001). Mean POPQ C point was higher ( 6.75) without concomitant paravaginal repair than with ( 5.075) concomitant paravaginal repair at 3 and 6 months (p 0.0001). Conclusions: The symptoms of frequency, urgency, urge incontinence in the first 3 months, abdominal pain and constipation all improved significantly with the combined ASC/Rectopexy when we controlled for the type of rectopexy performed (Ripsteins vs. Suture vs. Low anterior resection). The POPQ C points improved significantly at 3 months and 6 months compared to baseline with the combined ASC/Rectopexy. The addition of a paravaginal repair reduced support of the POPQ C point adjusting for the changes at 3 and 6 months compared to baseline. Disclosures: C.K. Olivera, None; A.D. Garely, pfizer, Grant/Research Support; AMS, Grant/Research Support; covidian, Consultant; AMS, Consultant; Tri-anim, Consultant; Pfizer, Speakers Bureau; Astellas, Speakers Bureau; Allergan, Speakers Bureau; Medtronics, Speakers Bureau; Covidian, Speakers Bureau; Tri-anim, Speakers Bureau; J. Garbus, None; D.P. Pappas, None; S. Bajaj, None; P. Yadlapalli, None; J. David, None; S. Bajaj, None; D. Yadlapalli, None; M. Feuerman, None; C. Mondesir, None; A. Shahryarinejad, None; T. Samuels, None; S. Ginath, None; C. Ascher-Walsh, None; M.D. Vardy, GSK, Speakers Bureau; Wyeth, Speakers Bureau; Astellas, Speakers Bureau; Tyco, Grant/Research Support; Astellas, Grant/Research Support; Tyco, Consultant; Astellas, Consultant.
Presentation Number: Poster 37 Combined Abdominal Sacral Colpopexy and Rectopexy for Prolapse: A Functional and Anatomical Outcome Surgical Series C. K. Olivera,* A. D. Garely, J. Garbus, D. P. Pappas, S. Bajaj, P. Yadlapalli, J. David, S. Bajaj, D. Yadlapalli, M. Feuerman, C. Mondesir, A. Shahryarinejad,* T. Samuels,* S. Ginath,* C. AscherWalsh,* and M. D. Vardy* *Mount Sinai School of Medicine, New York, NY, Winthrop University Hospital, Mineola, NY Category: Other Surgery. Objective: To evaluate the anatomical and functional outcomes of patients with pelvic organ and internal rectal prolapse, when surgical correction was performed concomitantly.
TABLE 1. Symptoms Parameters Frequency Urgency Urge Incontinence Stress Incontinence Abdominal pain Constipation Baseline N 29 62.1% p 44.8% p 34.5% p 48.30% p 57.10% p 75.0% p 1 month N 29 20.7% 0.0017 20.7% 0.0184 6.9% 0.0043 27.6% 0.0755 17.9% 0.0007% 28.6% 0.0002 3 month N 25 p p p p p p 16.0% 0.0020 20.0% 0.0272 8.0% 0.0253 25.0% 0.0817 0.0% 0.0001 16.0% 0.0001 6 month N 21 p p p p p p 28.6% 0.0318 9.5% 0.0032 9.5% 0.0714 28.6% 0.1456 10.0% 0.0029 5.0% 0.0001
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Presentation Number: Poster 38 Robotic Versus Vaginal Colpopexy for Apical Prolapse A CaseControl Study D. Shveiky, A. I. Sokol, B. I. Kudish, and C. B. Iglesia, Washington Hospital Center, Washington, DC Category: Robotic/Laparoscopic/ASC. Objective: The aim of this retrospective case-control study was to compare objective and subjective outcomes of robotic-assisted laparoscopic versus vaginal colpopexy procedures for apical prolapse. Methods: IRB approval was obtained for this study. Over the period of 12 months, 15 patients who had robotic-assisted laparoscopic colpopexies were compared to 30 controls who had vaginal colpopexy procedures and were matched for age, POP-Q stage and procedure type. Main outcome measures included short-term objective cure rate (POP-Q stage 2), validated quality-of-life measures (PFDI and PFIQ short forms) at 3 months postoperatively and perioperative complications. Descriptive and univariate analyses were used to examine statistical significance. Results: During the study period, 45 patients with stage 23 apical prolapse underwent apical suspension procedures. Patients mean age was 53.5 with 67% of them had stage 3 prolapse. Parity, BMI, ethnicity and menopausal status were similar between the two groups. No intraoperative complications occurred. Mean operating time was 338.13 ( 55.3) minutes for the robotic cases and 198.8 ( 46.8) minutes for the vaginal controls (p .001). Estimated blood loss was significantly lower for the robotic than vaginal cases (78.6 vs. 148.6cc, p 0.02). Mean hospital stay was similar in both groups. Two weeks postoperatively, visual analog pain scale scores were similar between groups. One patient from the robotic group presented with symptoms of peritonitis and underwent diagnostic laparoscopy on postoperative day 10, with a final diagnosis of vaginal cuff cellulitis. The cure rate was 93.3% for the robotic group and 86.6% for the vaginal controls (p 0.51). Vaginal mesh erosion occurred in 2 of the 16 controls (12.5%) and in none of the robotic cases (p 0.3). Both groups showed significant improvement in PFDI and PFIQ scores (p 0.01) compared to baseline. However, the improvement in these scores did not differ significantly between the two groups. Conclusions: Robotic-assisted apical suspension is a valid treatment option for apical prolapse with short-term results comparable to the vaginal approach and a low rate of perioperative complications. Disclosures: D. Shveiky, None; A.I. Sokol, None; B.I. Kudish, None; C.B. Iglesia, None.
on the suture used. We compared the knots when subjected to tensile force until the suture broke or untied. Results: Average peak force required to break suture was 94.4 N (SD 14.6) for conventional and 85.8 N (SD 32.3) for robotically tied knots (p 0.20). The average force required for suture to untie was 47.7 N (SD 18.8) and was seen only among the robotically tied polyglactin 910 knots. Robotically tied polyglactin 910 knots were significantly weaker than all other robotic and conventional knots tested (p 0.05). The robotically tied polypropylene knots were significantly stronger than the conventionally tied polyester and polypropylene knots (p 0.05). The tying modality and material interaction was significant, (p 0.001), suggesting that the effect of suture material varied depending on the tying modality. Conclusion: Knot failure rates for conventional or robotically tied suture varied based on the suture material utilized. Disclosures: T.M. Muffly, None; T.C. McCormick, None; J. Dean, None; A. Bonham, None; R. Hill, None.
Presentation Number: Poster 39 An Evaluation of Conventionally Versus Robotically-Tied Suture Knot Integrity T. M. Muffly,* T. C. McCormick,* J. Dean, A. Bonham,* and R. Hill, *University of Missouri at Kansas City, Kansas City, MO, Arizona College of Osteopathic Medicine, Glendale, AZ, St. Lukes Hospital of Kansas City, Kansas City, MO Category: Robotic/Laparoscopic/ASC. Objective: To evaluate the knot integrity of three commonly used sutures in sacrocolpopexy tied conventionally and robotically. Methods: Knots were tied with polyglactin 910, polypropylene, and polyester, both conventionally and robotically. The number of strandto-strand square throws varied from four to six knots tied dependent
Presentation Number: Poster 40 Laparoscopic Sacral Colpopexy May be a Cost Effective Option Compared to Abdominal Sacral Colpopexy for the Surgical Management of Apical Prolapse: A Cost Minimization Analysis B. A. Suozzi,* J. L. Klauschie,* M. O Brien, and A. W. McBride *Exempla Saint Joseph Hospital Department of Obstetrics and Gynecology, Denver, CO, Biometrics/Clinical Science Department University of Colorado Health Sciences Center, Denver, CO, Mountain States Urogynecology, Exempla Saint Joseph Hospital, Denver, CO Category: Robotic/Laparoscopic/ASC. Objective: Sacral colpopexy is a well established surgical treatment of apical prolapse which can be performed abdominally or as a minimally invasive laparoscopic procedure. Our group has shown comparable anatomic outcomes between these procedures; however, there is little information comparing the cost of the two procedures. The objective of this study was to perform a cost minimization analysis of the two procedures with analysis of hospital charges. Methods: This study is a single-centered, retrospective chart review of all patients undergoing abdominal sacral colpopexy (ASC) or laparoscopic sacral colpopexy (LSC) at a community teaching hospital during the 2005 calendar year. Groups were compared with regards to total operating room (OR) time and OR level of complexity. Total hospital charges were broken down into the following groups: OR charge (derived from total OR time and level of complexity), general equipment, suture, mesh/grafts, laparoscopic specific equipment, pharmacy, laboratory, post-anesthesia care unit (PACU), hospital floor and services, pathology, and additional work-ups. Statistical significance was established at the 5% level for all analyses. Results: Hospital charges for a total of thirty patients were reviewed. Eleven patients underwent ASC and 19 underwent LSC. The mean number of concurrent procedures was slightly higher for the LSC group (ASC 3.45 vs. LSC 3.95). There was no statistical difference between the mean and median total hospital charges for the two groups (ASC mean 29723, median 25480 vs. LSC mean 27604, median 28110). The OR charges accounted for a substantial percentage of the total charges (ASC mean 40.1%, median 40.0% vs. LSC mean 44.1%, median 43.7%). No significant difference existed between OR charges for both groups (ASC mean 11966, median 9630 vs. LSC
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mean 12190, median 12603). There were identical mean total OR times (235minutes) and the median varied by 14 minutes (ASC 208 vs. LSC 222), which was not statistically significant. No statistical differences were noted for total equipment charges, total laboratory charges, or PACU charges. The ASC group had lower suture charges (ASC mean 509, median 525 vs. LSC mean 1136, median 791, p 0.04). The mean and median laparoscopic specific charges were 3128 and 2793, respectively. The LSC group incurred less total pharmacy expenses (ASC mean 3090, median 2543 vs. LSC mean 1863, median 1840, p 0.006) and less charges for oral pain medications (ASC mean 80, median 80 vs. LSC 47, median 42, p 0.014). The LSC group had lower floor charges (ASC mean 3971, median 3547 vs. LSC 2468, median 2286, p 0.002) and a shorter length of stay (ASC mean 2.5 days, median 2.0 vs. LSC mean 1.4, median 1.0, p 0.003). Conclusions: Patients undergoing LSC are likely to incur lower pharmacy and floor related charges and are likely to have a shorter length of stay. LSC may be a cost effective option compared to ASC for the surgical management of apical prolapse. Disclosures: B.A. Suozzi, None; J.L. Klauschie, None; M. OBrien, None; A.W. McBride, None.
Presentation Number: Poster 41 A Comparison of Anterior Compartment Outcomes in Patients Undergoing Sacral Colpopexy with and Without Concurrent Anterior Colporrhaphy J. Klauschie,* B. Suozzi,* M. O Brien, and A. W. McBride *Exempla Saint Josesph Hospital, Department of Obstetrics and Gynecology, Denver, CO, Biometrics/Clinical Science Department, University of Colorado Health Sciences Center, Denver, CO, Mountain States Urogynecology, Exempla Saint Josesph Hospital, Denver, CO Category: Robotic/Laparoscopic/ASC. Objective: Sacral colpopexy is commonly used for the correction of apical vaginal prolapse, but also may help correct prolapse of the anterior compartment. When sacral colpopexy alone, does not address these anterior wall defects, additional procedures may be needed. In this study, anatomic outcomes of the anterior compartment were examined after sacral colpopexy in patients with and without concurrent anterior colporrhaphy (AC). Methods: This is a retrospective study of 84 patients who underwent either laparoscopic (n 43), or abdominal sacral colpopexy (n 41); patients were included if they had one postoperative exam. The patients were from a single urogynecological practice at a community teaching hospital. Patients were stratified into two groups: those who underwent concurrent anterior colporrhaphy (AC ) and those who did not (AC ). POP-Q points Aa and Ba were compared preoperatively and postoperatively (6 weeks, 6months, and 1yr). Anatomical failures in the anterior compartment were defined as POPQ Stage 2 or greater after the 6 week postoperative exam, symptoms of anterior wall prolapse (AWP), or additional treatment such as pessary or surgery. Patients with AWP of Stage 2 or greater present at the 6 week exam were classified as persistent prolapse. Results: Twenty-five percent (21/84) of the patients undergoing sacral colpopexy had concurrent AC. The AC ( ) group had more advanced preoperative AWP (AC ( ) Aa/Ba 1/1.8 vs. AC ( ) 0.1/1.3 p 0.02). Both groups had significant postoperative improvements in the anterior compartment. There were no significant
differences in postoperative Aa/Ba values between the two groups at any postoperative visit. Mean Aa/Ba at 6 months for AC ( ) was 1.8/ 1.5, and 2.1/ 2.1 (p NS), for AC ( ). At one year the mean Aa/Ba measurements for AC ( ) were 1.5/ 1.9 and for AC ( ) were 2.3/ 2.3 (p NS). Anatomic failures occurred in both groups. None of the AC ( ) patients had persistent prolapse at the 6 week exam with the mean Aa/Ba 2.6/ 2.6. There were 4 failures (25%, n 16) in the AC ( ) group at the 6 month exam and one new failure at one year (11%, n 9). Two patients in this group underwent additional treatment for their AWP. In the AC ( ) group, mean Aa/Ba values at 6 weeks were: 2.4/ 2.4; however, there were ten patients with persistent AWP. These patients had a mean preoperative Aa value 1.5 which was significantly higher than the mean preoperative values of the AC( ) group (1.0) and of the AC ( ) group ( 0.4), p 0.001. There were 5 patients with failures (13%, n 40) in the AC ( ) group at 6 months, and 2 new cases at one year (8%, n 24). One patient underwent additional surgery for AWP, and one other requested reoperation for symptoms, but did not fit criteria for anatomic failure. Conclusions: In many cases sacral colpopexy alone does reduce anterior compartment defects, primarily with less advanced AWP. Persistent prolapse of the anterior compartment is a risk when no concurrent repair is performed especially in patients with more advanced AWP. Disclosures: J. Klauschie, None; B. Suozzi, None; M. OBrien, None; A.W. McBride, None.
Presentation Number: Poster 42 Dynamic Magnetic Resonance Imaging And Clinical Staging of Pelvic Organ Descent: Comparison of Pubococcygeal Versus Midpubic Reference Lines With Clinical Correlation B. S. Hampton,* C. A. Woodfield, V. W. Sung,* and J. A. Brody *Brown Alpert Medical School/Women and Infants Hospital, Providence, RI, Women and Infants Hospital, Providence, RI Category: Imagining. Objective: Currently, there is no consensus regarding which magnetic resonance imaging (MRI) reference line for staging pelvic organ descent, pubococcygeal line (PCL) (inferior symphysis pubis to last coccygeal joint) vs midpubic line (MPL) (midsagittal long axis of symphysis pubis), correlates best with clinical staging. The primary study objective is to determine which MRI reference line (PCL vs MPL) agrees best with clinical staging. Methods: An IRB approved retrospective study of all patients with pelvic floor complaints and clinical records at our institution who underwent dynamic pelvic floor MRI examinations on a 1.0 or 1.5 T MRI magnet from January 2004 through April 2007 was performed. All MRIs were read by two experienced body MRI radiologists blinded to clinical data. The degree of descent on MRI for each pelvic compartment (anterior, vault, posterior) was staged by consensus, first using the PCL and then the MPL reference line. Readings for each reference line were temporally spaced by 4 weeks. Clinical records were reviewed by a fellowship trained Urogynecologist blinded to MRI results. Demographic and clinical data, including symptoms of pelvic floor dysfunction and pelvic organ prolapse staging using the pelvic organ prolapse quantification (POPQ), were recorded. Agreement between MRI staging and clinical staging was estimated using weighted kappas. All statistical analyses were performed using STATA 9.0.
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Results: Twenty two patients were included in this study with mean age of 54.9 years (SD 11.7) and median parity of 2 (range 0 3). Clinical patient characteristics included prior pelvic surgery 71.4%, urinary incontinence 61.9%, pelvic organ prolapse 85%, pelvic pain 23.8%, constipation 27.8%, and fecal incontinence 14.3%. POPQ and MRI staging (median, range) by vaginal compartment were as follows: 1) anterior: POPQ 1 (0 3), MPL 2 (13), PCL 0.5 (0 2); 2) posterior: POPQ 2 (0 3), MPL 2 (12), PCL 2 (13); 3) vault: POPQ 1 (13), MPL 1 (0 2), PCL 0 (0 2). Agreement between clinical and MR staging using the PCL was fair in the anterior compartment ( 0.29), and poor in the vault ( 0.03) and posterior ( 0.08) compartments. Agreement between clinical and MR staging using the MPL was fair in the anterior ( 0.37), vault ( 0.31), and posterior ( 0.25) compartments. Conclusions: The MPL reference line shows better agreement with clinical staging than the PCL reference line for this population of women with pelvic floor complaints. Agreement for the PCL reference line and clinical staging in this population is particularly poor in the posterior compartment and vault. Disclosures: B.S. Hampton, Ethicon Womens Health and Urology, Consultant; C.A. Woodfield, None; V.W. Sung, None; J.A. Brody, None.
Presentation Number: Poster 43 Magnetic Resonance Imaging of Abdominal Versus Vaginal Prolapse Surgery With Mesh S. Ginath,* M. Vardy, J. S. Luchs, A. Shahryarinejad, C. Olivera, S. Zhou, C. Ascher-Walsh, M. Brodman, A. Condrea,* and A. Garely, *Wolfson Medical Center & Sackler School of Medicine, Holon & TelAviv, ISRAEL, Mount Sinai School of Medicine, New York, NY, Winthrop University Hospital, Mineola, NY Category: Imaging. Objective: Compare 2 surgeries for symptomatic apical vaginal prolapse with normal controls, by analyzing MRI measured landmarks and quality of life (QOL) measures, before and after surgery. Methods: Prospective multicenter pilot study (n 16). Nuliparous controls (N 6) were compared to 10 parous (3.0 1.0) women with a uterus and apical prolapse stage 2. Group A (N 5) underwent ASCP with monofilament polypropylene mesh (MPM), and Group B (N 5) vaginal MPM kit repair (total ProLift). Subtotal hysterectomy was performed in all Group A and none in B. All study patients underwent pre-op and 3 months post operative POPQ, dynamic MRI, validated health status, quality of life (QOL) and sexual function questionnaires (SF-36, PFIQ-7, PISQ-12, PFDI-20). Comparison of MRI pelvic angles, and distances (Figure 1) was performed and analyzed by Mann-Whitney Rank Sum test and chisquare test. Results: Group B were older than A patients (67.2 8.4 years versus 53.6 8.3 years, p 0.03). There were no significant differences in parity, menopausal status, BMI, general health and QOL scores between study groups postoperatively. No differences were seen in MRI landmarks postoperatively (Table 1). Conclusions: ASCP compared to Prolift for vaginal apical support are similar at 3 months by POPQ, QOL, and MRI analysis. Both treatments returned POPQc and QOL measures to values comparable to nulliperous controls by 3 months. Changes in g angle may reflect levator atrophy. Longer follow-up with larger numbers seems warranted.
Disclosures: S. Ginath, None; M. Vardy, Tyco, Grant/Research Support; Astellas, Grant/Research Support; AMS, Consultant; Astellas, Consultant; Wyeth, Speakers Bureau; GSK, Speakers Bureau; Astellas, Speakers Bureau; J.S. Luchs, None; A. Shahryarinejad, None; C. Olivera, None; S. Zhou, None; C. Ascher-Walsh, None; M. Brodman, None; A. Condrea, None; A. Garely, Pfizer, Grant/Research Support; AMS, Grant/Research Support; Covidian, Consultant; Tri-Anim, Consultant; AMS, Consultant; Pfizer, Speakers Bureau; Allergen, Speakers Bureau; Covidian, Speakers Bureau; Astellas, Speakers Bureau; Medtronics, Speakers Bureau; Tri-Anim, Speakers Bureau.
Presentation Number: Poster 44 Two Valsalva or not Two Valsalva: Do Repetitive Valsalva Maneuvers Help Women Obtain their Maximum Prolapse on Dynamic MRI? J. A. Tumbarello, Y. Hsu, S. Rohrer, and J. O. DeLancey University of Michigan, Ann Arbor, MI Category: Imaging. Objective: Dynamic magnetic resonance imaging (MRI) is increasingly used to study pelvic organ prolapse. During clinical examination several attempts are often needed to achieve a maximally developed prolapse for quantification. This study seeks to quantify differences in anterior vaginal wall prolapse during sequential Valsalva attempts. Methods: Subjects were taken from an ongoing case-control study evaluating anterior vaginal wall prolapse. Women with a prolapse whose leading edge extends 1 cm beyond the hymenal ring and who were enrolled after February 1, 2007 were included (n 45). Prior to the MRI portion of the study all women underwent clinic pelvic floor testing, including POP-Q, at which time they were given instructions and asked to
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practice pushing their prolapse out to its maximal extent. During the MRI, women were again instructed to push their prolapse to the maximum extent. All subjects performed 2 maximal Valsalvas during mid-sagittal dynamic MRI scans. The most dependent bladder point was marked in each MR image and its vertical distance to a horizontal reference line placed at the inferior pubic bone was measured (Figure 1). The amount of bladder descent between the first and second maximal Valsalva efforts were compared. Results: Of the 45 subjects included, 91% (n 41) had a significant (p .001) increase in bladder descent from the first Valsalva attempt to the second with a mean change of 1.38 1.54 cm. Of the patients that had a significant increase in bladder descent, 44% (n 18) had more than a centimeter of difference (mean 2.58 1.66 cm) and 20% (n 8) had more than 2 cm difference (mean 3.96 1.6 cm) between their first and second attempt. Conclusion: As is true during clinical examination, several attempts may be required to have anterior compartment prolapse present at its maximal size during dynamic MR imaging of the pelvic floor.
Disclosures: J.A. Tumbarello, None; Y. Hsu, None; S. Rohrer, None; J.O. DeLancey, Johnson & Johnson, Consultant.
Presentation Number: Poster 45 Accuracy of the Midpubic Line in Estimating the Location of the Vaginal Hymen with the Midpubic Line Measurement on Dynamic Magnetic Resonance Imaging in Women with Pelvic Organ Prolapse K. J. Wohlrab,* B. S. Hampton,* C. A. Woodfield, V. W. Sung,* C. R. Rardin,* and J. M. Brody *Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology; Alpert Medical School at Brown University, Providence, RI, Department of Radiology; Alpert Medical School at Brown University, Providence, RI Category: Imaging. Objective: The midpubic line (MPL) is defined as the line along the midsaggital axis of the symphysis pubis, and is used as an approximation of the vaginal hymen (VH) for MRI assessment of pelvic organ prolapse. The primary aim of this study is to test the accuracy of the MPL in locating the VH in women with complaints of pelvic organ prolapse who undergo dynamic MRI. The secondary aim of this study is to estimate the agreement between radiologic staging using both the MPL and VH as references points to clinical Pelvic Organ Prolapse Quantification (POPQ) staging.
Methods: We performed an IRB-approved prospective cohort study. Women undergoing dynamic MRI for complaints of pelvic organ prolapse were consented. Demographic and POPQ measurements were collected from patient charts. Prior pelvic surgeries, complaints of a vaginal bulge, pain, urinary or fecal incontinence were recorded at the time of the MRI. A MRI surface marker (Beekley MR Spot; Bristol, CT) was placed at the level of the posterior vaginal hymen immediately prior to MRI examination. All images were viewed by a radiologist with expertise in pelvic floor imaging. Images were obtained during rest, Kegel, and Valsalva maneuvers, and the distance between the MPL and VH was measured with each. The radiologic measurements of the leading edge of prolapse for the anterior, apical and posterior compartments during Valsalva were also measured, with reference to both the MPL and VH. These measurements were then staged based on POPQ definitions. Descriptive statistics were performed. Weighted kappas were used to estimate the agreement between both methods of radiologic assessments and clinical measures. Results: Thirteen women were recruited into the study; POPQ measures were available in 8. The mean age was 49.2 years (SD 12.0), median parity was 2 (range 14), and the median POPQ stage was 2 (range 13); 81.8% had prior pelvic surgery, 75% complained of a vaginal bulge, 66.7% had pelvic pain, 16.7% had urinary incontinence and 8.3% had fecal incontinence. The MPL accurately located the VH in 12 out of 13 patients at rest and with Kegel; however, during Valsalva, the MPL correctly located VH in only 2 patients. The median difference between the MPL and VH marker during Valsalva was 1 cm (range 02.5 cm). Agreement in staging between clinical and MR techniques using the MPL reference line was fair in the anterior ( 0.31) and poor in the posterior ( 0.04) compartments. Agreement between clinical and MR staging using the VH reference line was fair in the anterior ( 0.23) and very good in the posterior ( 0.86) compartment. Data were not sufficient to estimate agreement in the apical compartment. Conclusions: This study demonstrates that the MPL approximates the vaginal hymen at rest, but with Valsalva, excursion of the hymen reduces this accuracy. Staging of pelvic organ prolapse using MR measurements showed only fair agreement to clinical staging in the anterior compartment, but very good agreement in the posterior compartment when VH was used as the reference point. Disclosures: K.J. Wohlrab, None; B.S. Hampton, Ethicon, Consultant; C.A. Woodfield, None; V.W. Sung, None; C.R. Rardin, Boston Scientific, Consultant; J.M. Brody, None.
Presentation Number: Poster 46 A New Technology to Measure the Biomechanical Properties of the Vaginal Wall H. van Raalte,* V. Lucente,* L. Lipetskaia, and V. Egorov *Institute for Female Pelvic Medicine, Allentown, PA, St. Lukes Hospital and Health Network, Bethlehem, PA, Artann Laboratories, Trenton, NJ Category: Imaging. Objective: The objective of this study is to demonstrate the potential use of mechanical imaging technology to measure and compare biomechanical properties of the vaginal wall in women with and without pelvic organ prolapse. Methods: Thirteen women were enrolled in the study and underwent transvaginal MI evaluation. The women enrolled included 5 women with normal pelvic support, 3 of which had had prior reconstructive pelvic surgery, and 8 women with current pelvic organ
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prolapse. MI was performed utilizing a vaginal probe, similar in dimensions to a transvaginal ultrasound probe, which was comprised of two separate pressure sensor arrays and orientation sensors. The images were obtained in an office setting at the time of routine vaginal examination. Imaging results were electronically recorded and then analyzed at Artann Laboratories. Results: Among women with and without prolapse, the elasticity coefficient is calculated as the slope (Es) of scanhead applied force versus elevation angle of the probe and is used to characterize the elasticity of the vaginal wall against which the scanhead has been pressed. Comparison of a woman with normal pelvic support to a woman with pelvic organ prolapse revealed a measurable difference in elasticity coefficient (Es) values. Es values were 0.18 0.01 in a patient with normal support compared to 0.025 0.01 in a patient with Stage 3 prolapse for the anterior compartment. Similarly, Es values were 0.11 0.01 in a patient with normal support compared to 0.035 0.01 in a patient with Stage 2 prolapse for the posterior compartment. Using these values, the ratio of normal-to-prolapse vaginal wall elasticity as detected by the MI device was found to be 7.2 for the anterior compartment and 3.1 for the posterior compartment. For patients with prior reconstructive surgery, areas of previous scar tissue and graft placement could be easily seen on mechanical imaging with a measurable increase in tissue rigidity. Even within the vaginal site of graft placement, areas of increased rigidity, such as mesh arms used in graft kits, could be visually discerned. Conclusions: Our findings suggest that MI offers a non-invasive, quantitative evaluation of vaginal elasticity with the potential for a more comprehensive evaluation of overall vaginal support structures. In a transvaginal scanning application, MI can reproduce a real-time, circumferential evaluation of the vaginal walls. The potential gynecologic application of the MI could impact our further understanding of risk factors for the development of prolapse, individual variations in biomechanical properties and provide insight into optimal approaches for surgical repair. This last application is particularly important with the increasing use of graft materials for pelvic reconstructive surgery and the need to more extensively evaluate the functional properties of the vaginal walls following these repairs. Disclosures: H. van Raalte, Ethicon, Consultant; V. Lucente, Ethicon, Bard, AMS, Cook, Consultant; L. Lipetskaia, None; V. Egorov, Employee at Artann Labs, Other.
Boston Scientific or Ethicon mid-urethral slings. The primary outcomes of suburethral sling shrinkage and migration from the mid-urethra were compared by One-way ANOVA test. Results: Eighteen women with AMS slings (transobturator), ten with Boston Scientific slings (8 retropubic, 2 transobturator) and fourteen with Ethicon (8 retropubic, 6 transobturator) were statistically similar across the demographics of age, race, weight, parity, menopausal status, previous pelvic surgery, and concomitant surgery. Cure/improved rates were 88.9, 100 and 92.9, respectively. Mean percent sling shrinkage was 49.8 21.3, 50.1 32.6 and 39.1 23.7 (p 0.43) and mean percent sling migration was 4.11 25.0, 12.4 13.5 and 9.9 31.3 (p 0.67), respectively. Conclusions: All three types of slings showed similar degrees of shrinkage and migration away from the mid-urethra. Such alteration from the intended sling width and implanted location does not seem to have a significant effect on cure rate. Disclosures: B.J. Vassallo, Unrestricted grant from Boston Scientific, Grant/Research Support; Boston Scientific, Consultant; Novartis, OrthoMcNeil, Speakers Bureau; C.D. Harris, Boston Scientific, Consultant; D.E. Pesch, None; M.D. Moen, Ethicon, Consultant; Astellas, Allergan, Speakers Bureau; M.B. Noone, Boston Scientific, Ethicon, Consultant; Ortho-McNeil, Astellas, Allergan, Speakers Bureau.
Presentation Number: Poster 48 Translabial Ultrasound (TLU) Accurately Depicts Anal Sphincter and Pubovisceralis (PV) Anatomy T. B. Omotosho, R. J. Hall, H. Abed, L. L. Leeman, and R. G. Rogers University of New Mexico Hospital, Albuquerque, NM Category: Imaging. Objective: To describe and compare anal sphincter and PV anatomy using 2D and 3D TLU and endoanal ultrasound (EAU) images. Methods: We compared TLU and EAU of 31 primiparous women with a mean age of 25 5 years. All women were examined in the dorsal lithotomy position after voiding, using a Philips IU22 3-9 MHz 3D endovaginal and a B & K 16 MHz 3D endoanal transducer. 2D axial images of the internal anal sphincter (IAS) were measured at 3 levels (proximal, mid and distal) at 12, 3, 6 and 9 oclock. External anal sphincter (EAS) images were measured at the distal level. 2D and 3D transverse width measurements of the PV were taken at the mid level. Sphincter and PV integrity were qualitatively assessed. Pearsons correlations were performed for paired measurements of IAS, EAS and PV. Results: 31 women underwent both TLU and EAU. No sphincter defects or disruptions or asymmetries in the PV were identified with either modality. Figure 1a compares TLU and EAU 3D images obtained at the mid level and figure 1b compares TLU to EAU at the distal level. Both TLU and EAU images accurately depict the PV and anal sphincters. No correlations were found between TLU and EAU measurements; qualitative agreement was a 100% between modalities. Conclusion: TLU 2D and 3D ultrasound accurately image pelvic floor anatomy. Sphincter and PV measurements do not correlate between modalities. Further study is needed to determine if the detection of sphincter and levator ani disruption is equivalent between methods.
Presentation Number: Poster 47 3-D Ultrasound Characterization of Mid-Urethral Slings: A Comparison of Three Different Sling Types B. J. Vassallo,* C. D. Harris, D. E. Pesch, M. D. Moen,* and M. B. Noone* *Illinois Urogynecology, Park Ridge, IL, Knoxville Urology Clinic, Knoxville, TN, Advocate Lutheran General Hospital, Park Ridge, IL Category: Imaging. Objective: To describe the changes in suburethral sling width and the degree of migration from the mid-urethra which occur after sling placement and to compare the differences in these characteristics across three of the leading mid-urethral sling products. Methods: Forty-two women were studied by transvaginal 3-dimensional ultrasound after undergoing placement of American Medical System,
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including BMI, type of past or recent surgery, presenting complaint, and diagnosis were recorded for all patients. The main outcome was the mean difference of the two PVR volume measurements (catheterultrasound). Results: Bladder ultrasound and catheter postvoid residual volume were measured for each of 112 subjects. The mean difference between the two measurements was 48.2ml with a standard deviation (sd) of 105.6 ml. A paired t-test of the null hypothesis that the difference between bladder ultrasound and catheter volume was zero was statistically significant (p 0.0001). When stratifying the results by patient weight, the mean difference within the extremely obese group (BMI 40 kg/m2) was 55.7 ml (sd 253.6) compared with 59.4 ml (sd 121.7) among the overweight group (BMI 2529.9 kg/m2). This difference in measurement between the weight groups was statistically significant (F test p-value 0.05). There was also a difference in measurement between the mean inpatient (62.3ml (sd 119.5)) and mean outpatient (19.7 ml (sd 61.6)) groups (p 0.01). The difference in measurement between PVR and ultrasound increased as PVR increased. Comparing patients with 50 ml PVR to those with 50 200 ml and greater than 200 yielded an F test p-value of 0.0001. Conclusions: Although the mean difference between the catheter and ultrasound PVR measurements was 48.2 ml, the standard deviation was large (105.6 ml). As a normal PVR measurement in the outpatient setting is 50 ml, one can see that a PVR ultrasound measurement that differs by greater than 50ml from the gold standard straight catheterization could be problematic in the clinical setting. This difference in PVR between ultrasound and straight catheter measurement is more pronounced as BMI increases and as the catheterized PVR increases. In addition, bladder ultrasound seems to be much less accurate in the immediate postoperative period. This study does not support the replacement of straight catheter measurement of PVR by ultrasound. Disclosures: M.E. Tarr, None; S. Valaitis, None.
Disclosures: T.B. Omotosho, Pfizer, Grant/Research Support; R.J. Hall, None; H. Abed, None; L.L. Leeman, None; R.G. Rogers, Pfizer, Grant/Research Support.
Presentation Number: Poster 50 Trends in Stress Urinary Incontinence Inpatient Procedures in The United States, 1979 2004 S. S. Oliphant,* L. Wang, C. H. Bunker, and J. L. Lowder* *University of Pittsburgh, Pittsburgh, PA, Clinical and Translational Science Institute, University of Pittsburgh, Pittsburgh, PA Category: Epidemiology. Objective: To describe national trends in surgery for female stress urinary incontinence (SUI). Methods: The National Hospital Discharge Survey (NHDS), a federal dataset sampling U.S. inpatient hospitals, was analyzed for patient and hospital demographics and ICD-9-CM diagnostic and procedures codes from 1979 to 2004. Age-adjusted rates (AARs) per 1000 women were created using 1990 U.S. Census population data. Results: The number of women undergoing SUI surgery has increased from 48,345 in 1979 to 103,467 in 2004. In women 52 years of age the AAR more than doubled from 0.64 to 1.6, while in women 52 the AAR fell from 0.57 to 0.47. AARs for Retropubic urethral suspensions (ICD-9 59.5) fell from 0.37 in 1979 to 0.14 in 2004. Suprapubic sling (59.4) AARs rose from 0.02 in 1979 to a peak of 0.10 in 1997, and then fell to 0.03 in 2004. AARs for Other repair of SUI (59.79) rose from 0.06 in 1979 to 0.64 in 2004. No specific code for midurethral sling exists.
Presentation Number: Poster 49 Is Bladder Ultrasound Measurement of Postvoid Residual Volume Accurate When Used in The Evaluation of Post Surgical and Clinic Urogynecology Patients? M. E. Tarr, and S. Valaitis University of Chicago, Department of OBGYN, Chicago, IL Category: Imaging. Objective: To determine if the measurement of postvoid residual volume (PVR) with the use of a bladder ultrasound accurately reflects the true PVR as determined by the gold standard, straight catheterization of the urethra, in postoperative and ambulatory urogynecology patients. Methods: After receiving Institutional Review Board approval, 112 subjects were recruited from both the urogynecology clinic and following urogynecologic operative procedures. After written consent was obtained, subjects who had recently voided underwent an ultrasound measurement of PVR using the Bladder Scan (Diagnostic Ultrasound) followed by immediate straight catheterization of the urethra to reveal the true PVR measurement. Demographic data
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Conclusion: The number of women undergoing SUI surgery has increased significantly from 1979 to 2004. NHDS data does not include ambulatory procedures, so accurate information on same-day surgeries is unavailable. Missed sampling, coding changes, and imprecise codes may explain the decline in Suprapubic sling procedures as well as rising numbers of Other repair of SUI. To obtain accurate national estimates of female incontinence procedures a specific ICD-9-CM code for midurethral sling needs to be created and the National Survey of Ambulatory Surgery needs to be reinstituted.
Methods: Women presenting to a midwestern tertiary care urogynecology clinic for POP were included. Comprehensive initial evaluation of new patients included a standardized questionnaire addressing onset and progression of prolapse symptoms, as well as a complete urogynecologic examination with the Pelvic Organ Prolapse Quantification system (POP-Q). Patients perception of (1) initial prolapse discovery, (2) timeframe from symptom onset to worsening, (3) symptoms perceived as most bothersome, and (4) factors that drove treatment seeking were assessed. Descriptive statistics were used for baseline data and differences in means were compared with Students t-tests. Responses were correlated with clinical data. The study was IRB approved (HUM00010718). Results: One hundred and seven women participated. The mean participant age was 57.5 14.0 years and mean BMI was 26.9 4.2 kg/m2. Ninety-four percent were vaginally parous (median parity 3.0, range 0 to 8); only 6 were nulliparous. Almost fifty percent (47.4%) of women sought medical attention immediately after discovering a bulge, irrespective of whether or not they had symptoms of pelvic floor dysfunction. The median time to seek care was 4 months (range 1 month to 45 years). Care was sought by 80.0% of women within one year of discovering their prolapse; the most common reason cited was worsening of the bulge. Twenty-six percent of the women associated their prolapse with a sentinel event (moving furniture, pushing a car). These women were significantly younger than those that reported a gradual onset of prolapse (52.0 3.0 vs. 58.4 1.6 years, p 0.05). The prolapse was self discovered by 75.7% (81/107) of women, with the remainder being discovered by health care providers. The anterior wall (mean point Ba) of the self-discovery group was 1.3 cm beyond the hymen; this was significantly greater than that of women diagnosed by their physicians (mean Ba 0.1, p 0.03). The most common bothersome symptom reported was bulge/pressure (84.1%) followed by urinary incontinence (24.3%). Other symptoms that patients attributed to their prolapse included: back pain (15.9%), a feeling of incomplete bladder emptying (15.9%), and constipation (11.2%). Conclusions: Most women describe a gradual development of their pelvic organ prolapse, yet seek medical advice soon after they initially discover it. Self-discovery of prolapse is associated with a higher stage of prolapse than prolapse diagnosed by health care providers. Disclosures: C. Lewicky-Gaupp, None; R.U. Margulies, None; K. Larson, None; D.E. Fenner, None; D.M. Morgan, None; J.O. DeLancey, Johnson & Johnson, Consultant.
Disclosures: S.S. Oliphant, None; L. Wang, National Institutes of Health, Grant/Research Support; C.H. Bunker, National Institutes of Health, Grant/Research Support; J.L. Lowder, None.
Presentation Number: Poster 51 Self-Reported Natural History of Pelvic Organ Prolapse as Described by Women Seeking Treatment C. Lewicky-Gaupp, R. U. Margulies, K. Larson, D. E. Fenner, D. M. Morgan, and J. O. DeLancey University of Michigan Hospital, Ann Arbor, MI Category: Epidemiology Objective: To describe the self-perceived natural history of pelvic organ prolapse (POP) in women presenting to a tertiary-care center.
Presentation Number: Poster 52 Current Trends in Help Seeking Behavior Amongst Women with Socially Bothersome Urinary Incontinence A. Nguyen, S. Aschkenazi, T. Gamble, P. Sand, R. Goldberg, J. Beaumont, P. Stibbe, A. Ching, and S. Botros Evanston Incontinence Center, Northwestern University, Feinberg School of Medicine, Evanston, IL Category: Epidemiology. Objective: Many prior studies have published rates regarding help seeking among women with UI however, few have reported rates in women who specifically report socially bothersome UI. We sought to determine the current rates of help seeking among women with socially bothersome urinary incontinence (UI), the reasons cited for not seeking care and the factors promoting help seeking behavior. Methods: A multi-item survey was administered to 1287 twin sisters at the annual Twinsday Festival held in Twinsburg, Ohio during the
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years 20032006. Women were questioned about whether they felt socially bothered by their incontinence, whether they sought care from their physician, whether the physician brought up the issue with them, and their reasons/perceptions for not seeking care. Logistic regression for repeated binary measures was used to evaluate risk factors accounting for shared genetics within pairs. Generalized estimating equation (GEE) methodology was used for comparisons between women who did and did not successfully seek medical attention for bladder, bowel, or other pelvic symptoms. Results: Of 1287 twin sisters, 21% had stress incontinence, 4% had urge incontinence, and 27% had mixed incontinence. More women with mixed UI reported socially bothersome symptoms than women with pure stress or urge incontinence- 45% (N 155), 21% (n 270) vs. 16% (N 9), respectively. Over 60 80% of women with socially bothersome UI failed to seek help from their physician- 63% versus 80% and 87% respectively for mixed, stress and urge incontinence. A dramatically lower percentage of physicians brought up the issue with their patient-9% and 2% for stress and urge UI respectively. Womens reports of socially bothersome symptoms were associated with help seeking for all three types of urinary incontinence. Prior hysterectomy (OR 2.95, 95% CI 1.117.80), severity of stress incontinence (OR 2.94, 95% CI 1.137.68) and Urinary Distress Inventory score (OR 1.03 95% CI 1.011.06) predicted help seeking for mixed UI after multiple regression. The most common reasons cited for not seeking help for UI included the misconceptions that UI is a normal part of aging (40 47%), a normal part of childbirth (19 34%), that their physician never asked (20 27%), personal embarrassment (19 25%) and unawareness of treatment options (8 21%). Conclusions: This study indicates that the majority of women with socially bothersome urinary incontinence do not seek help from their physicians and very few are screened by their physicians. There is still the common misconception that urinary incontinence is a normal part of aging or childbirth. Educational efforts are desperately needed to dispel the misconceptions associated with urinary incontinence and increase physician involvement in screening in order to improve help seeking behavior over the next decade. Disclosures: A. Nguyen, None; S. Aschkenazi, None; T. Gamble, None; P. Sand, Astellas, Indevus, Watson, Boston Scietntific, American Medical Systems, Pfizer, Ortho-McNeil and Allergan, Consultant; R. Goldberg, Boston Scientific, Consultant; J. Beaumont, None; P. Stibbe, None; A. Ching, None; S. Botros, None.
TABLE. Prevalence per year (%) 20022003 20042005 Urinary incontinence Pelvic organ prolapse 0.023 0.020 0.016 0.021
(O:E). Individual regions within NH and VT were the variance in the O:E ratios exceeded 20% were further analyzed by hospital type (academic medical center, community hospital, critical access hospital) and gynecology and urology provider frequency. Results: The prevalence of pelvic floor surgery is displayed in the table below. Of 13 regions across NH and VT, two regions (northwestern ME and eastern NH seacoast) had observed pelvic floor surgery rates that exceeded 20%. Neither region had higher than mean provider frequency and of the four regions that had higher than mean provider frequency one had observed surgery rates 20% below expected. In the two high O:E regions, 30% of women originating from these regions had surgery at an academic medical center. For the period 20022005, 69% of urinary incontinence surgery was done in critical access or community hospitals. Fifty-four percent of pelvic organ prolapse surgery was performed in critical access or community hospitals. Seventy percent of coded rectocele and cystocele surgery was done outside of the academic medical centers, whereas 70% of apical suspensions were done in an academic medical center. Conclusion: There are significant variations in pelvic floor surgery rates across northern New England. These variations, where high, do not follow the usual pattern of higher provider frequency. Overall the prevalence of pelvic floor surgery in northern New England was low between 2002 and 2005. Apical suspensions were performed more often in academic medical centers. Disclosures: J.L. Whiteside, Duramed Incorporated, Grant/Research Support; American Medical Systems, Consultant; M.A. McCutcheon, None; K. Strohbehn, Duramed Incorporated, Grant/Research Support; E.A. Gormley, None; P.D. Hanissian, Duramed Incorporated, Grant/Research Support.
Presentation Number: Poster 53 Regional Variation in Pelvic Floor Surgery In Northern New England J. L. Whiteside,* M. A. McCutcheon, K. Strohbehn,* E. A. Gormley,* and P. D. Hanissian* *Dartmouth Medical School, Lebanon, NH, Dartmouth-Hitchcock Medical Systems, Lebanon, NH Category: Epidemiology. Objective: To investigate regional variations in pelvic floor surgery rates across northern New England. Methods: Using state discharge data from the Uniform Hospital Discharge Data Set (UHDDS), utilization rates in NH, MA, ME, and VT for inpatient pelvic floor surgeries by ICD-9 procedures codes for women 18 years and older from 2002 to 2005 were examined. These rates were age and sex normalized to the NH/VT region using Claritas demographic data establishing expected utilization rates. Observed surgical utilization rates for published hospital service areas were compared to the expected rate creating observed to expected ratios
Presentation Number: Poster 54 Incidence and Clinical Characteristics for Urethral Diverticulum: A Population-Based Evaluation M. M. Nunn, S. A. El-Nashar, and C. J. Klingele Mayo Clinic, Rochester, MN Category: Anatomy. Objective: To determine the incidence and clinical characteristics of urethral diverticulum (UD) from a population-based study. Methods: Using the record linkage system of the Rochester Epidemiology Project (REP), women diagnosed with or surgically managed for non-congenital UD in Olmsted County (OMC) Minnesota were identified. Incidence of UD with its corresponding 95% confidence interval (95%CI) in OMC was determined. Demographic, clinical and surgical data were obtained from patients treated at Mayo Clinic. Results: From January 1980 thorough December 2006 a total of 104 cases of UD were identified. Age adjusted incidence of UD in Olmsted County was 0.79 per 100,000 (95%CI, 0.27, 1.30). Information was available for 96 (92%) of women. Mean age at diagnosis was 46.2 15.6 (95% CI, 42.9 49.5) range, 18.0 83.1 years) with mean BMI of
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27.4 (range was 26.0 28.7 kg/m2). Caucasian women represented 93.8 % (95% CI 87.0, 97.1). Median parity was 2 (range, 0,6 and IQR was 1,3); cesarean was performed in 15.6% (95% CI 9.7, 24.2) and forceps assisted delivery was reported in 1% (95% CI 0.1, 5.9). Abdominal hysterectomy was reported in 21.9 % (95% CI 14.8, 31.1%) and vaginal hysterectomy was reported in 8.4% (95% CI 4.3, 15.7). Anterior colporrhaphy was performed in 7.4 % (95% CI 3.6, 14.6). Most common presenting symptoms was urinary incontinence (61.7%, 95% CI, 51.6, 70.9) with mixed incontinence observed in 41.5% (95% CI 32.1, 51.6). Other symptoms included dysuria, 59.1% (95% CI, 49.0, 68.6); dyspareunia, 47.9% (95% CI 36.7, 59.3); hematuria, 17.2 % (95% CI 10.9, 26.1); & pelvic pressure, 43.6% (95% CI 34.0, 53.7). Tests used for diagnosis are illustrated in figure. Out of 96, 82 patients (85.4%) underwent surgical treatment. Most common procedure performed in 70 out of 82 patients was diverticulectomy followed by marsupialization in 10 women. Post operative recurrence occurred in 13 patients (15.9 %). Conclusion: Urethral diverticulum has a true incidence of 0.79 per 100,000. Parity and abdominal surgery may be risk factors for development. Clinical presentation makes diagnosis challenging. Patients are treated primarily with surgery with minimal risk of recurrence.
January 2000 to December 2005 at Division of Female Pelvic Medicine and Reconstructive Surgery, Yonsei University Health System in Seoul. The patients were divided into three groups; 121 patients with anterior leading point, 38 patients with apical leading point, and 51 patients with posterior leading point. Patients were examined in a supine and a 45 upright position using the Pelvic Organ ProlapseQuantification system. The coexistence of other compartmental defect was defined when the value of its representative point was greater than -1. This study was approved by the Institutional Review Board of Yonsei University Health System Center. The chi-square test, Fishers exact test, ANOVA test and Pearson correlation were used for statistical analysis by using the SAS package 8.2 version (SAS Inc., Cary, NC, U.S.A.). p 0.05 was determined to be significant. Results: In case of anterior leading point, posterior defect coexisted with anterior defect independent of stage (stage II; 86.96%, stage III; 94.57%, stage IV; 100%) and the coexistence rate of apical defect increased, depending on developing stage (stage II; 8.70%, stage III; 50.0%, stage IV; 83.33%). In case of apical leading point, the coexistences of anterior and posterior compartments were 87.50% in stage III, 100% in stage IV. Posterior leading point was associated with anterior compartment generally in all stage (stage II; 42.11%, stage III; 76.67%, stage IV; 50.0%) and was associated with apical compartment in far advanced stage (stage II; 5.26%, stage III; 3.33%, stage IV; 100%). As a result of the relationship between each compartments, anterior, apical and posterior compartments are significantly correlated with other compartments (p 0.001). Conclusion: Anterior, apical and posterior compartmental defects are significantly associated with others. Therefore, identification and correction of all support defects are important to prevent recurrence when pelvic reconstructive surgeries are being planned. Disclosures: S. Bai, None; Y. Jung, None; H. Jung, None; M. Jeon, None; S. Kim, None.
Disclosures: M.M. Nunn, None; S.A. El-Nashar, None; C.J. Klingele, None.
Presentation Number: Poster 55 The Correlation of Anterior Defect, Apical Defect and Posterior Defect in Pelvic Organ Prolapse S. Bai, Y. Jung, H. Jung, M. Jeon, and S. Kim Department of Obstetrics and Gynecology, Seoul, Republic of Korea Category: Anatomy. Objective: The purpose of this study is to investigate the prevalence that one leading point brings other compartments in pelvic organ prolapse, and to analyze the correlation between each compartment. Methods: Two hundred ten women who underwent surgery for pelvic organ prolapse (stage II) were included in this study from
Presentation Number: Poster 56 The Relationship of Anterior Vaginal and Apical Position to Post Void Residual Urine K. S. Wong,* C. K. Wieslander, and C. M. Tarnay* *UCLA Medical Center, David Geffen School of Medicine, Los Angeles, CA, Olive View-UCLA Medical Center, David Geffen School of Medicine, Los Angeles, CA Category: Anatomy. Objective: To investigate the association between the severity of anterior vaginal and apical prolapse to post void urine volume. Methods: The charts of all women who presented to the Urogynecology Clinic between January 2006 to December 2007 were reviewed. Demographic data were recorded in addition to the degree of prolapse POP-Q points Aa, Ba, C and post void residual volume (PVR). Patients with incomplete POP-Q assessment or improperly measured PVR were excluded. Results: 352 patients had the requisite information for analysis. Median age was 54 years (range 26 80). Mean gravidity and parity were 4.4 and 3.7 respectively. Mean BMI was 29.9 kg/m2. 149 women had previous genitourinary surgery (cesarean section, hysterectomy, midurethral sling, or vaginal surgery). The median PVR was 25 cc. Forty (11.4%) patients had a PVR 100 cc with a median of 132 cc. Because the biologic distribution of PVR values is skewed we examined the relationship between the logarithm of PVR and the
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covariates via bivariate and multivariate (simultaneous) regression. Considering 16 potential PVR predictors, we found that the position of the apex/cervix (point C) significantly correlated with an increase in PVR and also after controlling for the other significant covariates (rate of change b 4.7% increase in PVR/cm, p 0.0007, see figure). The other significant (p 0.05) covariates were gravidity (b 5.6%/pregnancy), post menopausal status (b 32.5%) and surgical history (vaginal, sling, hysterectomy). A positive correlation did not exist, however, for the anterior vaginal position (points Aa, Ba; r 0.10, p 0.15). There was no difference in mean PVR in patients with versus without a hysterectomy (p 0.236). This model posits that, controlling for the other covariates; PVR increases 4.7% on average for every one centimeter increase in point C. Conclusions: Elevated PVR values have long been linked with prolapse of the anterior vaginal wall. This study examines for the first time the relationship of the severity of anterior vaginal/apical prolapse to the volume of residual urine. We found that there is a linear association of log PVR only to the anatomic variable: point C. There was no association of PVR with points related to the anterior vaginal wall.
hysterectomy or who have had cervical lesion were excluded in this test. Result: Of 185 Korean women the ages arrange from 14 to 81. The average age is 38.5 10.5, and the average vaginal length is 85.9 10.7 mm, and the average vaginal width is 31.1 3.6 mm, and the average thickness is 17.6 2.7 mm, and the average weight is 57.1 9.0 kg, and the average height is 158.8 4.5 cm. According to the ages(14 year to 19, 20 to 49, above 50 year), there is no differences in vaginal length and thickness in statistics, but there is a meaningful statistic difference in vaginal width in accordance of ages. And the parity does not make any statistical difference of the length and thickness of vagina, however the width of vaginal done by normal delivery is significantly wider than that by cesarean section. Conclusion: This research proves that there is no difference in the vaginal length between Korean women and Western women. And it also shows the length of vaginal has no association with parity, ages and physical characters, but the width of vaginal has something to do with the increasing of the age and delivery method. It is thought that this is rather related to functional reasons by the relaxation or weakness of muscles and supporting structures around, and is suggested to make a further study of the functional aspects. Key words: Total vaginal length, Total vaginal thickness, Total vaginal width, Computed Tomography, Parity. Disclosures: M. Kim, None; S. Kim, None.
Disclosures: K. S. Wong, None; C.K. Wieslander, None; C.M. Tarnay, Bard Urologic, Consultant; Boston Scientific, Paid Instructor.
Presentation Number: Poster 57 Determinants of Vaginal Length, Thickness and Width in Korean Women M. Kim, and S. Kim The Catholic University, Seoul, Republic of Korea Category: Anatomy. Objective: The purpose of this study is to find out the interrelation of the vaginal length, thickness and width measured by computed tomography, and age, height, weight, delivery experience and method in Korean women. Methods: 185 women were examined and measured by the computed tomography from March in 2006 to March 2008. For an objective test each of two clinicians in obstetrics and gynecology department and Radiology measured twice the vaginal length, thickness and width in optical way. Women who have received total
Presentation Number: Poster 58 Nerve Injury During Uterosacral Vaginal Vault Suspension: a Cadaver Study S. A. Collins,* S. A. Downie, T. R. Olson, and M. S. Mikhail *AECOM, Montefiore Medical Center, Bronx, NY, Albert Einstein College of Medicine, Bronx, NY Category: Anatomy. Objective: Postoperative pain after uterosacral vaginal vault suspension (USVVS) arising in the S 2S3 dermatome was described in 7 of 182 cases in a series by Flynn, et al in 2006. Symptoms were attributed to entrapment of the posterior femoral cutaneous nerve (PFCN). No anatomic studies have confirmed this. The objective of this study is to describe the nerve(s) vulnerable to entrapment by sutures placed during USVVS. Methods: Female cadavers used for the Fall-Winter term 2007 08 Clinical and Developmental Anatomy course at Albert Einstein College of Medicine were the subjects of this study. Cadavers were preserved on site using traditional embalming and curing methods. Subjects were included if they had clearly identifiable uterosacral ligaments insitu. The left ligaments were selected for use in this study for uniformity. Each ligament was measured from the center of the cervix or vaginal cuff to the posterior-most point at which the ligament was clearly identifiable. It was then marked off by thirds. Before the students pelvic dissection, a 2 0 prolene suture was placed in the middle third of each ligament as described by Buller, et al in 2001. The suture was then tied securely, and the ends were left long. After the students dissected the pelvic viscera and retroperitoneal structures, each suture was re-evaluated. If a nerve was included in the stitch, further dissection was performed to identify and characterize it. The PFCN was also identified. Results: Twelve sutures were placed as described. Nine remained in place after the students dissection. In one, an entrapped nerve was
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identified. Further dissection, including midline hemisection of the cadaver and disarticulation of the left hemipelvis and lower extremity, was performed. The nerve entrapped was part of the autonomic inferior hypogastric plexus and was dissected proximally to nerve roots S2 and S3. Its fibers radiated only to the bladder and rectum. The PFCN was also identified in this cadaver and was located far laterally and posteriorly to the site of the suture. All findings were confirmed with experienced anatomists (SD and TO). Conclusions: The nerves closest to the sutures placed during USVVS are autonomic nerves of the inferior hypogastric plexus. Entrapment of S2 and S3 fibers in this plexus could cause referred pain in their respective dermatomes. The PFCN is safely lateral and posterior to the USVVS operative site and may not be responsible for the postoperative pain previously described. Disclosures: S.A. Collins, None; S.A. Downie, None; T.R. Olson, None; M.S. Mikhail, None.
regional variations in the biomechanical properties of the LA and incorporate this data into a FEM.
Presentation Number: Poster 59 Passive Constitutive Properties of the Levator ANI Muscles in Fresh Female Cadavers M. A. Barker,* A. Nagle, A. Pancholy,* S. Siddighi,* B. Haridas, and S. Kleeman* *Advance Urogynecology and Pelvic Surgery, Cincinnati, OH, University of Cincinnati, Cincinnati, OH Category: Anatomy. Objective: To develop a protocol for measuring passive biomechanical parameters of the levator ani muscles (LA). Current finite element models (FEM) lack true regional variations in the passive biomechanical process of the LA essential to predicting tissue deformations. Our study describes a protocol to measure these properties as a function of fiber direction in fresh female cadavers. Methods: Five iliococcygeus sections from two fresh female cadavers were oriented in direction of muscle fibers, cut, and measured for gauge length, width, and thickness in the unloaded state. Samples were mounted in TestResourcesTM system, preconditioned, and extended uniaxially to failure while measuring load and position every 0.03s. Data obtained before tearing was used to calculate true stress (load/current cross sectional area) and stretch ratio (current length/original length). Exponential-linear model was fitted using least-squares method to the test data to identify its parameters. Toe region or nonlinear portion of the stress-stretch curve fits to equation 1, T 2B1B2(eB2(( * ) (2/ ) 3)) ( -(1/ )), and the linear portion of the stress-stretch curve to equation 2, T E( ) i.. T true stress, stretch ratio, B1 (dimension of stress), B2 (dimensionless measure of nonlinearity), E, the elastic modulus (dimensions of stress and is the slope of the linear portion of the curve), and i, the intercept, are parameters calculated from data. B1 times B2 is initial stress-stretch slope. Results generate passive properties of the LA showing the force on the muscle for a given lengthening. Results: Mean width, thickness and length were 4, 3.5, and 25 mm. Toe region parameters had a mean of 0.24 0.36 MPa for B1 and 12 17 for B2. Transition point between the toe region and the linear region was 1.07 .03. E had a mean of 2.2 2.6 MPa. Figure 1 compares the stress-stretch response of the theoretical model to the experimental data. Conclusions: Passive morphologic properties of the LA can be obtained and tested from fresh cadavers. Theoretical stress-stretch curves generated are highly variable, but may be used to accurately predict true LA in vivo properties. Our goal is to further quantify
Disclosures: M.A. Barker, None; A. Nagle, None; A. Pancholy, None; S. Siddighi, None; B. Haridas, None; S. Kleeman, None.
Presentation Number: Poster 60 Is the Dorsal Nerve of the Clitoris in Danger of Damage in Performing the Outside-In Transobturator Sling Procedure? S. B. Tate, J. J. Clark, J. Patterson, L. Harmon-Hardin, and R. D. Acland University of Louisville, Louisville, KY Category: Anatomy. Objective: An anatomical study on fresh cadavers was done to determine whether the dorsal nerve of the clitoris is at risk in performing the outside-in transobturator sling procedure. Methods: In 18 hemi-pelvis specimens from 10 bodies, the dorsal nerve of the clitoris was identified. The distance between the nerve and the superior margin of the ischio-pubic ramus was measured. Results: The nerve runs medially in close approximation to the ischio-pubic ramus. In no instance did the nerve follow an aberrant course such that it traversed the obturator foramen, thereby being exposed to damage by passage of the hook. The distance between the nerve and the superior margin of the ischio-pubic ramus ( the inferior margin of the obturator foramen) represents the closest possible passage of the hook. The mean distance between the nerve and the superior margin of the ischio-pubic ramus was 9.3 mm, range 314 mm. These measurements represent the most conservative measurement anatomically possible in these specimens. Conclusions: Since the introducer cannot pass through the ischiopubic ramus, but must pass above it, we conclude that the dorsal nerve of the clitoris is not in danger of damage when performing the outside-in transobturator sling procedure. American Association of Clinical Anatomists Twenty-third Annual Meeting Podium Presentation, July 12, 2006. Disclosures: S.B. Tate, Honoraria Bard, Other; J.J. Clark, None; J. Patterson, None; L. Harmon-Hardin, None; R.D. Acland, None.
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Presentation Number: Poster 61 A Cadaveric Model for Determing Soft Tissue Fixation Strength for Pelvic Reconstructive Surgery M. Jean Michel, P. A. Castillo, and G. Davila Cleveland Clinic Florida, Weston, FL Category: Anatomy. Objective: To evaluate the maximum fixation strength of several tissue structures within the female pelvis. Design: Internal tissue fixation is becoming the preferred approach for suture and graft attachment in pelvic reconstructive surgery. This is evident in many of the surgical techniques employed in addressing vaginal vault prolapse, paravaginal defects, vaginal enteroceles, and urinary incontinence. However, there is limited data available describing the strength of these pelvic structures. We conducted a descriptive study assessing the strength of various tissue sites within the female pelvis in cadavers. Setting: A cadaveric anatomy lab. Patients: Five cadavers were studied by 2 examiners. Interventions: Tissue anchors were randomly placed at 23 sites on 9 anatomical structures: the sacrospinous ligament (SSL), between 0 1 cm, 1 or 2 cm, 2 or / 3 cm of its attachment onto the ischial spine (IS); the arcus tendineus fascia pelvis (ATFP), between 0 1 cm, 1 or / 2 cm, 2 or / 3 cm of its attachment onto the pubic symphysis (PS); the ATFP, between 0-1 cm, 1 or / 2 cm, 2 or / 3 cm of its attachment onto the IS; the most anteromedial aspect of the obturator membrane (OM), between 0 1 cm, 1 or / 2 cm, 2 or / 3 cm below the insertion of the adductor longus muscle onto the pubic ramis (PR); the most posteromedial aspect of the OM, between 0 1 cm, 1 or / 2 cm, 2 or / 3 cm below the insertion of the adductor longus muscle onto the PR; the iliococcygeus muscle (IL), between 0 1 cm, 1 or / 2 cm, 2 or / 3 cm of its attachment onto the IS; the uterosacral ligament (USL); the paraurethral fascia (PUF); the sacral promontory (SP); Coopers ligament (CL); and the rectus abdominus fascia (RAF). An independent examiner, a pelvic anatomist, assessed accuracy of anchor placement. Maximum pull-out strength values were obtained using a tensiometer. Reproducibility of tissue strength was assessed using t-test analysis. Measurements & Main Results:
Duramed, Grant/Research Support; AMS, Watson, Adamed, Consultant; Watson, AMS, Synovis, USSurgical, Pfizer, Astellas, Adamed, Other.
TABLE. Overall Strength Mean per structure (lbs.) SSL ATFP OM IL USL PUF SP CL RAF 6.56 4.38 4.47 5.57 7.37 1.55 3.75 4.93 6.10 Standard deviation 2.23 1.99 2.54 2.04 2.39 1.01 3.04 2.72 2.12
Presentation Number: Poster 62 Urodynamics Comparison Between Symptoms and Outcomes Study K. S. Rathod, S. Chattopadhyay, S. Argandhawi, and J. Swinhoe Barking, Havering and Redbridge Trust, King George Hospital (London), Essex, United Kingdom Category: UDS. Introduction: Urodynamic Studies (UDS) are used to investigate the function of the urinary tract system in patients with sensory, urge and stress incontinence. The study uses physical measurements including urine pressure, flow rate and filling cystometry.21 The test is then correlated with the patients history, examination findings and therefore a diagnosis is reached. Aim: The aim of our study was to investigate the correlation between patient symptoms and results from urodynamic studies. Methods: The study was carried out prospectively over a period of 4 months. Initially, patients who were selected for UDS investigation were requested to complete a pre-designed questionnaire, which included questions about their symptoms and prior knowledge of the UDS. The same patients then underwent UDS on the same day. The results of the UDS were then compared to the patients answers on the questionnaire. Results & Analysis: A total of 50 patients took part in this study. 22 (48.90%) patients presented with stress incontinence. 20 (44.40%) of patients complained of urge incontinence. 9 patients out of 22 (41%) who had presented with stress incontinence showed leakage and therefore stress incontinence during the UDS. 8 patients out of 20 patients (40%) who had presented with urge incontinence demonstrated detrusor instability during the UDS. 11 patients (24.4%) had a completely normal bladder during the test. We also learnt that 84.44 86.70% of patients understood what was involved in the procedure and 68.9% of patients had received some form of written information before coming for the test. In addition, we also learnt that only 11% of patients had been given a bladder frequency chart. Conclusions: The main conclusions from our study are that less than half of the patients with positive symptoms of stress or urge incontinence have a positive result during UDS. Nearly a quarter of patients have a completely normal bladder at UDS even though they have positive symptoms of incontinence. Hence we can conclude that there is poor correlation between symptoms and UDS.
