IMPORTANCE Over 300,000 surgeries are performed annually in the United States for pelvic organ prolapse. Sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) are commonly performed transvaginal surgeries to correct apical prolapse. Little is known about their comparative efficacy and safety, and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training (BPMT) improves outcomes of prolapse surgery. OBJECTIVE To compare outcomes between 1) SSLF and ULS and 2) perioperative BPMT and usual perioperative care in women undergoing surgery for vaginal prolapse and stress urinary incontinence. DESIGN, SETTING AND PARTICIPANTS Multi-center, 2×2 factorial randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 U.S. medical centers. Two-year follow-up rate was 84.5%. INTERVENTIONS Surgical intervention: Transvaginal surgery including mid-urethral sling with randomization to SSLF (n = 186) or ULS (n=188); Behavioral intervention: Randomization to perioperative BPMT (n = 186) or usual care (n=188). MAIN OUTCOME MEASURES The primary outcome for the surgical intervention (surgical success) was defined as: 1) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen (anatomic success); 2) no bothersome vaginal bulge symptoms and 3) no retreatment for prolapse at 2 years. For the behavioral intervention, primary outcome at 6 months was urinary symptom scores (Urinary Distress Inventory; range 0–300, higher scores worse), and primary outcomes at 2 years were prolapse symptom scores (Pelvic Organ Prolapse Distress Inventory; range 0–300, higher scores worse) and anatomic success. RESULTS At 2 years, surgical group was not significantly associated with surgical success rates [ULS 59.2% (93/154) vs. SSLF 60.5% (92/152), OR 0.9 (95% CI 0.6, 1.5)] or serious adverse event rates [ULS 16.5% (31/188) vs. SSLF 16.7% (31/186), OR 0.9 (95% CI 0.5, 1.6)]. BPMT was not associated with greater improvements in urinary scores at 6 months [treatment difference −6.7 (95% CI −19.7, 6.2)], prolapse scores at 24 months [treatment difference −8.0 (95% CI −22.1, 6.1)] or anatomic success at 24 months. CONCLUSIONS AND RELEVANCE Two years after vaginal surgery for prolapse and stress urinary incontinence, neither ULS nor SSLF was significantly superior to the other for anatomic, functional, and or adverse event outcomes. Perioperative BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years.

II-3.

Objective To compare the effectiveness of a continence pessary to evidence-based behavioral therapy for stress incontinence and to assess whether combined pessary and behavioral therapy is superior to single-modality therapy. Methods Multi-site, randomized clinical trial (“Ambulatory Treatments for Leakage Associated with Stress Incontinence” (ATLAS)) randomized 446 women with stress incontinence to pessary, behavioral therapy, or combined treatment. Primary outcome measures, at 3months, were Patient Global Impression of Improvement (PGI-I) and the stress incontinence subscale of the Pelvic Floor Distress Inventory (PFDI). A priori, to be considered clinically superior, combination therapy had to be better than both single-modality therapies. Outcomes measures were repeated at 6 and 12 months. Primary analyses used intention-to-treat approach. Results At 3 months, 40% of the pessary group and 49% of the behavioral group were “much better” or “very much better” on PGI-I (p=0.09). Compared to the pessary group, more women in the behavioral group reported having no bothersome incontinence symptoms (49% vs. 33%, p=0.006) and treatment satisfaction (75% vs. 63%, p=0.02). Combination therapy was significantly better than pessary on PGI-I (53%, p=0.02) and PFDI (44%, p=0.05), but not better than behavioral therapy; it was therefore not superior to single-modality therapy. Group differences were not sustained to12 months on any measure, and patient satisfaction remained above 50% for all treatment groups. Conclusions Behavioral therapy resulted in greater patient satisfaction and fewer bothersome incontinence symptoms than pessary at 3 months, but differences did not persist to 12 months. Combination therapy was not superior to single-modality therapy.

Most women adhered to exercise during supervised intervention; however, adherence declined over the long term. Interventions to help women remember to exercise and to integrate PFM exercises and UI prevention strategies into daily life may be useful to promote long-term adherence.

