Incontinence Surgical Treatment Efficacy Trial Research Articles

Effect of Surgery for Stress Incontinence on Female Sexual Function.

To evaluate the effects of four different surgical interventions for stress urinary incontinence (SUI) on 2-year postoperative sexual function. This is a combined secondary analysis of SISTEr (Stress Incontinence Surgical Treatment Efficacy Trial) and TOMUS (Trial of Mid-Urethral Slings). Women in the original trials were randomized to receive surgical treatment for SUI with an autologous fascial sling or Burch colposuspension (SISTEr), or a retropubic or transobturator midurethral sling (TOMUS). Sexual function (assessed by the short version of the PISQ-12 [Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire]) was compared between groups at baseline, 12 and 24 months. Secondarily, the effects of subjective and objective surgical cure rates and the effect of concomitant surgical procedures on 24-month sexual function was explored. Nine hundred twenty-four women were included in this study: 249 (26.9%) had an autologous fascial sling, 239 (25.9%) underwent Burch colposuspension, 216 (23.3%) had a retropubic midurethral sling placed, and 220 (23.8%) had transobturator midurethral sling placed. Baseline characteristics (including PISQ-12 scores) were similar between the four treatment arms, with notable exceptions including race-ethnicity, prolapse stage, concomitant surgery, and number of vaginal deliveries. After adjustment for differences between the groups, there was a clinically important improvement in PISQ-12 scores over the 24-month postoperative period for all treatment groups, with no significant differences attributed to the type of anti-incontinence procedure (baseline PISQ-12: 32.6, 33.1, 31.9, 31.4; 24-month PISQ-12: 37.7, 37.8, 36.9, 37.1, P<.01). There was no significant difference in mean PISQ-12 scores between 12 months and 24 months (12-month PISQ-12: 37.7, 37.8, 36.9, 37.1; 24 months as above, P=.97). Multivariable analysis showed independent associations between objective and subjective cure rates as well as concomitant procedures with a 24-month PISQ-12 score. Women undergoing anti-incontinence surgery show overall improvement in sexual function from baseline to 24 months postoperatively, without significant differences based on surgical procedure performed. The majority of this improvement occurs in the first 12 months and is maintained over 24 months.

Long-Term Results of Burch and Autologous Sling Procedures for Stress Urinary Incontinence in E-SISTEr Participants at 1 Site.

We report long-term outcomes in participants in the E-SISTEr (Extended Stress Incontinence Surgical Treatment Efficacy Trial) at 1 tertiary care center who underwent a Burch or a fascial sling procedure for stress urinary incontinence. After receiving institutional review board approval E-SISTEr participants at 1 center who underwent midterm office evaluation in 2010 were further reevaluated at longer term followup by office visits and structured telephone interviews. The telephone interviews were performed by a third party not involved in patient care for those not seen in the last 2 years. Each group received validated questionnaires, including the UDI-6 (Urogenital Distress Inventory-Short Form), the IIQ-7 (Incontinence Impact Questionnaire-Short Form) and the visual analogue quality of life score questionnaire. Failure was measured by Kaplan-Meier curves using time to reoperation for stress urinary incontinence. Of the 29 eligible patients, including 14 treated with a Burch procedure and 15 treated with a sling procedure, 21 had long-term information available, including 11 and 10, respectively. Median followup was 15.1 years (range 11.2 to 16.0). One of the 8 patients was lost to followup, 1 died and 7 were unreachable by telephone. The UDI-6 question 3 score was lower for the 13 patients followed by telephone, including 13 and 7 with a Burch and a sling procedure compared to the 8 seen in clinic, including 5 and 3 with a Burch and a sling procedure, respectively (mean ± SD score 0.3 ± 0.6 vs 1.3 ± 1.1, p=0.0208). The UDI-6 scores were similar for the 2 procedures. Stress urinary incontinence reoperation was performed in 3 cases, including placement of a fascial sling in 1 Burch case. The other 2 cases in the Burch and sling groups received an injectable agent at 11.6 and 13.5 years, respectively. The overall Kaplan-Meier 15-year reoperation-free survival rate was 85.2% (95% CI 60.8-95). In this well characterized cohort with a median followup of 15.1 years there was sustained improvement in continence scores and quality of life related to stress urinary incontinence in each group and the reoperation rate was low.