Conclusions: Structures currently used for suture and mesh fixation are all quite strong, with the SSL and USL being the strongest. This data can now be used in creating computerized pelvic floor models for new surgical techniques. Disclosures: M. Jean Michel, None; P.A. Castillo, None; G. Davila, AMS, Adamed, Synovis Astellas Watson Zuidex Protein Polymer Technologies
1 Jarvis GJ, Hall S, Stamp S et al. An assessment of urodynamic examination in incontinent women. Br J Obstet Gynaecol 1980; 87: 893 6.
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Disclosures: K.S. Rathod, None; S. Chattopadhyay, None; S. Argandhawi, None; J. Swinhoe, None.
Presentation Number: Poster 63 Stress Urinary Incontinence in Symptomatic Pelvic Organ Prolapse: The Role of Urodynamics S. Ahmed, R. Adam, and T. H. Duong Emory University School of Medicine, Atlanta, GA Category: UDS. Objective: To investigate whether urodynamic testing can clearly identify stress incontinence in women with symptomatic pelvic organ prolapse. Methods: We conducted a retrospective cohort study of women with symptomatic pelvic organ prolapse (POP) seen between 1999 and 2007. Study approval was obtained from the Emory University IRB. All women underwent multi-channel urodynamic evaluation and had POPQ stage 2 or greater POP. Patients underwent a standardized history and physical examination and completed a 3-day urinary diary and post void residual volume measurement. Cases were patients with complaints of stress urinary incontinence (SUI). Controls were women with no symptoms of stress urinary incontinence. Data was abstracted from the medical record and demographic data and clinical information was reviewed. Statistical analysis was performed using the SPSS statistical package. Results: A total of 170 patients met the inclusion criteria for the study. Eighty patients had no complaints of SUI and 90 patients had symptoms of SUI. There was no statistically significant differences in mean age (62.5 11.0 years vs. 59.1 11.7 years), parity (2.8 1.4 vs. 2.6 1.3) and prior hysterectomy (51% vs. 57%), respectively. Women with complaints of SUI were more likely to have a positive cough stress test (62% vs. 33%, p 0.001). Women with complaints of SUI were also more likely to have SUI on urodynamics (69% vs. 53%, p 0.05). Patients with complaints of SUI had higher UDI-6 scores (9.3 4.3 vs. 6.6 3.7, p 0.001). However, there was no statistical difference between IIQ-7 scores (7.9 5.6 vs. 7.1 5.5, p 0.4). Patients in the control group were more likely to have a more advanced POPQ stage when compared to the cases (3.1 vs. 2.8, p 0.001). Conclusions: Our data indicates that patients with more advanced pelvic organ prolapse are less likely to have complaints of stress urinary incontinence. In patients with symptomatic pelvic organ prolapse and no complaint of stress urinary incontinence, formal urodynamic testing is superior to a simple cough stress test. Disclosures: S. Ahmed, None; R. Adam, None; T.H. Duong, None.
to kinking of the urethra. Some of these patients develop urinary incontinence after surgery for prolapse. Methods: Retrospective chart review of 45 consecutive patients that had undergone pelvic reconstructive surgery for advance prolapse from 01/01/2006 to 12/31/2006. Inclusion criteria: All patients that had undergone pelvic reconstructive surgery for advance prolapse, and had no subjective complaint of incontinence. Exclusion criteria: Patient with advanced prolapse with incontinence history. Results: The 45 patients with advanced prolapse underwent urodynamic testing (UD testing), and 29 were identified as having occult incontinence and 15 having no incontinence. After pelvic reconstructive surgery, 1 out of the 15 (6.7%) continent patients complained of post-operative urinary incontinence.
Conclusions: 1 out of 16 patients (6.3%) with advanced prolapse and negative urodynamic testing for occult incontinence, developed urinary incontinence post-op. A false negative rate of approximately 7% should be quoted while counseling patient for surgery with advance prolapse but no complaint of incontinence. Disclosures: S. Hessami, None; K. Hassan, None; X. Guan, None; F. Diarbakerli, None; M. Yung, None.
Presentation Number: Poster 64 False Negative Rate of Urodynamic Testing in Diagnosing Occult Incontinence in Patients with Advance Prolapse S. Hessami, K. Hassan, X. Guan, F. Diarbakerli, and M. Yung Mount Sinai School of Medicine, Saint Joseph Regional Medical Center, Paterson, NJ Category: UDS. Objective: In this study we seek to determine false negative rate of urodynamic testing in diagnosing occult incontinence (masked incontinence) in patients with advance prolapse. Urinary incontinence may be masked in patients with advance prolapse (Stage 3 or 4) due
Presentation Number: Poster 65 Unmasking Occult Incontinence in Advanced Vaginal Prolapse: Which Reducing Tool Works Best? R. Lefevre,* J. Pollak, C. Apostolis,* V. Aguilar,* and G. Davila* *Cleveland Clinic Florida, Weston, FL, Florida Center for Urogynecology, Hollywood, FL Category: UDS. Objective: To compare three separate prolapse-reducing tools in unmasking occult incontinence in women with advanced vaginal prolapse. Background: Occult incontinence, although not an officially recognized condition is a marker for an increased risk of developing post-operative stress incontinence. Various tools may be utilized to reduce advanced vaginal prolapse during urodynamics testing. Patient discomfort and risk of urethral occlusion often determine the tool utilized. Standardization of a single most effective method may increase the detection rate of occult incontinence. Methods: 36 patients with Grade 3 prolapse and no complaints of incontinence were recruited at two clinical sites. They were separated into two groups and randomized as to the order of prolapse-reducing tools used during urodynamic testing. Group 1 (18 patients):
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TABLE. Occult Inc Tool Unreduced Speculum Pessary Packing p-value Detection % 10.04% 47.21% 41.64% 30.10% 0.023 95% CI 2.42 31.72 26.83 15.6 33.41 63.27 58.13 50.08 MUCP (cm H2O) Leak/No Leak 42.20/52.35 39.68/44.55 37.52/43.58 43.05/50.13 p-value 0.25 0.25 0.16 0.28 LPP (cm H2O) Leak/No Leak 66.83/63.80 52.42/52.73 46.65/53.58 52.61/50.48 p-value 0.8 0.96 0.23 0.81 FUL (cm) Leak/No Leak 2.87/3.06 2.75/2.85 2.53/3.02 2.98/2.93 p-value 0.58 0.5 0.004 0.82
speculum/pessary/vaginal packing and Group 2 (18 patients): unreduced /pessary/speculum. Demographic information, prolapse severity, occult incontinence and urodynamic parameters were measured with each prolapse-reducing tool. Changes in the maximal urethral closure pressure (MUCP), functional urethral length (FUL) and leak point pressure (LPP) were recorded in order to assess any urethral occlusive effect. Comparisons between patients with incontinence and those who did not leak were later made using the SAS 9.1.3 and R2.6.1 software. A significance level of 0.05 was assumed for all analyses. Results: The overall average MUCP (cm H2O)/LPP (cm H2O)/FUL (cm) were calculated for each tool respectively. Speculum: 42.25/52.59/2.81, Pessary: 41.06/50.69/2.83, Packing: 48.72/40.33/3.02 and Unreduced: 50.67/76.47/2.96. The patients were then divided based on the detection of occult incontinence and the rates are reported below by instrument. Comparisons of MUCP/LPP/FUL were made between the leak and no leak groups. Conclusion: All three devices increased the unmasking of occult incontinence, with a speculum having the highest rate. Urethral occlusion by prolapse-reducing tools remains a valid concern. In this study, only the pessary affected FUL most significantly. The speculum or vaginal packing did not have any statistical significant effect on any of the urodynamic parameters assessed. Disclosures: R. Lefevre, None; J. Pollak, None; C. Apostolis, None; V. Aguilar, None; G. Davila, AMS, Adamed, Synovis Astellas Watson Zuidex Protein Polymer Technologies Duramed, Grant/Research Support; AMS, Watson, Adamed, Consultant; Talks/honorarium: Watson, AMS, Synovis, USSurgical, Pfizer, Astellas, Adamed, Other.
hours) and urodynamic results. Following surgery, subjects were randomized using sequentially numbered sealed opaque envelops into one of two groups for voiding trials Group A autofill (bladder allowed to fill spontaneously until the subject reported a strong urge) followed by backfill (bladder backfilled with 300cc of fluid and the subject asked to void within 15 minutes) or Group B backfill followed by autofill . The postvoid residual was measured by straight catheterization within 15 minutes of each individual void. A void 66.67% of the total volume (voided volume post-void residual) on the second of the two voids was considered passed. Those subjects were discharged home without a urethral catheter. Those voiding less than 2/3 of the total bladder volume were discharged with an indwelling catheter and reassessed as an outpatient. Subjects were followed for a total of 6 weeks postoperatively. Results: A total of 108 subjects participated and complete data were available for 92. The mean age of our population was 55 yrs (range 33 81), 61% were postmenopausal, and 18% had undergone a prior incontinence procedure. Type of surgical procedures performed in this study: 35% incontinence repair only, 35% a prolapse repair only and 30% both. Thirty-nine percent experienced retention resulting in discharge with a transurethral catheter and outpatient follow-up. Of the 56 subjects discharged without a catheter, none experienced subsequent retention. Both voiding trials showed similar rates of retention. There was a high rate of concordance between both approaches in subjects with retention. However, the backfill trial regularly resulted in a higher percentage of bladder emptying (mean 53% vs. 66% p 0.0001). There was no difference in the void trial results with regards to sequence. The only variable predictive of postoperative retention was evidence of Valsalva voiding on preoperative urodynamic testing. Conclusions: Both autofill and backfill void trial techniques reliably predict adequate postoperative voiding function. The backfill technique results in more complete bladder emptying. Disclosures: J.Q. Pulvino, None; E.E. Duecy, None; G.M. Buchsbaum, Pfizer, Grant/Research Support; Ethicon, Consultant; M.K. Flynn, None.
Presentation Number: Poster 66 Assessment of Two Postoperative Techniques Used to Predict Voiding Efficiency After Gynecologic Surgery J. Q. Pulvino, E. E. Duecy, G. M. Buchsbaum, and M. K. Flynn University of Rochester Medical Center, Rochester, NY Category: UDS. Objective: To compare two techniques used to assess adequate voiding function after gynecologic surgery. Study Design: This prospective, randomized control cross-over study was approved by the institutional review board. All patients preparing to undergo inpatient or outpatient surgery for urinary incontinence or pelvic organ prolapse through the division of Urogynecology at our institution who met inclusion criteria were offered the opportunity to participate. Preoperatively, all subjects underwent history and physical examination. Data extracted from the medical records include demographic information, past medical history, body mass index, menopausal status, medications, preoperative history of incomplete bladder emptying (PVR 100 cc), history of prolonged catheterization following surgery ( 48
Presentation Number: Poster 67 Preoperative Urodynamics as a Predictor of De Novo Urgency Following Placement Of A Tension-Free Vaginal Tape Sling R. M. Ward,* D. Masterton,* J. D. Blume, and D. L. Myers* *Women and Infants Hospital/Warren Alpert Medical School of Brown University, Providence, RI, Center for Statistical Sciences, Brown University, Providence, RI Category: UDS. Objective: To identify preoperative urodynamic indices that are predictive of de novo urgency following placement of a tension-free vaginal tape (TVT) sling.
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Methods: We examined a retrospective cohort of women who underwent a TVT sling between January 2004 and December 2006 at our tertiary center. All subjects were identified by CPT code 57288. Inclusion criteria were preoperative urodynamics and a TVT sling. Exclusion criteria were subjective complaints of urinary urgency or urge incontinence preoperatively, the diagnosis of overactive bladder syndrome or detrusor overactivity, or known neurologic disease. De novo urgency was defined as complaints of urinary urgency, urge incontinence or overactive bladder in the absence of a urinary tract infection at 6 12 weeks postoperatively and persisting at 4 12 months postoperatively. For subjects with postoperative urinary retention requiring catheterization, de novo urgency was considered present only if it persisted after resolution of the urinary retention. We hypothesized that the volume of first sensation on preoperative urodynamics would be an important predictor of de novo urgency. ROC curves and logistic regression were used to assess the predictive value of first sensation alone and in concert with other participant characteristics and multichannel urodynamic indices (e.g., age, parity, body mass index (BMI), menopausal status, tobacco use, caffeine intake, comorbidities, concomitant surgical procedures, preoperative postvoid residual and bladder capacity). Descriptive statistics were reported for patient characteristics and predictors of de novo urgency. Results: 69 of 462 women identified by CPT code met eligibility criteria. Women with de novo urgency were of similar age, parity and educational status as those without de novo urgency. The mean first sensation for women with de novo urgency was 199.1 mL compared to 143.4 mL for women without de novo urgency, with a mean difference of 55.7 mL (95% CI 9 mL to 101 mL; p 0.018). Higher volume at first sensation was the strongest predictor of de novo urgency (AUC 71%, 95%CI 58% to 84%). As a dichotomous predictor, first sensation at 144 ml has a sensitivity of 83%, specificity of 59%, PPV of 41%, and NPV of 91% for determining future de novo urgency. The combination of first sensation, BMI, and preoperative postvoid residual slightly improved the overall predictive ability (AUC 76%, 95% CI 62% to 89%). In this model, higher BMI and higher postvoid residual were associated with an increased risk of de novo urgency. No other combination of participant characteristics and preoperative urodynamic indices was as predictive in our cohort. Conclusions: Patients with higher volumes at first sensation on preoperative urodynamics are at an increased risk of de novo urgency following a TVT sling. Disclosures: R.M. Ward, None; D. Masterton, None; J.D. Blume, None; D.L. Myers, None.
fashion, and urethral pressure profiles were performed using an automated puller at 1mm/sec. The mean MUCP was statically compared in each patient pre & post procedure using a paired t-test. Results: The patients had a mean age of 54.3 11.8, BMI of 29.9 5.6, and a mean parity of 2.9 1.6. Mean time to follow up was 10 weeks (6 wks5 months). 68% patients had prolapse and underwent concomitant prolapse surgery. Measures of quality of life at follow up significantly improved postoperatively. UDI-6 and IIQ-7 scores showed statistically significant improvement after TOT (p 0.001). MUCP measurements did not show statistically significant change post op (p 0.14.). Also MUCP was unchanged in patients with no documented leakage on post TOT. Patients who scored zero on both IIQ-7 and UDI-6 surveys after surgery (100% satisfied) revealed no statically significant change in the MUCP. Subgroup analysis of patients with prolapse grade 3 or greater, with pessary placed for reduction of prolapse at preoperative urodynamics (27% of patients), showed statistically significant decrease in MUCP after TOT (p 0.006). Conclusions: This is a descriptive prospective study examining the change in MUCP after TOT procedure, to attempt to understand the mechanism by which TOT cures incontinence. In our study there was no significant change in MUCP after TOT. This is in contrast to prior studies showing a increase in MUCP after TVT procedure. Our data supports the theory that the TOT replicates the normal anatomy of the pubourethral ligaments and therefore would not affect urethral pressure. Our analysis also reveals that the use of pessary for reduction of prolapse at time of pre op urodynamics may falsely elevate MUCP. Disclosures: A.L. Smith, None; G. Siddiqui, None; V. Ali, None.
Presentation Number: Poster 68 Comparison of Urethral Closure Pressure Pre and Post Transobturator Tape Procedure A. L. Smith, G. Siddiqui, and V. Ali University of Texas Houston Medical School, Houston, TX Category: UDS. Objective: To compare maximal urethral closure pressure (MUCP) pre and post surgical treatment of stress urinary incontinence with the transobturator tape (TOT) procedure. Methods: 22 consecutive patients who consented to inclusion were enrolled and underwent TOT procedure (outside-in). These patients underwent standard evaluation including voiding diary, UDI-6 and IIQ7 questionnaires, urinalysis, Q-tip testing, physical exam and multichannel urodynamics at both preoperative and postoperative visits. Urodynamic evaluation was performed in a standardized
Presentation Number: Poster 69 The Utility Of The Empty Supine Stress Test as a Predictor of Intrinsic Sphincter Dysfunction M. H. Parekh*, and T. Ginn *GMC, Section of Urogynecology, Danville, PA, GMC, Danville, PA Category: UDS. Objective: To assess the utility of the Empty Supine Stress Test (ESST) to predict presence of intrinsic urethral sphincter dysfunction (ISD) without performing any invasive testing. Methods: The study population included all patients seen by one provider in the urogynecology clinic who had multi-channel urodynamic testing. The initial evaluation included a thorough history and physical exam that included gravity, parity, menopausal status, voiding and incontinence issues as well as previous medical and surgical care as well as medications. The patient then had an exam that included a cough stress and a post void empty supine stress test as well as a post voids residual urine volume and culture and sensitivity. Standard urodynamic testing was done at a subsequent visit. The test indices were evaluated as to the result of the ESST, the presence of stress urinary incontinence and or detrusor instability, maximal urethral closure pressure, prolapse correction, and post void residual volume. Objective data collected from the exam and urodynamics were maximum straining cotton swab angle, maximum cystometric capacity, maximum urethral closure pressure, presence or absence of stress incontinence and detrusor instability, prolapse correction for testing, post void residual, and empty supine stress test results. The data were analysed using SAS version 9.1 (SAS Institute; Cary, NC). Two independent samples t-test, Chi-square test and Wilcoxon two-sample test were used to determine which variables were significantly associated with a positive test and maximum
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urethral closure pressure of 20 cm H2O. Two by two contingency tables were used to calculate indices. Results: Five hundred ninety six patients qualified to be included in the study. One hundred sixty had a positive ESST and 436 had a negative test. The data were further evaluated as to the post void residual volume and calculations were performed on the total group regardless of post void residual value and those with post void residual 100ml. Upon analysis Diagnostic indices for using stress urinary incontinence and positive empty supine stress test as a test for maximum urethral closure pressure 20 cm H2O showed sensitivity of 31.8% of detecting intrinsic sphincter dysfunction, specificity of 73.0% of excluding it and a positive predictive value of 5.5% and a negative predictive value of 95.6%. The post void residual data show that there was little difference between the positive and negative groups as to the results even when all PVR were included. Conclusions: The empty supine stress test has been touted as a screening test for intrinsic urethral sphincter dysfunction. Given the data collected from a broad range of patients, the utility of this procedure as a screening test for intrinsic sphincter dysfunction is questionable. With the data presented, we cannot recommend this test as a screening test for intrinsic urethral sphincter dysfunction. Disclosures: M.H. Parekh, Astellas, Speakers Bureau; T. Ginn, None.
character curve as 0.585. There was a positive correlation between maximal urethral closure pressure and opening vesical pressure (p 0.01). Conclusion: Opening vesical pressure may be a useful parameter to detect intrinsic sphincter deficiency, but there is a limitation to decide intrinsic sphincter deficiency independently. Disclosures: S. Bai, None; K. Ryu, None; H. Jung, None; M. Jeon, None; S. Kim, None.
Presentation Number: Poster 70 The Significance of Opening Vesical Pressure as a Parameter to Predict Intrinsic Sphincter Deficiency S. Bai, K. Ryu, H. Jung, M. Jeon, and S. Kim Department of Obstetrics and Gynecology, Seoul, Republic of Korea Category: UDS. Objective: The aim of this study is to verify the opening vesical pressure as an independent parameter to detect intrinsic sphincter deficiency and to evaluate the relationship among valvalsa leak point pressure, maximal urethral closure pressure and opening vesical pressure. Methods: This retrospective study included 530 patients who were diagnosed as urodynamic stress incontinence and underwent antiincontinence operation from January 2002 to March 2007 at Division of Female Pelvic Medicine and Reconstructive Surgery, Yonsei University Health System in Seoul. The patients were divided into two groups: urodynamic stress incontinence with intrinsic sphincter deficiency (group 1) and urodynamic stress incontinence without intrinsic sphincter deficiency (group 2). Intrinsic sphincter deficiency was defined as valvalsa leak point pressure 60 cmH2O or maximal urethral closure pressure 20 cmH2O. This study was approved by the Institutional Review Board of Yonsei University Health System Center. The Students t-test, 2 test, Fishers exact test and receiver operating character curve analysis were used for statistical analysis by using SPSS, version 12.0 (SPSS Inc., Chicago, IL, U.S.A.). p 0.05 was determined to be significant. Results: Of 530 patients, 110 (20.7%) and 420 (79.3%) were included in group 1 and 2, respectively. There was no significant difference in the patients characteristics except age, menopause status and hormone replacement therapy history. Preoperative mean values of valvalsa leak point pressure (51.6 27.8 cmH2O vs. 99.1 29.1 cmH2O), maximal urethral closure pressure (50.5 29.5 cmH2O vs. 66.5 28.0 cmH2O) and opening vesical pressure (29.5 24.9 cmH2O vs. 38.4 30.5 cmH2O) were significantly different between the two groups (p 0.01). Twenty cmH2O of opening vesical pressure, as the cut-off value, had 70% of sensitivity and 34% of specificity under the result of the area under the receiver operating
Presentation Number: Poster 71 Does Aging Affect Sphincter Function Differently In Continent Vs. Stress Incontinent Women? K. Kenton,* T. Spirka, R. Butler, M. Damaser, and L. Brubaker* *Loyola University Stritch School of Medicine, Maywood, IL, Dept. of Biomedical Engineering, Cleveland Clinic, Cleveland, OH, Dept of Quantitative Health Sciences Cleveland Clinic, Cleveland, OH, Dept. of Biomedical Engineering, Cleveland Clinic, Cleveland, OH Category: UDS. Objective: It is well known that aging decreases the number of striated muscle fibers present in the female urethral sphincter decreases with age (1,2). It is not known whether the sphincteric aging process affects continent women less than stress incontinent women. The main goal of this study was to quantify the effects of aging on the amount of urethral pressure generated in response to the increases in abdominal and vesical pressure and to assess this aging difference by stress continence status. Methods: Following IRB approval, standardized urodynamic data, including vesical (Pves), abdominal (Pabd), and urethral (Pura) pressures, were acquired from 2 well-characterized groups of women: (1) continent women and (2) stress incontinent women. Urodynamic pressure data, including Pabd, Pves and Pura, were obtained during cough and valsalva manoeuvres at 0.2 second intervals at maximum cystometric capacity (MCC). The ratios of Pura/Pabd (UPAP) and Pura/Pves (UPVP) were calculated for every time interval during each event and the maximum and minimum ratios for each type of event in each patient was determined. The calculated variables were then analyzed by the method of repeat measures mixed models, both as a single cohort, then, separately based on stress continence status. Least squares means were computed for the calculated variables in each category. A coefficient for the continuous variable of age was determined to provide an estimate of the change in the maximum and minimum ratios per year. A p value of less than 0.05 was taken to indicate a significant difference. Data is presented as mean (range). Results: Standardized urodynamic data were obtained from 14 continent women and 12 stress incontinent women. We did not detect significant differences in age or MCC between the two groups. When the whole cohort was considered, the maximum and minimum UPAP decreased by 0.038 and 0.007 per year increase in age, respectively. Similarly, the maximum and minimum UPVP decreased by 0.05 and 0.005 per year increase in age, respectively.. When dichotomized by stress continence status, there was a significant decrease in the maximum and minimum UPAP and UPVP with age in the continent group. In contrast, neither maximum nor minimum UPAP nor UPVP of stress incontinent women changed significantly with age. Conclusion: The findings of this study provide additional evidence and quantify the degradation of urethral function in women with aging. Clearly, as women experience a quantifiable decrease in urethral function as they age, the response of the urethral sphincter
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complex to increases in Pabd also decreases. The decline is more pronounced in continent women than stress incontinent women. References: 1) Am J Obstet Gynecol (2002) 186:351355. 2) Ann. N.Y. Acad. Sci (2007) 1101:266 296. Funded by: NIH NICHD 5K23HD047325 & 5K24DK064044. Disclosures: K. Kenton, Pfizer, Grant/Research Support; T. Spirka, None; R. Butler, None; M. Damaser, AMS, TDOC, LLC, Grant/Research Support; TDOC, LLC, Consultant; L. Brubaker, Pfizer, Allergan, Grant/Research Support.
Presentation Number: Poster 72 Post Void Dribbling: Its Incidence and Risk Factors T. S. Ablove University of Wisconsin, Madison, WI Category: UDS. Objective: The primary aim of this study is to determine the incidence of post-void dribbling in women being evaluated for pelvic floor dysfunction. The secondary aim of this study is to determine which other conditions are present in women with symptoms of post void dribbling. Methods: 163 consecutive patients who underwent urodynamic testing during 2005 and 2006 were evaluated. The testing was performed for symptoms of incontinence, overactive bladder, urinary retention and pelvic organ prolapse in women scheduled for surgery. All Subjects completed a medical history questionnaire, voiding questionnaires and a voiding diary prior to their appointments. All patients were specifically asked in the questionnaire and confirmed during the interview Do you ever leak urine upon standing after you have finished voiding on the toilet? A complete pelvic exam was performed including evaluation for prolapse, measurements of the genital hiatus and perineal body, levator strength, qtip testing, and a residual urine culture. Parameters examined included symptoms of post-void dribbling, stress incontinence, urge incontinence and insensible loss. Menopausal status, hormone replacement therapy status, Age, body mass index, residual urine volume, genital hiatus length, and evidence of pelvic organ prolapse were recorded. During urodynamic testing maximum urethral closure pressure, urethral length, pressure transmission ratio, and documentation of detrusor instability or urodynamic stress incontinence were recorded. The data was analysed using multivariate analysis. Results: 42% of patients presenting with pelvic floor dysfunction had symptoms of post void dribbling. Few parameters demonstrated statistically significant differences between patients with and without post void dribbling. The incidence of post-void dribbling significantly decreased with age (p value .01). In pre and peri menopausal women there was a significant increase in post void dribbling in women with detrusor instability (p value .02). In post menopausal women there was a statistically significant increase in post void dribbling with younger age (p value .002), higher body mass index (p value .01), and longer genital hiatus length (p value .05). Conclusion: Post void dribbling is a very common symptom found in women presenting with complaints of pelvic floor dysfunction. The overall incidence of post void dribbling decreases with age. Pre- and peri-menopausal women with detrusor instability are more likely to also have complaints of post void dribbling. Post menopausal women with higher body mass index and genital hiatus length are more likely to have complaints of post void dribbling. Further studies are needed to identify the cause and potential treatments of this under-recognized form of voiding dysfunction. Disclosures: T.S. Ablove, None.
Presentation Number: Poster 73 Uroflow Measurements in Healthy Female Volunteers S. Ahmed, M. Perevich, A. McNanley, and G. Buchsbaum University of Rochester Medical Center, Rochester, NY Category: UDS. Objective: To determine normal parameters for micturition flow in healthy female volunteers on repeated spontaneous voids. To compare spontaneous voids of study subjects to prompted voids of patients undergoing urodynamic testing as part of an incontinence work-up in an urogynecology practice. Methods: Female staff at a gynecology office were recruited to participate in this study. Excluded were potential subjects who reported any difficulty voiding, treatments for lower urinary tract problems and pregnancy. For two consecutive weeks, all spontaneous voids by study subjects during work hours were recorded by uroflowmetry. One void during the two weeks was prompted. At each void, participants reported urge to void (scale 010), whether it was a typical void (yes/no) and amount of fluid intake since the last void including amount of caffeinated beverages. Uroflow studies of age-matched controls were reviewed. Voids 50 cc from consecutive patients undergoing urodynamic testing at an urogynecology office practice were compared to staff voids. Results: We analyzed 118 flow studies from 12 volunteer subjects. Average voided volume was 306.2 ml (SD 148.3 ml), the maximum flow rate was 49.5 ml/sec (SD 16.3 ml/sec, median 51.0 ml/sec), average flow rate 16.6 ml/sec (SD 5.6 ml/sec) and voiding duration 21.4 sec (SD 12.0 sec). Prompted voids were lower in volume 161.5 ml (p 0.001), maximum flow 38.1 ml/sec (p 0.024) and average flow 13.0 ml/sec (p 0.028) than spontaneous voids. When corrected for volume, these differences were not significant. Self-identified not typical voids did not differ in any parameter from typical voids. Voids not preceded by caffeine intake had an average volume of 272.8 ml while those following caffeine consumption averaged 344.9 ml (p 0.007). Strength of urge to void was volume dependent. No subject perceived an urge of less than 3 with a volume 300 ml or greater than 7 with a volume 300 ml. The maximum flow in control patients seen in the urogynecology practice averaged 28.9 ml/s (median 27.5 ml/sec), versus 49.5 ml/s in volunteer subjects (p 0.001). There were no significant differences in voided volumes, duration or average flow. Conclusions: Uroflow parameters vary widely between normal volunteers. Within subjects, uroflowmetry parameters appear to be predominantly volume-dependent. Uroflow studies from prompted voids are representative of usual urination when corrected for volume. Caffeine intake effects voided volume but no other parameters. Maximal flow rates of patients undergoing urodynamic evaluation as part of an incontinence work-up were significantly lower than both prompted and spontaneous voids of volunteer subjects. Using a maximum flow rate of 2 SD as a cut-off for normal, a peak flow rate of less than 17 ml/sec would be abnormally low. Disclosures: S. Ahmed, None; M. Perevich, None; A. McNanley, None; G. Buchsbaum, Pfizer, Grant/Research Support; Ethicon, Consultant.
Presentation Number: Poster 74 Is there a Difference in Intra-Abdominal Pressure in Women with Pelvic Organ Prolapse? D. D. Marshall,* C. K. Wieslander, and C. M. Tarnay* *David Geffen School of Medicine at UCLA, Los Angeles, CA, Olive ViewUCLA Medical Center, Sylmar, CA
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Category: UDS. Objective: To investigate if there are differences in the intraabdominal pressures in women presenting with and without pelvic organ prolapse. Methods: This is a prospective case control study. Study patients were identified as women presenting to the Olive View-UCLA Urogynecology clinic with symptomatic pelvic organ prolapse (POP) (POP-Q St II). Controls did not have symptomatic POP (POP-Q St II) and presented with other pelvic floor complaints requiring further diagnostic testing. All patients underwent multichannel urodynamic testing with air-charged (T-DOC) pressure catheters followed by a series of predesigned uniform maneuvers repeated in the upright position: cough, valsalva, and standardized lifting maneuvers with 10 and 30 lb weights. Intrabdominal (rectal) pressures were recorded throughout both routine and provocative testing. Results: 11 cases and 8 control subjects were enrolled with mean age 58.6 and 53.7 years respectively. There were no significant differences between the groups in BMI, parity, smoking, menopausal status or history of pelvic surgery. During cough and the lifting 10 lb maneuvers, the prolapse group had lower median intra-abdominal pressures (64.5 and 17 cmH20) compared to the control group (134.8 and 34 cmH20) (p 0.10). In the valsalva and lift 30 lb maneuvers, women with prolapse also had lower median intra-abdominal pressures (p 0.10 in this sample size)(see figure). Using linear regression methods, we simultaneously (multivariately) evaluated the relation between each of the pressure outcomes controlling for six covariates and there were no statistically significant differences between groups. Conclusions: In this exploratory study women with POP displayed lower intra-abdominal pressures during all provocative maneuvers. The difference was significant during cough and lifting 10 lbs where pressures exhibited were nearly half of those in the controls (47.5% and 64.3% respectively). Intra-abdominal pressure was diminished in women with prolapse during all other maneuvers but this trend will need validation with a larger sample size. This study underscores the need to further evaluate the impact of pressure exerted on the pelvic floor and its potential relationship to pelvic support.
Presentation Number: Poster 75 Comparison of Room and Body Temperature Saline During Cystometric Testing: A Prospective Randomized Double-Blind Trial G. McWilliams,* M. Hill, A. Gehrich,* T. McCartin,* and W. Larsen *Tripler AMC, Honolulu, HI, Blanchfield Army Medical Hospital, Ft. Campbell, TN, Darnall Army Community Hospital, Fort Hood, TX Category: UDS. Objective: To determine if sterile saline solutions infused at room temperature significantly change bladder sensations and bladder capacity during urodynamic testing. Methods: This prospective randomized double blinded trial enrolled volunteers undergoing routine complex urodynamic testing for symptomatic lower urinary tract symptoms. Patients were enrolled at time of testing and underwent two cystometries. They were randomized to receive either body or room temperature fluid during the initial cystometry, after which a pressure flow study was performed. A second cystometry was performed with the other fluid utilizing the same standard technique. The patient, physician and investigator were blinded to the fluid temperature. Only the technician in charge of fluid temperature was aware of the differences. Data collected included volume at first sensation, strong urge and maximum cystometric capacity (MCC). Urgency and pain sensations were further evaluated by Lickert questionnaire at the completion of each cystometry. Results: Forty-eight patients have been enrolled between May 2006 and April 2008. The mean body and room temperature of the solutions were 98.3oF and 80.8oF, respectively. The mean age was 49.1 12.9 years. The mean gravidity and parity were 2.8 1.5 and 2.4 1.3, respectively. The mean weight was 158.9 36.9 lbs. No significant difference was found between the two solutions with regard to volume at first sensation, strong urge and MCC, nor with sensory urgency or pain. The number of idiopathic detrusor contractions was low and not significantly different between solutions. Further analysis looking at order of installation also revealed no significant difference in any of the parameters measured. Conclusion: The temperature of instilled fluid at the time of cystometry does not appear to significantly alter measurements of bladder sensation or capacity, nor does room temperature more readily evoke idiopathic detrusor overactivity. Disclosures: G. McWilliams, None; M. Hill, None; A. Gehrich, None; T. McCartin, None; W. Larsen, None.
Disclosures: D.D. Marshall, None; C.K. Wieslander, None; C.M. Tarnay, Bard Urologic, Consultant; Boston Scientific, Paid Instructor.
Presentation Number: Poster 76 Significance of Positive Urine Dipstick in Asymptomatic Patients with Advance Prolapse S. Hessami, K. Hassan, M. Wang, and M. Yung Saint Joseph Regional Medical Center, Paterson, NJ Category: UDS. Objective: We investigated the need to perform a urine dip on asymptomatic patients with prolapse wearing pessaries. Patients wearing pessary devices are routinely screened for urinary tract infection using urine dipstick. Positive dipsticks (i.e. WBC, RBC, Leukocyte. Esterase, Nitrites,) are sent for confirmatory urine culture before initiation of therapy. Methods: Retrospective chart review of 50 consecutive patients with advance prolapse, stage 3 and 4, and using a pessary device. The
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inclusion criteria were: all asymptomatic patients with positive urine dipstick, advance prolapse, and using a pessary device. Patients were excluded if they were symptomatic (urgency, frequency, dysuria, CVA tenderness, fever or chills). Results: 48 patients were included in the study. 15 patients (31.25%) had urinary C&S of 100,000, 10 (20.83%) had C&S of 10,000 50,000, 12 (25%) with C&S 10,000, and 11 (22.92%) had no growth.
TABLE. Organism (>100,000) E.coli Klebsiella GBS Staph n 9 2 2 2 % 60% 13.3% 13.3% 13.3%
study participant were blinded to the lubricant assignment. After the patient was placed in a lithotomy position, the assigned lubricant was used for insertion of, first a straight catheter and, then a cotton swab into the urethra. Wong-Baker FACES visual scale was used to rate pain level before any other physical manipulation. Demographic and other relevant information was also collected on all women. All variables were compared between the groups. Based on our power analysis targeting a power of 0.80 ( 0.05), a total sample of 132 subjects will be sufficient, as we believe that 20% difference in pain perception between the groups is clinically significant. Results: In this interim analysis, a total of 79 adult women were randomized to either Lidocaine or Surgilube arm. There were 41 (51.8%) and 38 (48.1%) women in each group, respectively. Age, parity, race, body mass index, number of vaginal births, frequency of diabetes, vaginal atrophy, and estrogen use were similar between the groups. There was no statistical difference in mean visual pain scores between the lubricants (Lidocaine: 1.0 1.1 and Surgilube: 1.2 1.0, p 0.06). The percentage of women who felt any degree of pain was also statistically similar: 26/41 (63.4%) in the Lidocaine, and 30/38 (78.9%) Surgilube groups, p 0.13. Conclusions: In this interim analysis of our data, Surgilube was found to be comparable to Lidocaine jelly in pain control during urethral catheterization and the Q-tip test in women with pelvic floor dysfunction. We intend to present our results with adequate power at the annual meeting. Disclosures: O. Okafor, None; O. Harmanli, None.
Conclusions: We found that 31% of asymptomatic patients with positive urine dipstick, had a positive culture of 100,000 organisms and 21% of the asymptomatic patients had positive bacteruria growth of 10,000 50,000, a total of 25 patients (52% of all patients). Taking into consideration the advanced age and co-morbidities of these patients, a urine dipstick and confirmatory urine culture may be recommended. Disclosures: S. Hessami, None; K. Hassan, None; M. Wang, None; M. Yung, None.
Presentation Number: Poster 77 Double Blinded Randomized Comparison Between Lidocaine Jelly And Surgilube For Urethral Straight Catheterization And The Q-Tip Test O. Okafor and O. Harmanli, Tufts University Baystate Medical Center, Springfield, MA Category: UDS. Objective: Urethral catheterization for post void residual volume measurement and the Q-tip test are essential elements in the evaluation of women with pelvic organ prolapse or urinary incontinence. Despite lack of evidence, standard textbooks recommend use of Lidocaine jelly for these examinations. Our objective is to compare the pain perception between 2% Lidocaine jelly and Surgilube when they are used as lubricants for urethral straight catheterization and the Q-tip test. Methods: All women who presented to a single urogynecologists practice were offered to participate in this study which was approved by our institutional review board. They were randomized to either Lidocaine jelly or Surgilube. Both the examining physician and the
Presentation Number: Poster 78 Urodynamics and Interstitial Cystitis/Painful Bladder Syndrome D. N. Sastry* and K. E. Whitmore *UMDNJ/RWJ, Cooper University Hospital, Camden, NJ, Drexel University College of Medicine, Philadelphia, PA Category: UDS. Objective: Interstitial cystitis/Painful Bladder Syndrome (IC/PBS) is a diagnosis based on clinical symptoms including urinary frequency, urgency and bladder pain or discomfort in the absence of other pathologic findings. There is a paucity of literature discussing urodynamics and its role in IC/PBS. The objective of this study is to evaluate correlations between symptom severity in IC/PBS and objective data from urodynamic testing (UDT) and cystoscopy. Methods: Patients who underwent cystoscopy and bladder overdistention from January 1, 2006 July1, 2007 were identified by procedure codes. All charts were reviewed for data points, questionnaires as a quantification of symptoms, UDT results, and results of cystoscopy and bladder overdistention. The questionnaires included three, ten point visual analog scales for urgency, frequency and pain, the OLeary-Sant Symptom Index (ICSI) and Problem Index (ICPI), and the Short Form Urinary Distress Inventory (UDI-6). From UDT the following were recorded: first sensation, first desire to void, strong desire to void, maximum cystometric capacity (MCC), presence of detrusor overactivity (DO), post-void residual, and (in the past four months) when pain was felt upon filling. From the cystoscopy and overdistention, bladder capacity (BC), glomerulations (0 5), presence of Hunners ulcers and mast cell counts were recorded. Subjects were excluded if malignancy was found during the procedure, if cystoscopy was not performed for initial diagnosis of IC/PBS, or if questionnaires were done greater than 6 months before the date of surgery. Pearson correlations were performed between questionnaires, urodynamic data, and cystoscopic findings.
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Results: A total of 202 charts were reviewed, out of which 128 met inclusion criteria. Forty-nine patients of 115 who underwent UDT expressed pain or discomfort with filling, although not explicitly asked, with a median volume of 125 cc. Significant correlations were found between pain felt during UDT and pain Likert scores (p .01) and ICPI (p .05). Significant negative correlations were found between pain Likert scores and first sensation, first urge, strong desire to void and MCC (p .05). ICSI and ICPI scores negatively correlated with first urge, strong desire to void, and MCC. Significant correlations were also found between strong desire and anesthetic BC and glomerulations, and between MCC and anesthetic BC and glomerulations. Conclusions: Symptom severity was significantly associated with urodynamic parameters seen in earlier first sensation, first urge, strong desire, and lower MCC. Symptom severity, anesthetic BC and glomerulations were also related to these urodynamic parameters. A subset of patients revealed a correlation between urodynamic pain and pain Likert scores which may prove to be another indicator of pain. Assessing pain upon bladder filling may be an important key in differentiating the persistent urge to void in IC/PBS patients versus patients with DO or urgency seen in overactive bladder patients. Disclosures: D.N. Sastry, None; K.E. Whitmore, Astellas Pharmaceuticals, Consultant; Medtronics, Grant/Research Support; Advanced Bionics, Grant/Research Support; Ortho McNeil Pharmaceuticals, Consultant.
Presentation Number: Poster 80 The Response of Interstitial Cystitis/Painful Bladder Syndrome to Intravesical Dmso/Lidocaine Treatments Using the Pain Urgency Frequency Questionnaire D. Shalom,* S. Lin, and A. Klapper *New York Presbyterian Weill Cornell, New York, NY, Weill Cornell Medical College, New York, NY, NY Downtown Hospital and Weill Cornell Medical College, New York, NY Category: Pain/IC. Objective: To assess the response of patients with Interstitial Cystitis (IC)/Painful Bladder Syndrome (PBS) treated with an intravesical solution of DMSO and 1% lidocaine as measured by the Pain Urgency Frequency (PUF) questionnaire. Methods: Patients with a clinical history consistent with IC / PBS, tenderness on palpation of the bladder and PUF scores 12 were prospectively evaluated for their response to the treatment regimen. All patients completed the PUF questionnaire prior to initiation of treatment (baseline). Patients were treated with weekly intravesicular infusions of a solution containing 50 ml of Rimso-50 DMSO and 10 ml of 1% lidocaine for a total of six weeks. Patients were asked to complete the PUF questionnaire one week following each infusion. Total, symptom, and bother scores following each weekly visit were compared to baseline. Results were analyzed using the paired student t test and the Wilcoxon signed rank test. Results: 41 patients completed the six week treatment course. No patients were lost to follow up. Mean scores at baseline and following each treatment are seen in Figure 1. By week two there was a significant decrease in the mean total score (17.0 4.9 vs 20.5 3.8, p .0001), symptom score (11.4 3.3 vs 13.4 2.3, p .0001) and bother score (5.7 2.2 vs 7.0 1.9, p .0005) compared to baseline. After six weeks of treatment the mean total score remained significantly decreased (10.9 4.7 vs. 20.5 3.8, p .0001). At the end of six weeks all but one patient experienced a decrease in total score. Conclusions: Weekly infusions of DMSO and 1% Lidocaine significantly improved total, symptom and bother scores as assessed by the PUF questionnaire. Because all women in this study received the treatment regimen, we cannot exclude the possibility of a placebo effect. Based on this observational study, a larger controlled trial is warranted to further evaluate the significance of this treatment regimen.
Presentation Number: Poster 79 The Incidence of Urodynamically Observed Detrusor Overactivity in Women With Interstitial Cystitis E. J. Stanford,* M. Noone, D. Elser, and M. Moen *University of Tennessee, Memphis, TN, Illinois Urogynecology, Park Forest, IL, Illinois Urogynecology, Chicago, IL Category: UDS. Objective: To assess the incidence of urodynamically observed detrusor overactivity (DO) in patients with interstitial cystitis (IC). Methods and Materials: The urodynamic results of 90 women with IC were retrospectively analyzed to evaluate the incidence of urodynamically confirmed DO. UD measures of interest were the first sensation to void, maximum cystometric capacity (Max), uroflowmetry pattern, and postvoid residual (PVR). A pelvic pain/urgency (PUF) questionnaire was obtained on each patient from which total score and voids per day were assessed. Statistics were evaluated with a pvalue of 0.05 indicating significance. Results: Seventy-two (22) of the 90 IC patients (24.4%) were found to have UD observed DO. The overall mean PUF score was 20.9 6.9 (range 9 32). There was no significant difference in PUF scores between patients with or without DO (p 0.38). The average voids per day was 13.3 4.6 (range 6 20) with no difference between groups (p 0.77). The mean first sensation to void (53 52 mL; range 9 264 mL) and maximum cystometric capacity (249 118 mL; range 124 600 mL) also showed no difference between groups (p 0.66; 0.29). A PVR of 100 mL was noted in 10 IC patients (15.4%) of which 4 were in the DO group. Normal voiding was noted in most patients however, Valsalva type voiding was noted in 12. Conclusions: This retrospective analysis shows that the incidence of urodynamically observed detrusor overactivity in women with IC is approximately 25%. PUF scores, uroflowmetry, and UD measures are not predictive of the presence of urodynamic DO. Disclosures: E.J. Stanford, None; M. Noone, None; D. Elser, None; M. Moen, None.
Disclosures: D. Shalom, None; S. Lin, None; A. Klapper, None.
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Presentation Number: Poster 81 Patients with Painful Bladder Syndrome have Altered Response to Thermal Stimuli And Catastrophic Reaction to Painful Experience L. Lowenstein, K. Kenton, E. R. Mueller, L. Brubaker, M. Heneghan, J. Senka, and M. FitzGerald Loyola Medical Center, Chicago, IL Category: Pain/IC. Objectives: The aim of the current study is to determine if subjects with painful bladder syndrome (PBS) demonstrate increased dermal sensitivity to thermal and vibratory stimulation and higher score on Pain cathstrophizing scale (PCS). Methods: PBS group included patients who had complained of bladder pain rated at least 4 on a visual analogue scale (VAS) from 0 no pain at all to 10 worst imaginable pain, on average over the previous month, (2) their bladder pain has been present for at least 3 months. Control group: if they (1) have no symptoms of incontinence on all subscales of the MESA, and (2) have a pain-free bladder. All participants were tested for thermal and vibratory sensory threshold at (C6, T1, T12 and S3) using TSA (Medoc, Israel). Continuous suprathreshold stimuli were applied at T12 and S3 to all participants for 60 seconds. Patients were asked to rank the intensity they sensed the stimuli in between 0- not at all, 10 very intense stimuli after 10 second and again after 55 seconds from stimulation. All participants filled out PCS, ICS and MESA questionnaire prior to the testing. Man Whitney was used to compare independent continues variables in between the two groups. Spearmens correlation was used for independent variables. Results: Twenty one participants, 10 control and 11 PBS patients took part in the study. Median age was 47 (22 69) years old. PBS and asymptomatic patients were not statistically significant differ in their age, BMI or parity (p .05). PBS patient were less sensitive to warm sensation in T-12 dermatome compared to asymptomatic control (36.6 1.1 vs. 35 3, p .02). Sensitivity for thermal and vibratory stimuli were not significantly different in between the two groups at all other sites. Habituation to supra-threshold stimuli was more common in controls than in PBS patients, occurring in 8 (70%) vs. 1 (9%), p .03 and 6 (60%) vs. 1 (9%), p .02 at T12 and S3 dermatomes respectively. Specifically, one minute of tonic (continuous) heat stimulus was perceived at a significantly more intense level by PBS patients at both T12 and S3 dermatomes than by controls (5 (range 0 8) vs. 1 (0 4), p .006 and 5 (3 8) vs. 2 (1 8) , p .005 respectively). Total PCS score was significantly higher among PBS than controls (30(0 52), 1(0 11),p .0001 respectively). We also found total PCS to be highly correlated with ICSI and ICPI scores (rho .77, p .0001 and (rho .8, p .0001 respectively), the duration of PBS symptoms (r .65, p .03) and thresholds to warm stimuli at T12 dermatome (rho .5, p .021 respectively). The scores for rumination and helplessness, subscales of the PCS, were inversely correlated with the degree of habituation to suprrathreshold stimuli at supra pubic area (rho .462, p .035, (rho . 487, p .025 respectively). Conclusions: PBS patients are less sensitive to warm stimuli in the suprapubic area. Habituation mechanism to suprathrshold stimuli is less frequent among patients with PBS symptoms. The longer the patient has the symptoms the more they score on pain catastrophizing scale Disclosures: L. Lowenstein, Pfizer, Grant/Research Support; Astellas, Grant/Research Support; K. Kenton, Allergan, Grant/Research Support; Pfizer, Grant/Research Support; E.R. Mueller, Allergan, Grant/Research Support; Pfizer, Grant/Research Support; L. Brubaker, Q Med, Grant/Research Support; Allergan, Grant/Research Support; Pfizer,
Grant/Research Support; M. Heneghan, None; J. Senka, None; M. FitzGerald, Pfizer, Grant/Research Support; Allergan, Grant/Research Support; Medtronic, Grant/Research Support.
Presentation Number: Poster 82 Cost Effective Analysis of Diagnosis Interstitial Cystitis
and
Treatment
of
S. A. Barr, A. C. Steele, M. T. McLennan, and F. Leong St. Louis University, St. Louis, MO Category: Pain/IC. Objective: To perform a cost effective analysis conducted from a societal perspective on three diagnostic approaches to interstitial cystitis (from minimal to complex). Methods: Outlined three diagnostic pathways for the evaluation of interstitial cystitis and evaluated the direct costs as main outcome measures, taking into account both the cost of the work-up for IC and the excess cost attributed to false positive and false negative test results. Algorithms described represent minimal, intermediate, or complex diagnostic pathways. All algorithms included a new office visit. The conservative algorithm includes a urine culture, a PUF questionnaire, a potassium sensitivity test, and starting treatment with elmiron if indicated based on the results of these tests. The intermediate algorithm adds a cystoscopy/hydrodistension before the decision to start elmiron is made. The complex algorithm includes all modalities of the intermediate pathway, plus a potassium sensitivity test and urodynamic testing; however, treatment with elmiron is only started if indicated based on cystoscopy/hydrodistension. Data on direct cost contributed to false positive and negative diagnoses were calculated based on reported sensitivities and specificities of individual diagnostic modalities. Results: The cost of the minimal work-up to evaluate a patient for IC- $153.29(Regimen #1), an intermediate evaluation cost$264.11(Regimen #2), and a complex evaluation- $686.54(Regimen #3) per patient. The cost of missed diagnosis for each of these regimens was calculated combining costs associated with false positive and negative diagnosis, taking into account the sensitivity and specificity of the best diagnostic modality used for each pathway. For each regimen total cost was calculated by adding the cost of diagnostic work-up, the cost of false positives, and the cost of false negatives. For each 1000 patients, the cost for regimen 1 is $2,258,606.50, regimen 2 is $264,110, and regimen 3 is $686,540. This reflects both the higher cost of a more complex diagnostic work-up and the higher direct medical costs associated with increased false positives/negatives when less sensitive and specific diagnostic modalities are used. This amount does not reflect the cost associated with a failure to consider IC and initiate a diagnostic pathway. Conclusions: While diagnostic evaluation costs can differ by up to $533.25 per patient depending on the number of tests obtained, the greatest contributor per capita comes from costs to the patient for missed diagnosis. A diagnostic pathway starting with a sensitive, lowcost screening tool such as the PUF questionnaire, followed by confirmation with cystoscopy/hydrodistension prior to the initiation of therapy, provides the most cost-effective method of approaching the disease condition. Disclosures: S.A. Barr, None; A.C. Steele, Boston Scientific, Paid Instructor; M.T. McLennan, GSK, Speakers Bureau; F. Leong, Astellas, Speakers Bureau.
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Presentation Number: Poster 83 Use of Cromolyn Sodium 4% Solution in Treatment of Interstitial Cystitis Through Consecutive Bladder Instillations P. Safaeian, J. Fariello, A. Rejba, S. Kellogg-Spadt, and K. E. Whitmore Pelvic and Sexual Health Institute, Philadelphia, PA Category: Pain/IC. Objective: The objective of this study was to evaluate the effects of consecutive bladder instillations composed of Cromolyn Sodium 4% solution and 0.5% Marcaine on patients diagnosed with Interstital Cystitis (IC). Methods: Ten women with the diagnosis of IC through NIDDK guidelines participated in this preliminary study. All subjects completed four weekly bladder instillations consisting of 40 mg/4ml Cromolyn Sodium 4% solution and 50ml of 0.5% Marcaine. Prior to the first bladder instillation each patient completed a questionnaire packet consisting of the OLeary-Sant Interstitial Cystitis Symptom and Problem Index (ICSI and ICPI), Urogenital Distress Inventory (UDI-6), and the Visual Analog Scale (VAS) for Urgency and Pain. Student ttests were used to analyze quantitative variables. Results: The mean age in this study was 43 with a range from 22 to 63 years of age, with an average BMI of 22.35. Six patients (60%) also had a diagnosis of vulvodynia and/or high tone pelvic floor dysfunction. When comparing the pre and post ICSI these patients had a decrease in symptoms which was significant (12 to 7.5, p .01). Scores for the ICPI significantly decreased (13 to 8.15, p .01). The UDI-6 for bladder pain and incontinence resulted in statistically significant lower scores with an initial mean of 8.83, reduced to 6.23 following treatment (p .05). These patients experienced significantly less pain as seen with the VAS score for pain (7.92, reduced to 4.56, p .01). Finally, these patients had a decrease in the sense of urgency following instillation treatment as established with the VAS score for urgency (6.33 to 3.45, p .01). Conclusions: Patients receiving bladder instillations consisting of Cromolyn Sodium 4% solution and Marcaine have shown statistically significant improvement in ICSI and ICPI scores, the UDI-6 and the VAS of both Urgency and Pain. These results indicate a potentially useful tool in the treatment of Interstitial Cystitis and a double blind cross-over study is pending. Disclosures: P. Safaeian, None; J. Fariello, None; A. Rejba, None; S. Kellogg-Spadt, Johnson and Johnson Pharma, Zestra Laboratories, Consultant; Pfizer, Procotor and Gamble Pharma, Zestra Laboratories, Glaxo Smith Kline Pharma, Speakers Bureau; K.E. Whitmore, Advanced Bionics, Medtronic, Pfizer, Grant/Research Support; Medtronic, OrthoMcNeil, Consultant; OrthoMcNeil, Astellas, Speakers Bureau.
group (n 16) had catheters dripping 0.5% bupivacaine on either side of the posterior vaginal wall with the tips implanted near the sacrospinous ligament. The control group (n 19) was treated with a patient-controlled analgesia pump (PCA). Morphine was administered intravenously via a patient-controlled analgesia pump in all patients. A visual analog pain scale and a Wisconsin Brief Pain Inventory were completed in the post-anesthesia care unit (PACU) and each postoperative day. Results: The two groups were comparable with regard to patient age (58.4 9.5 years vs. 61.3 9.9 years, p 0.39), estimated blood loss (182.5 130.7 mL vs. 122.1 79.4 mL, p 0.10) and length of time in the operating room (129.7 31.0 mins vs. 121.3 36 mins, p 0.68), experimental and control groups respectively. Patients in the experimental group had significantly lower mean pain scores in the PACU (3.1 2) compared with the control group (4.6 1.9, p 0.025). The maximum pain score in the post-anesthesia care unit was also significantly lower in the study group compared with control group (4.9 2.4 versus 6.4 1.8, p 0.045). There was a trend towards less morphine utilization on post-operative day zero in the experimental group (15.2 mg 12) when compared to the PCA group (23.7 14, p 0.071). There were no other significant differences in pain scores noted for the duration of the hospital stay or in narcotic or NSAID consumption. Conclusion: Our data suggest that direct continuous local infusion of bupivacaine after elective pelvic organ prolapse surgery results in improved short-term pain control. Disclosures: T.M. Muffly, None; A. Lovegrove, None; J. Reddoch, None; D. Weber, None; R. Hill, None.
Presentation Number: Poster 84 Post-Operative Pain Control Using Direct Continuous Bupivacaine Infusion After Pelvic Organ Prolapse Repair T. M. Muffly,* A. Lovegrove,* J. Reddoch,* D. Weber,* and R. Hill *University of Missouri at Kansas City, Kansas City, MO, St. Lukes Hospital of Kansas City, Kansas City, MO Category: Pain/IC. Objective: To evaluate the efficacy of continuous local anesthesia on decreasing pain scores for patients undergoing posterior colporrhaphy and sacrospinous ligament fixation. Methods: Patients undergoing elective pelvic organ prolapse procedures were randomized into two groups: the experimental
Presentation Number: Poster 85 Chronic Pelvic Pain: Is Pelvic Floor Physical Therapy Effective? B. Patterson, and S. T. Mahajan Case Western University, University Hospitals of Cleveland, Cleveland, OH Category: PT. Objective: To determine the therapeutic benefit of transvaginal pelvic floor physical therapy for the treatment of myofascial pelvic pain, including patient subjective improvement in pelvic floor symptoms. Methods: After obtaining IRB approval, a chart review was performed on all patients diagnosed with myofascial pelvic referred for transvaginal pelvic floor physical therapy (PT) between January 2005 and December 2007. All women 18 years old or pregnant were excluded. Only patients with initial and at least one follow-up visit pain rating were included in this review. Myofascial pelvic pain was defined as point tenderness in any of the striated muscles of the pelvic floor on vaginal examination. Pelvic floor PT included transvaginal trigger point release, skin rolling, muscle stretching, and biofeedback. Patient demographic information, medical history, and pelvic floor symptoms (urinary urgency, frequency, incontinence, pelvic pressure, constipation, and dyspareunia) were collected. Pain scores were assigned at the initial visit using a verbal scale of 0 to 10 (0 no pain and 10 severe pain) or verbal description and again collected at follow-up visits. Patients were asked to rate their degree of improvement at PT completion which was then translated into one of three categories: 1-significant improvement ( 60% better, pain score 75% improved, or significant improvement); 2-moderate improvement ( 60% but 30% better, pain score 30%74% improved, or moderate improvement); and 3-minimal improvement ( 30% better, pain score 30% improved, or minimal or no
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improvement). Statistical analysis included the Students T test and chi square. Statistical significance was set at p 0.05 and the study was powered to detect a 60% difference in pain scores. Results: Of the146 patients referred for pelvic floor PT, 75 (51%) were included in this study. Mean patient age was 48 years and 81% were parous. Sixty-one (81%) patients reported pelvic floor complaints, including dyspareunia (49%). Twenty-five (33%) patients presented for all three follow-up visits, while 26 (35%) had an initial and midway visit and 24 (32%) only an initial and final visit. Seventyfive percent of patients had an initial pain score of 7, citing vaginal (37%), pelvic (15%) and abdominal (15%) pain as the most common sites. Thirty-two (43%) patients had follow-up pain scores while 43 (57%) gave a percentage or verbal description of pain improvement. Pain improvement was proportional to the number of PT visits completed, with a median pain score of 5 at mid-treatment and a median pain score of 2.5 after completing of PT. Forty-four (71%) patients reported improved pelvic floor symptoms and 17 (45%) noted improved dyspareunia. Conclusions: Pelvic floor PT is an effective treatment for myofascial pelvic pain. Given the paucity of information on sources of pelvic pain, this study demonstrates the important role of myofascial pain and the efficacy of pelvic floor PT as a treatment. Disclosures: B. Patterson, None; S.T. Mahajan, None.
straining with bowel movements (p 0.005), incomplete bowel emptying (p 0.005), dyschezia (p 0.006), and higher scores on the Beck inventory (8.9, p 0.02). There was a 77% prevalence of abnormal needle EMG findings in the group with LM. Seven were given a pathophysiologic classification: 3 (33%) progressive neurogenic, 4 (44%) chronic neurogenic and 2 (22%) were normal. In contrast, there were 2 controls (25%) classified as chronic neurogenic. Using a one-sided Fishers Exact test, we found a statistically significant difference in the needle EMG results (p 0.044). Conclusions: In this pilot study, neuropathy was seen in 77% of the patients with LM. No myopathies were seen. It is not clear whether these are primary or secondary disorders. This may result from nerve compression from the muscle spasm or primary nerve injury that evolves into end-organ pain. These results may also be used to preliminary expand treatment options for patients with LM to include therapies directed at both neuropathic pain and local muscle treatment. This calls for a comparative study of muscle rehabilitation vs. other treatments such as neuromodulatory drugs. Disclosures: S.I. Diaz, None; E.J. Fuller, None; T. Colin, None; J.T. Benson, None.
Presentation Number: Poster 86 Is Levator Myalgia a Syndrome of Pelvic Floor Dysfunction? S. I. Diaz,* E. J. Fuller,* T. Colin, and J. T. Benson* *Indiana University/Methodist Hospital, Division of Female Pelvic Medicine and Reconstructive Pelvic Surgery, Indianapolis, IN, Clarian Health, Medical Research, Indianapolis, IN Category: PT. Objective: To compare the results of clinical assessment of the pubococcygeus muscle between control subjects without pelvic pain and females presenting with chronic non-cyclical pelvic pain and tender pelvic floor muscles (levator myalgia). Methods: The study was conducted in 10 controls and in 9 cases with levator myalgia (LM). Participants underwent history and completed the Pelvic Floor Distress Inventory (PFDI-20) and the Beck depression inventory. Uroflow (Urocap III, Laborie), postvoid residual with ultrasound (Ultramark 4 plus, ATL), pelvic floor physical examination, anal manometry, recording length and strength of Kegel contraction (Endotek OM-3), and surface kinesiologyc electromyography (EMG, with a vaginal sponge electrode) at the pubococcygeus muscle to record total electrical activity as root mean square were performed. We evaluated a trigger point with concentric needle EMG (Dantec Keypoint, Medtronic) for insertional, spontaneous, and voluntary activities. The needle EMG was used to assign one of the physiologic conditions based on the interpretation of the following parameters: recruitment, morphology, and variability. Results: In the control group, 2 had significant pelvic floor dysfunction and risk factors for EMG abnormalities (prolapse and sacral radiculopathy secondary to spinal cord tumor surgery). Eliminating these 2 from the comparison left 8 controls. Mean ages were 28 and 35 years for the controls and cases, respectively. Cases had a higher BMI (29.2, p 0.038) and higher gravity and parity (3, p 0.002) than controls. All of the following were more prevalent in the cases and were statistically significant differences as compared to the controls: urinary hesitancy (p 0.035), slow flow (p 0.048), dysuria (p 0.038), frequency (p 0.034), urgency (p 0.002),
