Trial Of Mid-Urethral Slings Research Articles

Return to work and normal activities after mid-urethral sling: secondary analysis of the Trial of Mid-Urethral Slings.

We aim to evaluate the timing of patients returning to work and to normal daily life following mid-urethral sling surgery. This is a secondary analysis of the Trial of Mid-Urethral Slings (TOMUS). Our primary outcome is the timing of return to work and normal activities. Secondary outcomes included paid days off, number of days to return to normal daily life, and objective and subjective failures. Predictors affecting the timing of return to work and normal activities were also assessed. Patients who underwent concomitant surgery were excluded. Among patients undergoing a mid-urethral sling, 183 (41.5%) returned to normal activities within 2weeks. Within 6weeks of surgery, 308 (70.0%) had returned to normal activities including work. At the 6-month follow-up, 407 (98.3%) had returned to normal activities including work. Patients took a median of 14days (interquartile range 1-115days) to return to normal activities including work and took a median of 5 (interquartile range 0-42days) paid work days off. Those who returned within 2weeks versus after 2weeks did not have significantly different characteristics, or failure and complication rates. In the multivariate regression analysis, there was no significant predictor of the timing of returning to normal activity/work. Less than half of patients returned to work and normal activities within 2weeks of a mid-urethral sling surgery and took many fewer paid days off. The timing of return to work was not associated with significant differences in treatment failure or adverse outcomes.

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.

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)

Preoperative Urodynamic Parameters (Valsalva Leak Point Pressure and Maximum Urethral Closure Pressure), Urinary Collagen and Plasma Vitamin D Levels as Predictors of Mid Urethral Sling Surgery Outcome

To determine the best predictor of the mid urethral sling outcome we calculated the AUC of ROC curves of preoperative parameters, including Valsalva leak point pressure, maximum urethral closure pressure, urinary NTx (N-telopeptide of crosslinked type I collagen) and plasma vitamin D values (D2, D3 and D2 plus D3). This was an ancillary study of TOMUS (Trial of Mid-urethral Slings) and the ValUE (Value of Urodynamics Evaluation) trial in which subjects underwent mid urethral sling surgery for stress urinary incontinence. Valsalva leak point pressure and maximum urethral closure pressure were measured in 427 subjects, whereas NTx, vitamin D2, vitamin D3 and vitamin D2 plus D3 levels were obtained from 150, 116, 115 and 116 subjects respectively. Outcome success was defined using identical outcome (subjective and objective) variables for all subjects. ROC curves with corresponding AUC values were compared. TOMUS and ValUE subjects were significantly different in age, body mass index, UDI (Urogenital Distress Inventory) scores. TOMUS subjects had alower surgical success rate compared to ValUE subjects (66.3% vs 76.0%, p=0.03). The AUC values of Valsalva leak point pressure, maximum urethral closure pressure, NTx, and vitamins D2, D3 and D2 plus D3 were 0.542, 0.561, 0.702, 0.627, 0.645 and 0.640, respectively. The AUC of NTx was significantly higher than the AUCs of Valsalva leak point pressure and maximum urethral closure pressure (p = 0.02 and 0.03, respectively). Urinary NTx was the best predictor of the mid urethral sling outcome. This test is not only noninvasive, it is also modifiable. Finding ideal modifiable risk factors prior to mid urethral sling surgery should be subject to future investigations.