11: The effect of anti-incontinence surgery on female sexual function: a combined secondary analysis of the stress incontinence surgical treatment efficacy trial and trial of mid-urethral slings

To determine the impact of surgery for stress urinary incontinence (SUI) on 24-month postoperative condition-specific sexual function. This is a combined secondary analysis of the Trial of Mid-Urethral Slings (TOMUS) and the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr). SISTEr subjects (Burch colposuspension or Autologous fascial sling) and TOMUS subjects (retropubic or transobturator mid-urethral sling) who completed 24-month postoperative sexual function questionnaire (PISQ-12) were included. PISQ-12 scores were used to compare sexual function between groups at baseline, at 24 months postoperatively and the change in score. Descriptive statistics compared sexual function between the treatment groups and a multivariable model was fit to the data to control for significant baseline differences between treatment groups. Repeated measures ANOVA was used to identify time and treatment effects on sexual function. A total of 852 participants were included. Baseline differences between treatment groups include race/ethnicity, number of pregnancies and vaginal deliveries, stage of prolapse, and concomitant surgeries (Table 1). On univariate analysis, there was no significant difference between baseline, 24-month and change in sexual function between treatment groups (Table 2). Surgical treatment group was not associated with 24-month sexual function on multivariate analysis after adjusting for differences between groups, however objective failure rate was an independent predictor of postoperative sexual function. There is a significant improvement in sexual function over the 2 years following anti-incontinence surgery, but there is no treatment effect attributed to surgery type on repeated measures ANOVA (Figure 1). Women who are sexually active and undergoing surgical treatment for stress urinary incontinence have improved sexual function at 24 months postoperatively with no differences attributed to type of anti-incontinence surgery.View Large Image Figure ViewerDownload Hi-res image Download (PPT)View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Missing data frequency and correlates in two randomized surgical trials for urinary incontinence in women.

Missing data is frequently observed in clinical trials; high rates of missing data may jeopardize trial outcome validity. We determined the rates of missing data over time, by type of data collected and compared demographic and clinical factors associated with missing data among women who participated in two large randomized clinical trials of surgery for stress urinary incontinence, the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) and the Trial of Midurethral Sling (TOMUS). The proportions of subjects who attended and missed each follow-up visit were calculated. The chi-squared test, Fisher's exact test and t test were used to compare women with and without missing data, as well as the completeness of the data for each component of the composite primary outcome. Data completeness for the primary outcome computation in the TOMUS trial (62.3%) was nearly double that in the SISTEr trial (35.7%). The follow-up visit attendance rate decreased over time. A higher proportion of subjects attended all follow-up visits in the TOMUS trial and overall there were fewer missing data for the period that included the primary outcome assessment at 12 months. The highest levels of complete data for the composite outcome variables were for the symptoms questionnaire (SISTEr 100 %, TOMUS 99.8%) and the urinary stress test (SISTEr 96.1%, TOMUS 96.7%). In both studies, the pad test was associated with the lowest levels of complete data (SISTEr 85.1%, TOMUS 88.3%) and approximately one in ten subjects had incomplete voiding diaries at the time of primary outcome assessment. Generally, in both studies, a higher proportion of younger subjects had missing data. This analysis lacked a patient perspective as to the reasons for missing data that could have provided additional information on subject burden, motivations for adherence and study design. In addition, we were unable to compare the effects of the different primary outcome assessment time-points in an identically designed trial. Missing visits and data increased with time. Questionnaire data and physical outcome data (urinary stress test) that could be assessed during a visit were least prone to missing data, whereas data for variables that required subject effort while away from the research team (pad test, voiding diary) were more likely to be missing. Older subjects were more likely to provide complete data.