Presentation Number: Poster 87 Vaginal Diazepam Suppository use in the Treatment of High Tone Pelvic Floor Dysfunction: A Retrospective Review P. Safaeian,* M. Rogalski, S. Kellogg-Spadt,* J. Fariello,* A. Rejba,* and K. E. Whitmore* *Pelvic and Sexual Health Institute, Philadelphia, PA, Drexel University College of Medicine, Philadelphia, PA Category: PT. Objective: This a retrospective chart review evaluating the effects of vaginal diazepam suppositories in the treatment of high tone pelvic floor dysfunction (HTPFD). Methods: Seventeen women were diagnosed with HTPFD through physical exam, confirmed with perineometry and completed the Female Sexual Function Index (FSFI) prior to treatment. All subjects used 5 mg compounded diazepam suppositories in a silica gel base vaginally for an average of 40 days with a range from 30 to 60 days. Upon follow-up, physical exam, perineometer score and FSFI were completed. HTPFD diagnosis was determined with initial baseline perineometer score of 40cm of water or greater. Physical exam made note of pain with palpation of the levator group with scores ranging from 1 4. A score of 4 indicating severe pain, 3 for moderate, 2 for mild and 1 indicating pressure/absence of pain. Student t-tests were used to analyze quantitative variables. Results: Thirty two charts were evaluated, 17 were included. Exclusion was based on receiving trigger point injections into the pelvic floor or physical therapy treatment during this period. The average age was 32.18, (19 to 50 years). The average Body Mass Index (BMI) score was 25.64. Six (35.3%) subjects were not sexually active before or after the study, four (23.5%) became active following treatment and seven (41.2%) were sexually active throughout. The initial baseline perineometer score was 69.31, following treatment it was reduced to 49.92, the mean difference between baseline scores was reduced by 19.39 cm of water. There was a significant reduction of pain with palpation of the levator group following treatment, with a mean of 3.17 prior to and 2.25 following treatment (p 0.0001). A decrease in the Pain domain of the FSFI was noted in the subset of patients sexually active throughout treatment (7). Prior to treatment the average Pain domain score was 4.31 (SD 1.98) which reduced to 2.74 (SD 1.92) following treatment. No side effects were noted among these patients.
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Conclusions: This study illustrates diazepam suppository use to be safe and efficacious in the treatment of HTPFD. Perineometry scores and physical exam significantly improved and a subset of sexually active patients showed significant improvement in the Pain domain of the FSFI and four patients became sexually active following treatment. A double blind cross-over study is pending. Disclosures: P. Safaeian, None; P. Safaeian, None; M. Rogalski, None; S. Kellogg-Spadt, Johnson and Johnson Pharma, Zestra Laboratories, Consultant; Pfizer, Proctor and Gamble Pharma, Zestra Laboratories, Glaxo Smith Kline Pharma, Speakers Bureau; J. Fariello, None; A. Rejba, None; K.E. Whitmore, Advanced Bionics, Medtronic, Pfizer, Grant/Research Support; Medtronic, OrthoMcNeil, Consultant; OrthoMcNeil, Astellas, Speakers Bureau.
Presentation Number: Poster 88 Pelvic Muscle Function in Women Presenting with Pelvic Floor Disorders M. D. Moen, M. B. Noone, B. J. Vassallo, and D. M. Elser Illinois Urogynecology, Ltd, Park Ridge, IL Category: PT. Objective: To determine knowledge, prior instruction, frequency of performance and ability to correctly perform pelvic muscle exercises (PMEs) in a group of women presenting for evaluation of pelvic floor disorders. Methods: Three hundred and twenty-five women presenting for urogynecologic examination were questioned concerning knowledge and performance of pelvic muscle exercises. Patients were examined to determine their ability to perform appropriate pelvic muscle contractions and contraction strength was reported using the Oxford classification ranging from 0 to 5. Results: The average age of the women in this study was 57.8 years. 236 women (73%) stated they had heard of pelvic muscle exercises, but only 81(25%) stated they were currently performing them. 136 women (42%) stated they had been instructed to perform PMEs, with 85 (63%) stating they had received verbal instruction only and 52 (38%) stating they had been told to start and stop their urine stream. Table 1 lists the percentage of patients with each level of PFM strength. 38 patients (11.7%) were noted to perform Valsalva when attempting PMEs and 144 (44.3%) were noted to have uncoordinated contractions when attempting PMEs. Increased age, parity and stage of pelvic organ prolapse were associated with worsening pelvic muscle strength. Conclusions: The majority of women with pelvic floor disorders are familiar with pelvic muscle exercises, but do not perform them or are unable to perform them correctly. Opportunity exists to increase the use of PMEs in women with pelvic floor disorders, but because of the high prevalence of pelvic muscle dysfunction in this group of women, more intensive instruction and physiotherapy may be required in order to achieve the potential benefits of PMEs. Disclosures: M.D. Moen, Ethicon, Consultant; Astellas, Speakers Bureau; Allergan, Speakers Bureau; M.B. Noone, Ethicon, Consultant; Boston Scientific, Consultant; Ortho-McNeil, Speakers Bureau; Novartis, Speakers Bureau; Allergan, Speakers Bureau; B.J. Vassallo, Boston Scientific, Consultant; Ortho-McNeil, Speakers Bureau; Novartis, Speakers Bureau; D.M. Elser, Ethicon, Consultant; Boston Scientific, Paid Instructor; Novasys Medical, Grant/Research Support.
Presentation Number: Poster 89 Pelvic Floor Muscle Training During Pregnancy: A Randomized Single-Blind Controlled Study on Improvement of Antenatal and Postpartum Lower Urinary Tract Symptoms F. Dokmeci,* S. Bayramov,* B. S. Tur, V. Bayramov,* M. Seval,* and H. Gok *Ankara University School of Medicine, Department of OB & GYN, Ankara, Turkey, Ankara University School of Medicine, Department of Physical Medicine and Rehabilitation, Ankara, Turkey Category: Childbirth. Objective: To examine the role of antenatal pelvic floor muscle exercises on pelvic floor muscle strength, lower urinary tract symptoms and quality of life scores during pregnancy and early postpartum period. Methods: In this study, nulliparous pregnant women who attended to Ankara Medical Faculty antenatal outpatient-clinic between 2005 and 2007, were studied in a prospective trial. The subjects (n 40) were randomized to a pelvic floor muscle training (PFMT) intervention group and control group. Twenty four pregnant women, eleven in exercise group and thirteen in control group, attended regularly all of their control visits at 12th, 22th, 32th gestational weeks and postpartum 6th week. During the visits, valsalva- urethral rotation angle assessment with perineosonography were performed. Pelvic floor muscle activity was examined by using electromyography biofeedback with a vaginal electrode. Examinations were carried out in lying position with knees flexed and legs supported on pillows after a warm-up of 8 10 low intensity short contractions. Maximal high intensity muscle contractions were recorded on three trials each lasting 10 second. The best trial was considered for calculation. All study subjects were asked to complete UDI-6, IIQ-7 and PISQ-12 questionnaires to determine their lower urinary tract symptoms (LUTS), sexual function and quality of life scoring. Results: Urethral rotation angle measures were decreased during pregnancy and early postpartum period progressively, in PFMT group (p 0.05). Maximum pelvic floor muscle strength was increased significantly between first and third visits in PFMT group (p 0.03) and between first and postpartum visits in control group (p 0.03). Although we observed no significant differences in scores of IIQ-7 and PISQ-12 during pregnancy and postpartum visits.We observed significant decrease in scores of UDI-6 between first and 3rd trimester (p 0.02) and between first trimester & postpartum 6th week (p 0.001). We did not observe any significant decrease in UDI-6 scores between first & last trimester visits in control group, however significant improvement was observed after postpartum period (p 0.001). This study showed that both UDI-6 scores and maximum muscle strength were improved before and after the delivery either in PFMT and control groups. However due to inter trimester results in PFMT group, the improvement in UDI-6 scores, maximum muscle strength and urethral rotation angle were also statistically comparable from the control group. Conclusions: The results of this study is promising to show the positive impact of pelvic floor muscle training on pelvic floor muscle strength during pregnancy which provides less valsalva-uretral rotation angle also. These objective measures correlates well with improvement of lower urinary tract symptom scoring during pregnancy progressively. A larger randomized study is needed to show the effectiveness of PFMT during pregnancy and postpartum period on muscle activity and improvement of LUTS. Disclosures: F. Dokmeci, None; S. Bayramov, None; B.S. Tur, None; V. Bayramov, None; M. Seval, None; H. Gok, None.
TABLE. Contraction Strength 0 1 2 3 4 5 Percentage of patients 16% 32.6% 28% 14.2% 7.4% 1.8%
Presentation Number: Poster 90 Attitudes and Practice Patterns of Obstetrician-Gynecologists Towards Cesarean Delivery on Maternal Request at a Single Tertiary Care Institution A. M. Friedman, A. Jayakrishnan, A. Davidson, and V. W. Sung Women and Infants Hospital, Providence, RI
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Category: Childbirth. Objective: To describe the attitudes and practice patterns of obstetrician-gynecologists regarding cesarean delivery on maternal request (CDMR) at a tertiary care hospital. Methods: We identified all obstetrician-gynecologists at our institution practicing obstetrics from June 1 to August 1, 2007. Following recruitment, obstetricians completed a survey regarding practice patterns and attitudes towards CDMR, including knowledge regarding the NIH State-of-the Science Conference on CDMR. Demographic data of the physicians participating was collected, which included race, age, gender, practice type, years in practice, marital status and number of children. Patient population demographics as described by the obstetrician were also collected. Descriptive statistics were performed as appropriate. Results: We identified 70 eligible obstetrician-gynecologists. All were enrolled, and 66 (94.2%) returned completed surveys. The mean age of respondents was 45.0 (std 8.8), mean children was 2.2 (std 1.4), mean years in practice was 13.1 (std 9.2), 60.6% were female, and 87.9% were white. 82% described themselves as private practice generalists, and 67.7% reported performing 100 deliveries per year. Regarding practice patterns, 81.5% reported ever performing CDMR and 69.7% reported patients requested CDMR more frequently over the past year. 58.5% reported performing CDMR more often, and 41.5% recently started performing the procedure. There were no reports of discontinuing CDMR or performing it less often. 83.3% believed women have the right to choose CDMR and that it is ethical (90.9%). Most respondents believed CDMR prevents perineal injury (86.1%), fecal incontinence (72.7%), urinary incontinence (59.1%), pelvic organ prolapse (62.1%), and dystocia and birth trauma (63.6%). The majority also believe CDMR causes increased operative risk with future cesarean deliveries (98.5%), increased risk of uterine rupture (93.9%) and placenta accreta or previa (97.0%), and increased health care costs (74.2%). 71% would not choose CDMR for themselves or recommend it to a partner. Respondents with patient populations greater than 20% Latino or 20% African-American, were significantly less likely to believe women have the right to choose CDMR(p 0.03 and p 0.009 respectively), and were less likely to have ever performed CDMR (p 0.05 and p 0.002 respectively). Physician age, practice type, and years practicing obstetrics were not associated with differences in attitudes or practice patterns of CDMR. 42% of respondents were familiar with the findings of the NIH State-of-the Science Conference on CDMR, and of those 89% reported the conference did not change how they felt about the practice. Conclusions: Most obstetricians in this study population consider CDMR ethically acceptable, have performed the procedure, and report an increase in patient request. Obstetricians with larger minority populations may be less comfortable with CDMR and less likely to perform the procedure. Disclosures: A.M. Friedman, None; A. Jayakrishnan, None; A. Davidson, None; V.W. Sung, None.
Methods: Nulliparous women at 34 weeks were surveyed. Practices from 4 hospitals in 8 cities were used, including midwives. We surveyed demographic information as well as Likert-scale (15 with 5 most concerned) questions about their level of concern regarding complications during labor, delivery and postpartum. Chisquare with Fishers exact, students t-test and logistic regression were used as appropriate. Results: The mean age of the 294 respondents was 28.4 years ( 6.13 yrs SD) and the mean gestational age was 35.3 weeks ( 2.7 wks SD). Fifteen patients (5.1%) would request CDMR if offered. There were no significant differences on univariate analysis between CDMR and non-CDMR patients based on patient age, primary language, planned delivery hospital, gestational age, site of prenatal care, insurance, education, marital status, prior pregnancy loss, use of assisted reproductive techniques, if the pregnancy was planned, type of provider, and maternal/fetal health problems. Patients planning to breastfeed were less likely to desire CDMR (16.7% if bottle only vs. 3.2% breast, p 0.029). Patients who attended childbirth classes preferred a trial of labor over CDMR (7.5% CDMR if no classes, 2.2% if classes, p 0.048). There were trends toward increased demand in clinic patients, those not privately insured, and those with less than a college education. On multivariate logistic regression, patients planning to breastfeed (OR 0.125, p 0.007, 95% CI 0.028 0.561) and patients with private insurance (OR 0.119, p 0.013, 95% CI 0.022 0.632) were less likely to want CDMR. Patients who were married trended toward increased demand for CDMR (OR 4.621, p 0.087, 95% CI 0.80126.673). CDMR patients were more worried in general about their upcoming deliveries. Using the Likert-scale questions, CDMR patients reported a mean worry score of 3.46 ( 1.20 SD) compared to 2.72 ( 0.96 SD) for non-CDMR patients (p 0.0078). Among patients choosing CDMR the most common motivations were avoidance of pain (n 3, 20%), belief that this is safer for herself (n 3, 20%), and concern that the baby wont fit (n 3, 20%). Only one patient was most concerned about incontinence. No patients cited convenience of timing or wanting to avoid pushing as top reasons. The 196 patients who desired a trial of vaginal delivery most commonly indicated the wish to avoid surgical pain (n 53, 27%), feeling as if they wouldnt get the whole childbirth experience if they had CDMR (n 48, 25%), and the belief that vaginal delivery is safer for the baby (n 30, 15.3%). Conclusions: Few in our sample want CDMR, and those who do are motivated by short-term factors. We found trends toward CDMR in publicly insured, clinic patients with less than a college education. Disclosures: M.O. Schimpf, None; P.K. Tulikangas, None; C.A. LaSala, GlaxoSmithKline, Speakers Bureau; Invited Speaker, Ethicon, Other; M. Jacob, None; J.F. Egan, None.
Presentation Number: Poster 91 Cesarean Delivery on Maternal Request: Who Requests One? M. O. Schimpf,* P. K. Tulikangas,* C. A. LaSala,* M. Jacob, and J. F. Egan *Hartford Hospital, Hartford, CT, University of Connecticut, Farmington, CT Category: Childbirth. Objective: There is concern about the rising rate of cesarean delivery, especially the contribution of cesarean delivery on maternal request (CDMR). We surveyed nulliparous pregnant women to determine who would request CDMR.
Presentation Number: Poster 92 Attitudes Toward Vaginal Delivery VS. Cesarean Section in Nulliparous Pregnant Women M. O. Schimpf,* P. K. Tulikangas,* C. A. LaSala,* M. Jacob, and J. F. Egan *Hartford Hospital, Hartford, CT, University of Connecticut, Farmington, CT Category: Childbirth. Objective: Cesarean delivery on maternal request has received considerable attention. No study to date has studied patients thoughts and impressions of the two routes of delivery, particularly with regard
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to long-term impact on pelvic-floor function. We surveyed nulliparous pregnant women to assess their attitudes about route of delivery. Methods: Nulliparous pregnant women in the 3rd trimester were given a survey at a routine office visit and returned it at their convenience. Practices from four hospitals in eight cities enrolled patients. The survey included demographic information as well as Likert-scale (15 with 5 most concerned) questions regarding the patients level of concern regarding complications during labor, delivery and postpartum. Descriptive statistics, Chi-square with Fishers exact, and students t-test were used as appropriate for this convenience sample. Results: The mean age of the 294 respondents at the time of sampling was 28.4 years ( 6.13 years SD) and the mean gestational age was 35.3 weeks ( 2.7 weeks). If faced with a difficult vaginal delivery and offered operative vaginal delivery (OVD) or CD, the majority of patients selected CD (63.8% CD vs. 35.8% OVD). However, patients who had attended childbirth classes were significantly more likely to request OVD rather than CD (56.2% CD vs. 43.8% OVD, p 0.0064). There were no statistically significant differences between patients based on age, race/ethnic background, site of prenatal care, level of maternal education, or relationship status with the father of the baby. When asked which route of delivery would be better for her in 10 20 years, most patients picked vaginal delivery (n 119, 41% vs. n 10, 3.4%). Patients who received prenatal care at a hospital clinic most often selected vaginal delivery (54.4%), while private-practice patients more often felt that there would be no difference in the long term (39.1%) (p 0.0005). There were no statistically significant differences between patients based on age, race/ethnic background, level of maternal education, or attendance at childbirth classes. Conclusions: In difficult obstetrical cases, most patients in this study prefer cesarean delivery and few patients desire OVD. Patients believe vaginal delivery will be better for them in the long term. Disclosures: M.O. Schimpf, None; P.K. Tulikangas, None; C.A. LaSala, GlaxoSmithKline, Speakers Bureau; Invited Speaker, Ethicon, Other; M. Jacob, None; J.F. Egan, None.
The sample was 65.3% white, 18.4% Hispanic, 11.6% Black/African American, 2.7% Asian, and 2% other. Their top concern regarding the upcoming delivery was death of myself or my baby (n 48, 22.2%), followed by pain during delivery (n 33, 15.3%), and that the baby might have a long-term problem (n 30, 13.9%). The highest-ranking pelvic floor concern was episiotomy or laceration, cited by 6.5%. Concern for pelvic muscle damage, urinary incontinence (UI), fecal incontinence (FI) or the need for prolapse surgery was not cited by any patient. Patients indicated a low level of concern for possible future pelvic floor problems on the Likert questions: pelvic muscle damage (mean 2.79, median 3.0, 1.3 SD), UI (mean 2.61, median 2.0, 1.4), FIp 0.029) (mean 2.61, median 2.0, 1.5), need for surgery for prolapse (mean 2.71, median 3.0, 1.4). Concern was slightly higher for episiotomy (mean 3.35, median 4.0, 1.3) or laceration/vaginal tear (mean 2.94, median 3.0, 1.3). There were no significant differences between patients based on age, maternal education, attendance at childbirth classes or desire for CDMR for worry regarding episiotomy or vaginal laceration. Patients with lower levels of maternal education were significantly more nervous about UI (p 0.0002) or FI (p 0.0009) than patients with more education, but patients who had attended childbirth classes were less worried about UI (p 0.0004) or FI (p 0.0009) than those who had not attended. There were no significant differences regarding UI based on age or desire for CDMR. Patients 30 years old (p 0.005) were more worried about FI, but there was no difference based on desire for CDMR. Patients 30 years old (p 0.0004), with lower level of maternal education (p 0.0001), and who did not attend childbirth classes (p 0.0001) were more concerned about the risk of prolapse surgery. Conclusions: The degree of concern in this group of women for future pelvic floor disorders was low. Younger, less educated women were more concerned than older, more educated women. Disclosures: M.O. Schimpf, None; P.K. Tulikangas, None; C.A. LaSala, Glaxo-Smith-Kline, Speakers Bureau; Invited Speaker, Ethicon, Other; M. Jacob, None; J.F. Egan, None.
Presentation Number: Poster 93 Concern About Pelvic Floor Problems is Low in Nulliparous Third-Trimester Pregnant Women M. O. Schimpf,* P. K. Tulikangas,* C. A. LaSala,* M. Jacob, and J. F. Egan *Hartford Hospital, Hartford, CT, University of Connecticut, Farmington, CT Category: Childbirth. Objective: The impact of pregnancy and delivery on the pelvic floor is controversial, and no study to date has studied patients thoughts and impressions of the two routes of delivery, particularly with regard to long-term impact. We surveyed nulliparous pregnant women to assess their attitudes about the two routes of delivery. Methods: Nulliparous pregnant women in the 3rd trimester were given a survey at a routine office visit. Practices from four hospitals in eight cities enrolled patients. The survey included demographic information as well as Likert-scale (15 with 5 most concerned) questions regarding the patients level of concern about complications during labor, delivery and postpartum. Descriptive statistics, Chisquare with Fishers exact, and students t-test were used as appropriate for this convenience sample. Results: The mean age of the 294 respondents was 28.4 yrs. ( 6.13 yrs. SD) and the mean gestational age was 35.3 wks. ( 2.7 wks. SD).
Presentation Number: Poster 94 Postpartum Perineal Pain: Association with Genital Trauma, Labor Care and Birth Variables L. M. Leeman, A. M. Fullilove, N. Borders, R. Manocchio, L. L. Albers, and R. G. Rogers University of New Mexico School of Medicine, Albuquerque, NM Category: Childbirth. Objective: To determine rates of perineal pain and analgesic use in postpartum women with major perineal trauma compared to women with minor or no perineal trauma. Methods: This is a planned secondary analysis of a prospective study of midwifery patients who consented to documentation of genital trauma at birth and assessment of perineal pain and analgesic use postpartum. Data collected included patient characteristics and labor care measures, birth events, and a detailed map of genital tract trauma. Major trauma was defined as 2nd degree laceration of the perineum and/or trauma requiring suturing. Perineal pain was assessed using the Present Pain Intensity (PPI) and Visual Analog Scale (VAS) components of the short form McGill pain questionnaire; analgesic use was assessed at discharge and at 3 months. Results: 576 women gave vaginal birth; 11 women underwent episiotomy and/or operative delivery and were excluded from further
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analysis. 552/565 (98%) of women provided data regarding pain at time of discharge and 444/565 (79%) at 3 months. 152 (27%) women had major trauma with 104 (18%) 2nd degree lacerations; 4 ( 1%) 3rd and 2 ( 1%) 4th degree lacerations. At discharge, 60% of women reported no or mild pain on the PPI, nonetheless, women with major trauma were more likely to report increased pain by the VAS (2.16 1.61 vs. 1.4 1.40; p .001) and more likely to use analgesic medicines (76.3 vs. 23.7%, p .002) than women with minor trauma. Trauma groups differed in length of active pushing, education, parity, fetal weight, use of epidurals and oxytocin. In a multivariate model, only trauma group and length of active pushing predicted increased pain at the time of discharge while difference in analgesic use between groups was explained by parity. At 3 months, the majority of women 401(90%) reported no perineal pain and average VAS scores were not different between groups (0.19 1.49 vs. 0.17 .65; p NS). Conclusion: Women with spontaneous perineal trauma report low rates of postpartum perineal pain, although women with major trauma do report increased perineal pain compared to women with no or minor trauma. Length of active pushing is a potentially modifiable labor care measure to reduce postpartum perineal pain. Disclosures: L.M. Leeman, None; A.M. Fullilove, None; N. Borders, None; R. Manocchio, None; L.L. Albers, None; R.G. Rogers, Pfizer, Grant/Research Support; Pfizer, Consultant; Pfizer, Speakers Bureau.
maintained their significance with increased odds ratios for severe perineal laceration. Conclusions: Operative vaginal delivery, episiotomy, length of second stage and the requirement of insulin for glucose control all appear to increase the risk of severe perineal laceration at the time of vaginal delivery in a teenage population. These findings are consistent with similar studies in an adult population which demonstrated that primiparity, episiotomy, and operative vaginal delivery were all risk factors for severe perineal laceration.(13) References: 1. FitzGerald MP, Weber AM, Howden N, Cundiff GW, Brown MB. Risk factors for anal sphincter tear during vaginal delivery. Obstet Gynecol 2007;109:29 34. 2. Richter HE, Brumfeld CG, Cliver SP, Burgio KL, Neely CL, Varner E. Risk factors associated with anal sphincter tear: A comparison of primiparous patients, vaginal births after cesarean deliveries, and patients with previous vaginal delivery. Am J Obstet Gynecol 2002;187:1194 98. 3. Handa VL, Danielsen BH, Gilbert WM. Obstetric anal sphincter lacerations. Obstet Gynecol 2001;98:22530. Disclosures: D. Patterson, None; A.F. Hundley, None.
Presentation Number: Poster 95 Risk Factors for Perineal Lacerations in Teen Deliveries D. Patterson,* and A. F. Hundley *Brigham and Womens Hospital, Boston, MA, The Ohio State University, Columbus, OH Category: Childbirth. Objective: Severe perineal lacerations have been associated with the development of fecal incontinence in the general population. This study was designed to attempt to identify risk factors for severe perineal lacerations with vaginal delivery in a teen population. Such risk factors may, in turn, be associated with the development of fecal incontinence. Methods: This was a retrospective database analysis of 534 teen term, singleton, cephalic vaginal deliveries performed at our institution between January 2004 and December 2006. Maternal demographics, labor and delivery characteristics, and neonatal factors were examined. Statistical analysis consisted of univariate statistics, Students t-test, chi-square and logistic regression. The primary outcome was the occurrence of a 3rd or 4th degree laceration with vaginal delivery. Results: Overall 43 (8.1%) of our patients had 3rd or 4th degree lacerations during delivery while 491 (91.9%) had either no laceration or a 1st or 2nd degree laceration. The groups were similar in age, race, BMI, maternal glucose intolerance, use of epidural, frequency of occiput posterior head position, and fetal head circumference. The severe laceration group had a higher frequency of maternal glucose intolerance requiring insulin control (7% versus 0.8%, p 0.014), episiotomy (60.5% versus 18.5%, p 0.005), operative vaginal delivery (25.6% versus 10.4%, p 0.01), fetal birth weight (3380 438g versus 3196 406g, p 0.005), shoulder dystocia (18.6% versus 6.3%, p 0.008), and length of second stage (0.77 0.69 versus 1.11 1.24 hours, p 0.03). In a multivariate regression model that controlled for each of these factors, the use of insulin, episiotomy, operative vaginal delivery, and length of second stage all
Presentation Number: Poster 96 The Impact of Delivery on Bowel Symptoms in a Urogynecologic Population F. G. Khan,* J. Cunkelman,* S. Adams,* L. Lowenstein and K. Kenton *Washington University School of Medicine, St. Louis, MO, Loyola University School of Medicine, Maywood, IL Category: Childbirth. Objectives: To determine the effects of obstetric history on bowel symptoms in a urogynecologic population. Methods: We reviewed charts of consecutive new patients presenting to our urogynecologic clinic between July 2006 and April 2008. Demographic and obstetric variables, including gravidity, vaginal parity, weight of largest baby, and use of forceps or vacuum were recorded. All women also answered the following question: During delivery did you have a tear in the rectum? and completed the short form of the Pelvic Floor Distress Inventory (PFDI-20). Responses to the Colorectal-Anal Distress Inventory subscale (CRADI) PFDI-20 were scored from 0 to 100 with higher scores indicating more bother from colorectal symptoms. Nonparametric tests were used for bivariate and correlation analyses between independent groups. Multivariate linear regression was used to determine independent factors associated with CRADI scores. We included the following clinically and/or statistically significant variables in the final model: age, race, BMI, number of vaginal deliveries, weight of largest baby, forceps, vacuum, rectal tears and number of pregnancies. Results: Four hundred and eight women with a median age of 57 (range 24 91) years and BMI of 27.4 (16.8 60.7) were included. Majority were (90%) Caucasian, 8% African American and 2% other. Median number of vaginal deliveries was 2 (111), and median weight of the largest baby was 8.1 lbs. (2.9 11.6). CRADI scores were significantly higher in women who had a forceps delivery (n 145) compared to those who delivered spontaneously 25 (0 91) vs. 18.7 (0 100), respectively, p .02 , and in women with rectal tears (n 89) compared to those without rectal tears 34.4, (0 100) vs. 18.8, ( 0 88) respectively, p .0001 . CRADI scores did not differ in women who had vacuum deliveries (n 30) and who delivered spontaneously 25.1(0 75) vs. 23.9(0 100), respectively, p .39 . There was no association between CRADI scores and gravidity, vaginal
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parity, or weight of largest baby (p .15). In multivariate analysis, forceps delivery ( 4.9, p .035), rectal tear ( 7.4, p .001) and BMI ( .6, p .001) were significantly associated with CRADI scores. Conclusions: In women seeking urogynecologic care, bothersome colorectal symptoms are associated with higher BMI and a history of forceps-assisted vaginal delivery and rectal tear. Disclosures: F.G. Khan, Pfizer, Grant/Research Support; Pfizer, Speakers Bureau; J. Cunkelman, None; S. Adams, None; L. Lowenstein, Astellas, Grant/Research Support; Pfizer, Grant/Research Support; K. Kenton, Pfizer, Grant/Research Support; Pfizer, Consultant; Pfizer, Speakers Bureau.
Presentation Number: Poster 97 Vaginal Smooth Muscle Cell Apoptosis is Increased in Women with Pelvic Organ Prolapse P. Takacs,* M. Gualtieri,* N. Mehdi, K. Candiotti, and C. Medina *University of Miami, Department of Obstetrics and Gynecology, Miami, FL, University of Miami, Department of Pathology, Miami, FL, University of Miami, Department of Anesthesia, Miami, FL Category: Basic Science. Objective: To compare the smooth muscle content and apoptosis of the vagina in women with and without anterior vaginal wall prolapse. Methods: Vaginal tissues were sampled in women with (n 6) or without (n 6) anterior vaginal wall prolapse undergoing hysterectomy. Smooth muscle of the vagina was studied by immunohistochemistry. Digital image analysis was used to determine the fractional area of smooth muscle in the histologic cross-sections. Apoptosis was assessed by TUNEL assay. Results: Immunostaining revealed a well-defined, uniform distribution of smooth muscle in patients without POP. This is in stark contrast to the patchy distribution of smooth muscle seen in patients with POP. Quantitative morphometric analysis revealed that the fractional area of nonvascular smooth muscle in the vaginal wall biopsies from women with prolapse was significantly decreased compared to women without prolapse {mean, range, p-value (0.36 0.12 vs. 0.16 0.12 p 0.021). Assessment of the vaginal smooth muscle cell apoptosis by TUNEL assay demonstrated that the smooth muscle cell apoptotic index was significantly increased in women with POP compared to women without POP mean SD, p-value (0.04 0.01 vs. 0.02 0.03, p 0.041) . In addition, analysis of the smooth muscle cell nuclei demonstrated a significant decrease in the number of nuclei in women with prolapse compared to women without prolapse mean SD, p-value (2370 467 vs. 1166 727), 0.01 . The total smooth muscle cell nucleus area was significantly decreased mean SD, P-value (59135 18108 vs. 28780 23067), 0.03 . However, the mean smooth muscle cell nucleus area was not significantly different between the two groups mean SD, p-value (24.4 3 vs. 22.4 5), NS . Conclusions: The fraction of smooth muscle in the vagina is significantly decreased, and the rate of apoptosis is higher in women with anterior vaginal wall prolapse compared to women without prolapse Disclosures: P. Takacs, None; M. Gualtieri, None; N. Mehdi, None; K. Candiotti, None; C. Medina, None.
Presentation Number: Poster 98 Expression of Matrix Metalloproteinase-2 and Tissue Inhibitor of Matrix Metalloproteinase-2 in Patients with Pelvic Organ Prolapsed S. Bai, M. Kim, H. Jung, M. Jeon, and S. Kim Department of Obstetrics and Gynecology, Seoul, Republic of Korea Category: Basic Science. Objective: The uterosacral ligaments are an important part of the pelvic support system and connective tissue alterations are thought to contribute to the development of pelvic organ prolapse. The objective of this study was to compare the expression of matrix metalloproteinase2 and tissue inhibitor of matrix metalloproteinase-2 in patients with or without prolapse and to evaluate the correlation between mRNA expression of matrix metalloproteinase-2 and tissue inhibitor of matrix metalloproteinase-2 and clinical characteristics of patients with or without pelvic organ prolapse. Methods: From November 2006 through March 2007, the uterosacral ligaments were obtained from 20 women with pelvic organ prolapse and 20 women without pelvic organ prolapsed during the hysterectomy at Division of Female Pelvic Medicine and Reconstructive Surgery, Yonsei University Health System in Seoul. A quantitative real-time reverse transcriptase-polymerase chain reaction was used to analyze the expression of mRNA of matrix metalloproteinase-2 and tissue inhibitor of matrix metalloproteinase-2. This study was approved by the Institutional Review Board of Yonsei University Health System. The Students t-test and one way ANOVA test were used for statistical analysis by using SPSS, version 13.0 (SPSS Inc., Chicago, IL, U.S.A.). p 0.05) was determined to be significant. Results: The matrix metalloproteinase-2 expression was significantly increased in women with pelvic organ prolapse (p 0.044). The tissue inhibitor of matrix metalloproteinase-2 expression was also increased in women with pelvic organ prolapse, but there was no statistical difference (p 0.362). There was no significant relationship between mRNA expression of matrix metalloproteinase-2 and tissue inhibitor of matrix metalloproteinase-2 and clinical characteristics of patients with or without pelvic organ prolapse. Conclusion: Our results suggest that increased matrix metalloproteinase-2 and tissue inhibitor of matrix metalloproteinase-2 mRNA expression in uterosacral ligament may be associated with pelvic organ prolapse. Tissue inhibitor of matrix metalloproteinase-2 appears to be multifunctional molecule which may, independently of their ability to block matrix metalloproteinase-2 activity, modulate pelvic organ prolapse progression. Correlations did not exist between mRNA expression of matrix metalloproteinase-2 and tissue inhibitor of matrix metalloproteinase-2 and clinical characteristics of patients with or without pelvic organ prolapse. Disclosures: S. Bai, None; M. Kim, None; H. Jung, None; M. Jeon, None; S. Kim, None.
Presentation Number: Poster 99 Parity is Associated with Altered Collagen Ratios in the Primate Vagina K. Jones,* Z. Jallah, A. Feola, S. Abramowitch, and P. Moalli* *Magee Womens Hospital, Pittsburgh, PA, Musculoskeletal Research Center, Pittsburgh, PA Category: Basic Science. Objective: Distinct changes in vaginal morphology occur subsequent to vaginal delivery. The objective of this study was to define a
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structural basis for this change by quantitating differences in the amount of the fibrillar collagens I, III and V, and collagen orientation within the vaginal subepithelium and muscularis of nulliparous vs. parous nonhuman primates (NHPs). Methods: Collagen subtypes I, III, and V in the subepithelium and muscularis of primate vaginal tissue were quantitated by scanning confocal fluorescent microscopy. Vaginal specimens from nulliparous (n 3) and parous primates (n 3) were cut, fixed, and incubated simultaneously with primary antibodies to collagens I, III, and V followed by appropriate secondary antibody linked to a fluorophore. The subepithelium/muscularis of the resulting fluorescent micrographs were scanned with a laser confocal microscope interfaced to a quantitative computer program (Metamorph, 5.0) by a blinded technician. Collagen fiber orientation was quantified using Small Angle Light Scattering (SALS). By this method, the intensity distribution of diffracted light was used to define the collagen orientation index (OI) from defined points within the subepithelium and muscularis. Results are reported as percentage of aligned points (Table1). Studentss t-test and the Mann Whitney U were applied where appropriate with a p-value of 0.05. Results: Nulliparous and parous animals had similar age; however, the BMI of parous animals was slightly higher (18.3 vs. 16.1, p 0.05). Median vaginal parity was 7. Parity was associated with a decrease in the ratio of collagen I/III V in the subepithelium primarily due to an increase in collagen III. No differences were seen in collagen subtypes or ratios within the muscularis. By SALS, the percentage of aligned points in the subepithelium and muscularis of the two groups were similar. Conclusion: Parity is associated with altered collagen subtypes resulting in a decrease in the ratio of collagen I/III V, indicating decreased tensile strength. The structural change associated with altered collagen ratios did not impact collagen alignment. It is likely that altered collagen ratios contribute to the progression of prolapse over time.
for elastin, fibrillin-1, collagen I, collagen III, and smooth muscle actin. SigmaScan Pro 5.0 image analysis software was used to quantitate ECM protein expression and to measure the thickness and density of nonvascular smooth muscle beneath the mid-urethra. Results: Elastin immunostaining was observed in the lamina propria and in the muscularis layer between smooth muscle bundles. Fibrillin-1 localized to the basement membrane, colocalized with elastin fibers in the lamina propria, and was also expressed by smooth muscle cells. In general, collagen III showed more intense staining in the lamina propria than collagen I (p 0.01, paired t test). Statistically significant associations were not observed between ECM protein expression and prolapse or parity (p 0.05). Aging, however, was positively correlated with staining for elastin (R 0.82, p 0.0001), fibrillin-1 (R 0.49, p 0.05), and collagen III (p 0.003) in the lamina propria but not in the muscularis (p 0.05). Elderly specimens from animals with or without prolapse had shorter, thicker, darker-staining elastin fibers than those from middle-aged animals, while young animals had little measurable elastin. Of note, one monkey with prolapse demonstrated mimimal immunoreactivity for all ECM proteins examined, suggesting abnormal vaginal connective tissue composition. A second animal with prolapse demonstrated abnormal elastin morphology (excessive clumping) in the lamina propria. Thickness of the suburethral muscularis layer correlated with age (R 0.65, p 0.006) but not with prolapse (p 0.31) or parity (p 0.10). Density of nonvascular smooth muscle did not correlate with prolapse, parity, or age (p 0.05). No relationship between thickness and density was observed (R 0.22, p 0.43). Conclusions: The squirrel monkey anterior vaginal wall demonstrates age-related changes in the distribution of elastin, fibrillin1, collagen III, and nonvascular smooth muscle. Abnormal extracellular matrix protein expression is observed in the vaginal wall of some monkeys with prolapse. Disclosures: E. Higgins, None; S.S. Baumann, None; T.J. Kuehl, None; L.M. Pierce, None.
Disclosures: K. Jones, None; Z. Jallah, None; A. Feola, None; S. Abramowitch, None; P. Moalli, NIH K12HD043441 and RO1HD045590, Grant/Research Support.
Presentation Number: Poster 100 Age-Related Changes in the Distribution of Extracellular Matrix Proteins in the Anterior Vaginal Wall of Squirrel Monkeys with and Without Prolapse E. Higgins, S. S. Baumann, T. J. Kuehl, and L. M. Pierce Scott and White Hospital, Temple, TX Category: Basic Science. Objective: To evaluate differences in the expression of extracellular matrix (ECM) proteins and smooth muscle in the anterior vaginal wall from squirrel monkeys with and without vaginal prolapse. Methods: The vagina and urethra were harvested en bloc from 16 squirrel monkeys aged 4 to 25 years including 4 nulliparous females, 6 parous females with prolapse, and 6 parous females without prolapse similar in age, weight, and parity to animals with prolapse. Transverse sections from the mid-vagina were examined immunohistochemically
Presentation Number: Poster 101 Estradiol and Progesterone Suppress the Enzyme Activity of Matrix Metalloproteinase-13 in Vaginal Supportive Connective Tissue Cells W. Zong, and P. A. Moalli University of Pittsburgh, Pittsburgh, PA Category: Basic Science. Objective: The risk of developing pelvic organ prolapse accelerates following menopause. Previous studies suggest that this may be due to increased collagen degradation in the absence of hormones (Am J Obstet Gynecol 2004; 190: 620). This study was to determine whether the enzyme activity of a key collagen degrading enzyme, MMP-13, is regulated by 17- -estradiol (E2) and progesterone (P4) in cells derived from the vaginal supportive connective tissues. Methods: Following informed consent, biopsies from an intact portion of the arcus tendineous fasciae pelvis (ATFP) were obtained from 3 premenopausal women and 3 postmenopausal women not on hormone therapy for 1 year undergoing a surgical repair of prolapse. Biopsies were minced and the liberated cells were grown to confluence before weaning to serum free media for 24 hours. Cells were then treated with E2 (101010 8 M), P4 (101010 8 M), E2 (10 8 M) plus P4 (101010 8 M) or E2 (10 8 M) plus the estrogen receptor inhibitor Imperial Chemical Industries 182,780 (ICI 182,780, 10 810 6 M), and harvested 48 hours later. Cells without hormone treatment served as control. MMP-13 enzyme activity was quantified in duplicate using a Fluorokine E enzyme activity assay kit (R&D
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TABLE. Treatment Control E2 10 10 mol/L 10 9 mol/L 10 8 mol/L P4 10 10 mol/L 10 9 mol/L 10 8 mol/L E2 (10 8 mol/L) plus P4 10 10 mol/L 10 9 mol/L 10 8 mol/L E2 (10 8 mol/L) plus ICI 182,780 10 8 mol/L 10 7 mol/L 10 6 mol/L MMP-13 activity (ng/ml) Premenopausal Postmenopausal 1.31 0.43 0.51 0.69 0.63 0.70 0.73 0.79 0.63 0.70 1.45 1.64 1.68 0.19 0.03 0.17 0.22 0.23 0.11 0.16 0.15 0.03 0.21 0.13 0.33 0.18 1.64 0.93 0.95 0.72 0.97 0.86 0.94 0.81 0.97 0.79 1.43 1.49 1.56 0.19 0.001 0.14 0.08 0.11 0.001 0.23 0.24 0.25 0.001 0.22 0.08 0.17 0.586 0.30 0.20 0.44 p value
System). Enzyme activity was normalized to the concentration of total cellular protein. Data were analyzed at 0.05 level of significance using one-way analysis of variance. Post-hoc pairwise comparisons were made using Dunnets multiple comparison procedure Results: Subjects in the 2 groups had similar gravidity, parity, BMI and stage of prolapse, however, postmenopausal women were older. As shown in the Table, E2 in the presence or absence of P4 significantly decreased the activity of active MMP-13. This inhibitory response was abrogated by ICI. There was no difference in the degree of inhibition by each hormone or hormone combination. Inhibition was similar in cells derived from premenopausal vs postmenopausal women (Ps 0.05). Conclusion: 17- -estradiol in the presence or absence of progesterone inhibits the activity of the key collagen degrading enzyme, MMP-13, in a process that is mediated through the estrogen receptor. The data suggest a benefit of hormones on the integrity of intact vaginal supportive connective tissues. Disclosures: W. Zong, None; P.A. Moalli, R01HD045590, Grant/Research Support.
required for cell proliferation at different points in the cell cycle. When DNA is damaged after trauma, p53 functions to block the cell cycle causing apoptosis. The aim of this study was to determine the effect of HOXA11 expression on fibroblast proliferation, regulation of p53 and the cell cycle in the USL cells. Materials & Methods: We evaluated the effects of constitutive expression of HOXA11 in a murine fibroblast cell line and in primary cells cultured from a USL biopsy specimen obtained at the time of a benign hysterectomy. The USL specimen was digested with collagenase and DNAse I. These USL primary cells and NIH 3T3 cells were seeded onto a six well plate (1 10 5 cells/well) and transfected with either a vector carrying a HOXA11 cDNA insert or with empty vector alone as a control. Immunohistochemistry using bromodeoxyuridine (BrdU) was performed to evaluate cell proliferation after transfection. Real time PCR was used to determine effect of constitutive expression of HOXA11 on expression of p53 in USL cells. Results: Constitutive expression of HOXA11 in murine fibroblasts and primary USL cells resulted in significantly higher proliferation. Cells transfected with Hoxa11 had a mean BrdU incorporation of 40.8 8.8 cells/100 cells and 50.5 8.6 cells/100 cells compared with 32.2 7.5 cells/100 cells and 33.1 cells/100 cells in controls (p 0.03 for NIH 3T3 cells and p 0.01 for human USL cells, respectively). Overexpression of HOXA11 in USL cells resulted in a 40% decrease in expression of p53. Conclusion: HOXA11 is necessary for USL development, promotes proliferation of USL fibroblasts and increases type III collagen expression in vitro. HOXA11 also mediates p53 expression, which may be a mechanism by which HOXA11 regulates fibroblast proliferation in vivo during growth and the acute phase response following trauma when fibroblasts are activated to proliferate and remodel the ECM. Previously, we have shown that expression of HOXA11 is decreased in women with POP. It is likely that HOXA11 mediated proliferation of USL fibroblasts contributes to the tensile strength and resilience of these structures and prevents POP. Disclosures: K.A. Connell, None; M.K. Guess, None; R. Bercik, None; H.S. Taylor, Wyeth, Speakers Bureau. Acknowledgements: This work has been funded by the NICHD Womens Reproductive Health Research: K12 HD047018.
Presentation Number: Poster 102 Fibroblast Proliferation is Regulated by Hoxa11: Molecular Implications for Pelvic Organ Prolapse K. A. Connell, M. K. Guess, R. Bercik, and H. S. Taylor Yale University School of Medicine, New Haven, CT Category: Basic Science. Objective: The integrity of the extracellular matrix (ECM) is maintained by a delicate balance between synthesis and degradation. Previously, we demonstrated that Hoxa 11, a homeobox gene responsible in differentiation of the Mullerian tract, is essential for the development of the uterosacral ligaments (USLs) in mice and regulates the expression of collagen type III and MMP2. We have also shown that HOXA11 is deficient in the USLs of women with pelvic organ prolapse (POP) compared to women with normal support. The exact mechanism by which HOXA11 regulates pelvic floor integrity and repair remains to be elucidated. P53 regulates several key proteins
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This work was presented as a poster at the Society for Gynecological Investigation Annual Meeting, San Diego, CA, March 2008 (international meeting).
Presentation Number: Poster 103 Human Mesenchymal Stem Cells (HMSC) Increase the Stiffness of Collagen Meshes: Dependence of the Crosslink Percentage J. E. Robles,* I. Ochoa, M. Perez-Ilzarbe,* C. Alcaine, J. Grasa, F. Prosper* and M. Doblare *Clinica Universitaria. University of Navarra, Pamplona, Spain, Group of Structural Mechanics and Materials Modelling, University of Zaragoza, Zaragoza, Spain Category: Basic Science. Introduction: The use of graft materials in urogynecology surgery has been promoted to compensate for the inherent weakness in autologous tissues. The advantages of collagen matrix laminates made from porcine dermis as implantable xenograft products are well known. Collagen-based meshes possess good mechanical properties, strong resistance and poor antigenicity. Moreover, they allow a secondary cellular colonization and can become less degradable if modified. Objective: Porcine collagen meshes (Pelvicol, BARD) with different crosslink degrees were tested to determine their mechanical properties. Material and Methods: Monotonic and cyclic uniaxial tensile tests were carried out along the two principal directions of the mesh. Monotonic uniaxial tensile tests were performed under displacement control on an INSTRON 5848 microtester, using a 50 N full scale load cell with a non-contact videoextensometer. In order to avoid specimen drying, an ultrasonic humidifier was used, which delivered subcooling steam, allowing a constant temperature during the test. The specimens were loaded at a displacement rate of 0.01 mm/sec up to rupture. Cyclic tests were performed according to the following procedure. A maximum of 3 ramp cycles were applied, all of them under displacement control at the same displacement rate as for the monotonic test. When the 10, 25 and 50% of the maximum load is attained, unloading start until reaching a force value close to zero at which point reloading start. This protocol was repeated 3 times for each cycle. hMSC were seeded in the different collagen meshes (10000 cells/cm2) and cultured for one week at 37 C in a CO2 incubator. Results: Significant differences in mechanical properties between samples with different crosslink percentages were observed. The partial crosslink mesh showed higher anisotropy. The hMSC colonized the collagen mesh and were distributed all over the mesh and also increased the Young modulus (stiffness) of the collagen meshes depending on the crosslink percentage. Damage accumulation due to cyclic load (the slope of the stress-strain curve at the beginning of unloading) depends also on the crosslink percentage. Conclusions: Increasing the crosslink percentage produced a stiffness gain with a decrease in the damage accumulation in the collagen meshes. hMSC could increase the stiffness of the collagen meshes but not of the full crosslinked ones. This increase is inversely proportional to the crosslink degree. Disclosures: J.E. Robles, C.R. Bard, Inc, Speakers Bureau; C.R. Bard, Inc., Paid Instructor; I. Ochoa, None; M. Perez-Ilzarbe, None; C. Alcaine, None; J. Grasa, None; F. Prosper, None; M. Doblare, None.
Presentation Number: Poster 104 A Colia1 Gene SP1 Binding Site Polymorphism in Korean Women with and Without Pelvic Organ Prolapse S. Bai, H. Cho, H. Jung, M. Jeon, and S. Kim Department of Obstetrics and Gynecology, Seoul, Republic of Korea Category: Basic Science. Objective: In Korea, the prevalence of women with POP stage greater than stage II was reported to be 11.8%. Ethnic and racial variations in the incidence of POP have been reported. The aim of this study was to evaluate the possible influence of G3 T substitution in transcription factor Sp1-binding site of the gene encoding -1 chain of type I collagen (COLIA1 gene) on the risk of pelvic organ prolapsed in Korean women. Methods: This case-controlled study included 30 Korean women. The study group consisted of 15 women with advanced stage pelvic organ prolapse. Fifteen control subjects were matched for age and parity among the postmenopausal women with benign ovarian cysts, uterine myomas or adenomyosis to the study group, and thus, the two groups had no statistical significance. DNA was obtained from peripheral blood leukocytes. The fragments of the first intron of the COLIA1 gene were amplified by real time polymerase chain reaction. The polymorphism was identified by LightCycler Technology with hybridization probes. Sequencing reactions were performed on each template using commercial primer. This study was approved by the Institutional Review Board of Yonsei University Health System. The Students t-test, Fishers exact test, and Pearson chi-square test were used for statistical analysis by using SPSS, version 13.0 (SPSS Inc., Chicago, IL, U.S.A.). p 0.05 was determined to be significant. Results: Two groups had no significant difference in medical history, surgical, and smoking history. The homozygous peaks were noted at 57C on melting curve analysis. Sequencing reactions confirmed the G/G alleles in the 30 specimens tested. We could not find any polymorphism at the Sp1-binding site in COLIA1 gene with advanced stage pelvic organ prolapse. Conclusion: Polymorphism of the transcription factor Sp1-binding site in COLIA1 gene is unlikely to be of clinical value in identifying Korean women who are at risk for the development of pelvic organ prolapse. Disclosures: S. Bai, None; H. Cho, None; H. Jung, None; M. Jeon, None; S. Kim, None.
Presentation Number: Poster 105 Histological Evaluation of the Uterosacral Ligament: Do Elastin, Collagen, and Smooth Muscle Content Decrease with Increasing Age? S. A. Collins,* S. A. Downie, R. S. Sellers, T. R. Olson, and M. S. Mikhail *Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, Albert Einstein College of Medicine, Bronx, NY Category: Basic Science. Objective: To determine whether smooth muscle, collagen, and elastin content of the uterosacral ligament correlates with age. Methods: Female cadavers in the 2007 08 Clinical and Developmental Anatomy course at Albert Einstein College of Medicine were subjects of this study. Each cadaver was fixed on site using traditional embalming and curing methods with dilute formaldehyde. This study was conducted before the students pelvic dissection. Subjects were included if they had clearly identifiable uterosacral ligaments in-situ. The right ligaments were
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selected for use in this study for uniformity. Each ligament was measured from the center of the cervix or vaginal cuff to the posterior-most point at which the ligament was clearly identifiable. They were then marked off by thirds, and a cross-sectional slice was taken from the center of the middle third of each ligament. Sections were prepared with hematoxylin and eosin (H&E), Massons trichrome, and Verhoeffs Van Gieson stains. Slides were blinded for age. The H&E slides were used to verify that the correct tissue was isolated. Each Massons trichrome and each Verhoeffs Van Gieson slide was viewed at 20 and 40 magnification in 5 different fields. The trichome slides were scored by assigning percentages to the approximate collagen and smooth muscle components in each field to the nearest 5%. Care was taken to exclude vascular smooth muscle from the analysis. Verhoeffs Van Gieson slides were scored 0 for no elastin, 1 for rare elastin, and 2 for prevalent elastin seen. The same, blinded examiner viewed the slides multiple times and scored each twice to maximize precision. Averages were calculated for percent collagen and smooth muscle per field and elastin score per field. After averages were finalized, the examiner was unblinded to age, and statistical analyses were performed with the Students T-Test and ANOVA using JMP 7.0 by SAS. Results: Sixteen cadavers met inclusion criteria for this study. Of these, slides from 12 showed histologically typical-appearing uterosacral ligament. The average subject age was 79 (range 59 93). The average percentages of smooth muscle and collagen per field were 25.6 and 74.4, respectively. The average elastin score per field was 1.19. Although trends suggested increasing smooth muscle, decreasing collagen, and increasing elastin content with increasing age, there were no statistically significant relationships. This remained true after data was stratified for age greater than 70 or age 70 and younger. Conclusions: Although the increased prevalence of pelvic organ prolapse in elderly women may suggest that smooth muscle, collagen, and/or elastin content decrease with age, our data did not confirm this. Our findings imply that age alone is not a contraindication for use of the uterosacral ligament for vaginal vault suspension. Further analysis controlling for possible confounding variables is needed to further evaluate the relationship between age and histological composition of the uterosacral ligament. Disclosures: S.A. Collins, None; S.A. Downie, None; R.S. Sellers, None; T.R. Olson, None; M.S. Mikhail, None.
myosin antibodies. Histology and MRI were compared using side-byside analysis of acquired images. Results: The mean length of the urethra in nulliparous females was 20.1 mm 3.0 SD (range 16.3 to 24.9 mm). The wall of the midurethra contained different layers from the lumen to the periphery consisting of epithelium, lamina propria (network of collagen, elastin, and vasculature), 2 smooth muscle layers (inner longitudinal and outer circular), and an external striated muscle layer whose fibers were distinct from the levator ani. The EUS was identified in the middle and distal thirds of the urethra, and in the proximal urethra the smooth muscle layer thickened and replaced the EUS. The anal sphincter complex included the internal sphincter (thickening of the circular smooth muscle of the rectum), the longitudinal smooth muscle layer, and the striated external sphincter that formed a cylinder distally around the anal canal and internal sphincter. The EAS measured 5.8 mm 1.5 SD dorsally (range 4.3 to 9.3 mm) in nulliparous females. Both the EUS and EAS contained slow and fast fiber types. The percentage of type I fibers ranged from 26% to 73% in the EUS and from 16% to 58% in the EAS and increased with age (p 0.019 EUS; p 0.035 EAS; t test). Histological evidence of chronic denervation (extensive fibrosis, fatty replacement) or reinnervation (fiber type grouping) was not observed in any female. Conclusions: The urethral and anal sphincter complexes in the female squirrel monkey are structurally similar to those in women, suggesting that this species may be used as a model to investigate urinary or fecal incontinence. A mixture of type I and type II fibers in the striated urethral and anal sphincters enables the squirrel monkey to maintain continence at rest and during stress conditions. Disclosures: R. Huffaker, None; L. Pierce, None; V. Runge, None; J. Gendron, None; S. Baumann, None; T. Kuehl, None.
Presentation Number: Poster 106 Magnetic Resonance Imaging and Histopathology of Anal and Urethral Sphincters in The Squirrel Monkey R. Huffaker, L. Pierce, V. Runge, J. Gendron, S. Baumann, and T. Kuehl Scott & White Hospital, Temple, TX Category: Basic Science. Objective: To describe urethral and anal sphincter anatomy in the female squirrel monkey using magnetic resonance imaging (MRI) and histology. Material and Methods: Axial T 1-weighted images were obtained from 10 anesthetized nulliparous female squirrel monkeys, and 3dimensional models were constructed to obtain urethral and anal sphincter measurements. The anal sphincter complex and urethra with anterior vaginal wall from 16 parous and nulliparous female monkeys ranging in age from 4 to 25 years were processed for histology and immunofluorescence. Serial sections were stained with Masson trichrome, hematoxylin and eosin, elastin/van Gieson, and antibodies to smooth muscle actin. Fiber typing in the striated external urethral sphincter (EUS) and external anal sphincter (EAS) was performed with anti-fast (type II) and anti-slow (type I) skeletal
Presentation Number: Poster 107 Regeneration of Levator Ani by Muscle-Derived Stem Cells M. H. Ho,* S. Heydarkhan, D. Vernet, I. Kovanecz, M. G. Ferrini, N. N. N Bhatia and N. G. Cadavid *Division of Urogynecology and Pelvic Reconstructive Surgery, Harbor-UCLA Medical Center/Charles Drew University of Medicine, Torrance, CA, Division of Urogynecology and Pelvic Reconstructive Surgery, Harbor-UCLA Medical Center, Torrance, CA, Harbor-UCLA Medical Center, Torrance, CA Category: Basic Science. Objective: The objective of this study is to investigate whether implantation of muscle-derived stem cells (MDSC) into atrophic and defective levator ani in the female pelvic floor can reverse their atrophy and regenerate the muscles. Specifically, we have investigated in the rat models whether MDSC: a) can generate in vitro skeletal muscles and other cell types; b) express specific markers applicable to their detection upon implantation into the target tissues; and c) can in vivo reverse the atrophy, regenerate the muscles, and improve the function of levator ani with implanted stem cells. Methods: MDSC were isolated from skeletal muscle by the preplating technique. Cell populations were negative for CD 45 expression and were characterized by flow cytometry for CD34 and Sca-1 expression. Desmin expression was assessed via immunocytochemistry. CD34 and Sca-1 are stem cell markers, whereas desmin is a myogenic marker. For in vitro characterization, cell morphology was determined by phase-contrast light microscopy and differentiation was tested by immunocytochemistry (ICC), quantitative western blot, and real time PCR. Putative MDSC markers were screened by DNA microarrays
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(SuperArray) followed by RT-PCR, ICC, and western blot. To examine multipotency, MDSC were induced to undergo myogenic, osteogenic, and adipogenic differentiation. Short-term growth kinetics and longterm proliferation potential were examined. For in vivo studies, 1 6 10 cells were transplanted into the atrophic/defective levator ani of female rat models. Immunofluorescent images of dystrophin, desmin, and MyHC were acquired. Results: MDSC differentiated in vitro into skeletal muscle, as determined by MyHC, and smooth muscle cells (SMC), as determined by -smooth muscle actin (ASMA), calponin, and smoothelin. For in a vivo studies, MDSC expressed Oct-4 and myoglobin, in addition to myst 4, Nanog, Notch 3, Wnt 1, CD63, and muscle creatine kinase, which are potential markers. Control group with intact levator ani and studied group with atrophic/defective levator ani were compared. Dual immunofluorescence was used to detect MDSC differentiation and hematoxylin/eosin was used for histology at 4, 8, and 12 weeks after stem cell implantations. The ability of MDSC to form myotubes was demonstrated by fast MyHC staining. Both fluorescent nuclear marker 4,6-diamidino-2-phenylindone (DAPI) and myoglobin antibody detected MDSC implanted in the levator ani, and dual DAPI/MyHC indicated their conversion into myofibers. For transplantations of lacZMDSC, cells were first labeled with retrovirus encoding for the lacZ gene and X-gal staining was performed to quantify the total number of these lacZ-positive nuclei and the number that were located within new muscle fibers also indicated the regeneration of levator ani by MDSC. Conclusions: MDSC implanted into atrophic/defective levator ani is a novel and promising approach for their atrophy reversion and muscle regeneration in the pelvic floor as demonstrated in female rat models. Disclosures: M.H. Ho, None; S. Heydarkhan, None; D. Vernet, None; I. Kovanecz, None; M.G. Ferrini, None; N.N. N Bhatia, None; N.G. Cadavid, None.
performed and the composite mid-urethral type sling was placed. Four weeks later, under urethane anesthesia, a suprapubic tube was placed and LPP was measured using a Crede maneuver. In each animal LPP was measured 5 6 times and the mean was taken. Pairwise differences in LPP between the traditional and sham slings, between the composite and sham slings, and between the composite and traditional slings were calculated using the Wilcoxon signed rank test with p 0.05 considered significantly different. Results: The traditional sling increased LPP compared to the sham group (54.83 vs. 38.16 cm H20, respectively, p 0.0017). The composite sling did not increase the LPP compared to the sham group (36.83 vs. 38.16 cm H20, respectively, p 0.7072).
Presentation Number: Poster 108 Mechanisms of Mid-Urethral Sling Effects: Role of Suburethral And Lateral Support for Anti-Incontinence Effects in a Rat Model S. E. McAchran,* U. Lee,* M. Kavran,* Y. Lin,* A. Hijaz and F. Daneshgari* *Cleveland Clinic, Cleveland, OH, University Hospitals of Cleveland, Cleveland, OH Category: Basic Science. Objective: Previous studies in a rat model of incontinence have suggested that the suburethral portion of the mid-urethral sling was not necessary to produce the effect of increased urethral resistance as measured by leak point pressure (LPP). In response to these findings, a composite sling model was developed to further test the hypothesis that the lateral support, rather than the suburethral support is all that is required to produce the anti-incontinence effect. The object of this study was to evaluate the long term efficacy of a novel composite mid-urethral type sling in a rodent model of incontinence. Methods: SUI was created in XX Sprague-Dawley rats by bilateral pudendal nerve transaction (PNT) under ketamine/xylazine anesthesia. In 6 rats, the traditional group, vaginal dissection was performed, followed by placement of a 2 0.3 cm strip of Prolene (Ethicon, Somerville, New Jersey) mesh at the mid-urethral level. In 4 rats, the sham group, vaginal dissection and retropubic trocar passage was performed. In 4 rats, the composite group, no vaginal dissection was
Conclusions: In early studies, it does not appear that the composite sling model is as effective at restoring LPP in the rat model of incontinence induced by PNT. Further refinements in technique and larger numbers of procedures will help us to clarify the utility of this novel composite sling model. Disclosures: S.E. McAchran, None; U. Lee, None; M. Kavran, None; Y. Lin, None; A. Hijaz, None; F. Daneshgari, None.
Presentation Number: Poster 109 Biomechanical Changes of Vaginal Tissue In Premenopausal Women With Prolapse A. Feola,* R. Duerr, S. Abramowitch,* and P. Moalli *Musculoskeletal Research Center, Pittsburgh, PA, Magee-Womens Research Institute, Pittsburgh, PA Category: Basic Science. Objective: Little is known about the mechanical changes associated with the development of prolapse, partly due to the small size of biopsies that can be ethically obtained from humans that precludes conventional testing. Developing a biomechanical test that can utilize small biopsies would offer a means to track the development and progression of prolapse in women with minimal risk and morbidity. To this end, we developed a test in which the rheological viscous properties of premenopausal age-matched women with and without prolapse could be examined. Methods: Histologically confirmed full-thickness biopsies from the proximal 14 vagina (57 mm) were obtained from age-matched regularly cycling premenopausal women (age: 3750) with prolapse (n 6) and without prolapse (n 11). A single lap shear test was
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performed and samples were secured between a lower fixed plate and an upper plate attached to an EnduraTEC Electro-Force Mechanical Testing System (Model ELF 3200, Bose, Minnetonka, MN). Oscillating sinusoidal strains (10% at 1 Hz90 Hz) were applied and the stresses were recorded. From these data, the parameters of consistency and flow were used to describe the dynamic viscosity of the specimens. While flow (slope of the dynamic viscosity vs. rate) has been shown to be generally consistent for biological tissues, a higher consistency (y-intercept of dynamic viscosity) indicates an increased viscosity. Data was compared using a Students t-test (p 0.05). Results: The 2 groups had similar height, weight, body mass index, gravidity, and parity. Most women in both groups were in the follicular stage of the menstrual cycle. Consistency was significantly increased in vaginal biopsies from prolapsed women (403.2 162.2 Pa-s) compared to nonprolapsed women (205 133.4 Pa-s; p 0.03). As predicted, flow was similar for the prolapsed and nonprolapsed groups ( 0.81 0.05 and 0.78 0.02; p 0.21) in agreement with previous literature (Figure).
Results: None of the animals had Stage II prolapse. Typical stressstrain curves are shown in Figure 1. Both curves demonstrated nonlinear behavior with a distinct toe, linear, and failure region. The nulliparous group displayed a significantly higher tensile strength and strain energy density than the parous group (Table 1; p 0.05). Its behavior was also more nonlinear beyond 3% strain, demonstrated by the higher slope of the stress-strain curve. However, differences were not detected in the tangent modulus.
Conclusions: Rheological testing successfully identified biomechanical differences in small biopsies of vaginal tissue in women with and without prolapse. Future studies will aim to correlate these findings with biochemical data in order to help gain a better insight as to how these changes are related to prolapse. Disclosures: A. Feola, None; R. Duerr, None; S. Abramowitch, None; P. Moalli, None.
Conclusions: Parity has a distinct negative impact on the biomechanical properties of the vagina demonstrated here as a decrease in tensile strength and strain energy density. Such changes may contribute to the development and/or progression of prolapse. Disclosures: K. Jones, None; A. Feola, None; S. Abramowitch, None; P. Moalli, NIH K12HD043441 and RO1HD045590, Grant/Research Support.