PII-03 5-YEAR OUTCOMES AFTER RETROPUBIC AND TRANSOBTURATOR MIDURETHRAL SLING

You have accessJournal of UrologyPlenary Session II: Best Abstracts1 Apr 2014PII-03 5-YEAR OUTCOMES AFTER RETROPUBIC AND TRANSOBTURATOR MIDURETHRAL SLING Kimberly Kenton, Anne Stoddard, Halina Zyczynski, Leslie Rickey, Clifford Wai, Mike Albo, Peggy Norton, Larry Sirls, Stephen Kraus, and Holly Richter Kimberly KentonKimberly Kenton More articles by this author , Anne StoddardAnne Stoddard More articles by this author , Halina ZyczynskiHalina Zyczynski More articles by this author , Leslie RickeyLeslie Rickey More articles by this author , Clifford WaiClifford Wai More articles by this author , Mike AlboMike Albo More articles by this author , Peggy NortonPeggy Norton More articles by this author , Larry SirlsLarry Sirls More articles by this author , Stephen KrausStephen Kraus More articles by this author , and Holly RichterHolly Richter More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.1144AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail Introduction and Objectives To compare 5-year continence rates, complication rates and pelvic floor outcomes after retropubic (RMUS) and transobturator (TMUS) midurethral slings. Methods Women in Trial of Midurethral Slings (TOMUS) who did not undergo surgical retreatment for SUI were approached for extended follow-up (E-TOMUS). Participants completed annual in-person visits, including pelvic examination and QOL questionnaires. Treatment success was defined as no retreatment for SUI and no self-reported SUI symptoms on MESA. Time to failure and log rank test assessed differences in success between treatment arms. Results 404 of 597 (68%) of TOMUS subjects participated in E-TOMUS. All women randomized in TOMUS were included in Kaplan Meier time to event analysis (Figure 1). There was no difference in success rates between RMUS and TMUS groups over time (p=0.09). Treatment success for RMUS is 7.9% higher than TMUS (51.3% vs 43.4%, 95% CI -1.4, 17.2) and did not meet criteria for equivalence (Figure 2). There were no differences in the proportion of women who experienced complications (p=0.17) including mesh erosions requiring surgery, RMUS (3) and TMUS (4). Urinary symptoms increased and QOL declined (as measured by UDI and IIQ) significantly over time (p<0.001) with TMUS having better urinary QOL scores than RMUS (p=0.02). Sexual function significantly declined over time in both groups (p=0.004), but more so in the RMUS group (p=0.001). A higher percentage of women in the TMUS group report being ‘very much better’ or ‘much better’ than in the RMUS group (88% vs. 77%, p=.01). Overall satisfaction was similar between RMUS and TMUS at 5 years (78.9%, RMUS vs 84.7%, TMUS, p=.15); however, proportion who were completely or mostly satisfied decreased significantly over time in both groups (from 93% at 6 mo to 79% at 5 yr in RMUS and 92% at 6 mo to 85% at 5 yr in TMUS, p= 0.0001). Conclusions 5-year- continence rates declined after RMUS & TMUS, and did not meet pre-specified criteria for equivalence; however, satisfaction remains high. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e493 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Kimberly Kenton More articles by this author Anne Stoddard More articles by this author Halina Zyczynski More articles by this author Leslie Rickey More articles by this author Clifford Wai More articles by this author Mike Albo More articles by this author Peggy Norton More articles by this author Larry Sirls More articles by this author Stephen Kraus More articles by this author Holly Richter More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

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.

The minimum important difference for the International consultation on incontinence questionnaire-Urinary incontinence short form in women with stress urinary incontinence

Minimum important difference (MID) estimates the minimum degree of change in an instrument's score that correlates with a patient's subjective sense of improvement. We aimed to determine the MID for the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) using both anchor based and distribution based methods derived using data from the Trial of Midurethral Slings (TOMUS). Instruments for the anchor-based analyses included the urogenital distress inventory (UDI), incontinence impact questionnaire (IIQ), patient global impression of improvement (PGI-I), incontinence episodes (IE) on 7-day bladder diary, and satisfaction with surgical results. After confirming moderate correlation (r ≥ 0.3) of ICIQ-UI SF and each anchor, MIDs were determined by calculating the difference between the mean instrument scores for individuals with the smallest amount of improvement and with no change. The distribution-based method of MID assessment was applied using effect sizes of 0.2 and 0.5 SD (small to medium effects). Triangulation was used to examine these multiple MID values in order to converge on a small range of values. Anchor-based MIDs range from -4.5 to -5.7 at 12 months and from -3.1 to 4.3 at 24 months. Distribution-based MID values were lower. Triangulation analysis supports a MID of -5 at 12 months and -4 at 24 months. The recommended MIDs for ICIQ-UI SF are -5 at 12 months and -4 at 24 months. In surgical patients, ICIQ-UI SF score changes that meet these thresholds can be considered clinically meaningful.

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.

Association of Baseline urodynamic measures of urethral function with clinical, demographic, and other urodynamic variables in women prior to undergoing midurethral sling surgery

To explore how baseline demographic, clinical, and urodynamic (UDS) variables correlate with measures of urethral function in women planning midurethral sling surgery. Women with predominant stress urinary incontinence (SUI) as part of the trial of mid-urethral slings (TOMUS) were characterized preoperatively including: demographics, body mass index (BMI), responses to the Medical and Epidemiologic Social Aspects of Aging (MESA) and Urogenital Distress Inventory (UDI) questionnaires, pad weight (PW), incontinence duration, prior SUI surgery, prolapse, strength of pelvic contraction, Q-tip test, uroflow, cystometrogram, and detrusor pressures at maximum flow (Pdet at Qmax). Multivariate regression analysis and modeling confirmed variables with significant correlations with maximal urethral closure pressure (MUCP), functional urethral length (FUL), and Valsalva leak point pressure (VLPP). Five-hundred thirty-nine women were included in the analysis. In multivariable analyses, PW (P = 0.045) and age (P < 0.0001) were negatively correlated with MUCP (as PW and age increased, MUCP decreased); BMI (P = 0.02) and Pdet at Qmax (P < 0.0001) were positively correlated with MUCP (as BMI and Pdet at Qmax increased, MUCP increased). Age (P = 0.002) was negatively correlated with FUL; Qtip delta (P = 0.006), pelvic organ prolapse quantification examination (POPQ) stage (P = 0.002) and strength of pelvic contraction (P = 0.03) were positively correlated with FUL. Duration of incontinence (P = 0.01) was negatively correlated with VLPP; Qtip delta (P = 0.02), BMI (P = 0.0005) and Pdet at Qmax (P = 0.0005) were positively correlated with VLPP. Age, BMI, Qtip delta, and Pdet at Qmax were variables that correlated with two or more measures of urethral function. These correlations may help direct future research in female urethral function.