Effect of Aging on Storage and Voiding Function in Women with Stress Predominant Urinary Incontinence

We investigated age related changes in urodynamic parameters in 2 large cohorts of women planning stress urinary incontinence surgery. Using a standardized protocol we obtained urodynamic parameters for participants in SISTEr (Stress Incontinence Surgical Treatment Efficacy Trial) and TOMUS (Trial of Mid-Urethral Slings) undergoing baseline noninvasive flow followed by filling cystometrogram and pressure flow study. The bladder contractility index (defined as detrusor pressure at maximum flow+5×maximum flow) and detrusor hypocontractility (defined as detrusor pressure at maximum flow less than 10 cm H2O) were also characterized. Patients excluded from analysis had undergone prior stress urinary incontinence surgery or had prolapse stage greater than II. Propensity score analysis controlled for the potential bias of combining participants from 2 clinical trials. Linear and logistic regression analysis adjusting for propensity score quintile was done to assess the association of age and an age cutoff (less than 65 vs 65 or greater years) with urodynamic parameters. A total of 945 women (468 in SISTEr and 477 in TOMUS) were included in analysis. Mean age was 50 years in SISTEr (range 27 to 75) and 51 years (range 24 to 82) in TOMUS. Noninvasive maximum urinary flow decreased significantly with age (26.2 vs 22 ml per second, p=0.002). Noninvasive flow voiding time increased 2.7 seconds for each 10-year age increment and detrusor pressure at maximum flow decreased 2.1 cm H2O for each 10-year increase in age (each p=0.003). Hypocontractility was more likely in women 65 years old or older (OR 2.89, 95% CI 1.59, 5.27). The bladder contractility index was inversely related to age, decreasing a mean±SD of 7.68±1.96 cm H2O for each 10-year age increase (p<0.001). In these 2 cohorts the observed changes in voiding parameters suggest that detrusor contractility and efficiency decrease with age.

Preoperative clinical, demographic, and urodynamic measures associated with failure to demonstrate urodynamic stress incontinence in women enrolled in two randomized clinical trials of surgery for stress urinary incontinence

The unexpected absence of urodynamic stress incontinence (USI) in women planning surgery for stress urinary incontinence (SUI) is a challenge to surgeons. We examined the prevalence and clinical and demographic factors associated at baseline (preoperatively) with the unexpected absence of USI among study participants of two multicenter randomized clinical trials of surgery for treating SUI. Women with SUI symptoms and positive stress tests on physical examination enrolled in two separate clinical trials-one comparing the autologous fascial sling with the Burch colposuspension [Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr), and the other comparing the retropubic mid-urethral sling with the transobturator midurethral sling [Trial of Mid-Urethral Slings (TOMUS)]-were evaluated for USI preoperatively. The association of clinical, demographic, and urodynamic parameters was examined in women without USI in univariate and multivariate analyses. Overall, 144 of 1,233 women (11.7 %) enrolled in the two studies showed no USI. These women had a significantly lower mean volume at maximum cystometric capacity than those with USI (347.5 vs. 395.8 in SISTEr, p = 0.012), (315.2 vs. 358.2 in TOMUS, p = 0.003) and a lower mean number of daily accidents reported on a 3-day diary (2.2 vs 2.7 in SISTEr, p = 0.030) (1.7 vs 2.7 in TOMUS, p < 0.001). Additionally, those without demonstrable USI were more likely to have Pelvic Organ Prolapse Quantification (POP-Q) stage III/IV (31.7 % vs 14.4 % in SISTEr, p = 0.002), (15.5 % vs 6.9 % in TOMUS, p = 0.025). SUI severity as recorded on the Urogenital Distress Inventory (UDI) correlated strongly with the presence of USI in both studies. We observed that about one of eight women planning surgery for SUI does not show USI. Stage 3/4 POP was strongly associated with the unexpected absence of USI. A diminished urodynamic bladder capacity among women who did not display USI may reflect an inability to reach the limits of capacity during urodynamics, at which these women normally leak.