Presentation Number: Poster 110 Parity Negatively Impacts the Biomechanical Properties of Vaginal Non-Human Primate Vagina K. Jones,* A. Feola, S. Abramowitch, and P. Moalli* *Magee Womens Hospital, Pittsburgh, PA, Musculoskeletal Research Center, Pittsburgh, PA Category: Basic Science. Objective: Vaginal parity is considered the leading risk factor for the development of pelvic organ prolapse. The aim of this study was to determine the impact of parity on the biomechanical properties of the vagina in the nonhuman primate. Methods: Following a modified POP Q exam, the vaginas of three nulliparous and six parous primates were harvested for uniaxial tensile testing. A longitudinal section of tissue was isolated and dissected to a dogbone shape (aspect ratio 5). Cross-sectional area was measured. Following a 0.5 N preload, a load to failure test was performed at an elongation rate of 10 mm/min. Tensile strength, ultimate strain, tangent modulus, and strain energy density were calculated. Nonparametric statistical analysis was applied.
Presentation Number: Poster 111 Peptidomic Techniques Demonstrate Alpha-1 (I) Collagen is Greater in the Urine of Subjects with Interstitial Cystitis Compared To Asymptomatic Controls M. P. Canter,* C. A. Graham, M. H. Heit, L. S. Blackwell, D. W. Wilkey, J. B. Klein and M. L. Merchant *Urogynecology and Pelvic Surgery Center, Arlington, VA, Urogynecology Specialists of Kentuckiana, Louisville, KY, Clinical Proteomics Center, University of Louisville, Louisville, KY Category: Basic Science. Objective: To use peptidomic techniques to identify differences in high abundant urinary peptides between subjects with interstitial cystitis (IC) and asymptomatic controls (AC). Methods: Women diagnosed with IC (mean voiding frequency 10 times/day, mean nocturnal voids 1, and bladder pain for six months) were recruited with age, race, and sex matched AC. All subjects volunteered a first morning voided urine. Urine specimens were dialyzed and separated into low and high molecular weight protein fractions using a 10,000 Dalton molecular weight cut-off membrane. This investigation utilized the low molecular weight protein fraction which is composed mainly of protein fragments or peptides. These peptides were concentrated and desalted using solid phase extraction methods and then analyzed by Matrix Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry (MALDI-TOF MS). These peptides were analyzed using manual spotting onto the MS target plates; an approach amiable to high abundant peptides. Positive ion MALDI-
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TOF MS mass spectra were data acquired with a mass to charge ratio (m/z) of 700 to 4000 m/z and evaluated using Principal Component Analysis, a statistical method for analysis of complex data sets. These peptide profiling methods were used to examine the detected presence of a particular peptide in each sample. Urine peptide samples that sorted into two groups were compared by statistical t-test techniques to discern peptides that were present at levels statistically different between the two groups. Peptides with a t-test probability 95% were considered candidates. Candidates underwent peptide fragmentation with MALDI-TOF-TOF MS. The resulting peptide fragments were compared to potential parent protein amino acid sequences in the Swiss-Prot database. Peptides with a total ion score 20 were considered homologous. Results: A total of 36 women were enrolled (18 IC, 18 AC). One parent protein, alpha-1 (I) collagen was found in a significantly greater concentration in the urine of IC subjects compared to AC. Conclusion: Many studies suggest that IC is a disease involving a dysfunction of the urothelium. The increased concentration of alpha-1 (I) collagen in the urine of IC subjects is consistent with these hypotheses. This finding may indicate up-regulation of collagen at the site of wound repair or inflammation-mediated collagenase break down of the extracellular matrix collagen resulting in increased permeability of the bladder and increased urinary collagen. Future studies will elucidate this mechanism and determining the sensitivity and specificity of alpha-1 (I) collagen in diagnosing patients with IC. Disclosures: M.P. Canter, None; C.A. Graham, None; M.H. Heit, None; L.S. Blackwell, None; D.W. Wilkey, None; J.B. Klein, None; M.L. Merchant, None.
Conclusions: Our murine autoimmune cystitis model has comparable functional and histological alterations to those observed in human IC, and may provide a useful model for the study of the pathogenesis and treatment of interstitial cystitis. Disclosures: G. Liu, None; Y. Lin, None; M. Kavran, None; C. Altuntas, None; G. Gasbarro, None; V. Tuohy, None; F. Daneshgari, None.
Presentation Number: Poster 112 Lower Urinary Tract Phenotype of Experimental Autoimmune Cystitis in Mouse: A Potential Animal Model for Interstitital Cystitis G. Liu, Y. Lin, M. Kavran, C. Altuntas, G. Gasbarro, V. Tuohy, and F. Daneshgari The Cleveland Clinic, Cleveland, OH Category: Basic Science. Objective: We aimed to examine the bladder function in a newly developed experimental autoimmune cystitis (EAC) model in female SWXJ strain mice, as a potential animal model for Interstitial Cystitis (IC). Methods: Twenty SWXJ female mice were divided into two groups: an EAC group immunized with mouse bladder homogenate in complete Freunds adjuvant (CFA) and a control group immunized with CFA alone. Four months after injections, bladder function of some animals (n 6) was studied with 24-hour micturition habits using metabolic cages, and conscious cystometrogram (CMG). The Bladder and lung were harvested for histological examination and assessment of Interferon-gamma (IFN- ) mRNA analysis. Results: Histology examination showed obviously thickened lamina propria, infiltration of lymphocytes, giant cells, and increased mast cells in detrusor muscle in EAC animal. The lung of EAC rat showed normal histology. IFN- mRNA expression increased significantly in the bladder, but not in the lung of EAC rat. 24-hour micturition habits measurements showed increased frequency of urination in the EAC group compared to controls. Similarly, CMG measurement showed decreased intercontraction interval and voided volume per micturition in the EAC group compared to controls. However, there were no significant differences in peak voiding pressure or total voiding volume between the EAC and control group.
Presentation Number: Poster 113 Augmentation Cystoplasty: Histological Comparison of Laboratory Made Bladder Acellular Matrix Graft Versus a Commericial Xenograft M. H. Parekh,* A. Cavanaugh, M. Wilkerson, P. Zangh and L. Rothblum *GMC, Danville, PA, GMC, Weis Center for Research, Danville, PA, GMC, Department of Pathology, Danville, PA Category: Basic Science. Objective: Bladder reconstruction or augmentation is one recommended treatment for voiding disorders. Currently, a segment of small bowel is grafted in situ for bladder augmentation. Complications include electrolyte imbalance, mucus production, stone formation, abscess, peritoneal adhesions, and malignant potential. An alternative that has been tried in animal models is the preparation of an acellular matrix from a donor bladder of the same species. This study compares bladder augmentation in a rabbit model using allograft and xenograft acellular matrices. Methods: One group of 15 rabbits had bladder augmentation with a donor allograft acellular matrix prepared from rabbit bladder after the removal of mucosa. A second group of 15 had augmentation using a commercially available xenograft prepared from porcine small bowel. The bladder from 5 animals in each group (AF) was harvested after 1, 2, and 3 months. Results: All bladders had epithelialization of the luminal aspect of the grafts, muscle had grown into the grafts and there was histologic evidence of nerves. At 3-month interval rabbits receiving allograft showed better histologic grade as compare to xenograft group, although the difference was small (see table 1).
Conclusions: These findings suggest that bladder augmentation using a donor acellular matrix may someday be an alternative to the small bowel grafting that is presently offered for treatment of a non-compliant human bladder. Further studies are needed to
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compare functional differences between the two grafts as well as longer time period for histologic normalization of augmented tissue. Disclosures: M.H. Parekh, Astellas, Speakers Bureau; A. Cavanaugh, None; M. Wilkerson, None; P. Zangh, None; L. Rothblum, None.
Presentation Number: Poster 115 Initial Experience Incorporating Robotic-Assisted Laparoscopic Sacrocolpopexy Surgery Into a Urogynecology Training Program E. S. Lukacz, and C. W. Nager UCSD, La Jolla, CA Category: Education. Objective: To describe our experience of incorporating robotic surgery in an academic urogynecology fellowship program; and to report surgical times and complications for robotic-assisted laparoscopic sacrocolpopexy (RLSC). Methods: A retrospective chart review of the first 51 robotic surgery cases scheduled by 2 fellowship-trained urogynecologists at 1 institution between July 2006 and March 2008 was performed. The first 12 cases were performed by 2 attendings while 1 attending and 1 fellow performed subsequent procedures. All RLSC procedures were performed mimicking our standard open techniques, including multiple sutures for mesh attachment to anterior and posterior vagina, 2 sacral sutures, and reperitonealization. Data collection included length of vaginal dissection, number of sutures, estimated blood loss (EBL), postoperative complications, hemoglobin, and hospital stay. Surgical times assessed included: Set up time-calculated as time in room to incision and included anesthesia induction and patient preparation, skin time-calculated as incision to close, RLSC timecalculated as skin time minus an estimated time for the additional procedures. Descriptive statistics were reported and RLSC time trends were assessed using one-way ANOVA. Results: Of the first 51 scheduled cases, 2 did not include LSC and 1 procedure was changed prior to surgical start because of a short torso preventing safe placement of ports. Of the 48 RLSC procedures, 3(6%) were converted: 1 vaginal repair due to difficult exposure of the sacrum, 1 open abdominosacrocolpopexy (ASC) due to respiratory acidosis, and 1 aborted due to a rectosigmoid injury - repaired robotically. The mean age SD (range) of the 48 subjects was 59 8 (3779) yrs and mean weight was 146 26 (104 229) lbs. Median POPQ stage was 3 (Ba 2, C 2, D 6.5, Bp 2.0). Mean times in minutes: set up 46 12 (1573), skin 302 72 (196 495), RLSC 247 53 (130 430). Mean RLSC time decreased from the first 5 to the last 5 patients in the series (320 64 vs. 202 51 min, p 0.01). Median length of dissection and number of sutures was 6 cm and #7 anteriorly, and 7 cm and #7 posteriorly. Median EBL was 100 (25350) ml. Three colpotomies and 1 cystotomy were recognized intraoperatively and repaired robotically. Postoperatively, mean hemoglobin change was 2.9 1.1 mg/dl and 1 patient received a blood transfusion for bleeding from a horseshoe kidney over the sacrum. Mean hospital stay was 1.2 0.5 (13) days. One patient was transiently admitted to the ICU for respiratory acidosis and 1 had extended admission (3 days) for electrolyte imbalance and fluid overload. Conclusions: For surgeons performing open ASC, the RLSC approach is feasible with acceptable conversion and complication rates. Operative times appear long, but there is a steep learning curve and surgical time reduces even when incorporating a fellow training experience. We anticipate that increased experience will further improve these outcomes. Long-term follow up is needed to assess the overall utility of RLSC. Disclosures: E.S. Lukacz, Pfizer, Inc., Consultant; Medtronic Corp., Consultant; Novartis Pharmaceuticals, Speakers Bureau; Proctor & Gamble Pharmaceuticals, Speakers Bureau; Intuitive Corp., Speakers Bureau; C.W. Nager, None.
Presentation Number: Poster 114 Laboratory Preparation of Acellular Matrix Graft, Augmentation Cystoplasty, from Donor Rabbit Bladder
for
M. H. Parekh,* A. Cavanaugh, M. Wilkerson and L. Rothblum *GMC, Section of Urogynecology, Danville, PA, GMC, Weis Center for Research, Danville, PA, GMC, Department of Pathology, Danville, PA Category: Basic Science. Objectives: Bladder reconstruction or augmentation is one recommended treatment for voiding disorders. Currently, a segment of small bowel is grafted in situ for bladder augmentation. Complications include electrolyte imbalance, mucus production, stone formation, abscess, peritoneal adhesions, and malignant potential. An alternative that has been tried in animal models is the augmentation with an acellular matrix graft. As these grafts were from different organs and often from different species, it may fail or produce functionally inferior neo-bladder. We modified and perfected a previously reported process for acellular matrix graft preparation to create an acellular bladder graft from frozen donor rabbit bladder. Methods: The source of normal rabbit bladder tissue was obtained commercially from PelFreez. Bladders were removed from young rabbits and immediately frozen in liquid nitrogen by the company. The frozen bladders were stored at 80 degrees F until used. Bladders were thawed in PBS containing 0.1% sodium azide. The bladders were inverted and the mucosa scrapped off with a glass slide. The remaining lamina propria and detrusor muscle were treated with 0.1M PBS (13.8 mM NaCl, 0.27 mM KCl) containing 0.1% sodium azide with gentle agitation overnight at room temperature. Bladders were then washed with PBS followed incubation with 2000 Kunitz units of DNase in 1M NaCl for overnight at room temperature. These treatments caused cell lysis and release of the cellular components. The samples were then treated with 4% sodium deoxycholate containing 0.1% sodium azide overnight at room temperature. This incubation was repeated an additional five hours. The matrix was then washed with PBS and stored in 10% neomycin sulfate at 4 degrees until used. A 20 30 mm patch was cut to perform the bladder augmentation. Results: These grafts were studied histologically to confirm acellularity and implanted in recipient rabbit bladders to perform bladder augmentation. Conclusions: It is possible to prepare an acellular matrix graft from donor rabbit bladder. When this acellular matrix bladder graft is used in situ to augment a rabbit bladder it produces a functional and histologically normal bladder. In theory, bladder acellular grafts may provide better architecture for creation of in-vivo neo-bladder compared to tissue from different source. Presented @ IUGA 2007, Cancun, Mexico. Disclosures: M.H. Parekh, Astellas, Speakers Bureau; A. Cavanaugh, None; M. Wilkerson, None; L. Rothblum, None.
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TABLE. Representative (9 of 34 reported) Procedures and Percent of Fellows Reporting Competence 1st Yr Mean Pubovaginal sling Abdominal Burch Abdominal sacrocolpopexy Sacrospinous ligament fixation Vaginal USS Apical suspension kit AR with Mesh/Graft Vaginal PVR Sphincteroplasty 3 7 12 9 17 8 12 8 2 Range 18 21 17 45 34 26 33 25 4 2nd Yr Mean 3 6 10 19 33 37 41 17 7 Range 19 34 27 128 175 317 317 136 74 3rd Yr Mean 5 4 14 25 24 23 29 12 4 Range 30 24 57 116 60 162 302 61 12 All Fellows Mean 4 6 12 19 26 26 30 13 5 % Competent 52% 76% 88% 79% 88% 60% 76% 60% 76%
Presentation Number: Poster 116 Urogynecology Fellowship Surgical Experience And SelfAssessment E. E. Weber LeBrun,* A. N. Morse,* S. P. Baker and S. B. Young,* *University of Massachusetts Medical Center, Worcester, MA, University of Massachusetts Medical School, Worcester, MA Category: Education. Objective: To determine the surgical experience within urogynecology fellowship programs and to ascertain fellows impression of their training. Methods: A pilot study based on fellows recollection of surgical cases was previously presented. 50 current or recent urogynecology fellows responded to a new online survey. Procedures completed were reported from their case logs. Trainees noted if they felt competent to perform each procedure and indicated if a surgical rotation at another institution would enhance training. The cases were weighted based on completed training-to-date. Results: Respondents-7 first, 15 second, 14 third year fellows and 6 recent graduates. Programs-93% Urogynecology FPMRS, 90% three year, 61% Board approved. Location-47% Northeast (NE), 21% Southeast (SE) and 31% West of the Appalachian Mountains (West). Yearly mean number of cases performed (Table 1). West fellows did fewer vaginal uterosacral suspensions (USS) (NE p 0.016), apical kits (NE p 0.001, SE p 0.029) and anterior repairs (AR)/posterior repairs (PR) with graft or mesh (NE p 0.002, SE p 0.005) than those in the eastern states. Accredited programs performed more abdominal Burches (p 0.002), AR with native tissue (NT) (p 0.018) and sphincteroplasties (p 0.044) and felt more competent in abdominal Burches (p 0.023), robotic USS (p 0.038), rectovaginal fistula repairs (p 0.049) and Martius transplants (MT) (p 0.014). Trainees desiring additional surgical training did fewer laparoscopic/robotic (L/R) USS (p 0.021), L/R paravaginal repairs (PVR) (p 0.025) and MT (p 0.004). They felt less competent at PVR (vaginal p 0.014, abdominal p 0.044,) and extended perineorrhaphy (p 0.048). Some third year trainees performed no traditional pubovaginal slings (3), abdominal Burches (2), sacrospinous ligament fixations (2), AR/PR with NT (1), PVR (2), sphincteroplasties (1), diverticulectomies (2) or MT (7). Less than half of fellows feel competent to perform L/R surgery and MT. 59% of all trainees desire outside surgical training. Conclusion: FPMRS surgical experience differs significantly between regions and types of programs. Trainees recognize deficiencies in their surgical training and appreciate the value of additional outside rotations.
Disclosures: E.E. Weber LeBrun, None; A.N. Morse, None; S.P. Baker, None; S.B. Young, None.
Presentation Number: Poster 117 Feasibility of Using Motion Analysis To Quantify Vaginal Surgical Skills G. B. Diwadkar, A. J. van den Bogert, M. D. Barber, and J. E. Jelovsek Cleveland Clinic, Cleveland, OH Category: Education. Objective: To determine the feasibility of applying motion analysis to vaginal surgery with the hypothesis that there are differences between novice and expert surgeons allowing for targeted areas of improvement. Methods: Videotapes were obtained from 13 vaginal hysterectomies (VH) performed by surgical trainees from post-graduate years 1 to 7. Analyses were performed using SiliconCoach Pro and Logger Pro software by a single investigator blinded to the identity of the surgeons. This analysis focused only on the specific task of clamping, transecting, and suturing the left uterosacral ligament during VH. Time, path distances, velocity, angles between instruments (retractor, needle-driver, and Heaney clamp), and trajectories of hand motion were measured. Cumulative translational motion (smoothness) and cumulative, maximum and mean velocity were calculated. These variables were compared to training level, number of VH performed, and scores on the Vaginal Surgical Skills Index and Global Rating Scales. Trainees were grouped as novice (PGY 13, N 3), intermediate (PGY-4, N 5), and expert (PGY 57, N 5). Results: When suturing the left uterosacral ligament, the angle between the vertical axis (bladder retractor) and Heaney clamp decreased with level of training: novice 124 (95% CI 108 140), intermediate 98 (CI 86 110), and expert 92 (CI 79 104) (p 0.01). Level of training had a moderate correlation with this angle (R 0.6, p 0.03), as did the number of VH performed by each trainee (R 0.7, p 0.05). The angle between the clamp and vertical axis remained constant from insertion to removal of the needle from the tissue with a difference of only 4 5. This demonstrates that clamp to retractor angle, rather than needle-driver to retractor angle, is a critical skill separating surgeon level. Cumulative translational motion and hand trajectory (Figure 1) demonstrated interesting trends with level of training.
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Conclusions: Video motion analysis is feasible to quantify surgical performance and has considerable potential as a tool for surgical education. In this feasibility study, a technique was identified, angle of the clamp during suturing, that differed between levels of experience and provides a potential area where education can be targeted. Disclosures: G.B. Diwadkar, None; A.J. van den Bogert, None; M.D. Barber, American Medical Systems, Grant/Research Support; J.E. Jelovsek, None.
prior to lecture #1 on female pelvic and perineum muscle anatomy, study subjects for lecture #1 are given access to 3D images specific to lecture #1 only. Following lecture #1, a 30 question multiple choice posttest specific to the anatomy of the female pelvis and perineum muscles is given. After completing the first lecture, and one week prior to the second lecture, study subjects for lecture #2 are given access to 3D images specific for lecture #2 (the female bony pelvis and ligaments). Following lecture #2, a multiple choice posttest containing 30 questions specific to the anatomy of the female bony pelvis and ligaments is given. The test questions were created by the investigators based upon CREOG objectives for pelvic and perineum anatomy. Out of a pool of 100 questions, 60 questions were randomly selected for the tests, with 30 questions from each subject area. The same instructor gives each of the 30 minute anatomy lectures to the residents and is blinded to which questions are asked until after both lectures are given. The pretests and post tests contain the same questions asked in different numerical order. Results: Thus far the use of 3D images of the female pelvis and perinuem along with lecture enhance residency education compared to lecture alone. Complete results will be available prior to abstract presentation. Conclusions: Understanding pelvic anatomy is both complex and essential to obstetricians and gynecologists. To date there have been studies done on using clay models, cadavers, and even virtual reality images to enhance teaching of pelvic anatomy to OBGYN residents. Cadaver labs and virtual reality programs have been shown to be helpful; however they are costly and not readily available to all OBGYN residents in training. While clay models have also been shown to be helpful, residents may be restricted to the time they can spend learning with these models due to availability. Online 3 dimensional interactive images allow individual access 24 hours a day. Residents can choose from views of the whole pelvic region or focus on specific areas including the pelvic floor, bony pelvis, and pelvic ligaments. Layers of anatomy can be viewed from skin to bone and the models rotated at any stage to view and identify any anatomical structure. The use of these interactive online 3 dimensional anatomy programs along with formal lecture on the subject of pelvic anatomy can greatly enhance resident education. Disclosures: N.P. Bhatia, None; J. Hutchinson-Colas, None; C. Ananth, None.
Presentation Number: Poster 118 Teaching Pelvic Anatomy to Obstetrics And Gynecology Residents: the Benefits of Using 3 Dimensional Online Interactive Images of the Pelvis and Perineum N. P. Bhatia, J. Hutchinson-Colas, and C. Ananth UMDNJ/Robert Wood Johnson Medical School, New Brunswick, NJ Category: Education. Objective: To determine whether using online interactive 3dimensional images along with lecture is more effective than lecture alone when teaching female pelvic anatomy to OBGYN residents. Methods: A randomized, controlled, prospective study of 22 OBGYN residents at our institution is being conducted. After taking a pretest containing 60 questions on female pelvic anatomy, residents are randomized to either the study or subject group for each of the two lectures. Controls for lecture #1 are study subjects for lecture #2, and study subjects from lecture #1 are controls for lecture #2. One week
Presentation Number: Poster 119 Evaluating Patient Learning After an Educational Program on Incontinence and Pelvic Prolapse R. Geoffrion, M. Robert, S. Ross, D. VanHeerden, G. Neustaedter, S. Tang, and J. Milne University of Calgary, Calgary, AB, Canada Category: Education. Objective: Conservative interventions such as pelvic floor muscle exercises (PFME), bladder training, fluid intake or dietary modifications and weight loss are mainstays of initial therapy for pelvic floor symptoms. Despite growing evidence in support of these self-care strategies, they are often performed sporadically. Womens awareness of pelvic floor health remains limited. To enhance patient and general public access to pelvic health information, we implemented a 2.5-hr workshop run by a nurse continence advisor several times a month. There is some evidence to suggest that focused patient education can positively impact knowledge, quality of life, pelvic symptoms and PFME performance. The objective of the current study was to evaluate participant knowledge regarding pelvic floor
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issues before, immediately after and 3 months after our workshop. Related quality of life and symptoms were also evaluated before and 3 months after our workshop. Methods: We used a prospective cohort design. All women who registered for our workshop between April 2007 and January 2008 were mailed an introductory letter and invited to participate. A convenience sample of 50 participants was chosen. Before the workshop, women provided demographic data and information on pelvic floor symptoms. They also completed a knowledge questionnaire, developed based on workshop material, before, immediately after and 3 months after the workshop. Conditionspecific, validated symptom and quality of life questionnaires (PFDI20, PFIQ-7) were completed before and 3 months after the workshop. To minimize the confounding impact of additional information or care, women who had individual appointments with a pelvic floor health care professional in the 3 month follow-up interval were excluded. Descriptive statistics and paired t-tests were used for data analysis. Results: 125 women consented to participate. Complete 3-month follow-up data were available for 50 women. 51% of initial recruits were excluded because of additional interventions in the 3 months following the workshop. Response rate for questionnaire completion at 3 months was 83%. Characteristics of the 50 study participants were as follows: mean age 62 (SD 11); 47 (94%) Caucasian; 32 (64%) higher education; 27 (54%) had UI, majority stress predominant (20,38%). 44 (88%) had prolapse symptoms. Knowledge scores significantly improved from baseline immediately after the workshop (p 0.001, 95% CI 6.37.6) and at 3 months (p 0.001, 95% CI 3.75.6). Symptom and quality of life scores significantly improved from baseline at 3 months (PFIQ: p 0.004, 95% CI 4.321.5; PFDI: p 0.001, 95% CI 9.8 29.9). Differences were most marked for the bladder subscales of the PFIQ-7 and PFDI-20. Conclusions: Womens pelvic floor health knowledge and symptoms significantly improved after our workshop. This study provides adequate evidence in support of our decision to offer this workshop in rural or outlying areas and to strongly recommend attendance for all patients referred to our clinic. Disclosures: R. Geoffrion, None; M. Robert, None; S. Ross, Boston Scientific, J&J, unrelated grants, Grant/Research Support; D. VanHeerden, None; G. Neustaedter, None; S. Tang, None; J. Milne, None.
Cincinnati, OH). The gynecologic procedures evaluated were: total abdominal hysterectomy (TAH), total vaginal hysterectomy (TVH), laparotomy, incontinence/pelvic floor surgery, operative laparoscopy, hysteroscopy, cervical conization, and surgical sterilization. Our analysis considered each institution and its residents separately. The total number of each procedure performed by residents graduating in 2007 was compared to those of residents graduating in 2003. We also compared the numbers of each procedure performed as the primary surgeon. The mean number of procedures performed during their residency was compared between those graduating in 2003 and 2007. The mean difference in number of procedures was defined as the mean number performed by 2007 graduates minus the mean number performed by 2003 graduates. All comparisons were analyzed using a two-sided, two-sample t-test with a type I error level of 5%. Results: In the year 2003, Mayo Clinic and Good Samaritan Hospital each had 4 residents graduate. In the year 2007, Mayo Clinic had 3 residents graduate and Good Samaritan Hospital had 4 residents graduate. At Mayo Clinic, 2007 graduates logged significantly less cervical conizations than 2003 graduates (p 0.006). This was also seen for the number of cervical conizations logged as primary surgeon (p 0.013). At Good Samaritan Hospital, 2007 graduates logged significantly more surgical sterilizations (p 0.001). The same findings were seen for the number of sterilizations (p 0.001) in which the 2007 graduate was the primary surgeon. Conclusions: We observed little impact on the number of gynecologic surgeries performed by residents since the implementation of duty-hour restrictions. There were no significant differences in the number of the abdominal hysterectomies or vaginal hysterectomies performed by residents. Graduates in 2007, from the institutions we evaluated, performed fewer conizations and more sterilizations when compared to 2003 graduates. Institution numbers can impact resident surgical experience and may be partially responsible for the differences found. Those who opposed the duty-hour restrictions believed that limiting work hours would negatively affect resident surgical experience; however, our study does not support this. Further investigation is warranted to more completely evaluate this topic. Disclosures: J.A. Occhino, None; T. Hannigan, None; M.S. Baggish, None; J.B. Gebhart, None.
Presentation Number: Poster 120 Duty-Hour Restrictions and their Effect on Resident Operative Experience in Obstetrics and Gynecology J. A. Occhino,* T. Hannigan, M. S. Baggish and J. B. Gebhart* *Mayo Clinic, Rochester, MN, Good Samaritan Hospital, Cincinnati, OH Category: Education. Objective: Our objective was to determine the effect of duty-hour restrictions on the operative experience of obstetrics and gynecology residents. Methods: We compared operative numbers of gynecologic surgeries between 2 groups of residents: those graduating residency in 2003 (entire residency completed without duty-hour restrictions) and those graduating residency in 2007 (entire residency completed with dutyhour restrictions). Residents operative numbers were obtained from two separate, midwestern institutions, one academic (Mayo Clinic, Rochester, MN) and one community-based (Good Samaritan Hospital,
Presentation Number: Poster 121 Do we Know the Literature? Trends in Publication of Urogynecology Research in Obstetric and Gynecology Journals M. T. McLennan, A. C. Steele, and F. Leong St. Louis University, St. Louis, MO Category: Education. Objective: Urogynecology has experienced many changes over the past 10 years: accredited fellowship status; proposed boards; innovations in treatment of incontinence/prolapse; new medical therapies all resulting in increased interest in the field. One would therefore hypothesize that the number of publications in the Ob/Gyn literature would increase during this time. The goal of this study was to determine the numbers and types of urogynecology publications in the American Journal of Obstetrics & Gynecology (grey) and Obstetrics & Gynecology (green) over time. Methods: All original scientific articles in the grey and green journal from 1996 2007 were reviewed. Articles were classified into the following categories: obstetrics; gynecology; oncology; urogynecology;
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ultrasound; education. Trends over time were assessed. Urogynecology articles were categorized into one of 14 types: epidemiology; anatomy; basic science; surgery for USI; surgery for POP for example. Results: A total of 10,192 articles (6,153 in grey and 4039 in green) were published and evaluated. The breakdown was: 5874 obstetrics; 2086 gynecology; 776 urogynecology; 591 oncology; 454 education; 396 ultrasound. The percentage of urogyn articles in the grey journal varied from 2.46% in 1999 to 16.10% in 2005 and from 4.04% in 1999 to 10.63% in 2001 for the green. In the grey journal, two clear trends were noted: the percentage of urogyn articles increased (correlation with year r 0.845; p 0.05) and the percentage of Ob articles decreased (negative correlation r 0.589; p 0.05). There appeared to be two time points where a sharp increase in average percentage of urogyn articles occurred: between 2000 2001 (4.26% vs. 9.53%) and 2004 2005 (6.65% vs. 16.1%). This appears to correspond to the acceptance for publication of AUGS meeting presentations in 2001 and publication of combined SGS and AUGS in 2005. Overall for the green journal, the number of urogyn articles increased with time with a strong positive correlation of r 0.743; p 0.05. Similar to the grey, there was a jump in the percentage of urogyn articles published from 2000 2001 (6.91% vs. 10.63%) but not quite as strong in 2004 2005 (8.8% vs 10.36%). The most common type of article published was in epidemiology (187/776, 24%) followed by anatomy (15%), surgery for POP (13.4%), surgery for USI (11.8%), testing (11.7%), and basic science (7%) with pharmaceutical therapy at 0.7%. Epidemiology had a strong correlation with year of publication (r 0.817 and 0.688; p 0.05). Conclusions: The numbers of urogynecology articles published in the general Ob/Gyn literature has increased with time. Trends towards increasing publication appear to be related to presentation at national meetings. Types of publications reflect desire for understanding of the scope and nature of problems within the specialty and do not appear to be in response to industry or pharmaceutical advances at this time. Disclosures: M.T. McLennan, GSK, Speakers Bureau; A.C. Steele, Boston Scientific, Paid Instructor; F. Leong, Astellas, Speakers Bureau.
peri-operative variables. Logistic regression was used to identify independent risk factors for peri-operative complications. Results: Five hundred sixty-five patients were identified. Four hundred seventy-three patients met inclusion criteria. The mean age of patients was 50 15 (range 1394). Seventy-eight percent were white, 13% were African-American, and 8% were other minorities. Patients had a mean BMI of 29.2 6.8 (range 17 62) and a median Charlson Comorbidity Index of 0 (range 0 6). Surgery was performed using the vaginal approach in 51.1% of patients, laparoscopic approach in 32.4%, abdominal approach in 4.2%, and a combined approach in 12.3%. The primary surgical assistant was a resident in 40.8%, physician assistant in 24.1%, the referring attending in 24.3%, and no assistant in 10.8%. Of the 51 cases when no assistant was used, 40 were mid-urethral slings. Regardless of type of surgical assistant, there was no difference in length of surgery for laparoscopic sacral colpopexy (p 0.59), laparoscopic hysterectomy (p 0.48), laparoscopic excision of advanced endometriosis (p 0.08), laparoscopic prolapse or incontinence surgery (p 0.51), or all nonminor surgeries (p 0.11). Abdominal approach was an independent risk factor regardless of surgical assist for a peri-operative complication (OR 6.78, 95% CI 2.4 19.1). Younger age was mildly protective against a peri-operative complication (OR .969, 95% CI 0.95 0.99). Conclusion: In this study, surgical assistant is not an independent risk factor for increased surgery time or peri-operative complication. Disclosures: K.J. Stepp, Medtronic, Grant/Research Support; Covidien, Consultant; Cooper Surgical, Consultant; Immersion Medical, Consultant; Covidien, Speakers Bureau; A. Dharmani, None; C. Wilkins, None; M. Uy-Kroh, None.
Presentation Number: Poster 122 Influence of Resident, Attendings, or Physician Assistants As Surgical Assistants in Benign Gynecologic and Urogynecologic Surgeries K. J. Stepp, A. Dharmani, C. Wilkins, and M. Uy-Kroh MetroHealth Medical Center/Case Western, Cleveland, OH Category: Education. Objective: To determine the effect that type of surgical assistant has on operative time and peri-operative complications in benign gynecologic and urogynecologic surgery. Methods: IRB exempt status was confirmed. A retrospective chart review of patients who underwent urogynecologic or gynecologic surgery by the principle investigator between July 2005 and February 2008 was performed. Type of surgical assistant was identified as resident, attending, or physician assistant. In general, residents and attendings performed at least 50% of the surgical procedure except for advanced urogynecologic procedures. Demographics, comorbidities, and intraoperative and post-operative ( 6 weeks) complications were recorded. Patients with minor general gynecologic, primary oncologic or colorectal surgeries, and sacral neuromodulation were excluded. Charlson Comorbidity Index was calculated to summarize the patients overall perioperative risk. Analysis was performed including and excluding minor vaginal urogynecologic procedures. Chi-Square, Fishers exact test, and ANOVA were used to compare surgical assistant, type of surgery, and
Presentation Number: Poster 123 Security of Different Surgical Knots Used for Cuff Closure in a Vaginal Hysterectomy Model S. Balgobin, C. A. Hamid, M. D. Ruff, S. A. Brown, and C. Y. Wai University of Texas Southwestern Medical Center, Dallas, TX Category: Education. Objective: Knot security and tying technique have been identified as etiologic factors for dehiscence and evisceration after vaginal hysterectomy. Many techniques have been described for vaginal cuff closure using different types of surgical knots. The objective of this study was to compare the strength and integrity of 3 different types of sliding knots commonly used to close the cuff during vaginal hysterectomy. Methods: A bench model was constructed to simulate surgical knottying during cuff closure following vaginal hysterectomy. Using synthetic absorbable braided 0 0 polyglactin suture (Vicryl, Ethicon, Somerville, NJ), non-identical sliding (NS), parallel sliding (PS), and loop-to-strand sliding (LTS) knots with four throws each were tested. One faculty surgeon wearing surgical gloves and blinded to the study objective was instructed to tie 15 of each different type of knot on the model for a total of 45 sets of knots. A random number table was used to determine the sequence of the type of sliding knots tied. The surgeon was observed for proper technique and each set of knots was examined microscopically to confirm configuration. Another faculty surgeon, unblinded to the study objective, repeated the protocol for an additional 45 sets of knots. Knot tails were trimmed to 3 mm and the loops were divided opposite the knots. After presoaking in 0.9% NaCl for 60 seconds, knots were distracted at 50 mm/min using an Instron tensiometer
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until knot failure, defined as slippage beyond 3 mm or knot rupture. The maximum load required to cause slippage or rupture and the mode of failure were recorded. Maximum failure loads for each knot type were expressed as the mean SEM. Statistical analysis was performed using analysis of variance with P-values of 0.05 considered statistically significant. Results: A total of 90 sets of knots were tied and the results were pooled. Mean SEM failure loads for NS, PS, and LTS knots were 5.1 1.4 Newtons (N), 42 1.1 N, and 6.8 1.5 N, respectively. PS knots were significantly stronger than either the NS or LTS knots (p 0.05), with no difference in failure strength between NS and LTS knots. While almost all the NS (97%) and LTS (97%) knots failed by slippage, 97% of the PS knots failed by rupture at the knot site. These differences were similar when the data were stratified according to surgeon, with the PS knots failing at a significantly higher force than either the NS or LTS knots (p 0.05). There were no statistically significant differences in the strengths of each knot type tied between the two surgeons. Conclusions: Parallel sliding knots using 0-vicryl knots with four throws are significantly stronger than non-identical sliding and loop-to-strand sliding knots when subjected to tension under experimental conditions and should be considered when closing the cuff during vaginal hysterectomy. Disclosures: S. Balgobin, None; C.A. Hamid, None; M.D. Ruff, None; S.A. Brown, None; C.Y. Wai, None.
PTs were excluded from participation. Questions addressed professional (entry-level, post-professional, and continuing) education in PFM dysfunction (hours, types of diagnoses, types of assessments discussed and practiced); and current type of assessments used in physical therapy practice. Descriptive statistics were used to examine the data. Results: Two hundred and three (n 203) PTs completed the survey (17.3% response rate). There appears to be increasing exposure to PFM dsyfunction in entry level professional education with 55.4% of subjects reporting some discussion of the topic. Seven subjects reported practicing the vaginal palpation of the PFM in their entry level education. The most common method of learning PFM examination is post professional continuing education (96.1%). One hundred and twenty eight (128, 62.1%) of subjects reported more than nine days of continung education in PFM therapy. Most students practice on class mates (84.5%). Physical therapists specialized in PFM dysfunction provided the majority of this edcuation (99%). Most PTs used vaginal palpation (73.9%) and perineal observation (68.5%) to examine the PFM. Conclusion: Most PTs are receiving instruction in PFM examination in post professional continuing education courses and most are using vaginal palpation to examine the muscles. Documentation of current US physical therapy practice allows comparision with other professions in the US and other PTs around the world. In addtion, future studies may show changes in practice patterns and educational methods. Disclosures: E.R. Shelly, None.
Presentation Number: Poster 124 Methods Used by Physical Therapists to Learn Pelvic Floor Muscle Examination E. R. Shelly Beth Shelly PT, Bettendorf, IA Category: Education. Objective: To investigate current methods by which physical therapists (PTs) in the United States learn how to perform pelvic floor muscle (PFM) examination. Treatment of PFM dysfunction is a growing specialty in physical therapy. There is no scientific evidence that identifies the methods by which PTs learn to perform PFM examination. Method: One thousand one hundred and seventy five (N 1,175) womens health PTs were invited to participate in a 38 question webbased survey that had been validated using four content experts. Subjects were solicited from the APTA Section on Womens Health, BCIA EMG courses, and personal PT contacts. All students, PTAs and international
Presentation Number: Poster 125 Combined Effects of Behavioral Intervention and Tolterodine In Subjects Dissatisfied with their Previous Overactive Bladder Medication K. Burgio,* J. Wyman, C. Klutke, Z. Guan, F. Sun, K. Rivera, S. Berriman, and T. Bavendam *Birmingham/Atlanta Geriatric Research, Birmingham, AL, University of Minnesota, Minneapolis, MN, Washington University School of Medicine, St. Louis, MO, Pfizer Inc., New York, NY Category: Overactive Bladder. Objective: To assess the effect of tolterodine extended release (TER) in conjunction with behavioral intervention on treatment satisfaction and clinical outcomes in subjects with overactive bladder (OAB) who were dissatisfied with their most recent antimuscarinic therapy.
TABLE. PFM Examination Techniques Practiced by PTs in Different Education Programs Entry-Level Professional Education None Examination of the PFM by observation of perineal mobility Examination with vaginal and or rectal palpation by the therapist EMG biofeedback assessment with intravaginal sensor EMG biofeedback assessment with external sensor Assessment with real-time ultrasound Pressure biofeedback assessment Assessment of pelvic floor muscle pain 2008 Lippincott Williams & Wilkins 78 (85.7%) 7 (7.7%) 7 (7.7%) 10 (11%) 8 (8.8%) 0 (0%) 5 (5.5%) 6 (6.6%) Post-Professional College Education 19 (36.5%) 30 (57.7%) 29 (55.8%) 28 (53.9%) 26 (50%) 5 (9.6%) 18 (34.6%) 26 (50%) Post-Professional Continuing Education 3 (1.4%) 193 (95%) 195 (96.1%) 184 (90.6%) 160 (78.8%) 21 (10.3%) 79 (38.9%) 174 (85.7%)
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Methods: Eligible subjects (men and women, aged 18 y) in this 16week, multicenter, single-arm, open-label study reported dissatisfaction with their prior antimuscarinic OAB medication; had a mean of 8 micturitions, 1 urgency urinary incontinence (UUI) episode, and 2 urgency-related micturitions per 24 hours in a 5-day bladder diary at baseline; and had self-reported OAB symptoms for 3 months. All subjects received TER plus self-administered behavioral intervention (educational handouts and counseling) for 8 weeks. Satisfied subjects continued on the same program, and dissatisfied subjects received TER plus individualized therapy (clinic-based pelvic floor muscle training with tailored behavioral techniques) for an additional 8 weeks. Endpoints were the proportion of subjects who were at least a little satisfied with treatment at weeks 8 and 16, the proportion dissatisfied with treatment at week 8 who became satisfied at week 16, and changes from baseline in OAB symptoms at weeks 8 and 16. Results: Among subjects dissatisfied with previous TER or other antimuscarinic therapy, 92% and 90%, respectively, were at least a little satisfied with TER plus behavioral intervention at week 16; 70% and 59%, respectively, were very satisfied (Table). Among subjects dissatisfied with treatment at week 8, 76% became satisfied at week 16. At 8 and 16 weeks, all groups reported improvements in total micturitions and UUI episodes per 24 hours compared with baseline (paired t test, P 0.0001).
Conclusion: TER plus behavioral intervention resulted in high treatment satisfaction and improved symptoms in subjects with OAB who were previously dissatisfied with antimuscarinic therapy, even among those who were dissatisfied with previous TER therapy. Further research is needed to delineate the contribution of self- and clinician-administered behavioral intervention in the context of drug therapy. Prior Presentation: SUNA 2008. Disclosures: K. Burgio, Investigator Pfizer Inc., Other; J. Wyman, Pfizer Inc., Consultant; Investigator Pfizer Inc., Other; C. Klutke, Pfizer Inc., Consultant; Lecturer Pfizer Inc., Other; Z. Guan, Employee Pfizer Inc., Other; F. Sun, Employee Pfizer Inc., Other; K. Rivera, Pfizer Inc., Consultant; S. Berriman, Employee Pfizer Inc., Other; T. Bavendam, Employee Pfizer Inc., Other.
Objective: Attempts to measure urgency are confounded by difficulties in understanding its definition and the context of the normal urge to void. This may be partly due to the controversy surrounding the term urgency and possibly also because there is no widely available, validated, clinical tool with which we can evaluate the severity of urgency symptoms and related bother. The objective of this study was to develop a validated, clinically useful, patient-oriented questionnaire to assess urgency and associated life impact. Methods: After IRB approval we interviewed 6 urogynecologists and urologists and 10 patients with overactive bladder (OAB) symptoms about urinary urgency, methods to evaluate its severity, and its effect on patients everyday lives. Based on this data, we composed the first draft of our Urgency Severity and Impact Questionnaire (USIQ). A focus group of OAB patients completed and provided feedback on the USIQ draft. The revised questionnaire has two parts: symptom severity (USIQ-S) and related quality of life (USIQ-QOL). The questionnaire was given to patients clinically diagnosed OAB or with urodynamically confirmed Urodynamic Stress Incontinence (USI), Detrusor Overactivity Incontinence (DOI) to establish face, content and discriminatory validity. Fifty three women with a mean age of 56 (29 87) years participated in this study. Most participants were Caucasian (87%). Item Reduction: All items had a good loading scores ranging from 0.48 to 0.85 (Table 1). Internal consistency for the USIQ-S and USIQQOL as measured by Cronbachs alpha was excellent; 0.85 and 0.90 respectively. USIQ-S and USIQ-QOL scores moderately correlated (r 0.69, p 0.001), thus supporting the association between the two parts of the questionnaire. Criterion Validity: USIQ-QOL, which measures the effect of urgency on HRQOL, correlated with existing, validated HRQOL questionnaires; UDI-6 (r 0.49, p 0.001), IIQ-7 (r 0.77, p 0.001) and OAB-q (r 0.73, p 0.001). Similar correlations were found between the USIQ-S and UDI-6 (r 0.34, p 0.02), IIQ-7 (r 0.42, p 0.002) and OAB-q (r 0.73, p 0.001). Except for a strong inverse correlation between USSBQ-QOL and the volume at which patients had strong desire to void (r 0.81, p 0.015), neither USIQ -S nor USIQ-QOL scores correlated with other urodynamic parameters. Discriminant Validity: Mean USIQ-QOL and USIQ-S scores differed by clinical diagnosis. OAB patients had higher mean USIQ-S and USIQQOL scores than patients with USI (66 18 vs. 34 24, p 0.001 and 48 22 vs. 19 25, p 0.005, respectively). The area under the ROC curve, which was used to assess urgency discrimination, was 0.87 and 0.82 for USIQ-S and USIQ-QOL, respectively. Conclusions: This new questionnaire has an excellent internal consistency, good construct, face and discriminatory. The USIQ is an easily-understood questionnaire with adequate validity for use in research and in clinical practice to describe the severity and life impact of urinary urgency. Disclosures: L. Lowenstein, Pfizer, Grant/Research Support; Astellas, Grant/Research Support; M. FitzGerald, Pfizer, Grant/Research Support; Allergan, Grant/Research Support; Medtronic, Grant/Research Support; K. Kenton, Pfizer, Grant/Research Support; Allergan, Grant/Research Support; L. Hatchet, None; R. Durazo-Arvizu, None; K. Goldman, None; L. Brubaker, Allergan, Grant/Research Support; Pfizer, Grant/Research Support; Q Med, Grant/Research Support.
Presentation Number: Poster 126 Evaluation of Urgency with a Validated Urgency Severity and Impact Questionnaire (USIQ) L. Lowenstein, M. FitzGerald, K. Kenton, L. Hatchet, R. DurazoArvizu, K. Goldman, and L. Brubaker, Loyola Medical Center, Chicago, IL Category: Overactive Bladder.
Presentation Number: Poster 127 Continuous Measure of Lower Urinary Tact Sensation During Bladder Filling in Women with Detusor Overactivity L. Lowenstein,* T. Pham,* S. Abassy,* K. Kenton,* K. Kenton,* L. Brubaker,* E. Mueller,* Y. Vardi, I. Gruenwald and M. FitzGerald*
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*Loyola Medical Center, Chicago, IL, Rambam Medical Center, Haifa, Israel Category: Overactive Bladder. Objectives: Clinicians and clinical investigators express increased interest in direct measures of lower urinary tract (LUT) sensation to supplement information from bladder diaries, symptom questionnaires and routine urodynamic testing. An instrument that allows patients to continuously report their LUT sensation in real time during urodynamic testing provides an opportunity to study the relationship between changes in sensation and other urodynamic events. The objective of this analysis was to describe the temporal relationship between increases in LUT sensation measured in real time and changes in detrusor and/or urethral pressures. Methods: We reviewed 33 multichannel urodynamic tracings that included a continuous recording of LUT sensation and that demonstrated detrusor overactivity incontinence (DOI) or detrusor overactivity (DO). For each urodynamic tracing reviewed, we evaluated each detrusor contraction. For this analysis, we considered an episode of DO or DOI to be present if a phasic detrusor contraction with an elevation of at least 5 cm H2O over baseline occurred. We considered a rise in LUT sensation as present if the sensation reading increased by at least 5 units. We defined a fall in urethral pressure as when the urethral pressure decreased by at least 10%. Four physician-urodynamicists reviewed the tracings separately and together reached agreement about each data-point. Results: The median age of the 33 patients was 60 (36 82) years. Fourteen (42%) had urodynamic diagnoses of mixed incontinence, 18 (55%) had DOI, and 1(3%) had DO without DOI. We reviewed 119 episodes of detrusor overactivity from the 33 recordings. The number of DO/DOI episodes per UDS recording ranged from 19, with a median of 3 episodes. We found no difference in change in sensation level when comparing DO episodes with DOI episodes or between different urodynamic diagnosis (p .5). There was no dominant temporal pattern seen for the whole group (p 0.84) i.e. there was no evidence that the change in sensation level was more likely to occur before, during, or after DO/DOI episodes. Interestingly when evaluating the temporal relationship between the onset of change in sensation recording and change in urethral pressure, the most common pattern seen was an increase in sensation level after a fall in urethral pressure. For each patient, the temporal relationship between DO/DOI episodes and changes in LUT sensation was also variable. Conclusions: Using real-time recordings of LUT sensation, we closely examined the temporal relationships between observed urodynamic events and LUT sensation. We found tremendous variability in those relationships. Importantly, we found that increases in sensation level commonly precede increases in detrusor pressure and/or changes in urethral pressure implying that at least some of the time, increased LUT sensation during DO/DOI is not caused by measurable alterations
in bladder or urethral pressure. Possibly, another event triggers increased urinary urgency at those times. Disclosures: L. Lowenstein, Astellas, Grant/Research Support; Pfizer, Grant/Research Support; T. Pham, None; S. Abassy, None; K. Kenton, Pfizer, Grant/Research Support; K. Kenton, Pfizer, Grant/Research Support; Allergan, Grant/Research Support; L. Brubaker, Pfizer, Grant/Research Support; Q Med, Grant/Research Support; Allergan, Grant/Research Support; E. Mueller, Allergan, Grant/Research Support; Pfizer, Grant/Research Support; Y. Vardi, None; I. Gruenwald, None; M. FitzGerald, Pfizer, Grant/Research Support; Medtronic, Grant/Research Support; Allergan, Grant/Research Support.
Presentation Number: Poster 128 Impact of Antimuscarinics on Mean Heart Rate Evaluated in a Randomized, Double-Blind, Placebo-Controlled, 3-Way Crossover Trial B. Olshansky,* U. Ebinger, J. Brum, M. Egermark and L. Rekeda, *University of Iowa Hospitals, Iowa City, IA, Novartis Pharmaceuticals Corporation, East Hanover, NJ, Procter and Gamble Pharmaceuticals Corporation, Cincinnati, OH, Novartis Pharma AG, Basel, Switzerland Category: Overactive Bladder. Objective: Antimuscarinic drugs (AMDs) for overactive bladder (OAB) may differ in their potential to increase heart rate (HR) via effects on cardiac M2 muscarinic receptors. A faster resting HR has been associated with increased risk of cardiovascular (CV) events and death,1 raising concerns for OAB patients who tend to be older, to have CV comorbidities and to be taking comedications.2 This is the first head-to-head analysis of the effects of once daily darifenacin 15 mg (DAR) and tolterodine ER 4 mg (TOL) on HR over 24 hours (h) under steady-state conditions. Methods: A prospective, double-blind, double-dummy, 3-way crossover study in healthy volunteers ( 50 years) randomized to 1 of 6 treatment sequences with DAR, TOL and placebo (PBO) over three 7day study periods, preceded by 14-day washouts. HR was assessed via 24-h Holter monitoring at baseline and end of each study period. Between treatment effects were measured using analysis of covariance with drug, study period and subject as main effects and baseline value as covariate.
1 2
Fox K et al. J Am Coll Cardiol 2007;50:82330. McGrother CW et al. Age Ageing 2006;35:16 24.
TABLE. Adjusted Mean Change from Baseline ( ) in Mean HR at the End of Each Study Period HR Parameter (bpm) Mean HR over 24 h A Mean HR in first 8 h Change from Baseline Adjusted Mean DAR TOL PBO 0.388 0.876 1.450 2.283 0.029 0.291 Treatment Comparison DARTOL DARPBO TOLPBO DARTOL DARPBO TOLPBO Treatment difference (95% Confidence Interval) 1.84 0.42 1.42 3.16 1.17 1.99 ( 2.68, 1.00) ( 1.26, 0.42) (0.59, 2.25) ( 4.56, 1.75) ( 2.58, 0.25) (0.59, 3.39)
p value 0.0001 0.3280 0.0009 0.0001 0.1056 0.0054
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Results: Of 162 randomized subjects (mean 58 years, 70.4% women), 140 completed all 3 study periods. TOL significantly increased mean HR/24 h vs PBO. DAR did not affect HR/24 h vs PBO but decreased HR vs TOL Table . The proportion of subjects with an increase of 5 beats per minute (bpm) in mean HR/24 h was significantly greater with TOL compared to DAR (25% vs 8.9%; p 0.0004, McNemar test) or PBO (26.5% vs 12.8%; p 0.0114). Greatest treatment effect (vs PBO) occurred at times close to Tmax for each drug: at 5 h for tolterodine (increase of 3.89 bpm) and at 7 h for darifenacin (decrease of 2.24 bpm). Post-hoc analyses showed numerically more pronounced changes from baseline in mean HR during the first 8 h than over the whole 24-h interval Table . The most common adverse event was dry mouth (12.5% DAR, 3.3% TOL, 3.3% PBO). There were no deaths or serious adverse events. Conclusion: TOL but not DAR causes an increase in mean HR. Thus, careful consideration may be warranted when prescribing AMDs to OAB patients who may have an increased susceptibility to the negative effects of increased HR. Disclosures: B. Olshansky, Novartis Pharmaceuticals Corporation, Consultant; U. Ebinger, Novartis Pharmaceuticals Corporation, Shareholder; Employee, Novartis Pharmaceuticals Corporation, Other; J. Brum, Procter and Gamble Pharmaceuticals Corporation, Shareholder; Employee, Procter and Gamble Pharmaceuticals Corporation, Other; M. Egermark, Novartis Pharma AG, Shareholder; Employee, Novartis Pharma AG, Other; L. Rekeda, Employee, Novartis Pharmaceuticals Corporation, Other.
W. He *Urogynecology Associates of Philadelphia, Media, PA, Advanced Urogynecology, Cincinnati, OH, Clinical Research of West Florida, Inc, Clearwater, FL, GlaxoSmithKline, King of Prussia, PA, Astellas Pharma US, Inc., Deerfield, IL Category: Overactive Bladder. Objective: Urgency is widely recognized as the cardinal symptom of OAB. The VESIcare Efficacy and Safety in PatieNts with Urgency Study (VENUS) is the first large US-based trial to focus on reduction in urinary urgency in OAB patients, using both objective and subjective patient-reported outcomes (PROs). Here we report a post hoc analysis of VENUS evaluating the efficacy of solifenacin in the subgroup of patients with severe OAB at baseline. Methods: VENUS was a randomized, double-blind, placebocontrolled, 12-week study of solifenacin (5 or 10 mg/day, flexible dosing) in OAB patients. The primary endpoint was mean change from baseline to study end in urgency episodes/day using 3-day bladder diaries. Secondary endpoints included mean changes in all other diary-recorded OAB symptoms (Table), and median change in warning time (WT; time from first sensation of urgency to voiding). PROs including the Indevus Urgency Severity Scale (IUSS), Urgency Perception Scale (UPS), Patient Perception of Bladder Condition (PPBC) scale, and Overactive Bladder Questionnaire (OAB-q) were also assessed. Results: In total, 158 (22%) patients had severe OAB (PPBC score 5 1 no problems, 6 many severe problems) in the full analysis set (FAS; n 707). Solifenacin reduced mean urgency episodes/day in the severe subgroup, similar to the significant improvements (p 0.0001) observed in the FAS vs placebo (Table). Patients with severe OAB also showed reductions in daily micturitions and incontinence vs placebo comparable to the significant reductions seen in the FAS. Patients in the severe subgroup showed improved scores on IUSS and UPS (urgency-related PROs), and there were improvement trends in WT, PPBC scale, and OAB-q vs placebo of comparable magnitude to
Presentation Number: Poster 129 Patients with Severe Overactive Bladder Symptoms: Impact of Solifenacin on Urgency and other symptoms M. Toglia,* M. Karram, C. Laramee, S. Forero-Schwanhaeuser, and
TABLE. Severe Subgroup Solifenacin Baseline (Change*) n 84 7.9 ( 4.6) 12.1 ( 2.9) 4.5 ( 3.3) 1.8 ( 0.6) 2.2 ( 0.7) 99.0 (23.0) 2.4 ( 1.2) 1.8 (0.5) 5.2 ( 2.1) 69.5 ( 41.1) 40.9 (35.6) Placebo Baseline (Change*) n 74 7.9 ( 3.1) 12.7 ( 2.4) 4.2 ( 2.1) 1.9 ( 0.8) 2.5 ( 0.9) 52.0 (9.0) 2.5 ( 0.8) 1.6 (0.4) 5.2 ( 1.3) 71.3 ( 25.5) 38.4 (25.2) VENUS FAS Placebo Baseline Solifenacin Baseline (Change*) n (Change*) n 357 350 6.2 ( 3.9) 11.7 ( 2.7) 2.8 ( 2.1) 1.7 ( 0.6) 2.0 ( 0.7) 67.8 (31.5) 2.0 ( 0.9) 2.0 (0.4) 3.8 ( 1.0) 52.4 ( 28.0) 60.4 (22.6) 6.0 ( 2.73) 11.7 ( 1.9) 2.6 ( 1.2) 1.6 ( 0.5) 2.0 ( 0.6) 65.0 (12.0) 2.0 ( 0.5) 2.0 (0.2) 3.9 ( 0.6) 51.5 ( 18.5) 60.5 (17.2)
Parameter Urgency episodes/d Micturitions/d Incontinence episodes/d Nocturia episodes/d Nocturnal voids/d WT (sec) IUSS score UPS score PPBC score OAB-q symptom bother score OAB-q overall HRQoL score
p-value 0.0001 0.001 0.0001 0.208 0.191 0.05 0.0001 0.002 0.0001 0.0001 0.001
*Adjusted mean change from baseline. Based on the comparison between treatment groups for the change from baseline in the FAS (p-values not reported for the severe subset owing to the post hoc nature of the analysis and small sample size). Negative score change indicates improvement. Median. FAS full analysis set; d day; WT warning time; IUSS Indevus Urgency Severity Scale; UPS Urgency Perception Scale; PPBC Patient Perception of Bladder Condition; OAB-q Overactive Bladder Questionnaire; HRQoL health-related quality of life.
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those seen in the FAS. Treatment-emergent adverse events (AEs) were mostly mild/moderate, and there were few AE-related discontinuations (severe subgroup: solifenacin 4.5%, placebo 6.5%; FAS: solifenacin 6.5%, placebo 4.6%). Conclusions: Although patient numbers were small, in those with severe OAB, solifenacin-associated improvements in urgency and other OAB symptoms, as assessed using diary records and PROs, were of comparable magnitude to the significant improvements observed in the VENUS FAS. Disclosures: M. Toglia, Astellas, Consultant; GlaxoSmithKline, Consultant; Ethicon Womens Health, Consultant; Ortho McNeil, Consultant; Astellas, Speakers Bureau; Ethicon Womens Health, Speakers Bureau; Ortho McNeil, Speakers Bureau; Ethicon Womens Health, Paid Instructor; M. Karram, Astellas, Grant/Research Support; Gynecare, Grant/Research Support; American Medical Systems, Grant/Research Support; Pfizer, Grant/Research Support; Allergan, Grant/Research Support; Gynecare, Consultant; Astellas, Consultant; Cooper Surgical, Consultant; C. Laramee, Astellas, Consultant; GlaxoSmithKline, Consultant; S. Forero-Schwanhaeuser, Employee GlaxoSmithKline, Other; W. He, Employee - Astellas Pharma US Inc., Other.
events (AEs) were dry mouth (23%) and constipation (5%); most AEs (94%) were of mild or moderate severity. No serious AEs were deemed treatment related. Conclusions: In this open-label study FESO significantly improved OAB symptoms, treatment satisfaction, PPBC, bother, and HRQL in subjects previously treated and dissatisfied with TOL 2 y prior to study. About 50% of subjects opted for the 8-mg dosage. FESO was well tolerated.
Disclosures: E. Goldfischer, Pfizer Inc., Consultant; J.J. Wyndaele, Pfizer Inc., Consultant; J.D. Morrow, EmployeePfizer Inc., Other; J. Gong, Employee - Pfizer Inc., Other; L.J. Tseng, Employee - Pfizer Inc., Other; M.S. Choo, Pfizer Inc., Consultant.
Presentation Number: Poster 130 Effects of Fesoterodine on Symptom Relief and Patient Satisfaction In Subjects With Overactive Bladder E. Goldfischer,* J. J. Wyndaele, J. D. Morrow, J. Gong, L. J. Tseng, and M. S. Choo *Hudson Valley Urology, P.C., Poughkeepsie, NY, Universitiet en Universitair Ziekenhuis Antwerpen, Antwerp, BELGIUM, Pfizer Inc., New York, NY, University of Ulsan College of Medicine, Seoul, Republic of Korea Category: Overactive Bladder. Objective: To assess whether flexible-dose fesoterodine (FESO) improves overactive bladder (OAB) symptoms, treatment satisfaction, and health-related quality of life (HRQL) measures in subjects previously treated and dissatisfied with tolterodine (TOL). Methods: In this 12-week, open-label, single-arm, flexible-dose study, adults reported 8 micturitions and 3 urgency episodes per 24 h in 5-day baseline diaries and dissatisfaction with TOL or TOL extended release received 2 y prior to study. Subjects received FESO 4 mg QD for 4 weeks; this was maintained or increased to 8 mg, based on efficacy and tolerability as assessed by subject and investigator. Subjects recorded micturitions, urgency urinary incontinence (UUI) episodes, and rated micturition-related urgency on the 5-point Urinary Sensation Scale (1 no urgency, 5 UUI) in 5-day diaries at baseline and week 12; urgency and severe urgency episodes were rated 3 and 4, respectively. Subjects completed the validated Treatment Satisfaction Question at week 12 and the Patient Perception of Bladder Condition (PPBC) and Overactive Bladder Questionnaire (OAB-q) at baseline and week 12. Mean changes from baseline were assessed using paired t test. Results: Among 516 subjects, 90% completed the study; about 50% opted for dose escalation to 8 mg at week 4. At week 12, micturitions (mean change, 3.0), UUI episodes ( 1.7), urgency episodes ( 5.0), and severe urgency episodes ( 3.5) per 24 h were significantly improved (p 0.0001; Table). 80% of subjects reported treatment satisfaction at week 12, including 38% very satisfied. Mean PPBC scores were significantly improved (p 0.0001) at week 12; 83% reported improvement and 59% reported 2 point improvement. OAB-q Symptom Bother and HRQL scale and domain scores were all significantly improved (p 0.0001). The most common adverse
Presentation Number: Poster 131 Satisfaction with Darifenacin Treatment for Overactive Bladder (Oab) in Patients Dissatisfied with Prior Antimuscarinic Therapy N. Zinner,* K. C. Kobashi, U. Ebinger, P. Koochaki, A. Luthra, G. Ligozio and M. Egermark *Western Clinical Research, Inc., Torrance, CA, Virginia Mason Medical Center, Seattle, WA, Novartis Pharmaceuticals Corporation, East Hanover, NJ, Procter and Gamble Pharmaceuticals Corporation, Cincinnati, OH, Novartis Pharma AG, Basel, Switzerland Category: Overactive Bladder. Objectives: Patient-reported outcome (PRO) tools provide important assessments of treatment benefits. We evaluated patient satisfaction with treatment benefits received from darifenacin (DAR) in OAB patients dissatisfied with prior extended-release (ER) oxybutynin (OXY) or tolterodine (TOL) treatment. Methods: This was a 12-week, open-label study in DAR-na adults ve ( 18 years), with OAB symptoms for 6 months, dissatisfied with prior OXY-ER or TOL-ER treatment. Following a 2-week screening and 1-week baseline period, patients received DAR 7.5 mg once daily (o.d.) for 2 weeks, then were offered up-titration to 15 mg o.d., with stable dose thereafter. The primary efficacy variable was the change from baseline to Week 12 (or last visit) in the Patients Perception of Bladder Condition (PPBC), a validated PRO tool.1 Satisfaction was measured with the Patient Satisfaction with Treatment Benefit (PSTB) questionnaire, a new PRO measure consisting of a global question on overall satisfaction (Part I) and 23 questions (Part II) on satisfaction with DAR for improving specific problems associated with OAB that patients report. Results: 500 patients enrolled, 497 were treated (mean age 60.9 years, 84.1% women) and 437 completed the study. PPBC scores improved significantly from baseline to treatment end (median: 4.0 to 3.0, mean SD: 4.5 0.77 to 3.1 1.25). This corresponds to a change in the PPBC scale from my bladder causes me some moderate/severe problems to my bladder causes me some minor problems. Results did not differ significantly between patients previously treated with OXY ER vs TOL ER. 405 (85.6%) respondents to the PSTB questionnaire Part I were at least somewhat satisfied with DAR treatment at last visit. Satisfaction