Adverse events over two years after retropubic or transobturator midurethral sling surgery: findings from the Trial of Midurethral Slings (TOMUS) study

Adverse events over two years after retropubic or transobturator midurethral sling surgery: findings from the Trial of Midurethral Slings (TOMUS) study

Adverse events over two years after retropubic or transobturator midurethral sling surgery: findings from the Trial of Midurethral Slings (TOMUS) study

Adverse events over two years after retropubic or transobturator midurethral sling surgery: findings from the Trial of Midurethral Slings (TOMUS) study

Adverse events over two years after retropubic or transobturator midurethral sling surgery: findings from the Trial of Midurethral Slings (TOMUS) study

To describe surgical complications in 597 women over a 24-month period after randomization to retropubic or transobturator midurethral slings. During the Trial of Midurethral Slings study, the Data Safety Monitoring Board regularly reviewed summary reports of all adverse events using the Dindo Surgical Complication Scale. Logistic regression models were created to explore associations between clinicodemographic factors and surgical complications. A total of 383 adverse events were observed among 253 of the 597 women (42%). Seventy-five adverse events (20%) were classified as serious (serious adverse events); occurring in 70 women. Intraoperative bladder perforation (15 events) occurred exclusively in the retropubic group. Neurologic adverse events were more common in the transobturator group than in retropubic (32 events vs 20 events, respectively). Twenty-three (4%) women experienced mesh complications, including delayed presentations, in both groups. Adverse events vary by procedure, but are common after midurethral sling. Most events resolve without significant sequelae.

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.

2158 URODYNAMIC CHANGES 12 MONTHS AFTER RETROPUBIC AND TRANSOBTURATOR MIDURETHRAL SLINGS

INTRODUCTION AND OBJECTIVES: To determine if changes in urodynamics (UDS) parameters after midurethral sling (MUS) differ between retropubic midurethral sling (RMUS) and transobturator midurethral sling (TMUS) procedures and whether they are associated with successful treatment outcomes. METHODS: The Trial of Midurethral slings (TOMUS) was a prospective randomized equivalence trial conducted at 9 sites, comparing 12 month subjective and objective outcomes of RMUS and TMUS. 597 women were randomized to RMUS or TMUS and underwent standardized UDS before and 12 months after surgery. UDS parameters are listed in table. Objective outcomes included: 300 cc bladder stress test, 24 hour pad test and stress urinary incontinence (SUI) re-treatment. Subjective outcomes included:self report of SUI, 3 day voiding diary and re-treatment of SUI. Linear models were fit to assess change in UDS measures from baseline to 12 months by treatment group and success status. Contingency tables were constructed for categorical measures; chi-square tests were used to test for associations. RESULTS: See Table. After MUS, both maximum and average uroflow rates were decreased, sensations were delayed and maximum urethral closure pressure (MUCP) decreased with no change in urethral length, Qmax was deceased while Pdet@Qmax slightly increased. No differences in UDS parameters between procedures were seen and no changes in UDS parameters correlated highly with either subjective or objective outcomes. Rates of denovo detrusor overactivity (DO) was similar between both procedures (p .61) and no difference was seen in the rates of resolution of DO (p .79). CONCLUSIONS: MUS procedures were associated with decreased flow rates and minimal increases in voiding pressures. Interestingly, no changes in urethral closure pressures were seen. Changes in UDS parameters did not differ by treatment group and were not associated with MUS subjective or objective outcomes.

Factors Associated With Quality of Life in Women Undergoing Surgery for Stress Urinary Incontinence

We determined the association of clinicodemographic factors with urinary incontinence related quality of life in women undergoing surgery for stress urinary incontinence, and compared the incontinence specific Incontinence Impact Questionnaire and the International Consultation on Incontinence Questionnaire. Secondary objectives were to evaluate the contributions of incontinence severity and sexual function on quality of life. We used baseline data on 597 women in the Trial of Mid-Urethral Slings. Tested quality of life correlates included health status and history, sexual function, and urinary incontinence type, severity and bother. On each questionnaire lower quality of life was associated with younger age, higher body mass index, more stress urinary incontinence symptoms, and more severe and bothersome urinary incontinence symptoms. Each measure identified factors associated with lower quality of life that were not identified by the other, including Hispanic ethnicity, poor health status and more urge urinary incontinence symptoms on the Incontinence Impact Questionnaire, and prior urinary incontinence treatment and more urinary incontinence episodes daily on the International Consultation on Incontinence Questionnaire. Sexually active women had similar quality of life as well as increased incontinence episodes on each questionnaire and more sexual dysfunction on the Incontinence Impact Questionnaire only. In women planning stress urinary incontinence surgery quality of life is associated with nonurinary incontinence factors, and with the type, severity and degree of urinary incontinence symptom bother. Many factors are associated with quality of life as measured by the Incontinence Impact Questionnaire and the International Consultation on Incontinence Questionnaire. However, more nonurinary incontinence factors were associated with quality of life when measured by the former than by the latter. More than 1 scale may be needed to evaluate quality of life after treatment for stress urinary incontinence.

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.