Changes in Urodynamic Measures Two Years After Burch Colposuspension or Autologous Sling Surgery

To characterize the urodynamic (UDS) changes in subjects 24 months after Burch urethropexy and autologous fascial sling surgery for stress urinary incontinence. In the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr), 655 women underwent standardized UDSs before and 2 years after Burch or sling surgery. Paired t tests were used to compare the pre- and postoperative UDS measures by treatment group. Analysis of variance models were fit predicting the change in UDS measures, controlling for the treatment group. The noninstrumented maximal flow rate decreased 3.6 mL/s in the Burch group and 4.7 mL/s in the sling group (P = .42). The average flow rates also decreased (2.4 mL/s in the Burch group and 3.8 mL/s in the sling group, P = .039). No difference was found in the increases in first sensation between the Burch and sling groups (23.3 and 29.3 mL, respectively, P = .61). Also, no differences were found in the reduction in the pressure flow study maximal flow rates (2.3 mL/s in the Burch group and 4.4 mL/s in the sling group, P = .11). An increased detrusor pressure at maximal flow rate (11.4 cm H(2)O, P < .001) was seen only after the sling procedure. Increases in the bladder outlet obstruction index occurred after both procedures, with greater increases seen after sling surgery (change, Burch +6.27 vs sling +20.12, P = .001). The Burch colposuspension and autologous fascial sling procedures were associated with similar decreases in noninstrumented flow rates, and the sling was associated with greater increases in the detrusor pressure at maximal flow rate and bladder outlet obstruction index. These changes suggest that both procedures are effective, in part, because of increased outlet resistance. However, the sling procedure might be more obstructive.

Urodynamic Changes Associated with Successful Stress Urinary Incontinence Surgery: Is a Little Tension a Good Thing?

To identify urodynamic changes that correlate with successful outcomes after stress urinary incontinence (SUI) surgery. Six-hundred fifty-five women were randomized to Burch colposuspension or autologous fascial sling as part of the multicenter Stress Incontinence Surgical Treatment Efficacy Trial. Preoperatively and 24 months after surgery, participants underwent standardized urodynamic testing that included noninvasive uroflowmetry, cystometrogram, and pressure flow studies. Changes in urodynamic parameters were correlated to a successful outcome, defined a priori as (1) negative pad test; (2) no urinary incontinence on 3-day diary; (3) negative cough and Valsalva stress test; (4) no self-reported SUI symptoms on the Medical, Epidemiologic and Social Aspects of Aging Questionnaire; and (5) no re-treatment for SUI. Subjects who met criteria for surgical success showed a greater relative increase in mean Pdet@Qmax (baseline vs 24 months) than women who were considered surgical failures (P = .008). Although a trend suggested an association between greater increases in bladder outlet obstruction index and outcome success, this was not statistically significant. Other urodynamic variables, such as maximum uroflow, bladder compliance, and the presence of preoperative or de novo detrusor overactivity did not differ with respect to outcome status. Successful outcomes in both surgical groups (Burch and sling) were associated with higher voiding pressures relative to preoperative baseline values. However, concomitant changes in other urodynamic voiding parameters were not significantly associated with outcome.

History and Future of Multi-Institutional Clinical Trials in Urinary Incontinence

History and Future of Multi-Institutional Clinical Trials in Urinary Incontinence