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was more frequently reported by women than men (87.2% vs 77.0%), but did not differ significantly between age groups (87.0% vs 83.7% 65 vs 65 years) or prior antimuscarinic treatment groups (84.1% vs 86.8% OXY ER vs TOL ER, respectively). PSTB Part II questions showed that satisfaction with DAR for specific benefits including reduced the number of times I urinated during the day (85% patients satisfied), gave me more time between visits to the bathroom (83.6% satisfied), and reduced how often I felt a sudden urge to urinate (84.4% satisfied) was very high. The most common adverse events were dry mouth (20.1%) and constipation (14.1%), infrequently leading to discontinuation (1.6% and 0.8% patients, respectively). Conclusions: Patients with OAB dissatisfied with previous antimuscarinic treatments, OXY ER or TOL ER, reported significant improvement in their bladder condition and a high level of satisfaction with treatment benefits when treated with a flexible-dose regimen with darifenacin (7.5/15 mg o.d.). Physicians may want to consider alternative antimuscarinic therapies when patients report being dissatisfied with their prescribed therapy. References: 1. Coyne KS et al. Eur Urol 2006;49:1079 86. Disclosures: N. Zinner, Allergan, Eli Lilly, Esprit, Glaxo SmithKline, Indevus, Novartis, Pfizer, and Watson, Consultant; K.C. Kobashi, Novartis, Astellas, and Coloplast, Consultant; U. Ebinger, Novartis Pharmaceuticals Corporation, Shareholder; Employee, Novartis Pharmaceuticals Corporation, Other (please specify type of relationship and company name); P. Koochaki, Employee, Procter and Gamble Pharmaceuticals Corporation, Other (please specify type of relationship and company name); A. Luthra, Employee, Novartis Pharmaceuticals Corporation, Other (please specify type of relationship and company name); G. Ligozio, Employee, Novartis Pharmaceuticals Corporation, Other (please specify type of relationship and company name); M. Egermark, Novartis Pharma AG, Shareholder; Employee, Novartis Pharma AG, Other (please specify type of relationship and company name).
Nyberg and Urinary Incontinence Treatment Network *Loyola University Chicago, Maywood, IL, New England Research Institute, Watertown, MA, University of Alabama at Birmingham, Birmingham, AL, University of Texas Southwestern Medical Center, Dallas, TX, University of Pittsburgh, Pittsburgh, PA, University of Texas, San Antonio, IL, **University of Utah, Salt Lake City, IL, University of California, San Diego, IL, Beaumont Hospital, Detroit, MI, University of Maryland, Baltimore, MD, NDDK, Bethesda, MD, NIDDK, Bethesda, MD Category: Overactive Bladder. Objective: To determine a scientifically sound definition of mixed urinary incontinence (MUI) in trial participants randomized to fascial sling vs. Burch colposuspension. Methods: Participants were assessed at baseline using standardized baseline measures including the Medical, Epidemiologic and Social Aspects of Aging (MESA), the Urogenital Distress Inventory (UDI), a three-day urinary diary and urodynamic studies (UDS). Eligibility at baseline required participants to have a MESA stress subscale score MESA urge subscale score. Several different definitions for mixed incontinence using these baseline measures were explored and tested against the clinical outcome. At 24 months post surgery, treatment success was based on a composite measure (negative stress test, no SUI retreatment, reduction in MESA stress symptoms, incontinence episodes on voiding diary and pad weight) Logistic regression analysis was used to estimate the association between this outcome and MUI. All analyses were carried out using the personal computer version of SAS statistical software (SAS Institute, Inc, Cary, NC. Version 9.1). Statistical significance was defined by a p-value 0.05. Results: Of the 655 participants, the proportion of women with MUI varied substantially according to the definition of MUI used, ranging from 93.3% to 8.3% (Table 1). All definitions were associated with severity as measured by the frequency of incontinence episodes at baseline; however very little of the variability was explained by any definition. No strict cut-off value for these baseline measures was identified by ROC analysis to predict clinical outcomes. Conclusions: As currently defined, mixed incontinence definitions do not adequately categorize clinically relevant UI subgroups. Use of the UDI and MESA categorized nearly all participants of this surgical trial into mixed category. Given the high prevalence of this condition in a surgical
Presentation Number: Poster 132 Mixed Incontinence: Comparing Definitions In Women Having Stress Incontinence Surgery L. Brubaker,* A. Stoddard, H. E. Richter, P. Zimmern, P. Moalli, S. Kraus, P. Norton,** E. Lukacz, L. Sirls, H. Johnson, L.
TABLE. Definition of Mixed Incontinence Based on MESA, UDI and UDS Definition MESA Questionnaire Low threshold MUI definition: any answer 1 on urge subscale (rarely, sometimes, quite a bit): Intermediate threshold MUI definition: Total urge score 2 (Urge index 11%): High threshold MUI definition: any answer 2 (Sometimes, quite a bit): Ratio (MESA score converted to a percentage based on the number of items) UDI Questionnaire Low threshold MUI definition: No to QC2, or Yes to QC2 and No to QC3 or Response to QC3a not at all Intermediate MUI definition: UDI Irritative Symptom Scale 20 Urodynamics Stress (N, %) Pure Stress 44 (6.7%) Stress predominant 116 (17.7%) Stress predominant 134 (20.5%) Pure stress 44 (6.7%) Stress predominant 281 (42.9%) Pure Stress 254 (39%) Stress predominant 114 (17.5%) USI 91.7% MUI (N, %) 611 (93.3%) 539 (82.3%) 521 (79.5%) Mixed 330 (50.4%) 397 (61%) Mixed 538 (82.5%) USI and DO 8.3% 2008 Lippincott Williams & Wilkins
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population, a scientifically sound and clinically relevant definition is needed. Disclosures: L. Brubaker, Pfizer, Allergan, Grant/Research Support; A. Stoddard, None; H.E. Richter, Pfizer, Grant/Research Support; P. Zimmern, None; P. Moalli, None; S. Kraus, None; P. Norton, None; E. Lukacz, None; L. Sirls, None; H. Johnson, None; L. Nyberg, None; &. Urinary Incontinence Treatment Network, None.
symptom severity and whether a patient responds to various treatments. Future studies are warranted to evaluate if more aggressive treatment of HPDO will lead to better control of OAB symptoms and improved quality of life. Disclosures: T.L. Gamble, None; S.O. Aschkenazi, None; A. Nguyen, None; V. Rivas, None; H. Du, None; S.M. Botros, None; R.P. Goldberg, Boston Scientific, Grant/Research Support; Boston Scientific, Consultant; Boston Scientific, Speakers Bureau; P.K. Sand, Boston Scientific, AMS, Speakers Bureau; Allergan, Astellas, Boston Scientific, Grant/Research Support; Coloplast, AMS, Indevus, Consultant.
Presentation Number: Poster 133 The Association of Detrusor Overactivity Pressure with Overactive Bladder Symptom Severity and Urge Urinary Incontinence T. L. Gamble,* S. O. Aschkenazi,* A. Nguyen,* V. Rivas, H. Du, S. M. Botros,* R. P. Goldberg* and P. K. Sand* *Evanston Northwestern Healthcare/ Northwestern University Feinberg School of Medicine, Evanston, IL, Northwestern University, Evanston, IL, Center for Outcomes Research and Education Evanston Northwestern Healthcare, Evanston, IL Category: Overactive Bladder. Objective: To evaluate the relationship between detrusor overactivity (DO) pressure and overactive bladder (OAB) symptom severity and its impact on urge urinary incontinence (UUI). Methods: All female patients attending a single tertiary uroygnecologic referral center between 6/058/05 and diagnosed with detrusor overactivity on urodynamic testing were included. High Pressure DO (HPDO) was defined as an involuntary detrusor contraction with a maximum rise from baseline exceeding 40 cm H2O. Subjects with and without HPDO were compared with regards to OAB symptoms, presence of UUI severity, Urodynamic Stress Urinary Incontinence (USUI), and response to various treatments. In univariate analysis, continuous covariates were compared using two sample test (independent t or Wilcoxon). Pearsons Chi-square or Fishers exact test was used to assess the association between categorical covariates and HPDO. Parameter estimates (odds ratios and 95% confidence intervals) were obtained using logistic regression with the maximum likelihood method in both univariate and multivariable analysis. Two-tailed alpha of 0.05 was used as the significance level. Results: DO was diagnosed in 383/551 women (70%) with 17% having HPDO. Mean age (range) was 63 (1889); BMI 28 (1547) cm/m2, and parity 3 (04 ). No significant differences were found in age, parity, or BMI between women with with HPDO versus women whose DO pressure was 40 cm H2O. Univariate analysis revealed that UUI episodes per week tended to be more prevalent in the HPDO group compared to 40 cm H2O (21.4 vs. 13.6, p .064). Patients with DO pressures of 40 cmH2O were significantly less likely to have improvement with treatment (p 0.003), more likely to have more severe UUI ( 21 episodes per week) (p 0.002) and less likely to have USUI (p 0.001). Marginal significant differences in urgency (p 0.055) and nocturia (p 0.062) were also noted. After controlling for age, BMI, cystocele Stage II, hysterectomy, post void residual 100 cc, and UTI, HPDO was directly associated with urgency, frequency, and nocturia. Women with HPDO were significantly more likely than those without HPDO to have 21 UUI episodes per week (Odds Ratio (OR): 2.23, 95% Confidence Interval (CI): 1.744.24, p 0.015). Women with HPDO were also significantly less likely to have USUI (OR: 0.29, 95% CI: 0.160.53, p 0.001) or improvement with antimuscarinics, behavioral therapy, and/or prolapse surgery (OR: 0.47, 95% CI: 0.250.89, p 0.020). Conclusions: High pressure Detrusor Overactivity was significantly associated with more severe OAB symptoms and a less favorable response to treatment. DO pressure can be a useful indicator of OAB
Presentation Number: Poster 134 Difference in Quality of Life In Women with Urge Urinary Incontinence Compared to Women with Stress Urinary Incontinence M. O. Schimpf, M. Patel, D. M. O Sullivan, and P. K. Tulikangas Hartford Hospital, Hartford, CT Category: Overactive Bladder. Objective: Urinary incontinence has been shown to negatively impact quality of life, and worsening severity of incontinence has been correlated with worsening quality of life (QOL) scores. Due to the unpredictability of urge urinary incontinence (UUI) and the potential for large-volume urine loss, this condition can be socially debilitating. We evaluated whether women with UUI have lower QOL than women with other forms of incontinence. Methods: Patients coming to the Division of Urogynecology from 7/1/06 8/31/07 prospectively completed the Pelvic Floor Distress Inventory (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7) and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). Based on their responses, women were divided into four groups: those with symptoms of stress urinary incontinence (SUI), UUI, both SUI and UUI (mixed UI), and neither SUI nor UUI (controls). Statistical comparisons used analysis of variance with post hoc Scheffes test. All results yielding p 0.05 were deemed statistically significant using SPSS v.14.0. Results: A total of 465 women were included in the analyses: 53 women with UUI (11.4%), 101 with SUI (21.7%), 200 with mixed UI (43%) and 111 controls (23.9%). The mean PFIQ bladder scale scores were 17.07 for controls, 22.31 for SUI, 32.67 for UUI, and 36.83 for mixed UI. This was a statistically significant difference (p 0.001). There was no significant difference between the controls and SUI patients, although there was between controls and UUI (p 0.009) and mixed UI (p 0.001). Individually, all seven questions in the PFIQ bladder domain were significantly different by group type (p 0.001). Patients with UUI were significantly more impaired than control patients for entertainment, travel, ability to socialize, emotional health and feelings of frustration. UUI patients also reported a significantly lower rate (p 0.001) of sexual activity (37.3% UUI vs. 79.8% SUI vs. 71% mixed UI vs. 64.1% controls). UUI patients were older (mean 62.58 years); there was a statistically significant difference in age between the four groups (p 0.006). Otherwise, there were no significant differences between the groups for number of pregnancies, history of forceps use, number of vaginal or cesarean deliveries, largest birth weight, prior hysterectomy/bladder surgery/other pelvic surgery, or current/prior smoking. Conclusions: Women with UUI and mixed UI have lower QOL scores than women without incontinence or with only SUI. Women with UUI also report lower rates of sexual activity.
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Disclosures: M.O. Schimpf, None; M. Patel, None; D.M. OSullivan, None; P.K. Tulikangas, None.
Presentation Number: Poster 135 Correlation Between Improvements in Incontinence Pad Usage, Bladder Diary Variables, and Health-Related Quality of Life Measures in Sexually Active Women Treated for Overactive Bladder R. Rogers,* M. Gurule,* F. Sun, J. T. Wang, T. Bavendam, and J. D. Morrow *Univ of New Mexico School of Medicine, Albuquerque, NM, Pfizer Inc., New York, NY Category: Overactive Bladder. Objective: To investigate the association between improvements in incontinence pad usage and improvements in bladder diary variables and health-related quality of life (HRQL) measures in sexually active women with overactive bladder (OAB) and urgency urinary incontinence (UUI) treated with tolterodine extended release (TER). Methods: A post hoc analysis was conducted using data from a double-blind, placebo (PBO)-controlled trial. Eligible women had selfreported OAB and UUI for 3 mo; recorded 8 micturitions per 24 h, including 3 urgency-related micturitions and 0.6 UUI episodes per 24 h, in 5-day bladder diaries at baseline; reported at least some moderate bladder-related problems; and were sexually active and in a heterosexual relationship for 6 mo. Subjects randomized to TER or PBO completed 5-day bladder diaries, pad counts, and the Overactive Bladder Questionnaire (OAB-q), which includes a Symptom Bother scale and a HRQL scale with 4 domains, at baseline and week 12. Associations between week 12 changes in incontinence pad usage and changes in bladder diary variables and OAB-q scores were assessed by Pearson correlations. Results: A total of 411 subjects were randomized and received study treatment (TER, n 201; PBO, n 210). The median percentage reduction in UUI episodes from baseline to week 12 was significantly greater in the TER group vs PBO (100% vs 82.5%; p 0.0003); 57% of subjects receiving TER reported no UUI episodes in 5-day diaries at week 12 compared with 42% of subjects receiving PBO (p 0.0039). Total micturitions, urgency-related micturitions, and all OAB-q scales and domains were significantly improved in the TER group vs PBO (all p 0.05). Incontinence pad usage by TER-treated subjects was significantly decreased at 12 weeks vs PBO (LS mean change, 1.5 vs 1.0 pads/day; p 0.0024). Among subjects who used pads at baseline, the proportion of subjects who reported no pad use during the week 12 diary period was significantly higher in the TER group (28.2%) than in the PBO group (12.1%; P 0.0004). Moderately sized but statistically significant positive correlations were observed between reductions in incontinence pad usage and improvements in bladder diary variables (total micturitions, |r| 0.350; urgency-related micturitions, |r| 0.448; UUI episodes, |r| 0.421; all p 0.0001) and between reductions in pad usage and improvements in all OAB-q scales and domains (Symptom Bother, |r| 0.331; total HRQL, |r| 0.339; Concern, |r| 0.319; Coping, |r| 0.289; Sleep, |r| 0.303; Social Interaction, |r| 0.268; all p 0.0001). Conclusion: TER significantly improved bladder diary variables and HRQL and reduced symptom bother and incontinence pad usage in sexually active women with OAB and UUI vs PBO. Reductions in pad usage were significantly correlated with improvements in bladder diary variables and OAB-specific measures of symptom bother and HRQL. Reduced pad usage likely contributes to improvements in HRQL and reduced bother in patients with OAB and UUI treated with TER.
Disclosures: R. Rogers, Pfizer Inc., Consultant; M. Gurule, None; F. Sun, EmployeePfizer Inc., Other (please specify type of relationship and company name); J.T. Wang, EmployeePfizer Inc., Other (please specify type of relationship and company name); T. Bavendam, EmployeePfizer Inc., Other (please specify type of relationship and company name); J.D. Morrow, EmployeePfizer Inc., Other (please specify type of relationship and company name).
Presentation Number: Poster 136 Sexual Dysfunction: Women in an Inner City Population B. L. Worly, M. Gopal, and L. Arya University of Pennsylvania, Philadelphia, PA Category: Quality of Life. Objectives: The prevalence and risk factors for female sexual dysfunction in inner city women has not been reported. Our primary aim was to assess the prevalence of sexual dysfunction in inner city women reporting to a resident GYN clinic. Secondarily, we investigated risk factors that are associated with sexual dysfunction in this population. Methods: We used a descriptive cross section study design. 102 consecutive women reporting to an urban GYN clinic were enrolled in this study. Women were included if they were sexually active. Exclusion criteria were women with neurologic disease, pregnancy and women unwilling to participate in the study. All women were administered the Female Sexual Function Index (FSFI), Center for Epidemiologic Studies Depression Questionnaire (CES-D), a Partner Sexual Function Questionnaire (Partner), the Revised Life Orientation Test (LOT-R), and Question for Urinary Incontinence Diagnosis (QUID). Demographic data and a health information survey were also collected. Female Sexual Dysfunction was defined as a FSFI score less than 27. Data was analyzed using univariate and multivariate techniques. Results: The prevalence of sexual dysfunction in our population was 37%. Mean age was 30 11.3 and mean BMI was 27.6 6. The specific aspects of sexual dysfunction reported were lack of desire (100%), problems with the arousal phase (100%), insomnia (53%), difficulty with orgasm (97%), decreased lubrication (97%), decreased satisfaction (97%), and dyspareunia (100%). On univariate analysis, women reporting sexual dysfunction were significantly more likely to be older, taking antidepressant medications (OR 2.3, 95% CI 1.1, 4.9), were currently unemployed (OR 0.4, 95% CI 0.2, 0.9), experienced urge incontinence (OR 2.5, 95% CI 1.03, 6.2), and had lower levels of optimism (OR 6.2, 95% CI 3.3, 9.1) than women not reporting sexual dysfunction. The following partner related factors were also associated with sexual dysfunction: erectile dysfunction (OR 0.2, 95% CI 0.1, 0.9), and initiation of sexual intimacy by the woman (OR 14.2, 95% CI 2.7, 76.4). Women with a history of depression, prior hysterectomy and diabetes had elevated risk of sexual dysfunction but did not reach significant levels. On multivariate analysis, significant risk factors for sexual dysfunction were age (OR 1.3, 95% CI 1.1, 1.6), erectile dysfunction (OR 0.2, 95% CI 0.1, 0.8), initiation of sexual intercourse by the woman (OR 4.8, 95% CI 1.2, 18.9), and low levels of optimism (OR 0.5, CI 0.3, 1.0). Conclusion: Sexual dysfunction is common in an urban, inner city population. Contributing factors include mental health issues, unemployment and partner sexual function. This information suggests the need for increased awareness and routine screening for sexual dysfunction in this population. Disclosures: B.L. Worly, None; M. Gopal, None; L. Arya, None.
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Presentation Number: Poster 137 Global Assessment of Recent Stress In Women with Pelvic Floor Disorders S. O. Aschkenazi, T. Gamble, A. Nguyen, A. Ching, S. Botros, P. K. Sand, and R. P. Goldberg Northwestern University, Feinberg School of Medicine, Evanston, IL Category: Quality of Life. Objective: To assess the relationship between current stress in women with pelvic-floor symptoms, as well as depressive symptoms, sexual dysfunction and/or pelvic bladder pain, all entities related to pelvic floor dysfunction. Methods: This was a cross-sectional survey administered to 354 sister-twins attending a annual twin-gathering in 2007. Identical and fraternal twins participated and scores compared. Demographic data and self-report, validated questionnaires were completed, including: Global Assessment of Recent Stress (GARS) Scale, Pelvic Floor Distress Inventory-20 (PFDI-20), the Modified Dysfunctional Voiding Scoring System (DVSS) for assessment of childhood voiding dysfunction, Beck Depression Inventory-II, the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and the Pain and Urgency/Frequency symptom scale (PUF). The GARS scale is a validated questionnaire allowing respondents to appraise the overall feeling of stress. Respondents are asked to rate 7 areas of their lives on a line with ten rating points for amount of stress. The eighth item is an overall global rating of stress. The GARS has high acceptability being simple to use, short and very uniform in its scoring system. The BDI-II was administered to assess depressive symptoms using a cutoff of 13. The PUF scale evaluates bladder-origin pelvic pain, assessing urinary urgency/frequency, pelvic pain and sexual dysfunction. A cut-off score of 15 was used. Sexual function was assessed by the PISQ-12. Mixed effects linear models for clustered data were used for group comparisons on summary scores, and generalized estimating equations were used for comparisons of categorical measures. Spearman correlation coefficients were calculated. Results: There were 354 women enrolled, with 256 (72%) identical-, and 98 (28%) fraternal twins. Of these, 290 questionnaires were complete for analysis (82%). All demographics were similar in all subgroups and were adjusted for. No differences in stress levels were noted between identical and fraternal twins. There was a highly significant correlation between the total mean scores of all the questionnaires and the total GARS stress scale scores (p-value 0.002 to 0.0001, spearman coefficient, 0.22 0.37), as well as with the final global stress item assessing overall level of pressure (p-value 0.009 to 0.0001, spearman coefficient, 0.24 0.32). Conclusions: This study demonstrated that pelvic floor disorders and related entities including, painful bladder, depression and sexual dysfunction are significantly associated with elevated stress levels measured by a validated scale, not only in specific areas of life, but most importantly, affecting the overall global level of perceived stress. Identifying high-stress responders among women with pelvic floor disorders using the GARS scale can improve treatment directed to stress-reduction, with better success rates, functionality and overall quality of life. Disclosures: S.O. Aschkenazi, None; T. Gamble, None; A. Nguyen, None; A. Ching, None; S. Botros, None; P.K. Sand, Boston Scientific, AMS, Indevus, Estella;, Consultant; R.P. Goldberg, Boston Scientific, Paid Instructor.
Presentation Number: Poster 138 A Modification of the Duration Subscale of the Brink Scale T. Gregory,* S. Hamilton Boyles, M. Denman,* R. Edwards,* V. King,* T. Worstell,* and A. Clark* *Oregon Health & Science University, Urogynecology & Reconstructive Pelvic Surgery, Portland, OR, Urogynecology Associates, Portland, OR Category: Quality of Life. Objective: Recently, the Brink scale showed poor correlation to pelvic floor symptom questionnaires in a multicenter study. We sought to determine if expanding the maximum number of seconds in the duration subscale would improve its correlation to symptom and pelvic muscle evaluation tools. Methods: Our study is a secondary analysis of a prospective cohort study of primigravid women who underwent evaluation during the 3rd trimester and at 2 weeks postpartum. At each visit, subjects completed questionnaires: Sandvik urinary incontinence scale; Urinary Distress Inventory (UDI-6) and Urinary Incontinence Impact Questionnaires (IIQ-7); the Fecal Incontinence Severity Index (FISI) and the Fecal Incontinence Quality of Life Index (FIQL). Examiners blinded to the questionnaires, but not to pregnancy status, evaluated pelvic floor muscle function by the Brink scale and maximum perineometer pressures. In addition to the published duration subscale of the Brink scale, we recorded the actual number of seconds (ANS) that a participant maintains peak pressure. Means and frequency distributions for the baseline evaluations were determined. Based on the distribution curve of ANS, 2 new duration subscales were proposed. Spearman correlations were performed. For those subjects who had completed a 2-week postpartum exam, we additionally performed paired t-tests or Wilcoxon tests. Results: We performed baseline evaluations on 127 women. 59% reported any urinary incontinence. The mean FISI score was 7.6 (SD 9.8) with 66% of the subjects reporting FI to gas at least once monthly. The displacement and pressure subscales of the Brink scale were normally distributed, whereas the duration was skewed toward the maximum score. The mean scores for the subscales were 2.7 ( SD 0.9), 2.9 (SD 0.7) and 3.3 (SD 0.7) for displacement, pressure and duration subscales respectively. Respective correlations to perineometer pressures were r 0.5, r 0.6, r 0.4 (all p 0.001). The 2 alternative duration subscales were normally distributed, however the means were statistically similar to the original. The Sandvik score correlated to the displacement and pressure subscales, (r 0.4, p 0.001), but not to the original or the 2 proposed duration scales. Neither the FISI nor the FIQL correlated to the Brink scale. In 103 women who have undergone 2-week postpartum exams, the changes in pressure, displacement and original duration subscales from antepartum values were 0.5, 0.5 and 0.65 (all p 0.001). In contrast, the 2 proposed alternative duration subscales changed by 0.1 (p 0.7) and 0.2 (p 0.3). Conclusions: Correcting the skewed distribution of the duration subscale of the Brink scale does not improve its symptom correlation. In fact, these modifications may decrease the responsiveness of the scale to change. To improve correlation to pelvic floor symptoms, additions, rather than simple modification, may be needed. Disclosures: T. Gregory, Intuitive Surgical, Consultant; S. Hamilton Boyles, None; M. Denman, Depuy. Spouse is Paid Instructor, Other (please specify type of relationship and company name); R. Edwards, Pfizer, Speakers Bureau; V. King, None; T. Worstell, None; A. Clark, None.
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Presentation Number: Poster 139 Normative Data for Commonly used Validated Pelvic Floor Disorder Questionnaires in Women Presenting for Routine Gynecologic Care without Prolapse J. L. Lowder, C. Ghetti, P. Moalli, R. Ellison, and H. Zyczynski Division of Urogynecology, Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, PA Category: Quality of Life. Objective: To report measures of central tendency for the Pelvic Floor Distress Inventory (PFDI) questionnaire, Pelvic Floor Impact Questionnaire (PFIQ), and the Pelvic Organ Prolapse-IncontinenceSexual Function Questionnaire (PISQ)-12 in women presenting for routine gynecologic care without pelvic organ prolapse. Methods: This is a secondary analysis of 67 women who participated as controls in an IRB approved case-control study of the Body Image in Pelvic Organ Prolapse. Controls were recruited from a general gynecology office. Inclusion criteria for control participants included: 1) Presenting complaint for evaluation could not be symptoms of incontinence or prolapse; 2) Answered NO to both of the following questions: A) Do you usually have a sensation of bulging protrusion from the vaginal area? B) Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? 3) Pelvic Organ Prolapse Quantification (POPQ) examination stage I; 4) No history of surgery for prolapse or incontinence. Means, medians, standard deviations, and ranges were determined for the PFDI, PFIQ, and PISQ12. Demographics were reported for the study population. Results: Mean age of controls were 54 8 years (Range: 40 75 years), mean Body Mass Index was 29 10, 93% were Caucasian, 5% AfricanAmerican, 91% non-smokers, 59% self-declared as post-menopausal, and 24% had a hysterectomy. The majority had POPQ stage I (64%) and mean leading edge of prolapse was 2 .6 cm. Questionnaire results listed in Table 1. Reliability testing with Cronbachs was performed for each of these measures in this population: PFDI ( .930), PFIQ ( .978), and PISQ-12 ( .469). Conclusions: Knowledge of normative data for existing pelvic floor symptoms questionnaires in women with no or minimal pelvic floors symptoms is important so we can better assess outcomes after reconstructive surgery and determine if previously symptomatic women return to symptom scores consistent with non-symptomatic women.
Disclosures: J.L. Lowder, None; C. Ghetti, None; P. Moalli, None; R. Ellison, None; H. Zyczynski, Johnson and Johnson Home Products, Ethicon Womens Health and Urology, Grant/Research Support.
Presentation Number: Poster 140 Psychometric Validation of the Kings Health Questionnaire in Patients with Overactive Bladder in the United States K. S. Coyne,* M. K. Margolis,* V. Vats, and C. Kelleher *United BioSource Corporation Center for Health Outcomes Research, Bethesda, MD, Pfizer Inc., New York, NY, St. Thomas Hospital, London, United Kingdom Category: Quality of Life. Objective: This study assesses the content and psychometric validity of the Kings Health Questionnaire (KHQ) in patients with overactive bladder (OAB) in the United States. Methods: Data from a multicenter, double-blind, placebo-controlled, randomized trial of patients with OAB in the United States were analyzed to assess the psychometric properties of the KHQ. Mean baseline scores, internal consistency reliability, discriminant validity, effect size, and standard error of mean were calculated. General linear models were used to compare KHQ mean change scores from baseline to end of therapy at 12 weeks by change category, controlling for site, age, treatment group, and baseline visit KHQ subscale score. Content validity was assessed in a stand-alone study. One-on-one interviews were conducted with patients with OAB to obtain feedback about the KHQ, including instructions, items, and response options. Content and descriptive analyses were used for content validity. Results: 798 patients were included in the analysis. Mean age was 58.9 13.1 years; 82% of the participants were white and 76% were women. Cronbach alpha values ranged from 0.64 0.91 at baseline to 0.72 0.93 at week 12. Mean scores on each subscale improved significantly from baseline to week 12 (p 0.0001). Among the 9 subscales, 8 (Incontinence impact, Role limitations, Physical limitations, Social limitations, Personal relationships, Emotions, Sleep/energy, and Incontinence severity measures; Exception: General health perceptions) significantly discriminated between patients who perceived a worsening or no change in his or her condition (n 291) from baseline to week 12 vs those who perceived an improvement (n 371, all p 0.0001). Among the 9 subscales, 8 (General health perceptions, Incontinence impact, Role limitations, Physical limitations, Social limitations, Emotions, Sleep/energy, and Incontinence severity measures; Exception: Personal relationships) significantly discriminated between patients who were not satisfied with treatment (n 352) vs those who were satisfied (n 324, all p 0.05). The Severity Measures subscale consistently discriminated between patients who reported worsened or no change in micturition variables in bladder diaries from baseline to follow-up vs those that reported an improvement. The Sleep/Energy subscale significantly discriminated between patients who reported worsened or no change in the number of nocturia episodes (n 246) from baseline to follow-up vs those that reported an improvement (n 381; p 0.001). Patients with OAB understood the content of the instructions, questions, and response options of the KHQ, with a few minor suggestions for improvement. Conclusion: The KHQ demonstrates acceptable content validity and psychometric properties, including reliability and validity, in patients with OAB in the United States. Disclosures: K.S. Coyne, Pfizer Inc., Consultant; M.K. Margolis, Pfizer Inc., Consultant; V. Vats, EmployeePfizer Inc., Other (please specify type of relationship and company name); C. Kelleher, Pfizer Inc., Consultant.
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Presentation Number: Poster 141 Assessing the Responsiveness of Satisfaction Questionnaire (Oab-S)
the
Overactive
Bladder
L. Brubaker,* E. Piault, J. Trocio, K. Fitzgerald, C. Evans, T. Bavendam, and Z. Jumadilova *Loyola University Chicago, Maywood, IL, MAPI Values, Boston, MA, Pfizer Inc., New York, NY Category: Quality of Life. Objective: To assess the responsiveness of the OAB-S multi-item domain scores measuring satisfaction with overactive bladder (OAB) control (SAT), satisfaction with impact of OAB on daily activities (IDL), and the OAB-S single item measuring overall satisfaction with medication. Methods: This was a 4-week observational study of 54 patients diagnosed with OAB who were naive to OAB medication at enrollment. Enrollment occurred 14 2 days before baseline (day 0); a follow-up visit occurred 14 2 days after baseline. Longitudinal analyses (within-group paired t tests) were conducted to assess the mean change occurring between baseline and follow-up for 2 groups of patients: 1 reporting no change vs 1 reporting improved OAB symptoms. Student t tests were used to compare the differences in mean change between the 2 groups. Cross-sectional analyses (Student t tests) were also performed to evaluate the differences in scores between the groups at follow-up. Standardized effect size (SES) and Cohens d were used to evaluate the magnitude of within-group change and between-groups differences, respectively. Results: Between baseline and follow-up, as expected, the IDL domain and the overall satisfaction item did not show a statistically significant change in scores ( 0.49, SD 14.33, p 0.8855, SES 0.02 and 0.22, SD 0.94, p 0.3313, SES 0.19, respectively) for the unchanged group (n 18). For the improved group (n 31), SAT domain and overall satisfaction item scores were significantly increased ( 7.59, SD 10.33, p 0.0004, SES 0.39 and 0.26, SD 0.63, p 0.0300, SES 0.36, respectively). Overall, the between-groups comparison of mean change was significant with a very large effect size for the SAT domain (p 0.0001, Cohens d 1.11), but nonsignificant with a small effect size for the IDL domain (p 0.2631, d 0.35) and a negligible effect size for the overall assessment item (p 0.8740, d 0.04). In the crosssectional between-group comparisons of follow-up scores, the differences were statistically significant, with higher scores for the improved group than the unchanged group on the measures (SAT and IDL domains, p 0.0001; overall satisfaction item, p 0.0016). The between-groups effect size for the overall satisfaction item and for the SAT was high (d 0.73 and p 1.38, respectively). Conclusion: Results on the IDL domains indicated that subjects need more than 4 weeks to translate the improvement of their OAB symptoms into satisfaction with their ability to perform their daily tasks. For the multi-item domain and the overall assessment item, larger differences were found between groups when comparing endof-study satisfaction than when comparing differences in mean change in satisfaction. This suggests that satisfaction endpoints may be better assessed on a cross-sectional basis at the end of a study than by comparing changes in satisfaction occurring during the study. The SAT domain and the single overall satisfaction item demonstrated good responsiveness in subjects who were naive to OAB medication. Disclosures: L. Brubaker, Pfizer Inc., Consultant; E. Piault, Pfizer Inc., Consultant; J. Trocio, Employee - Pfizer Inc., Other; K. Fitzgerald, Pfizer Inc., Consultant; C. Evans, Pfizer Inc., Consultant; T. Bavendam, EmployeePfizer Inc., Other; Z. Jumadilova, EmployeePfizer Inc., Other.
Presentation Number: Poster 142 Symptoms, Surgery, And The Urogynecology Patient: Predicting Treatment Choice M. A. Denman,* A. Clark, and T. Gregory* *Oregon Health Sciences University, Portland, OR, Portland Providence Medical Center, Portland, OR Category: Quality of Life. Objective: This study examined the clinical application of two validated symptom questionnaires; the short forms of the Pelvic Floor Distress Inventory (PFDI-20) and the Pelvic Floor Impact Questionnaire (PFIQ-7). We evaluated these tools, along with clinical characteristics, as predictors of subsequent pelvic reconstructive surgery. Methods: We performed a retrospective cohort study. Subjects were identified as new patients presenting to the University urogynecology practice from 2002-present who completed the PFDI-20 and/or the PFIQ-7 as part of a standard intake questionnaire. Electronic medical record review identified subjects who underwent subsequent pelvic reconstructive surgery. Demographic and physical exam data were abstracted. Parametric and nonparametric tests were used where appropriate. Results: In total, 1748 subjects were identified. Subjects were 93% Caucasian, 67% menopausal, with a mean age of 56.5 years. The mean score of the PFDI-20 was 102 (SD 61); the PFIQ-7 was 69 (SD 66). We identified 449 surgical cases. Results are summarized in Table 1. The mean global score of the PFDI-20 was significantly higher in subjects undergoing surgery. This significant finding held true for the urinary, pelvic organ prolapse, and colorectal subset analysis as well. The mean score of the PFIQ-7 was higher in surgical versus conservative treatment but failed to reach significance. Subset analysis of the PFIQ-7 showed significantly higher scores with only the pelvic organ prolapse questions for surgical subjects. In multivariate analysis, the leading edge of prolapse was the only significant predictor of surgery. Conclusions: The PFDI-20 discriminated between groups globally and in all subsets, whereas the PFIQ-7 discriminated only for the POP subset. Symptoms were more sensitive than lifestyle impact in distinguishing between groups. Neither predicted surgical management, reflecting the multi factorial nature of surgical decision making. This study is limited by the referral nature of the population examined, where higher scores on these instruments would be expected, thus reducing discriminatory ability. The large population studied demonstrates the wide range of symptom scores possible in patients seeking specialty care.
TABLE. Univariate Analysis of Subject Characteristics in Surgical versus Conservative Management Factor Age BMI Vaginal Parity Leading Edge of Prolapse PFDI-20 Score PFIQ-7 Score POPIQ
*mean (SD).
Surgery* 58.7 (13.6) 29.7 (13.0) 2.5 (1.5) 0.9 (2.6) 115.0 (61.0) 73.6 (68.3) 22.7 (28.8)
Conservative Management* 55.7 (16.2) 27.9 (9.4) 2.1 (1.6) 1.5 (2.0) 97.8 (60.6) 67.6 (65.4) 19.2 (28.7)
p 0.001 0.02 0.001 0.001 0.001 0.17 0.004
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Disclosures: M.A. Denman, Spouse is a paid Instructor for Depuy Spine, Other; A. Clark, None; T. Gregory, Intuitive Surgical, Consultant.
Presentation Number: Poster 143 Patient Opinions On Hysterectomy K. Hanaway, E. Elkadry, A. Disciullo, L. Hota, T. Ferzandi, P. Dramitinos, and P. Rosenblatt Boston Urogynecology Associates, Cambridge, MA Category: Quality of Life. Objective: Hysterectomies are often performed solely or in conjunction with other reconstructive procedures to correct uterovaginal prolapse. Many uterine-sparing procedures have been described that are effective at correcting prolapse. The purpose of this study was to determine womens opinions on hysterectomy. If given the choice, would they prefer to keep their uterus at the time of prolapse surgery and what is the reason for their decision? Methods: We developed a questionnaire addressing whether or not a patient would opt to have her uterus removed, and the reasons behind that decision. We also inquired about age, parity, the reason for their visit, and whether or not they were sexually active. For those women who had previously undergone a hysterectomy, we asked about symptoms of dyspareunia and pelvic pain and whether they thought those symptoms were due to the hysterectomy. This questionnaire was given to all new patients presenting to our office over a period of three months. The setting was a urogynecology and pelvic reconstructive surgery office affiliated with a community teaching hospital of a medical school. Results: Questionnaires were correctly completed by 53 patients. Of these, 16/53 (30%) had already undergone a hysterectomy. Of the remaining 37 responders, if given the choice, 29/37 (78%) would opt to keep their uterus at the time of prolapse repair. The average age of this group was 50 years. The respondents were more likely to choose to keep their uterus due to the fact that there was nothing wrong with it, or they were concerned that a hysterectomy would adversely affect sexual function. Of the 8/37 (22%) who would choose to have their uterus removed at the time of prolapse repair, their average age was 55 years. These women would choose hysterectomy because they wanted to reduce their risk of cancer or they felt that there was no reason to keep their uterus. Of the 16 women who had undergone a hysterectomy, 4/16 (25%) attributed symptoms of pelvic pain and dyspareunia to their hysterectomy. The remaining 12/16 (75%) did not attribute any symptoms to their hysterectomy. Conclusion: This questionnaire, given to our new office patients, suggests that women want alternatives to hysterectomy when undergoing surgery to correct their pelvic organ prolapse. Uterine sparing procedures should be considered an option for patients who do not want a hysterectomy, but still desire definitive treatment of their pelvic organ prolapse. Disclosures: K. Hanaway, None; E. Elkadry, None; A. Disciullo, None; L. Hota, None; T. Ferzandi, None; P. Dramitinos, None; P. Rosenblatt, None.
Category: Quality of Life. Objective: To determine the correlation of conditions of bladder dysfunction, bowel dysfunction, and pelvic organ prolapse with the extent of psychosocial impact on women as measured by the Pelvic Floor Impact Questionnaire (PFIQ). Methods: One hundred seventy-six patients who were recruited at 2 different medical centers for one of three studies validating the Pelvic Floor Impact Questionnaire (PFIQ) are the subjects of this study. All patients presented with one or more pelvic floor symptom. Each underwent a comprehensive urogynecologic evaluation that included structured history and pelvic examination using the Pelvic Organ Prolapse Quantitation system. Subjects with advanced prolapse (stage 3 4) or urinary complaints underwent complex urodynamics. All subjects completed the PFIQ, a validated condition specific quality of life instrument for women with pelvic floor disorders. The PFIQ assesses life impact and has 3 scales: Urinary Impact Questionnaire (UIQ), Colorectal-anal Impact Questionnaire (CRAIQ), and the Pelvic Organ Prolapse Impact Questionnaire (POPIQ). Increasing PFIQ score correlates with greater adverse impact on quality of life. Results: Fifty percent of subjects in this study had urinary incontinence with 30% having urodynamic stress incontinence (USI) and 20% having detrusor overactivity (DO) or mixed urinary incontinence. Forty-five percent had stage 3 or 4 pelvic organ prolapse, 42% had voiding dysfunction, 16% had fecal incontinence, and 21% had defecatory dysfunction. Fifty-five percent had more than one pelvic floor diagnosis. Increasing number of pelvic floor disorders correlated with increasing psychosocial impact on all three PFIQ scales (p 0.001 for each). The number of urinary incontinence episodes correlated weakly with increasing UIQ scores (r 0.25, p 0.0001), number of fecal incontinence episodes correlated weakly with increasing CRAIQ scores (r 0.28, p 0.01), and prolapse stage correlated moderately with increasing POPIQ scores (r 0.43, p 0.0001). Urinary incontinence and voiding dysfunction each had greater psychosocial impact than did advanced prolapse in this population (p 0.01). Detrusor overactivity impacted travel activities more than USI or advanced prolapse, but not more than bowel dysfunction (p 0.05). The activity or emotion most commonly affected in subjects with urinary incontinence was concern about visiting places with unknown restrooms (34.2%). In subjects with fecal incontinence, increased nervousness and anxiety was cited most often (40%). The most commonly affected activity in subjects with advanced prolapse was the ability to have sexual relations (35.8%). Conclusions: Pelvic organ prolapse, bladder dysfunction, and bowel dysfunction affect a womans quality of life in different ways. Bladder disorders appear to have more adverse psychosocial impact than advanced pelvic organ prolapse. Objective measures of severity of pelvic floor disorders correlate only weakly to moderately with their impact on womens lives. Disclosures: B. Ridgeway, None; K.J. Stepp, None; M.D. Barber, American Medical Systems, Grant/Research Support.
Presentation Number: Poster 144 Psychosocial Impact of Pelvic Floor Disorders in Women B. Ridgeway,* K. J. Stepp, and M. D. Barber* *Cleveland Clinic, Cleveland, OH, MetroHealth Medical Center, Cleveland, OH
Presentation Number: Poster 145 Prevalence and Degree of Bother from Pelvic Floor Disorders in Obese Women Seeking Medical Weight Reduction Compared to Community-Dwelling Women E. L. Whitcomb,* E. S. Lukacz,* D. A. Baja,* S. A. Menefee, J. M. Lawrence, C. W. Nager,* and K. M. Luber *University of California San Diego, La Jolla, CA, Kaiser Permanente San Diego Medical Center, San Diego, CA, Kaiser Permanente Southern California, Pasadena, CA
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Category: Quality of Life. Objective: To assess the prevalence and degree of bother from pelvic floor disorders (PFD) in obese women enrolled in a managed health care plan who participated in a medical weight loss program compared to obese women from the same health plan not enrolled in the program. We hypothesized that obese women seeking medical weight reduction would be more bothered by PFD than obese women who were not in the program. Methods: A validated questionnaire identifying PFD including pelvic organ prolapse (POP), stress urinary incontinence (SUI), overactive bladder (OAB), and anal incontinence (AI) was administered to a convenience sample of 128 obese (body mass index BMI 30 kg/m2) women enrolled in a medical weight loss program. Responses from these women were compared to those from a cohort of 1,155 obese women from the same health plan. Degree of bother for each PFD was assessed using a 100 mm visual analog scale (VAS). T-tests were used to compare mean VAS scores between those enrolled in the medical weight management program and community-dwelling obese women. Chi-squared and Mann Whitney U tests were used to compare the demographic and clinical characteristics of the two groups. Multivariable logistic regression analysis was used to assess the relative impact of each PFD on enrollment in a medical weight management program while controlling for confounding variables. Associations with a two-sided p-value of 0.05 were considered significant. Results: The mean age SD of the women seeking medical weight loss (n 128) was 49.0 12.7 years and the mean BMI was 39.3 6.2 kg/m2, and 56.4 14.8 years and 35.3 5.3 kg/m2 for those not in the program (n 1,555), p 0.001. The prevalence of POP, SUI, AI and any one or more PFD in the group of women seeking medical weight loss was not significantly different than those not in the program (POP 8% vs. 9%, SUI 20% vs. 24%, AI 26% vs. 29%, and any PFD 42% vs. 48%, all p 0.05). Of all PFD, only the OAB prevalence was higher in community-dwelling versus women enrolled in a medical weight loss program (23% vs. 14%, p 0.05). There were no significant differences in degree of bother for any of the PFD between the two groups. After adjustment for age, BMI, race, parity, mode of delivery, depression, diabetes, neurologic disease, pulmonary disease, recurrent urinary tract infection, hormone and menopausal status, and chronic lifting, enrollment in the medical weight loss program was positively associated with depression (1.83, 1.34 2.93) and BMI (1.09, 1.051.13), and negatively associated with age (0.96, 0.95 0.98), and OAB (0.49, 0.25 0.97). Conclusions: PFD are common and associated with significant bother in obese women, however the presence of PFD did not predict enrollment in a medical weight loss program. Rather, younger age, higher BMI and depression were the major correlates of enrollment in a medical weight management program in this population. Providers should recognize the common co-existence of obesity and PFD, and future study should evaluate the relationships between PFD and weight reduction. Disclosures: E.L. Whitcomb, None; E.S. Lukacz, Pfizer Inc., Medtronic Corp., Consultant; Novartis Pharmaceuticals, Proctor & Gamble Pharmaceuticals, Intuitive Corp, Speakers Bureau; D.A. Baja, None; S.A. Menefee, None; J.M. Lawrence, None; C.W. Nager, None; K.M. Luber, Pfizer Inc., Watson Pharmaceuticals, Astellas, Consultant; Pfizer Inc., Watson Pharmaceuticals, Astellas, Speakers Bureau.
Background: Urinary symptoms are common in women with pelvic organ prolapse (POP). Relatively few studies have described the type of urinary symptoms in women with POP using validated questionnaires. Objective: To describe urinary symptoms in patients with POP using validated questionnaires. Methods: 116 consecutive women with grade 2 or greater POP presenting for initial evaluation to the Urogynecology clinic were included in this study. Women with neurologic disease were excluded. All women were administered the Pelvic Floor Distress Inventory (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), and Incontinence Severity Index (ISI). All women underwent a complete urogynecologic examination and multi-channel urodynamics. Data was analyzed using univariate and multivariate techniques. Results: Mean age and parity were 60.6 12.9 and 2.6 1.5, respectively. The most common bladder symptom reported on the UDI-6 was frequency of urination (60%), followed by leakage with urgency (49%), and leakage with stress (46%). The most commonly affected quality of life measure on the UIQ-7 was feeling frustrated (47%) followed by ability to do physical activities (45%). There was a significant association of increasing number of compartments of POP and both UIQ-7 and UDI-6 scores (test for trend p 0.03 and p 0.02, respectively). There was a significant association of increasing cystocele grade with UIQ-7 score (test for trend p 0.001). UDI-6 score was positively correlated with the UIQ-7 score (0.38, p 0.0001). The bladder symptoms on the UDI-6 that were significantly associated with higher UIQ-7 score were leakage with urgency (p 0.008) and difficulty emptying bladder (p 0.013). Based on the ISI, 27% had mild, 23% had moderate, 12% had severe, and 9% had very severe urinary incontinence. Urinary incontinence as determined by urodynamic diagnosis was: stress 13%, urge 23%, and mixed 32%. The severity of urinary incontinence as determined by the ISI was positively correlated with both the UDI-6 (0.48, p 0.001) and the UIQ-7 (0.31, p 0.0017) scores. Urodynamic diagnosis was significantly associated with UDI-6 symptoms of leakage with urgency (p 0.004) and leakage with stress (p 0.024). On multivariate analysis, increasing grade of cystocele (p 0.006) and UDI-6 score (p 0.001) remained significantly associated with increasing UIQ-7 score. Conclusion: In addition to the presence of urinary symptoms, the severity of cystocele has a significant impact on the quality of life in women with pelvic organ prolapse. Disclosures: J. Gleason, None; H.S. Harvie, None; E.K. Saks, None; M. Gopal, None; G. Northington, None; L.A. Arya, None.
Presentation Number: Poster 146 Urinary Symptoms In Women With Pelvic Organ Prolapse J. Gleason, H. S. Harvie, E. K. Saks, M. Gopal, G. Northington, and L. A. Arya University of Pennsylvania, Philadelphia, PA Category: Quality of Life.
Presentation Number: Poster 147 PFIQ Scores Improve after Prolapse Surgery in Women with Depressive Symptoms but Remain Higher than in Women Without Depressive Symptoms C. Ghetti, J. L. Lowder, R. Ellison, M. A. Krohn, and P. A. Moalli University of Pittsburgh, Pittsburgh, PA Category: Quality of Life. Objective: Little is known about depressive symptoms in women with pelvic organ prolapse (POP). Our objective was to compare pelvic floor related QOL scores following reconstructive surgery in women with and without depressive symptoms at baseline. Methods: This is a secondary analysis of an IRB-approved prospective cohort study of 75 women with stage II POP planning surgery. Subjects were enrolled as part of a larger case-control study designed to assess the impact of POP on body image. Subjects were enrolled from a urogynecology referral practice and completed self-administered measures
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at baseline and at 6 months after surgery. Measures included: Pelvic Floor Distress Inventory (PFDI), Pelvic Floor Impact Questionnaire (PFIQ), and Patient Health Questionnaire-9 (PHQ-9). PHQ-9 is a validated measure of depression severity. Total scores of 10, correlate with moderate to severe depressive symptoms. Mean values and 95% confidence intervals were determined for the PFDI, PFIQ and change in scores. Results: Complete baseline and 6 month data were available for 58 women. Participants had a mean age of 60 8 years, mean BMI of 28 5 kg/m2, were predominantly Caucasian (96%), postmenopausal (82%), and 56% had a prior hysterectomy. Baseline POPQ stage distribution: stage II 6/57 (10%), stage III 47/57 (83%), and stage IV 4/57 (7%). At baseline 17/75 (23%) had moderate to severe depressive symptoms, 58/75 (77%) had none to minimal symptoms. Similar numbers of subjects in the two groups listed antidepressant medication at baseline (9/57 (16%) vs. 4/17 (25%) (NS). Surgeries included: sacrocolpopexy 42/57 (57%), uterosacral ligament suspension 7/57 (12%), total vaginal mesh 6/57 (11%), and posterior colporrhaphy 2/57 (3%). Women with depressive symptoms had higher PFIQ scores compared to women without symptoms at baseline. Women with depressive symptoms had improved PFIQ scores after surgery but remained elevated compared to women without depressive symptoms. See Table 1.
scale (VAS) were used to determine utility scores: Health Utilities Index Mark 3 (HUI3), EQ-5D, and Short Form 6D (SF-6D). Pelvic floor symptoms were measured by the Pelvic Floor Distress Inventory (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), and Prolapse and Incontinence Sexual Function Questionnaire (PISQ-12). The QUID and Incontinence Severity Index (ISI) were used to assess diagnosis and severity of urinary incontinence. Pearson correlations and t-tests examined relationships between scores and between group differences. Results: 42 women were enrolled. Mean age, parity and BMI were 57 10.3, 2.8 1.2, and 28.3 4.5 respectively. All women had stage 2 or greater prolapse. Concomitant urinary incontinence as determined by the QUID was: urge 14%, stress 21%, and mixed 26%. Concomitant fecal incontinence was 29%. Mean Charlson comorbidity index score was 0.24 0.48. All utility scores were positively correlated with each other and with self reported health status, Table 1. Utility scores were significantly correlated with PFDI-20 and PFIQ-7 scores as well as with their bladder, bowel, and prolapse subscales. Maximum stage of POP was significantly correlated only with the HUI3 (p 0.03). Significant differences in utility score with concomitant urinary incontinence was noted only for the SF-6D with the urge component (p 0.011). However, presence of concomitant fecal incontinence was associated with significantly lower utility scores on SF-6D (p 0.049) and HUI3 (p 0.0001).
Conclusions: Pelvic floor disorders appear to have a greater impact in women with depressive symptoms as measured by PFIQ before and after surgery. The relationship between depression, quality of life and pelvic floor symptoms needs further study to understand the true impact of POP on women. Disclosures: C. Ghetti, None; J.L. Lowder, None; R. Ellison, None; M.A. Krohn, None; P.A. Moalli, None.
Conclusion: Pelvic organ prolapse symptoms have significant relationships with health utility preference scores. Disclosures: H.S. Harvie, None; L.A. Arya, None; E.K. Saks, None; N.L. Guerette, American Medical Systems, Consultant; J.S. Schwartz, None; J.A. Shea, None.
Presentation Number: Poster 148 Health Related Quality of Life: Utility Preference Score for Pelvic Organ Prolapse H. S. Harvie, L. A. Arya, E. K. Saks, N. L. Guerette, J. S. Schwartz, and J. A. Shea University of Pennsylvania, Philadelphia, PA Category: Quality of Life. Background: While utility preference scores have been developed for urinary incontinence, currently there are no measures for pelvic organ prolapse (POP). Utility scores on a scale of 0 (death) to 1 (perfect health) measure health-related quality of life and are used to calculate quality adjusted life years (QALYs) for cost-effectiveness analysis. Objective: Evaluation of construct validity of utility scores for pelvic organ prolapse. Methods: Prospective observational study of consecutive new patients with POP presenting to urogynecology clinic. Three common multi-attribute health state classification systems and a visual analog
Presentation Number: Poster 149 Urinary Symptoms and Impact on Quality of Life in Women Following Treatment for Endometrial Cancer E. A. Erekson, V. W. Sung, R. Becher, P. A. DiSilvestro, and D. L. Myers Alpert Medical School at Brown University, Providence, RI Category: Quality of Life. Objective: The primary aim of this study is to describe urinary symptoms in women after treatment for endometrial cancer. The secondary aim is to compare urinary symptoms and impact on disease specific quality of life (QOL) in women treated with adjuvant radiation therapy after hysterectomy versus women treated with hysterectomy alone. Methods: We preformed a cross-sectional survey of women who had undergone surgical treatment for endometrial cancer and were
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returning for surveillance visits at the Gynecologic Oncology division at a tertiary care center. Exclusion criteria included: women who retained their uterus during cancer treatment, adjuvant treatment with chemotherapy, recurrence of endometrial cancer, and other concurrent pelvic cancers. Women were asked to fill out anonymous surveys including demographic and clinical information. Urinary symptoms were quantified by the Sandvik Severity Index (SSI) and the Urinary Distress Inventory- 6 (UDI-6). Impact of urinary symptoms on QOL was measured using the Incontinence Impact Questionaire-7 (IIQ-7). Statistical analysis included descriptive statistics, chi-square test, Fishers exact test, and two sample t-test, as appropriate. Results: Our study included 64 women treated for endometrial cancer; 21 women reported adjuvant radiation therapy after surgical staging. The mean age was 58.5 years ( 12.1) and 90.6% of women reported their race as white. Mean body mass index was 33.4 kg/m2 ( 9.8). Complete surgical staging which included pelvic and paraaortic lymph node dissection was performed in 81.3% (52/64) of women. For our first objective, symptom severity measured using the Sandvik Severity Index was absent, mild, moderate, and severe in 21.5%, 27.7%, 35.4%, and 15.4% of women, respectively. Overall, the mean UDI-6 and IIQ-7 scores for the study population were 40.7 ( 23.5) and 15.0 ( 23.6), respectively. For our second objective, women were categorized into two groups: adjuvant radiation therapy and no radiation therapy. No significant differences in age, race, education level, vaginal parity, BMI, or smoking status were found between the two groups. Mean UDI-6 scores for women treated with adjuvant radiation therapy trended towards higher symptom distress compared to women with no adjuvant radiation therapy (48.6 ( 20.9) vs. 36.9 ( 27.1) p .09)), although this did not reach statistical significance. Mean IIQ-7 scores were significantly higher (higher scores suggest more severe impact on quality of life) in women treated with adjuvant radiation therapy compared to women who were not (27.0 ( 29.4) vs. 8.8 ( 17.0) (p .016)). Conclusions: This pilot study suggests a high prevalence of urinary symptoms in women treated for endometrial cancer. Women treated with adjuvant radiation therapy report a significantly greater impact of incontinence symptoms on disease specific quality of life. Reasons for the differences in incontinence QOL impact needs further study. Disclosures: E.A. Erekson, NICHD T32 HD0406740-04, Grant/Research Support; V.W. Sung, 5 K12 HD0500108 02WIH, Grant/Research Support; R. Becher, None; P.A. DiSilvestro, None; D.L. Myers, None.
PFDI. Bowel symptom impact on quality of life was measured with the Colorectal-Anal Impact Questionnaire (CRAIQ) subscale of the PFIQ. Prolapse was evaluated with the Pelvic Organ Prolapse Quantification (POPQ) examination. Multivariable linear regression models were developed to estimate the effect of factors on leading edge of prolapse. Polytomous logistic regression modeling was used to estimate the factors that raised the CRADI and CRAIQ total scores. Results: The study population had a mean age of 62 13 years and was predominantly Caucasian (91%). Three women had stage I prolapse ( 1%), 129 (38.4%) stage II prolapse, 176 (52.4%) stage III prolapse, and 27 (8.3%) stage IV prolapse. The predominant compartment of prolapse was anterior or apical in 277 women, while 41 (13%; n 18 missing values) women had posterior-predominant prolapse. Bowel symptoms, as measured by CRADI total and subscale scores, and bowel-related quality of life scores, as measured by CRAIQ total and subscale scores, did not change as prolapse progressed by POPQ stage. When compared to women with anterior or apical-predominant prolapse, women with posterior-predominant prolapse reported significantly higher CRAIQ total and subscale scores (p 0.05). Multivariable linear regression showed that an increase in the CRADI was associated with an increase in the leading edge of prolapse (100 point increase in CRADI associated with a 1.0 cm increase in the leading edge of prolapse) after adjusting for age. When a multivariable linear regression model was developed for participants with posterior-predominant prolapse, only age ( .36, p 0.01) and history of a prior incontinence procedure ( .24, p 0.005) were significantly associated with leading edge of prolapse. Polytomous logistic regression demonstrated that prior hysterectomy (OR 3.6 to 6.4; p 0.008) was a significant predictor of higher total CRADI and CRAIQ scores. Prior incontinence procedure was associated with higher CRAIQ scores (RR 2.6 to 5.4; p 0.04). Conclusions: Bothersome bowel symptoms that negatively impact a womans quality of life may occur with any amount of prolapse and more severe symptoms may be related to the extent of prolapse. Prior hysterectomy appears to have the largest influence on bowel symptom scores and quality of life scores. Disclosures: E.A. Frankman, None; J.L. Lowder, None; C. Ghetti, None; L.J. Burrows, None; M.A. Krohn, None; H.M. Zyczynski, None.
Presentation Number: Poster 150 Bowel Symptoms affect Quality of Life in Women with Pelvic Organ Prolapse E. A. Frankman,* J. L. Lowder,* C. Ghetti,* L. J. Burrows, M. A. Krohn,* and H. M. Zyczynski* *Magee-Womens Hospital, University of Pittsburgh, Pittsburgh, PA, The Center for Vulvovaginal Disorders, Washington, DC Category: Defecatory Dysfunction. Objective: To determine if leading edge of pelvic organ prolapse is associated with bowel symptoms, distress, and quality of life. Methods: 336 women with stage I prolapse were enrolled in this cross-sectional study. Subjects completed the Pelvic Floor Distress Inventory (PFDI) and the Pelvic Floor Impact Questionnaire (PFIQ) prior to evaluation. Bowel symptom presence and bother was assessed using the Colorectal-Anal Distress Inventory (CRADI) subscale of the
Presentation Number: Poster 151 Bowel Symptoms and their Effect on Quality of Life in Women with Pelvic Organ Prolapse E. K. Saks, M. Gopal, U. Umoh, H. S. Harvie, N. N. Mahmoud, and L. A. Arya University of Pennsylvania, Philadelphia, PA Category: Defecatory Dysfunction. Objective: To describe bowel symptoms and their effect on quality of life in women with pelvic organ prolapse using validated questionnaires. Methods: 116 consecutive women presenting for initial evaluation to the Urogynecology office were included if they had pelvic organ prolapse grade 2 or greater on clinical exam. Women with neurologic disease were excluded. All women were administered the short forms of the Pelvic Floor Distress Inventory (PFDI-20) and the Pelvic Floor Impact Questionnaire (PFIQ-7). Data pertaining to bowel symptoms (CRADI-8 and CRAIQ-7) were analyzed. Presence of a rectocele was defined as presence of grade 2 rectocele or greater. A positive CRAIQ-7 score was defined as a positive response to any of the items on the CRAIQ-7. Associations between individual bowel symptoms and CRAIQ-7 scores were evaluated by univariable and multivariable logistic regression. Results: Mean age, BMI and parity were 60.6 12.9, 27.3 5.1 and 2.6 1.5 respectively. The most common type of prolapse was apical
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defect (84%) followed by anterior wall defect (76%) and posterior wall defect (23%). 73% of women had prolapse affecting more than one compartment. Mean CRADI-8 score was 18.5 18.3 and mean CRAIQ-7 score was 11.0 19.5. The most common bowel symptoms reported on the CRADI-8 was incontinence of flatus (49%), followed by the feeling of incomplete bowel emptying (43%) and straining to have a bowel movement (40%). The most commonly affected quality of life measure on the CRAIQ-7 was the feeling of frustration (29%). The mean CRAIQ-7 score of women with a rectocele was significantly greater than that of women without a rectocele (15.2 17.0 vs. 9.8 20.2, p 0.05). There was no significant difference in the mean CRADI-8 score among women with and without a rectocele (p 0.17). On univariable analysis, factors associated with a positive CRAIQ-7 score were presence of a rectocele (OR 3.1; 95% CI 1.2,8.4), incontinence of flatus (OR 3.3; 95% CI 1.4,8.0), the sense of incomplete emptying (OR 5.6; 95% CI 1.9,16.0) and splinting with a bowel movement (OR 4.3; 95% CI 1.4,13.4). With increasing number of compartments affected by prolapse, women were more likely to have a positive CRAIQ-7 score (test for trend p 0.01). On multivariable regression analysis, incontinence of flatus (OR 4.6; 95% CI 1.2,17.1), sense of incomplete emptying (OR 7.9; 95% CI 1.4,45.8) and the presence of prolapse in two compartments (OR 4.3; 95% CI 1.1,17.3) remained significantly associated with positive CRAIQ-7 scores. The presence of a rectocele was no longer associated with a positive CRAIQ-7 score on regression analysis. Conclusion: The most common bowel symptom associated with pelvic organ prolapse was incontinence of flatus while the most commonly affected quality of life measure was the feeling of frustration. The presence of bowel symptoms, rather than the presence of a rectocele, had a significant impact on quality of life.
Disclosures: E.K. Saks, None; M. Gopal, None; U. Umoh, None; H.S. Harvie, None; N.N. Mahmoud, None; L.A. Arya, None.
Presentation Number: Poster 152 Self-Report of Difficult Defecation is Associated with Overactive Bladder Symptoms, but Not Urinary Incontinence A. K. Pelletier Cameron, D. E. Fenner, J. O. DeLancey, and D. M. Morgan University of Michigan, Ann Arbor, MI Category: Defecatory Dysfunction. Objective: The impact of dysfunctional bowel elimination on lower urinary tract symptoms is well known in children, but not in adults. It is our objective to assess lower urinary tract symptoms in women that report difficult defecation. Methods: This is a secondary analysis of 2812 women, aged 35 64, who participated in a telephone interview as part of an epidemiologic study of urinary incontinence (UI) prevalence among women. All subjects were asked When you move you bowels, does the stool come out easily? Difficult defecation (DD) was considered present in those answering yes. All subjects were queried regarding bladder storage symptoms per ICS Standardized terminology (nocturia, the presence of urgency, and UI), daytime urinary frequency, urinary infections in the past year, dysuria, feelings of incomplete emptying, self perceived health status, medical history and demographics. Symptoms of stress incontinence (5 items), urge incontinence (5 items) and the impact of these symptoms on their quality of life as assessed by the incontinence impact questionnaire-7 (IIQ-7) were solicited from subjects reporting more than 12 episodes of UI in one year. Logistic regression was used to calculate unadjusted and adjusted odds ratios.
TABLE. Urinary Symptoms Lower urinary tract symptoms: Storage symptoms Data presented are mean std error unless otherwise noted Frequent strong sudden urges to urinate (n 2739) Nocturia, episodes (n 2741) Any urinary incontinence in past 12 months (n 2747) 12 episodes of UI in the past year (n 1227) Daytime urinary frequency, episodes (n 2750) Locate nearest toilet as soon as arriving at a new place (n 2739) Dysuria (n 2750) UTI in past year (n 2750) Sense of incomplete emptying (n 2743) IIQ-7 (n 555) Number of comorbidities (n 2733) Self perceived health status (n 2750): Excellent to very good Good Fair/poor Present 47.6% 1.8 0.1 61.1% 56.0% 8.2 0.3 Absent 29.2% 1.3 0.02 42.9% 44.4% 7.2 0.1 Difficult Defecation Unadjusted OR* (95% CI) 2.20 (1.712.81) 1.32 (1.201.44) 2.09 (1.632.68) 1.59 (1.162.20) 1.06 (1.031.09) 2.06 (1.582.67) 1.41 (1.121.79) 1.67 (1.222.31) 3.19 (2.484.09) 1.07 (1.031.11) 1.37 (1.241.50) Adjusted OR** (95% CI) 1.77 (1.362.30) 1.19 (1.081.32) 1.95 (1.492.54) 1.39 (0.991.96) 1.04 (1.011.07) 1.65 (1.242.18) 1.33 (1.051.68) 1.37 (0.971.91) 2.82 (2.183.66) 1.06 (1.011.10) 1.21 (1.081.36)
Other lower urinary tract symptoms
32.17% 22.9% 18.8% 55.6% 7.0 1.9 0.6 0.1
18.7% 13.7% 12.2% 28.2% 5.0 1.4 0.2 0.02
Quality of Life and health status
31.3% 34.0% 34.7%
47.6%* 35.1% 17.3%