Risk factors for urinary tract infection following incontinence surgery

The purpose of this study is to describe risk factors for post-operative urinary tract infection (UTI) the first year after stress urinary incontinence surgery. Multivariable logistic regression analyses were performed on data from 1,252 women randomized in two surgical trials, Stress Incontinence Surgical Treatment Efficacy trial (SISTEr) and Trial Of Mid-Urethral Slings (TOMUS). Baseline recurrent UTI (rUTI; ≥3 in 12 months) increased the risk of UTI in the first 6 weeks in both study populations, as did sling procedure and self-catheterization in SISTEr, and bladder perforation in TOMUS. Baseline rUTI, UTI in the first 6 weeks, and PVR > 100 cc at 12 months were independent risk factors for UTI between 6 weeks and 12 months in the SISTEr population. Few (2.3-2.4%) had post-operative rUTI, precluding multivariable analysis. In women with pre-operative rUTI, successful surgery (negative cough stress test) at 1 year did not appear to decrease the risk of persistent rUTI. Pre-operative rUTI is the strongest risk factor for post-operative UTI.

Patient satisfaction with stress incontinence surgery

To identify predictors and correlates of patient satisfaction 24 months after Burch colpopexy or autologous fascial sling for treatment of stress urinary incontinence (SUI). Participants were the 655 randomized subjects in the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr). Variables potentially associated with satisfaction were tested in bivariate analysis, including demographics, baseline clinical characteristics of incontinence, and outcomes on validated subjective and objective measures. Satisfaction with treatment was defined as a response of "completely satisfied" or "mostly satisfied" on the Patient Satisfaction Questionnaire (PSQ) at 24 months. Variables significantly related to satisfaction were entered into multivariable regression models to test their independent association with satisfaction. At 24 months post-surgery, 480 (73%) participants completed the PSQ. Mean (±SD) age of the sample was 52 (±10) years and 77% were white. Most (82%) were completely or mostly satisfied with their surgery related to urine leakage. In the final multivariable model, patient satisfaction was associated with greater reduction in SUI symptoms (from baseline to 24 months; OR = 1.17, 95% CI: 1.10, 1.24) and greater reductions in symptom distress (OR = 1.16; CI: 1.08, 1.24). Lower odds of satisfaction were associated with greater urge incontinence symptoms at baseline (OR = 0.09, CI: 0.04, 0.22), detrusor overactivity at 24 months (OR = 0.29, CI: 0.12, 0.69), and a positive stress test at 24 months (OR = 0.45, CI: 0.22, 0.91). Stress incontinent women who also have urge incontinence symptoms may benefit from additional preoperative counseling to set realistic expectations about potential surgical outcomes or proactive treatment of urge incontinence symptoms to minimize their post-operative impact.

Symptoms of Combined Prolapse and Urinary Incontinence in Large Surgical Cohorts

To estimate whether prolapse severity is a major contributor to urinary incontinence severity, as measured by validated incontinence questionnaires. We analyzed data from two large female stress urinary incontinence (SUI) surgical cohorts: the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) study (N=655) and the subsequent Trial of Mid-Urethral Slings (TOMUS) study (N=597). All participants completed a standardized baseline assessment including validated measures of symptom severity, quality of life, objective measures of urine loss (Urogenital Distress Inventory [UDI], Medical, Epidemiologic, and Social Aspects of Aging questionnaire, Incontinence Impact Questionnaire, and pad test), as well as the Pelvic Organ Prolapse Quantification assessment. Groups were compared using the chi; test (categorical measures) or the one-way analysis of variance (continuous measures). Statistical significance was defined as P<.05. The SISTEr and TOMUS samples were similar for many variables including age (52 and 53 years, respectively), nulliparity (9% and 12%), prior urinary incontinence (UI) surgery (14% and 13%), and prior hysterectomy (31% and 28%), but other differences necessitated separate analysis of the two cohorts. There was not a statistically significant difference in UDI scores according to prolapse stage in either study population. Patients with prior surgery for pelvic organ prolapse and SUI had more incontinence symptoms and were more bothered by their UI regardless of prolapse stage. Prolapse stage is not strongly or consistently associated with incontinence severity in women who select surgical treatment of SUI. Prior pelvic organ prolapse and UI surgery is associated with worse UI severity and bother. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00064662 and NCT00325039. II.

Complications in Women Undergoing Burch Colposuspension Versus Autologous Rectus Fascial Sling for Stress Urinary Incontinence

We determined the clinicodemographic factors associated with complications of continence procedures, the impact of concomitant surgery on the complication rate and the relationship between the incidence of cystitis and the method of postoperative bladder drainage. We reviewed serious adverse events and adverse events in the Stress Incontinence Surgical Efficacy Trial, a randomized trial comparing Burch colposuspension to the autologous rectus fascial sling. Clinicodemographic variables were analyzed to determine those associated with adverse events using logistic regression analysis. Complications were stratified based on the presence or absence of concomitant surgery. Differences in complication rates (controlling for concomitant surgery) and cystitis rates (controlling for the bladder emptying method) were compared using Fisher's exact test. Blood loss (p = 0.0002) and operative time (p <0.0001) were significantly associated with an adverse event. Patients who underwent concomitant surgery had a significantly higher serious adverse event rate (14.2% vs 7.3%, p = 0.01) and adverse event rate (60.5% vs 48%, p <0.01) than patients who underwent continence surgery alone. Cystitis rates were higher in the sling vs the Burch group up to 6 weeks postoperatively regardless of concomitant surgery status (p <0.01). Intermittent self-catheterization increased the cystitis rate by 17% and 23% in the Burch and sling groups, respectively. Concomitant surgery at continence surgery increased the risk of complications. Sling surgery was associated with a higher risk of cystitis within the first 6 weeks postoperatively. Intermittent self-catheterization increased the risk of cystitis in each group. Complications were associated with surgical factors and not with patient related factors.

Two-Year Outcomes After Surgery for Stress Urinary Incontinence in Older Compared With Younger Women

To estimate whether perioperative and postoperative outcomes after Burch colposuspension or pubovaginal sling for stress urinary incontinence (SUI) differed with age. This study was a prospective secondary analysis of the Stress Incontinence Surgical Treatment Efficacy Trial. Baseline characteristics, adverse events, and 2-year outcomes of women at least 65 years old were compared with those younger than 65 years using chi(2) and t tests. Multivariable analyses were performed, including age and outcomes that differed between age groups on univariable analysis, adjusting for variables that differed by age group at baseline and by surgical treatment group. Six-hundred fifty-five women were included in analyses of perioperative events and 520 for 2-year outcomes. Mean age (+/-standard deviation) was 69.7 (+/-3.7) years in the older group and 49.4 (+/-8.2) in the younger group. Older women had slightly longer time to normal activities (50 days compared with 42 days, P=.05), but there was no difference in time to normal voiding (14 days compared with 11 days, P=.42). Older women were more likely to have a positive stress test at follow-up (odds ratio [OR] 3.7, 95% confidence interval [CI] 1.70-7.97, P=.001), less subjective improvement in stress (8 point lesser decrease, 95% CI 1.5-14.1, P=.02), and urge incontinence (7 point lesser decrease, 95% CI 1.5-12.2, P=.01) by the Medical and Epidemiologic Social Aspects of Aging questionnaire, and were more likely to undergo surgical retreatment for SUI (OR 3.9, 95% CI 1.30-11.48). Perioperative adverse events and length of stay did not differ between groups. Older women undergoing surgery for stress incontinence can expect to do as well as younger women with respect to perioperative outcomes, but experience 2-year outcomes that are worse.

High Costs of Urinary Incontinence Among Women Electing Surgery to Treat Stress Incontinence