0.05
* p .004 for all values. ** Logistic regression controlling for age, menopausal status, medical comorbidities, self perceived health status, and race. p value considered significant.
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Results: DD was reported by 10.4% (288/2779) of women. Bladder storage symptoms (nocturia, urinary urgency, and higher rates of any incontinence), increased daytime frequency, dysuria, and symptoms of incomplete bladder emptying were all more commonly reported by women with DD (see table). Among women reporting more than 12 episodes UI in the past year, the rates of stress and urge incontinence did not differ between the groups on any of the items. However, IIQ-7 scores were higher among those with DD, suggesting that UI symptoms have a more negative impact on their quality of life. Women with DD were more often menopausal, reported a fair or poor self reported health status, and had a higher number of comorbidities, less formal education and lower annual household income. Conclusions: Women with symptoms of DD have an increased rate of bladder storage symptoms, consistent with the diagnosis of overactive bladder without incontinence. The pathophysiology underlying this association is worthy of future research. Disclosures: A.K. Pelletier Cameron, None; D.E. Fenner, None; J.O. DeLancey, Johnson & Johnson, Consultant; D.M. Morgan, None.
kg/m2) (n 144) had higher CRADI scores 25 (0 100) than normal weight women (BMI of 20 25 kg/m2) (n 118) 15(0 78), (p .002). In multivariate analysis, only BMI and history of concomitant cardiac disease or hypertension were independently associated with CRADI scores. The adjusted mean score difference for every 5 unit increase in BMI, the CRADI score increased by 2.units (p .0004). Similarly, the adjusted CRADI mean score was 4.9 units higher in patients with concomitant cardiac disease and/or hypertension (p .049). Conclusion: Our data demonstrate that women rarely seek urogynecologic care primarily for bowel symptoms, although, most bowel symptoms are highly prevalent in this population. Patients with higher BMI and concomitant medical disease tend to be more bothered by bowel symptoms. Bowel symptoms should be evaluated in all women presenting for urogynecologic care. Disclosures: F.G. Khan, Pfizer, Grant/Research Support; Pfizer, Speakers Bureau; J. Cunkelman, None; L. Lowenstein, Astellas, Grant/Research Support; Pfizer, Grant/Research Support; K. Kenton, Pfizer, Grant/Research Support; Pfizer, Consultant; Pfizer, Speakers Bureau; L. Wall, None.
Presentation Number: Poster 153 Bowel Symptoms: The Underreported Urogynecologic Complaint F. G. Khan,* J. Cunkelman,* L. Lowenstein, K. Kenton, and L. Wall* *Washington University School of Medicine, St. Louis, MO, Loyola University School of Medicine, Maywood, IL Category: Defecatory Dysfunction. Objectives: To determine the prevalence and impact of bowel symptoms in a urogynecologic population. Methods: We reviewed charts of consecutive new patients presenting to our urogynecologic clinic between July 2006 and April 2008. Women completed 2 bowel symptom questionnaires: (1) a non-validated questionnaire inquiring about symptoms of fecal/flatal incontinence, painful bowel movements, difficulties in bowel movement and the need for splinting; (2) the validated, Colorectal-Anal Distress Inventory (CRADI)subscale of the short form of the Pelvic Floor Distress Inventory (PFDI-20). The CRADI was scored from 0 to 100 according to standard scoring, with higher scores indicating more bother. Demographic and clinical information including previous surgical history, bowel and concomitant medical conditions were extracted from patients charts. For analysis, we categorized age to the following 3 groups: 40, 40 65 and 65, and BMI according to CDC guidelines: 20 kg/m2 (low body weight), 20 24 (normal weight), 2529 (overweight), and 30 (obese). Nonparametric tests were used to compare independent groups. We included the following clinically and/or statistically significant variables in the final linear regression model: age, race, BMI, concomitant medical disease, symptoms of pelvic organ prolapse and urinary incontinence. Results: Four hundred and sixty three women with a median age of 56 years (range19 94) and a BMI of 27(16 64) were included. Most women were (88%) Caucasian, 9% African American, and 3% other. Though only 3% (n 15) of women presented to our clinic with a defecatory dysfunction or fecal incontinence as their chief complaint, 76% (n 350) reported at least one bowel symptom. The most common bowel symptoms was difficulty in having bowel movements (BM) 42% (n 191), followed by flatal incontinence 34% (n 148), and fecal incontinence 19% (n 84). Middle-age women (40 to 65 years) (n 79) had significantly higher CRADI scores (25 (0 100)) than younger women ( 40 years) (n 245) 16(0 88), p .02). Similarly BMI was also found to be associated with the severity of bowel symptoms. Overweight women (BMI of 2530
Presentation Number: Poster 154 Health Care Cost and Utilization in Patients with Chronic Constipation T. Nguyen,* O. Palsson,* M. Von Korff, A. Feld, R. Levy, M. Turner,* and W. Whitehead* *University of North Carolina, Chapel Hill, NC, Group Health of Puget Sound, Seattle, WA, University of Washington, Seattle, WA Category: Defecatory Dysfunction. Objective: Determine health care cost and utilization in patients with chronic constipation (CC) compared to healthy controls. Methods: HMO patients were recruited into 2 groups: those with a clinical diagnosis of constipation (ICD-9CM codes 564.0X) in the last year vs. those without a clinical diagnosis of constipation for the previous 5 years. Questionnaires identified subjects who met Rome III criteria for CC. The 520 subjects with both clinical and Rome III diagnosis of CC (KCC) were compared to 416 non-consulters (NKCC) who met Rome III criteria for CC but did not have a clinical diagnosis of CC and 614 subjects who did not fulfill clinical or Rome III diagnostic criteria (HC). Health care cost in US$ and utilization data for the previous 5 years were extracted from administrative claims. Means and 95% confidence intervals are reported. Results: The KCC, NKCC and HC groups were similar in age, race, marital status, education and personal income. However, KCC and NKCC subjects were more likely to be female than the HC subjects (73.1% vs. 73.3% vs. 64.6%, p 0.002 and p 0.003). Mean annual health care costs were significantly higher in KCC vs. HC groups p 0.001). Previous year costs showed similar differences. The NKCC group had intermediate costs in all categories and was significantly different from both KCC and HC groups except previous year GI cost. Healthcare utilization showed a similar pattern. Compared to the HC group, the KCC group had higher mean annual outpatient visits and non-GI outpatient visits. Annual outpatient visits for NKCC were intermediate between the KCC and HC and were significantly different from both except previous year outpatient GI visit. Conclusions: Subjects with a clinical diagnosis of CC confirmed by Rome III criteria had higher GI-related and non-GI related health care costs and utilization than those without a clinical or Rome III diagnosis of CC. Subjects who met Rome criteria for CC but had not seen a physician had intermediate health care costs and utilization.
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Disclosures: T. Nguyen, None; O. Palsson, None; M. Von Korff, None; A. Feld, None; R. Levy, None; M. Turner, None; W. Whitehead, Novartis Pharmaceuticals, Grant/Research Support; R24 DK67674, Grant/Research Support.
Presentation Number: Poster 155 Satisfaction with Laxatives in Chronic Constipation and Irritable Bowel with Constipation T. Nguyen,* O. Palsson,* M. Von Korff, A. Feld, R. Levy, M. Turner,* and W. Whitehead* *University of North Carolina, Chapel Hill, NC, Group Health of Puget Sound, Seattle, WA, University of Wahington, Seattle, WA, University of Washington, Seattle, WA Category: Defecatory Dysfunction. Objective: Determine frequency of using laxative regimens, perceptions of effectiveness, side effects (SE) severity and satisfaction with laxative treatment in patients with chronic constipation (CC) and irritable bowel with constipation (IBS-C). Methods: HMO patients were recruited into 2 groups: those with a clinical diagnosis of constipation (ICD-9CM codes 564.0X) in the last year vs. those without a diagnosis of constipation for the previous 5 years. Postal questionnaires were used to identify subjects in both groups meeting Rome III criteria for CC or IBS-C. Subjects with CC or IBS-C but without a medical diagnosis of constipation were designated non-consulters. Results: There were 447 CC and 320 IBS-C subjects (consulters and non-consulters pooled). Groups were similar in race, education and income. However, CC were older (mean age 70 vs. 61 years, p 0.001), more likely to be male (34% vs. 21%, p 0.001) and widowed (20% vs. 13%, p 0.01). CC were less likely than IBS-C to consult physicians (47% vs. 59%, p 0.001) and less likely to use laxatives (33% vs. 47%, p 0.001). When they did use laxatives, CC reported less SE (mean rating 0 vs. 1 on a 0 4 scale, p 0.001) and greater satisfaction (5 vs. 4 on a 1 6 scale, p 0.001) compared to IBS-C. There were no differences in effectiveness rating (2 vs. 2 on a 0 4 scale, p 0.36). Ordinal regression tested the combined effects on satisfaction with laxatives of age, gender, race, consultation, diagnosis (CC vs. IBS-C), SE severity and perceived effectiveness. Significant predictors were perceived effectiveness p 0.001), less SE severity p 0.001) and CC diagnosis by Rome III criteria p 0.049). Total variance explained was 58.4%. Conclusions: Laxatives were equally effective in CC and IBS-C, but subjects with CC had less severe SEs and were more satisfied with laxative treatment. Disclosures: T. Nguyen, None; O. Palsson, None; M. Von Korff, None; A. Feld, None; R. Levy, None; M. Turner, None; W. Whitehead, Novartis Pharmaceuticals, Grant/Research Support; R24 DK67674, Grant/Research Support.
Category: Neuromodulation. Objective: We present results of sacral nerve neuromodulation (SNS) in patients with multiple sclerosis (MS) and lower urinary tract dysfunction. Methods: This is a retrospective case series of 28 patients with MS and lower urinary tract dysfunction who underwent SNS. Lower urinary tract dysfunction was divided into three categories based on urodynamics: overactive bladder (OAB), detrusor sphincter dyssynergia (DSD) and retention. Success was defined as greater than 50% improvement in clinical symptoms. Results: Mean age was 49.7. There were 21 females and 7 males. Nineteen of 28 patients (68%) had greater than 50% improvement in clinical symptoms and underwent implantation: 11 of 16 (69%) with OAB, 1 of 4 (25%) with DSD and 7 of 8 (88%) with retention. Twelve of nineteen (63%) maintained improvement in clinical symptoms at a mean follow-up of 16 months: 7 of 12 (58%) with OAB and 5 of 12 (42%) with retention. Six of nineteen (32%) had the device explanted: two for infection, two for loss of response, and two for progression of multiple sclerosis and need for magnetic resonance imaging. Conclusion: SNS is an effective treatment for lower urinary tract dysfunction in patients with multiple sclerosis. Disclosures: K.C. Hubert, None; A. Hijaz, Pfizer, Speakers Bureau; C. Moore, None; H.B. Goldman, Johnson & Johnson, Consultant; NDI Medical, Inc., Consultant; Johnson & Johnson, Speakers Bureau; Pfizer, Speakers Bureau; Novartis, Speakers Bureau; Investigator, NDI Medical, Other; R.R. Rackley, Generic Medical Devices, Consultant; NDI Medical, Inc., Consultant; Novartis, Consultant; Pfizer, Consultant; Boston Scientific, Consultant; Novartis, Speakers Bureau; Pfizer, Speakers Bureau; Founder, Generic Medical Devices, Inc., Other; Founder, NDI Medical, Inc., Other; S. Vasavada, None.
Presentation Number: Poster 156 Sacral Neuromodulation in Patients with Multiple Sclerosis K. C. Hubert,* A. Hijaz,* C. Moore, H. B. Goldman, R. R. Rackley, and S. Vasavada *University Hospitals Case Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH, Glickman Urological and Kidney Institute, The Cleveland Clinic, Cleveland, OH
Presentation Number: Poster 157 Lead Migration After Sacral Neuromodulation: Fascial Versus Tined Anchoring Systems N .Y. Siddiqui, C. L. Amundsen, E. G. Corey, and J. M. Wu Duke University Medical Center, Durham, NC Category: Neuromodulation. Objective: Sacral neuromodulation (InterStim) utilizes an implanted electrical lead and generator to treat urinary retention or overactive bladder symptoms. Traditionally, sacral leads were anchored to the lumbodorsal fascia using permanent sutures. The development of the tined lead has allowed for a less invasive anchoring technique. One potential complication of either anchoring system is lead migration. Our objective was to compare the rates of lead migration using the traditional fascial anchoring system versus tined leads. Methods: We performed a retrospective cohort study of patients who received an InterStim implant at a single academic center between January 2000 and December 2006. Our two cohorts consisted of subjects receiving fascial versus tined anchoring systems. We collected data regarding demographics, medical co-morbidities, body mass index (BMI), adverse events, and length of follow-up. Our primary outcome was lead migration, confirmed by radiologic imaging. Statistical analyses consisted of Students t-test, Pearsons chisquare, Fishers exact, and multivariate logistic regression. KaplanMeier curves were constructed and compared with the log-rank test. Results: Of 112 patients, 28 (25%) underwent fascial anchoring and 84 (75%) received tined leads. There were no significant differences between our two cohorts with respect to age, race, gender, BMI,
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diabetes, immunosuppressive medications, or tobacco use. However, patients with fascial anchors were followed for a longer duration of time (57.7 24.3 vs 20.7 15.7 months, p 0.001). Lead migration occurred in a total of 20 (17.9%) patients. The fascial anchoring system was associated with a higher risk of lead migration compared to tined leads (42.9% vs 9.5%, p 0.001). In a logistic regression model controlling for age, race, BMI, and tobacco use, fascial anchoring remained significantly associated with lead migration (OR 6.2, 95% CI: 2.0 19.4). Although there were fewer lead migrations with tined anchors, these events occurred at an earlier interval after implantation (mean 7.5 7.4 vs 30.7 20.8 months, p 0.003). Kaplan-Meier curves confirmed a significant difference in time to migration (p 0.02). Conclusions: Tined leads for sacral neuromodulation resulted in fewer lead migrations when compared to the fascial anchoring system. However, these events tend to occur at an earlier interval after implantation. Longer follow-up data on tined leads will determine if these lower rates are maintained over time. Disclosures: N.Y. Siddiqui, None; C.L. Amundsen, None; E.G. Corey, None; J.M. Wu, None.
muscle, or around peripheral nerves. The response included variable degrees of cellular activity surrounded by a collagen matrix. The degree of cellular activity was higher around the tines and the IPG, and substantially higher around a lead and IPG that cultured positive. Conclusions: The threshold measurements suggest tissue encapsulation of the leads was achieved during the first week and the following stabilization of thresholds indicate the leads did not migrate during the four-week period. The force required to remove the lead indicates its resistance to migration after implantation. The removal force for the lead is greater than the forces expected to be experienced by the lead due to movement and stresses in the proposed abdominal location. The tissue response indicates that the lead is suitable for human use. The results of this study suggest that the lead will remain stable in human adipose tissue under the stresses anticipated in clinical application. Disclosures: J. Mangel, None; J. Mrva, None; J. Boggs, None; R. Strother, None; S. Rubin, None; J. Grill, None.
Presentation Number: Poster 158 Pre-Clinical Evaluation of the Stability of a Lead Designed to be Placed in Adipose Tissue Near the Dorsal Genital Nerve J. Mangel,* J. Mrva, J. Boggs, R. Strother, S. Rubin, and J. Grill *MetroHealth Medical Center, Cleveland, OH, NDI Medical, Cleveland, OH Category: Neuromodulation. Objectives: A recent study indicates that electrical stimulation of the dorsal genital nerve (DGN) may reduce overactive bladder symptoms when stimulation is applied through a percutaneous electrode lead for 1 week. Those results suggest that long-term reduction in overactive bladder symptoms may be feasible if stimulation can be applied through a lead permanently implanted in the adipose tissue near the DGN. The present study used a pre-clinical animal model to evaluate the stability of the lead in adipose tissue over time, the force required to remove the lead over time, and the tissue response to the lead. Methods: Twenty-five leads were implanted in the adipose tissue of four miniature Yucatan swine and followed for a four-week period at a contract research facility according to an IACUC approved protocol. Four of these leads (one per animal) were connected to an IPG and positioned near a motor nerve such that activation thresholds could be measured over time. These leads were placed in the hip of the swine and were subjected to motion and pressure associated with animal activity over the four-week period. Sixteen leads were subjected to pull-out removal, and the force required to remove the leads was recorded. Eight leads and six IPGs were dissected and subjected to histological analysis after 4 weeks of implantation. Results: Threshold measurements made at 1 week increased slightly over thresholds at time of implant, and thresholds remained stable between 1 and 4 weeks post-implant. All leads were pulled out clean and intact, whether they were removed at time of implant, at 1 week, or at 4 weeks. The force required to remove the leads at 4 weeks (mean 4.1N) was substantially greater than the force required to remove the percutaneous leads used in a clinical feasibility study (mean 0.59N). The leads were removed easily and without trauma to tissue or the device. The range of tissue response to the lead and IPG was heterogeneous and consistent with the range of responses observed around other stimulating electrodes implanted in the subcutaneous space, within or on skeletal
Presentation Number: Poster 159 Cost-Effectiveness of Sacral Neuromodulation Versus Intravesical Botulinum a Toxin for Treatment of Refractory Urge Incontinence N. Y. Siddiqui, C. L. Amundsen, A. G. Visco, E. R. Myers, and J. M. Wu Duke University Medical Center, Durham, NC Category: Neuromodulation. Objective: Sacral neuromodulation (SNS) and intravesical botulinum A toxin (BoNT-A) are promising treatment options for patients with refractory urge incontinence. Both are potentially costly modalities, but the cost-effectiveness of these procedures has not been established. Methods: We developed a Markov decision model to compare costs (2008 US dollars) and effectiveness (quality-adjusted life-years, QALYs) of InterStim SNS and BoNT-A for the treatment of refractory urge incontinence. Efficacy and adverse event rates were estimated from a comprehensive literature search. Costs were estimated using the Medicare reimbursement and national physician fee schedules. We conducted this analysis from a societal cost perspective using cycles of three months over a two-year time period, discounted at a standard rate of 3% per year. Our primary outcome was the incremental costeffectiveness ratio (ICER), which was defined as (SNS cost-BoNT-A cost)/(SNS QALY-BoNT-A QALY). Sensitivity analyses were performed varying efficacy, costs, and adverse events over the range of reported values. Results: In the base case, the SNS treatment strategy was more expensive ($15,743 vs $4,392) and more effective (1.73 vs 1.63 QALYs) than the BoNT-A treatment over a two-year period. However, the incremental cost-effectiveness ratio was $116,427/QALY. Using the conventional ICER threshold of $50,000/QALY, SNS was not costeffective. In sensitivity analyses, we varied the following probabilities: BoNT-A failure (8 40%), receiving repeat BoNT-A injections (25100%), urinary retention after BoNT-A (4 43%), failure of SNS test stimulation (1234%), any complication related to SNS implant (233%), complications requiring surgical revision (30 100%), cost of BoNT-A injection ($820 4090), cost of SNS lead placement ($4,730 7,700), and cost of SNS generator placement ($10,940 12,530). Despite varying these parameters, botulinum toxin A remained cost-effective. Conclusion: In this cost-effectiveness analysis conducted over a twoyear time period, botulinum A toxin was cost-effective for the treatment of refractory urge incontinence. Additional data regarding BoNT-A effectiveness with repeat injections, time to failure after
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injection, and long-term SNS complications will be helpful for future cost-effectiveness studies. Disclosures: N.Y. Siddiqui, None; C.L. Amundsen, None; A.G. Visco, Intuitive Surgical, Consultant; Intuitive Surgical, Paid Instructor; E.R. Myers, Merck, Grant/Research Support; Precision Diagnostics, Grant/Research Support; Merck, Consultant; Precision Diagnostics, Consultant; J.M. Wu, None.
Presentation Number: Poster 161 Does Current Perception Threshold Testing & ThermalVibratory Sensory Analyzer System Testing Selectively Measure Different Populations of Afferent in the Genital Area? L. Lowenstein, C. Davis, K. Jesse, and K. Kenton Loyola Medical Center, Chicago, IL Category: Neuromodulation. Objectives: While multiple pelvic floor disorders are clearly associated with afferent neural changes, which warrant further investigation to further our understanding of the pathophysiology and treatment of pelvic floor disorders, we are currently unable to compare changes in the lower urinary tract and genital region secondary to limitations in techniques. Given the accumulating literature using CPT and QST in the genito-urinary tract, and the limited data regarding selectivity and reproducibility in this area, we aimed to determine the relationship between Current Perception Threshold (CPT) testing ( 2000 Hz, 250 Hz and 5 Hz) and Quantative Sensory Testing (QST) using vibratory and heat thresholds, to find if the methods are selectively activating the same afferent neurons in the genital area; and to assess the reproducibility of both methods. Methods: Sixteen asymptomatic women were enrolled in the study. Each woman underwent CPT and QST testing on a single day. CPT testing was done using a Neurometer. Stimuli at 2000 Hz, 250 Hz and 5 Hz frequencies (corresponding to A- , A- , and C fibers, respectively) were applied to the distal third of the anterior vaginal wall. The Genital Thermal and Vibratory Sensory Analyzer (GSA) was used for thermal (C fibers), vibratory (A- fibers) and cold (A- and C fibers) testing on the vaginal wall at the same place. Ten women underwent repeated CPT and QST testing one week apart to determine reproducibility. Results: Study participants had a mean age of 34 (2252) years. Median BMI was 28.5(20 44). Most women were Caucasian, 62% (10); 32% (6) were African American; 6%were Hispanic(1). Mean PFDI score was 5.32 10. None of the women had stress or urge incontinence according to their response on MESA questionnaire. Patients median parity and POP staging were 0.6 (0 2) and 0.5 (0 2), respectively. Only one participant had POP stage II. We found a moderate correlation between CPT at 5 Hz and thermal sensory testing both of which correspond to C fiber pathways 0.77, p 0.002). Current perception thresholds at 2000 (Spearmans Hz and vibratory sensory thresholds, which correspond to A- fibers, were also moderately correlated (Spearmans 0.6, p 0.01). Cold stimuli correlated neither with CPT at 250 Hz stimuli which correspond to A- (p 0.29), nor with CPT 5 Hz which correspond to C fibers (p 0.55). The repeated thermal vibratory and cold threshold tests were found to have moderate to high concordance correlation (rhoc .83, p .001, rhoc .96, p .001 and rhoc .77, p .001 respectively). Similarly, repeated CPT 5 HZ, and 2000 Hz tests done one week apart were found to have moderate concordance correlation (rhoc .69, p .001, rhoc .7, p .001 respectively). Repeated CPT at 250 Hz was not correlated when repeated one week apart (rhoc .2, p .45 ). Conclusions: CPT and QST testing stimulate similar afferent nerve fiber populations in the vaginal region. Both modalities proved to have good reproducibility while QST was found to be more reliable tool for evaluating A- fibers. Disclosures: L. Lowenstein, Pfizer, Grant/Research Support; Astellas, Grant/Research Support; C. Davis, None; K. Jesse, None; K. Kenton, Allergan, Grant/Research Support; Pfizer, Grant/ Research Support.
Presentation Number: Poster 160 Evaluation of Botulinum a Toxin for The Treatment of Detrusor Overactivity Incontinence Refractory to Interstim Sacral Neuromodulation A. Shariati, C. D. McDermott, E. Fuller, C. Terry, and D. Hale Methodist Hospital/Indiana University School of Medicine, Indianapolis, IN Category: Neuromodulation. Objectives: To describe the effect of botulinum toxin injections into the detrusor muscle on urinary frequency, urge incontinence, and quality-of-life in those patients with detrusor overactivity incontinence (DOI) who are refractory to InterStim sacral neuromodulation. Methods: Patients with DOI who had subjectively and objectively failed treatment with anticholinergics and sacral neuromodulation were recruited for the study. Prior to injection, patients were asked to complete a 48 hour bladder diary as well as the Incontinence Impact Questionnaire (IIQ) and the Urogenital Distress Inventory (UDI). Under cystoscopic guidance, 300 units of botulinum A toxin with indigo carmine were injected into the detrusor muscle. Patients then repeated a 48 hour bladder diary and the IIQ and UDI questionnaires at intervals of 10 days, one month, three months, and six months following injection. Results: Nine women were enrolled into the study with an average age of 61 and an average Body Mass Index of 38. When compared to baseline, urinary frequency decreased by an average of 1.8 voids/24 hours at 10 days post-injection (p 0.08), 2.7 voids/24 hours at one month post-injection (p 0.1), 2.6 voids/24 hours at three months post-injection (p 0.16), and 5.0 voids/24 hours at six months postinjection (p 0.04). Conversely, the average voided volume when compared to baseline increased by 37 mL at 10 days post-injection (p 0.04), by 75 mL at one month post-injection (p 0.001), by 105 mL at three months post-injection (p 0.06), and by 42 mL at six months post-injection (p 0.13). The number urge incontinence episodes decreased from baseline by an average of 2.6 episodes/24 hours at 10 days post-injection (p 0.04), 3.3 episodes/24 hours at one month post-injection (p 0.003), 3.2 episodes/24 hours at three months post-injection (p 0.02), and 1.4 episodes/24 hours at six months post-injection (p 0.45). Averaged UDI scores showed statistically significant improvement at all follow-up intervals p 0.05). Averaged IIQ scores showed statistically significant improvement at one month, three month, and six month intervals p 0.05), but improvement in averaged score at 10 days post-injection was not found to be statistically significant (p 0.16). Conclusions: Botulinum toxin detrusor injection is a reasonable treatment option for patients with DOI who have previously failed sacral neuromodulation. This study demonstrates reduced urinary frequency, increased voided volume, decreased episodes of urge incontinence, as well as improved quality-of-life following botulinum toxin detrusor injection, with effects lasting as long as six months. Disclosures: A. Shariati, None; C.D. McDermott, None; E. Fuller, None; C. Terry, None; D. Hale, None.
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Presentation Number: Poster 162 Noninvasive Screening for Pudendal Neuropathy in Women with Overactive Bladder. M. K. Guess,* S. B. Nosseir, R. Bercik,* and K. A. Connell* *Division of of Urogynecology & Reconstructive Pelvic Surgery, Department of Obstetrics, Gynecology, & Reproductive Sciences. Yale University School of Medicine, New Haven, CT, Department of Obstetrics and Gynecology, Bridgeport Hospital, Bridgeport, CT Category: Neuromodulation. Objective: The UDI-6 is a validated scale designed to assess genitourinary complaints in women, particularly those with incontinence. Biothesiometry is a proven method used to evaluate neurological function. Using a validated questionnaire, urodynamic testing, and biothesiometry, our goal was to determine if subtle neurological deficits of the pudendal nerve exist in patients with symptoms of overactive bladder (OAB) and decreased bladder capacity. Methods: One hundred and fifty eight patients were recruited from Urogynecology and Gynecology clinics. Subjects were screened for symptoms of OAB using the UDI-6 and a medical history was obtained using a demographic worksheet. Urodynamics was performed when indicated. Exclusion criteria included having a significant neurological history, diabetes, previous surgery for prolapse/incontinence, isolated stress urinary incontinence, and incomplete questionnaire or biothesiometry test. Neurological integrity of the pudendal nerve was evaluated with biothesiometry at the S2 dermatome level. Testing sites included the vulva, clitoris, external urethral meatus, and the right and left sides of the perineum. Vibratory thresholds were determined using the method of limits. Data was analyzed using Mann-Whitney U Test and Spearmans Correlation. Results: Fifty six women were enrolled of which thirty nine subjects showed symptoms of OAB. Twenty five percent were menopausal. The mean age was 42 15.4 years. The mean parity was 1.6 1.42. Overall, women with symptoms of OAB had decreased genital sensation at the labia p .035), clitoris (p .06), right perineum (p .02) and left perineum p .01). More specifically, a negative correlation was found between decreasing bladder capacity and increasing vibratory thresholds (indicating decreased genital sensation) at the clitoris (p .045), external urethral meats (p .014), and the right perineal body (p .029). Conclusion: Patients with symptoms of overactive bladder and/or decreased bladder capacity may have an underlying pudendal neuropathy. Biothesiometry may serve as a potential non-invasive technique in identifying patients at risk for refractory overactive bladder symptoms, who may require higher doses of anticholinergics and benefit from adjunct neurostimulation. Disclosures: M.K. Guess, None; S.B. Nosseir, None; R. Bercik, None; K.A. Connell, None.
Objectives: Our primary aim was to explore the spectrum of final diagnoses for women presenting to a urogynecology practice with a referral diagnosis of recurrent urinary tract infection (UTI). Methods: We performed a retrospective chart review of electronic medical records for patients referred by primary care physicians to a urogynecology practice for recurrent UTI from 04/2006 to 01/2007. Demographic and clinical data were extracted from the medical records of women with the referral diagnosis of recurrent UTI. Additionally, results from the urinalysis, urine culture, urodynamic exam and cystoscopy were recorded. In a subset of patients, detailed treatment history from primary care physicians was also recorded. The final diagnosis as assigned by a single urogynecologist was noted for each patient. Descriptive data that is normally distributed are reported as means with standard deviations. Non-parametric data are presented as medians. Results: One hundred and three (10.4%) women were referred with a diagnosis of recurrent UTI during the study period. The mean age of the women with a referral diagnosis of recurrent UTI was 51.9 ( 20.8) and mean parity was 1.45 ( 1.41) Prior to referral, mean number of courses of antibiotics taken by women was 2.8 ( 2.3). The most commonly prescribed antibiotic was ciprofloxacin (46%) followed by Bactrim (24.4%) and Macrobid (17.3%). Detailed prereferral treatment history was available for 45 women. In this subgroup, the median number of telephone calls and visits related to lower urinary tract symptoms to primary care physicians was 3 and 2, respectively. The median number of urinalysis and urine cultures performed prior to referral was 3 for both tests. Following complete evaluation, the final diagnosis of recurrent UTI was confirmed in 48 (47%) women. Fifty three percent of these women (N 55) received diagnosis other than UTI. Overactive bladder (18.4%), mixed urinary incontinence (7.8%) and interstitial cystitis (7.8%) were the three most frequent diagnoses. There was no significant difference in the mean age, parity and hormone status of women with and without final diagnosis of recurrent UTI. Conclusion: There is a significant disagreement between referral diagnoses provided by primary care physician and final diagnosis of the urogynecologist. Disclosures: L. Lipetskaia, None; G. Northington, None; E. Saks, None; L. Arya, None.
Presentation Number: Poster 163 Diagnoses of Patients Referred to Urogynecologist for Recurrent Urinary Tract Infections L. Lipetskaia,* G. Northington, E. Saks, and L. Arya *St.Lukes Bethlehem Hospital, Bethlehem, PA, University of Pennsylvania, Philadelphia, PA Category: Other.
Presentation Number: Poster 164 Low Dose 17- -Estradiol Cream: Serum and Vaginal Responses T. L. Wheeler, II, H. E. Richter, M. G. Conner, P. S. Goode, A. D. Markland, and C. R. Parker University of Alabama at Birmingham, Birmingham, AL Category: Other. Objective: A pilot study to describe the systemic (serum) and local (vaginal) responses to 50ug of intravaginal 17- -estradiol (E2) cream. Methods: Twenty women, 65 years or older, applied 50 ug intravaginal cream nightly for 8 weeks followed by a maintenance frequency of twice a week for an additional 8 weeks. This is a substudy of the clinical outcomes for this translational pilot project. Repeated measures analysis assessed for changes in vaginal maturation indexes (VMI), epithelial thickness, glycogen content, radioimmunoassays for serum E2 level, pelvic floor symptoms (Pelvic Floor Distress Inventory, PFDI and Pelvic Floor Impact Questionnaire, PFIQ)and atrophy questions at baseline, 8 weeks and 16 weeks. Tukeys HSD corrected for multiple testing. Results: The mean, SD age was 72.4, 6.3 years (median 70, range 65 84). The mean, SD BMI was 24.9, 3.0 (median 25.3, range
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TABLE. Clinical Outcomes with 50ug of Intravaginal Estradiol Cream Baseline Serum Estradiol pg/ml (mean, SD) Vaginal Maturation Index Score (mean, SD) Epithelial thickness, mm (mean, SD) Glycogen present (%) Vaginal Dryness (%) -Never -Rarely -Sometimes -Often Vaginal Itching (%) -Never -Rarely -Sometimes -Often
*8 weeks compared to baseline. **16 weeks compared to baseline.
8 Weeks 9.7, 5.7 56.7, 13.1 0.31, .10 88.2 21 26 16 37 16 26 47 11
16 Weeks 8.7, 5.8 54.5, 11.3 0.27, .10 76.5 35 15 35 15 25 50 25 0
p-value 0.2365 0.0001 0.0001 0.0195*(8weeks)0.3247**(16weeks) 0.0295
7.7, 3.3 34.2, 18.3 0.14, 0.07 25.0 25 5 45 25 30 30 30 10
0.0202
18.9 29.8). No statistical difference was found in serum E2 levels between time points, while improvement in the VMI score and thickness content occured, with no difference found between 8 and 16 weeks (Table). The presence of glycogen improved at 8 weeks. There was marginal evidence that serum E2 level correlated with VMI p-value 0.0579). In this small cohort, vaginal dryness and itching did improve (Table), but improvements in vaginal discomfort p-value 0.6024), discharge p-value 0.9168), and dyspareunia p-value 0.2792) did not, as these were rare at baseline. Again, likely due to low occurrences at baseline, pelvic floor symptoms did not improve (CRADI p 0.1845, CRAIQ p 0.8178, IIQ p 0.5200, UDI p 0.4190, POPDI p 0.2633, POPIQ p 0.1746). Conclusions: Older women using 50 ug of intravaginal estradiol nightly for 8 weeks followed by twice a week for 8 weeks had improvements in their vaginal maturation index and vaginal symptoms of dryness and itching without significantly elevating their serum estradiol levels when sampled with a highly sensitive immunoassay. There was no difference in pelvic lower urinary tract symptoms. This information may be useful when counseling older women with vaginal atrophy who may be concerned about initiating intravaginal estrogen therapy. Part of this abstract was presented at the 2008 AGS Annual Meeting, Washington, DC. Disclosures: T.L. Wheeler II, Pfizer, Speakers Bureau; H.E. Richter, Pfizer, Speakers Bureau; M.G. Conner, None; P.S. Goode, None; A.D. Markland, None; C.R. Parker, None.
Presentation Number: Poster 165 Levator-Ani Necrosis-A Rare Complication Following Pelvic Floor Repair of Apical and Posterior Vaginal Prolapse H. Yasmin, and M. L. Mokrzycki Saint Peters University Hospital, New Brunswick, NJ Category: Other. Objective: Necrosis of the levator ani muscle is extremely rare following pelvic reconstructive surgery. It is a complication that may result in severe constipation or worrying concern over a firm mass in the gluteal region. We present a 78 year old female who had necrosis of the levator ani muscle following the repair of apical and posterior vaginal prolapse resulting in a firm mass in the levator ani area.
Methods: The patient is a 78 year old female who initially presented to our office 3 years prior with a long history of vaginal bulging, pressure and discomfort as well as urinary incontinence. On examination in the supine lithotomy position, her vaginal apex and posterior vaginal wall extended 3 centimeters distal to the hymenal ring. Subsequently she underwent an uncomplicated sacrospinous ligament fixation, a posterior colporrhaphy augmented by a Gynemesh graft. Finally, the pubovaginal sling was performed placing the Tension Free Transvaginal Tape System in a U configuration underneath the midurethra. Her hospital course and postoperative follow-up was uncomplicated. She presented later with a five month history of a hard mass in the area of her right buttock. The mass was firm and mobile and did not cause any pain. There was a change in her bowel habits with a fluctuation between constipation and diarrhea. On pelvic exam in the supine lithotomy position, the posterior vaginal wall revealed a defect in the right levator ani muscle area where a firm mobile mass was palpated. The size of the mass was approximately 10 cms in diameter. On rectal exam the mass was confirmed to be the impacted stool in an area of the rectum that had prolapsed into the right levator ani muscle area. The stool was partially removed with resolution of the mass. Results: This defect in levator ani complex could have possibly resulted from haemorrhagic necrosis after either of the above two procedures or secondary to nerve damage during surgery leading to weakness of the Levator ani complex . This could have possibly resulted in a weakness defect of Levator ani causing prolapse of bowel into this defect. This patient had minimal symptoms related to bowel function and so was effectively managed with dietary modifications. Conclusions: This complication of levator ani necrosis associated with apical and posterior vaginal prolapse repair should be acknowledged as a postoperative possibility by all surgeons performing this procedure. Disclosures: H. Yasmin, None; M.L. Mokrzycki, None.
Presentation Number: Poster 166 Pelvic Reconstructive Surgery in Renal Transplant Recipients A Retrospective Chart Review D. Shveiky*, A. Blatt, A. I. Sokol,* B. I. Kudish,* I. C. Green,* and C. B. Iglesia* *Washington Hospital Center, Washington, DC, Georgetown University Hospital, Washington, DC
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Category: Other. Objective: In 2007 approximately 3000 postmenopausal women underwent renal transplantation. Similar to the general U.S. population, women with renal transplants may also have pelvic organ prolapse and/or urinary incontinence complaints, the latter of which often becomes more symptomatic after transplantation. Very little is known about the safety and efficacy of pelvic reconstructive procedures in renal transplant patients. The aim of this study was to describe our series of female renal transplant recipients undergoing pelvic reconstructive surgery. Methods: Retrospective chart review of surgical logs identified 4 patients undergoing renal transplantation and pelvic reconstructive surgery in our division, from 1/2000 3/2008. Data included medical and surgical history, POP-Q, as well as perioperative complications. Results: The mean age was 56.5 (range 50 70). The origin of the transplanted kidneys was cadaver in two, and living related in the other two. All transplanted kidneys were located in the pelvis and all ureters were implanted in the bladder dome. For these four patients, a total of two vaginal hysterectomies with utero-sacral ligament suspension, three anterior repairs, two posterior repairs and two suburethral sling procedures (TVT and TOT) were performed. There were no intraoperative or postoperative complications (Dindo grade 1 or more). At a mean follow-up period of 14.5 months (range 4 36 months), all patients were cured of their prolapse (defined as Stage 2 POP-Q) and were free of urinary incontinence symptoms. Case description is provided with an emphasis on the unique medical and surgical considerations of pelvic surgery in these patients. Conclusions: In well selected patients and with special consideration for their unique needs, pelvic reconstructive surgery can safely be performed in renal transplant patients. Disclosures: D. Shveiky, None; A. Blatt, None; A.I. Sokol, None; B.I. Kudish, None; I.C. Green, None; C.B. Iglesia, None.
alternate arm for 6 additional weeks. Subjects were required to complete a total of three 3-day voiding diaries and present for three 30-minute study visits. Results: From October 2005 through October 2007, a total of 106 individuals were screened for participation in the study. Most of the individuals (98%) responded to the posted advertisement. All individuals screened were female. Only nine (8.5%) were ultimately enrolled in the study. Thirteen individuals (12.3%) did not meet inclusion criteria. Forty-five individuals (42.5%) refused participation citing the following reasons: unwilling to collect and measure urine (9.4%), unwilling to take medication (15.1%), study is too involved and time consuming (12.3%), unwilling to take placebo (1.9%), work or transportation conflict (2.8%), and subject desired alternative therapy (0.9%). Finally, thirty-nine individuals (36.8%) did not respond to email or phone calls after they were mailed the consent form. The study was discontinued due to inadequate recruitment. Conclusions: Published literature regarding nocturia would suggest that this symptom is not only prevalent, but also bothersome. However, the majority of individuals who were interested in participating in this study met criteria for the diagnosis but ultimately refused or did not pursue participation. This is relevant to the utility of the current ICS definition of nocturia. Researchers wishing to study individuals with nocturia may choose to add a level of bother in the screening criteria to facilitate recruitment. Disclosures: M.M. South, None; J.H. Maynor, Pfizer, Grant/Research Support; A.C. Weidner, None; C.L. Amundsen, Pfizer, Grant/Research Support.
Presentation Number: Poster 167 Barriers to Study Recruitment in Individuals with an Isolated Symptom of Nocturia M. M. South, J. H. Maynor, A. C. Weidner, and C. L. Amundsen Duke University Urogynecology and Pelvic Reconstructive Surgery, Durham, NC Category: Other. Objective: Nocturia is the complaint of needing to wake at night one or more times to void (International Continence Society, 2002 definition) and is one of several lower urinary tract symptoms reported as extremely bothersome by men and women. Although anticholinergic medications are not specifically indicated for treatment of nocturia, several studies have shown that anticholinergic treatment for an overactive bladder is associated with improvement in nocturia. The objective of this study was to evaluate the efficacy of tolterodine compared to placebo in men and women complaining of nocturia due to decreased functional night-time bladder capacity. Methods: This was a randomized placebo-controlled crossover study evaluating men and women over 18 years of age complaining of voiding two or more times per night. Subjects were recruited from urology and urogynecology clinics and a posted advertisement. The advertisement read Are you getting up regularly two or more times per night to empty your bladder? Each subject was asked to complete a 3-day bladder diary to confirm nocturia and exclude nocturnal polyuria. Subjects were randomized to either placebo or study drug for 6 weeks, followed by a one week wash-out period and then crossed over to the
Presentation Number: Poster 168 Case Report of Vesicovaginal Fistula After Bladder Stone G. A. Azam LSU-HSC, New Orleans, LA Category: Other. A rare case of a vesicovaginal fistula following vesical calculi is presented. The patient complained of intermittent incontinence and vaginal discharge. Diagnosis was made clinically radiologically and endoscopically. Transvesical minilaparotomy with cystostomy followed by transvaginal (juxtacervical ) fistula repair and cystoscopy were done. The patient recovered very well postoperatively. Disclosures: G.A. Azam, None.
Presentation Number: Poster 169 Recurrent Adductor Abscess Secondary to Transobturator Synthetic Sling T. B. Hutchings, R. F. Flora, T. Murray, and D. Chonko Summa Health System, Akron, OH Category: Other. Background: Transobturator mid-urethral slings were developed as an alternative surgical technique in the treatment of female stress urinary incontinence. The transobturator approach reportedly decreases bladder perforations as compared to the retropubic approach and is generally considered a low morbidity procedure. Case: The orthopedic and urogynecology service was consulted on a 40 year old female with a ten month history of recurrent left medial adductor abscess. She twice had an incision and drainage performed
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with multiple courses of antibiotics over the previous ten months. Her history was significant for placement of a Mentor Obtape transobturator mid-urethral sling 2 years earlier and a chronic vaginal discharge for one year. On vaginal exam exposed vaginal mesh was visualized to both the right and left of the urethra. A combined vaginal removal of mesh and adductor incision and drainage took place. The patient remained hospitalized for 6 days post op and was discharged home on PO antibiotics. The patient is doing well with no complaints five month post op. Conclusions: Adductor abscess is a rare complication following a transobturator synthetic sling. To our knowledge this represents the first report of a recurrent adductor abscess following placement of a transobturator mid-urethral sling. Both urogynecologic and orthopedic surgeons need to be aware of this complication. As in this case, most reported abscess are in relation to vaginal mesh erosion. In order to avoid recurrent adductor abscess we suggest that strong consideration be given to vaginal removal of mesh with incision and drainage on all patients with thigh abscess and a history of transobturator midurethral slings. Disclosures: T.B. Hutchings, None; R.F. Flora, None; T. Murray, None; D. Chonko, None.
tissue defect and the development of pelvic organ prolapse. This is why that we have to give attention to management of lung function of those who develop pelvic organ prolapse earlier in life. Disclosures: S. Bai, None; H. Jung, None; M. Jeon, None; S. Kim, None.
Poster Video Presentations