To estimate costs for incontinence management, health-related quality of life, and willingness to pay for incontinence improvement in women electing surgery for stress urinary incontinence. A total of 655 incontinent women enrolled in the Stress Incontinence Surgical Treatment Efficacy Trial, a randomized surgical trial. Baseline out-of-pocket costs for incontinence management were calculated by multiplying self-report of resources used (supplies, laundry, dry cleaning) by national resource costs (USD2,006). Health-related quality of life was estimated with the Health Utilities Index Mark 3. Participants estimated willingness to pay for 100% improvement in incontinence. Potential predictors of these outcomes were examined by using multivariable linear regression. Mean age was 52+/-10 years, and mean number of weekly incontinence episodes was 22+/-21. Mean and median (25%, 75% interquartile range) estimated personal costs for incontinence management among all women were USD14+/-USD24 and USD8 (interquartile range USD3, USD18) per week, and 617 (94%) women reported any cost. Costs increased significantly with incontinence frequency and mixed compared with stress incontinence. The mean and median Health Utilities Index Mark 3 scores were 0.73+/-0.25 and 0.84 (interquartile range 0.63, 0.92). Women were willing to pay a mean of USD118+/-USD132 per month for complete resolution of incontinence, and willingness to pay increased significantly with greater expected incontinence improvement, household income, and incontinent episode frequency. Urinary incontinence is associated with substantial costs. Women spent nearly USD750 per year out of pocket for incontinence management, had a significant decrement in quality of life, and were willing to pay nearly USD1,400 per year for cure.

Urodynamic Measures Do Not Predict Stress Continence Outcomes After Surgery for Stress Urinary Incontinence in Selected Women

We determined the prognostic value of preoperative urodynamic results in patients with stress urinary incontinence. In a 9-center surgical trial, women with stress urinary incontinence were randomized to a Burch or pubovaginal sling procedure. Women were eligible for the study if they had predominant stress urinary incontinence symptoms, a positive cough stress test, a bladder capacity more than 200 ml and urethral hypermobility. Preoperative free uroflowmetry, filling cystometry and pressure flow studies were performed in all. Overall treatment success required a negative pad test, no urinary incontinence on a 3-day diary, a negative stress test, no self-reported stress urinary incontinence symptoms and no re-treatment for stress urinary incontinence. Stress specific success required all of the last 3 criteria. We examined urodynamic measures, and whether the presence of urodynamic stress incontinence, the presence of detrusor overactivity and Valsalva leak point pressure would predict surgical success. Subjects with urodynamic stress incontinence had a 2-fold greater odds of overall success when compared with the No urodynamic stress incontinence group, but this trend did not quite reach statistical significance (OR 2.26; 95% C.I. 0.99, 5.17). Odds of stress specific success did not differ by urodynamic stress incontinence status. Subjects with detrusor overactivity did not have significantly worse success rates. Stratifying by treatment group, there was no difference in mean Valsalva leak point pressure values between surgical successes and failures. We found a nearly statistically significant trend that women with urodynamic stress incontinence are twice as likely to have a successful overall outcome from surgical management of stress urinary incontinence as women without urodynamic stress incontinence. The level of Valsalva leak point pressure and the presence of detrusor overactivity do not predict the success outcomes after the Burch or autologous fascia sling procedures in women with pure or predominant stress urinary incontinence. The impact of urodynamic studies on surgical outcomes needs further investigation.

Prevalence and risk factors of fecal incontinence in women undergoing stress incontinence surgery

The objective of the study was to determine the prevalence and identify potential risk factors for monthly fecal incontinence (FI) in women presenting for stress urinary incontinence (UI) surgery. From 655 women enrolled in the Stress Incontinence Surgical Treatment Efficacy Trial, baseline data were analyzed. FI was defined as occurring at least monthly. Independent variables included sociodemographics, health status and history, physical examination, and validated UI questionnaires. Multivariable logistic regression models compared women with FI with women with only UI. Prevalence of monthly FI was 16%, 10% for liquid stool, and 6% for solid stool. In multivariable analysis, increased risk of FI was associated (odds ratio, 95% confidence interval) with decreased anal sphincter contraction (4.5, 2.0 to 10.4), perimenopausal status (2.4, 1.1 to 5.0), prior incontinence surgery/treatment (1.8, 1.1 to 2.9), and increased UI bother (1.1, 1.1 to 1.2). Women enrolled in a stress UI surgical trial have high rates of monthly FI and further evaluation of FI symptoms may be warranted.