Presentation Number: Poster Video 1 Surgical Anatomy of The Retropubic Space: An Educational Tool R. M. Ward, and C. R. Rardin Women and Infants Hospital/ Warren Alpert Medical School of Brown University, Providence, RI Clinical Problem: There is an increasingly complex array of minimally invasive surgical procedures for the treatment of female pelvic floor dysfunction. While these techniques may be performed blindly, a thorough understanding of pelvic anatomy, and especially the retropubic space, is critical in order to achieve safe outcomes. Surgical Solution: Knowledge of this complex anatomic space can minimize the risk of vascular and bladder injuries, as well as enable the surgeon to appropriately handle retropubic complications. Methodology: This video reviews the anatomy and surgically pertinent landmarks of the retropubic space with original illustrations, cadaveric dissections and laparoscopic video footage. It also reviews two commonly performed retropubic surgeries: a paravaginal repair and Burch urethropexy. Outcome: This video may be used as an educational tool to augment the knowledge of physicians-in-training and pelvic surgeons who will be performing retropubic procedures.
Presentation Number: Poster 170 Impairment of Lung Function in Postmenopausal Women with Pelvic Organ Prolapse S. Bai, H. Jung, M. Jeon, and S. Kim Department of Obstetrics and Gynecology, Seoul, Republic of Korea Category: Other. Objective: The objective of this study was to determine whether impairments of lung function are present in postmenopausal women with pelvic organ prolapse considering to a link between pelvic organ prolapse and connective tissue. Methods: This was a prospective, case-control study. The study population consisted of 207 women with pelvic organ prolapse (defined as POP-Q stage II) and 207 women without pelvic organ prolapse (defined as POP-Q stage 0 or I) matched for age, height, and years after menopause. All of them were postmenopausal without hormone replacement therapy and clinical signs or histories that are known to affect the pulmonary function. Each patient underwent a standard medicosurgical and urogynecology questionnaire, complete physical examination, chest X-ray and spirometric test. This study was approved by the Institutional Review Board of Yonsei University Health System. The Students t-test, ANOVA and Pearson correlation were used for statistical analysis by using SPSS, version 12.0 (SPSS Inc., Chicago, IL, U.S.A.). p 0.05 was determined to be significant. Results: There was significant decrease of forced vital capacity and peak expiratory flow in cases compared to controls (Forced vital capacity; 2.04 0.46 L (93.21 11.34 %) vs. 2.41 0.45 L (99.89 14.11 %), p-value 0.049 (0.046) and Peak expiratory flow; 4.12 1.44 L (82.73 19.05 %) vs. 4.63 1.67 L (91.87 20.77 %), pvalue 0.019(0.031)). Significant difference in the mean forced vital capacity was shown among stages II, III, and IV (stage II: 2.41 0.53 L (99.90 15.04 %), stage III 2.11 0.46 L (89.42 14.74 %), stage IV: 2.01 0.56 L (87.60 18.51 %), p-value 0.047 (0.020)). There was a positive correlation between the percentage of predictive value of forced vital capacity and peak expiratory flow and the age at the development of pelvic organ prolapse (p-value 0.000 and 0.000). Conclusion: We demonstrated a relationship between pelvic organ prolapse and impairment of lung function of restrictive pattern and pelvic organ prolapse. Patients have the behavioral tendency to limit the activity that can increase abdominal pressure. The pulmonary impairment of pelvic organ prolapse patients aggravates in advanced stages of pelvic organ prolapse and early developed pelvic organ prolapse. This suggests the connection between the basic connective
Disclosures: R.M. Ward, None; C.R. Rardin, Boston Scientific, Consultant; Novartis, Speakers Bureau.
Presentation Number: Poster Video 2 Large Vesicovaginal Fistula Repair M. Jean-Michel,* L. Espaillat, and G. Davila* *Cleveland Clinic Florida, Weston, FL, Temple University Hospital, Philadelphia, PA Clinical Problem: An 83 year old multiparous female developed a 5 cm vesicovaginal fistula as a result of a neglected pessary, which had eroded into the bladder. The fistula was located on the proximal aspect of the anterior vaginal wall with a second-degree midline cystocele. Surgical Solutions: Vesicovaginal fistula repair was performed via a vaginal approach. Methodology: The fistulous tract was dissected and ultimately excised after wide mobilization of the endopelvic fascia and bladder off the anterior vaginal wall. The bladder mucosa was reapproximated without tension in 2 layers and the endopelvic fascia was closed in 2 layers including a midline plication. The most proximal plication
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suture incorporated the pubocervical fascia and the cervix, restoring the continuity of the pubocervical fascia to the apex. The vaginal mucosa was then closed. Cystoscopy demonstrated an intact bladder and patent ureters. Outcome: Large vesicovaginal fistula repair is an uncommon complication of pessary use. This can be managed successfully from a vaginal approach by adhering to basic principles of fistula repair: wide tissue mobilization, tension-free closure, double-layer repair, and good hemostasis. Disclosures: M. Jean-Michel, None; L. Espaillat, None; G. Davila, AMS, Adamed, Synovis Astellas Watson Zuidex Protein Polymer Technologies Duramed, Grant/Research Support; AMS, Watson, Adamed, Consultant; Watson, AMS, Synovis, USSurgical, Pfizer, Astellas, Adamed, Other.
more traditional technique in the short-term and shows promise in the longterm. Like the traditional method, it is minimally invasive and can be done under local with or without conscious sedation without any additional risks to the patient. Based on our findings, this technique appears promising and worthy of further study. Disclosures: G.M. Buchsbaum, Pfizer, Grant/Research Support; Ethicon, Consultant; J.Q. Pulvino, None.
Presentation Number: Poster Video 3 A Modified Transurethral Collagen Injection Technique for the Management of Stress Urinary Incontinence. G. M. Buchsbaum, and J. Q. Pulvino University of Rochester Medical Center, Rochester, NY Clinical Problem: Transurethral collagen injections are one of the treatment options for women with stress urinary incontinence (SUI) in the presence of intrinsic sphincter deficiency with a fixed urethra. These injections are traditionally performed by injecting small amounts of bovine collagen at the 3 and 9 oclock positions at the bladder neck to reduce the lumen of the proximal urethra. In the short term, they have been shown to be very effective. However, the effectiveness of the injections appears to diminish with time, and patients often require repeat injections, limiting overall satisfaction with this technique. Surgical Solution: In an effort to enhance long term results we have modified our injection technique. Rather than injecting collagen solely at the bladder neck as reported in previous studies, we inject collagen along the entire length of the urethra. We present a video demonstrating this technique followed by the results of a recent retrospective chart review detailing our experience. Methodology: Collagen injections are performed transurethrally under IV sedation using a 12 degree lens through a 22 French array. Under direct cystoscopic visualization while slowly backfilling the bladder Contigen (purified bovine dermal glutaraldehyde cross-linked collagen, C. R. Bard Inc., Covington, Georgia) is injected at 2 to 4 sites starting in the proximal urethra and extending distally to level of the bladder neck. Collagen is injected until the walls of the urethra are completely coapted over the entire visible length. Outcome: Our technique for transurethral injection of collagen for the treatment of stress urinary incontinence appears to be comparable to the
Presentation Number: Poster Video 4 New Modification of Vesicovaginal Fistula Repair Using Interposition Graft and Retention Sutures; Increases Successes And Endurance of Fistula Repair B. Alnaif Western Branch Center for Women, Washington, DC Introduction: Most vesicovaginal fistulas (VVF) in United States result from surgical complications and typcially present as urinary incontinence. Factors which influence success of fistula repair include the fistula characteristics (size, location and numbers), health of the surrounding tissue, anatomical location and risk of infection. Objective: To improve success and endurance of fistula repair using minimally invasive technique with less morbidity and shorter recovery. Description of Technique: We followed the principles of fistula repair, which include excising the tract, tension-free repair of healthy tissue to healthy tissue in layers with adequate hemostasis, bladder drainage, and infection control. We found that separating the two epithelial surfaces by adding interposition graft decreases the risk of recanalization, thus increasing success as well as endurance. Moreover, the tension on the repair was decreased with retention sutures that were also designed to stabilize the graft in place. Surgisis graft was chosen because it is gentile, promotes healing and is not prominent. We performed this technique on eight patients; three had failed previous repairs. All patients had developed fistula as a result of a simple abdominal or vaginal hysterectomy. All repairs were performed vaginally in outpatient setting and without complications. Indwelling catheters were left in for a duration of 10 14 days. Cure, defined as achieving full continence with normal bladder function, and resumption of sexual function without pain or incontinence, was achieved in all these patients. Patients experienced minimal postoperative discomfort and returned to work early. Conclusion: This new modification of fistula repair which includes the use of interposition graft secured in place with retention sutures would increase success and endurance of vesicovaginal fistula repair. We used the same technique successfully to repair rectovaginal fistula, and in urethral diverticulum repair. Disclosures: B. Alnaif, None.
345