Race and ethnicity do not contribute to differences in preoperative urinary incontinence severity or symptom bother in women who undergo stress incontinence surgery

The purpose of this study was to determine whether race/ethnicity affects urinary incontinence (UI) severity and bother in women who undergo surgery for stress incontinence. We used baseline data from participants in the Stress Incontinence Surgical Treatment Efficacy trial. UI severity was measured by the number of leakage episodes during a 3-day urinary diary and by urodynamic evaluation. UI bother was measured with the Urogenital Distress Inventory. Race/ethnicity classification was based on self-report. Of the 654 women, 72 women (11%) were Hispanic; 480 women (73%) were non-Hispanic white; 44 women (6.7%) were non-Hispanic black, and 58 women (8.9%) were of other race/ethnicity. No differences were seen in any UI severity measures. Non-Hispanic white women had the lowest Urogenital Distress Inventory scores on bivariate analysis, which was explained by socioeconomic status, body mass index, and age on multivariate analysis. Factors other than racial/ethnic differences underlie variations in UI symptoms and bother in this group of women who sought surgery for stress incontinence.

The Volume at Which Women Leak First on Urodynamic Testing is Not Associated With Quality of Life, Measures of Urethral Integrity or Surgical Failure

We determined if the bladder volume at which urodynamic stress incontinence is first detected is related to preoperative quality of life, urethral sphincter assessment or surgical outcome in women undergoing continence surgery. Charts of consecutive women who underwent a sling or Burch procedure were reviewed. Preoperative and postoperative assessment included the Incontinence Impact Questionnaire and Urogenital Distress Inventory. Urodynamic stress incontinence volume is the bladder volume at which urodynamic stress incontinence was first detected. Women were divided into 4 groups according to urodynamic stress incontinence volume, and compared with respect to maximum urethral closure pressure, Valsalva leak point pressure, Incontinence Impact Questionnaire and Urogenital Distress Inventory. Urodynamic stress incontinence persistence was evaluated only in patients who had sling surgery. A total of 168 women were recruited for the study. Urodynamic stress incontinence volume was 100 ml for 31% of women, 200 ml for 17%, 300 ml for 17% and 400 ml or greater for 35%. Baseline and postoperative Urogenital Distress Inventory, Incontinence Impact Questionnaire, maximal urethral closure pressure and Valsalva leak point pressure did not differ by urodynamic stress incontinence volume. Among the 116 patients who had the sling procedure, urodynamic stress incontinence persistence did not differ by urodynamic stress incontinence volume (p=0.72). Women who demonstrate urodynamic stress incontinence at lower bladder volumes do not report greater bother from incontinence than women who leak at higher volumes, suggesting leakage severity on urodynamics is not an adequate reflection of incontinence related quality of life.

Reference urodynamic values for stress incontinent women

To determine reference urodynamic values for preoperative urodynamic studies in women undergoing surgery for pure or predominant stress urinary incontinence (SUI). Six hundred fifty-five women with pure or predominant SUI were enrolled in a multicenter surgical trial and were randomized to undergo a Burch or autologous fascia sling procedure as part of the Urinary Incontinence Treatment Network (UITN) Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr). Preoperative free uroflowmetry, filling cystometry, and pressure flow studies were performed in all women using a standardized research protocol and standardized urodynamic interpretation guidelines. We define the normal range of urodynamic values in this population as the values that encompass 95% of the results. In 655 women undergoing filling cystometry in the standing position, baseline vesical and abdominal pressures were between 12 and 60 cm H(2)O. The upper limit of detrusor pressure increase during bladder filling to maximum cystometric capacity was 16 cm H(2)O. Ten percent of women who qualified for stress incontinence surgery with a positive cough stress test on physical exam did not demonstrate urodynamic stress incontinence (USI) and less than 10% of subjects in this study demonstrated detrusor overactivity. Results from a large cohort of women with SUI are now available for quantitative plausibility assessments or as reference values when interpreting urodynamic studies.