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ABSTRACTS

Oral Paper Presentations

(J Urol April 2008 e-pub).

Distribution-based methods Effect size Standard error of Measurement (SEM)

0.5 SD (standard deviation) 1 SEM

UDI 20.3 15.6

UIQ 19.4 7.9

25% change from baseline to 3 months in UIE.

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

Post-hoc p 0.003 (a vs b) 0.001 (b vs c) 0.085 (a vs c)

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

Delta 11.1 7.4 5.0* 5.1

Vertical (mm) Rest 26.7 25.7 7.3 8.9

Squeeze 32.4 30.2 6.8 9.1

Delta 5.7 4.5 2.8 3.2

* unpaired t-test with unequal variances vs FI: p

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

Postoperative (mean SD) 3 17 20 0 0

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

* Overall P-value comparing control vs prolapse regardless of hormonal status;

Post-hoc P-value adjusted to a significance level of 0.017.

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

Disclosures: G. Sutkin, None; J.L. Lowder, None; K. Smith, None.

2008 Lippincott Williams & Wilkins

P Value .92 .003 .06

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

TABLE. Baseline N 238 6 weeks N 238 Long term visit (N 147)

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

2008 Lippincott Williams & Wilkins

Am J Obstet Gynecol, Vol 158: 872-881. 1988.

2008 Lippincott Williams & Wilkins