Background Women with urge urinary incontinence are commonly treated with antimuscarinic medications, but many discontinue therapy. Objective To determine whether combining antimuscarinic drug therapy with supervised behavioral training, compared to drug therapy alone, improves the ability of women with urge incontinence to achieve clinically important reductions in incontinence episodes and to and sustain these improvements after discontinuing medication. Design Two-stage, multi-center, randomized clinical trial (BE-DRI trial) (July 2004 – January 2006). Setting Nine university-affiliated outpatient clinics. Patients 307 women with urge predominant incontinence. Interventions Ten weeks of open-label, extended-release tolterodine alone (N = 153) or combined with behavioral training (N = 154) (Stage 1), followed by discontinuation of therapy and follow-up at 8 months (Stage 2); 237 participants completed the trial. Measurements The primary outcome, measured at 8 months, was defined as not taking drug or receiving any other therapy for urge incontinence and ≥70% reduction in frequency of incontinence episodes. Secondary outcomes were reduction in incontinence, self-reported satisfaction and improvement, and scores on validated questionnaires measuring symptom distress/bother and health-related quality-of-life. Study staff who performed outcome evaluations were blinded to group assignment, but participants and interventionists were not. Results At 8 months, there was no difference in successful discontinuation of drug therapy between combined therapy and drug alone (41% in both groups, 95% confidence interval on difference: -12% to +12%). A higher proportion of patients in combined therapy achieved ≥70% reduction of incontinence than in drug therapy alone at 10 weeks (69% vs. 58%; difference = 11%; 95% confidence interval: -0.3 to +22.1). Combined therapy yielded better outcomes over time on the Urogenital Distress Inventory and Overactive Bladder Questionnaire (both P<0.001), at both time points on patient satisfaction and perceived improvement, but not health-related quality-of-life. Adverse events were uncommon in both groups (12 events in 6 participants, 3 in each group). Limitations Inclusion of behavioral components (daily bladder diary and recommendations for fluid management) in the drug alone group may have attenuated group differences. Assigned treatment was completed by 68% of participants and 8 month outcome status was assessed on 77%. Conclusions The addition of behavioral training to drug therapy is of possible benefit for reducing incontinence frequency during active treatment, but does not improve women's ability to discontinue drug therapy and maintain improvement in urinary incontinence. Further, combined therapy has a beneficial effect on patient satisfaction, perceived improvement, and reducing other bladder symptoms.

Objective-The objective of the study was to investigate the impact of postpartum fecal incontinence (FI) and urinary incontinence (UI) on quality of life (QOL). Study Design-Seven hundred fifty-nine primiparous women in the Childbirth and PelvicSymptoms study were interviewed 6 months postpartum. FI and UI were assessed with validated questionnaires. We measured QOL with SF-12 summary scores, health utility index score (a measure of self-rated overall health), and the modified Manchester Health Questionnaire.Results-Women with FI had worse self-rated health utility index scores (85.1 ± 9.8 vs 88.0 ± 11.6, P = .02) and Medical Outcomes Study Short Form Health Survey (SF-12) mental summary scores (46.8 ± 9.2 vs 51.1 ± 8.7, P < .0001) than women without FI or flatal incontinence. Women with UI had worse SF-12 mental summary scores (48.3 ± 9.8 vs 51.6 ± 7.8, P < .01) and self-rated health utility index scores (84.1 ± 12.5 vs 88.7 ± 10.1, P < .01) than women without UI. Women with both FI and UI had the lowest SF-12 mental summary scores (44.5 ± 9.0).Conclusion-Six months after delivery, women experiencing FI or UI reported negative effects on health-related QOL. FI and UI together have a greater impact than either condition alone. Keywords childbirth; fecal incontinence; quality of life; urinary incontinenceIn studies of fecal incontinence (FI) and urinary incontinence (UI) during the postpartum period, UI is reported by 10-50% of women, [1][2][3][4][5][6] whereas FI is present in up to 25%. 2,3,7 The Pelvic Floor Disorders Network (PFDN) has previously published findings of the Childbirth and Pelvic Symptoms (CAPS) study, 8 which examined the prevalence of FI and UI in 3 cohorts of primiparous women. FI was more prevalent (17.0%) in women who delivered vaginally with recognized anal sphincter tears, compared with women who delivered Reprints not available from the authors. NIH Public Access Author ManuscriptAm J Obstet Gynecol. Author manuscript; available in PMC 2011 April 13.Published in final edited form as: Am J Obstet Gynecol. 2007 December ; 197(6): 636.e1-636.e6. doi:10.1016/j.ajog.2007.08.020. NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author Manuscript vaginally without recognized anal sphincter tears (8.2%) and women who delivered by cesarean prior to labor (7.6%). UI was reported by 31.2% of participants and did not differ significantly by group.In population-based studies, FI affects 2-12% of community-dwelling adults 9,10 and is associated with significant adverse impact on quality of life (QOL). 9 Although several case series report the impact of postpartum UI on QOL, 3,4,6 data are very limited on the impact of FI on QOL in the postpartum period. In a Canadian study, 3 FI was present in 20.6% of 1305 primiparous women 6 months postpartum, and QOL varied significantly with the severity of both FI and UI.The objective of this study was to examine the impact of postpartum FI and UI, alone and in combination, on health-related QOL in a cohort of primiparous American women. Materials ...

Adherence to PFM exercises and bladder control strategies for SUI can be high and sustained over time. However, behavioral interventions to help women link exercise to environmental and behavioral cues may only be beneficial over the short term.

The objective of this study was to identify clinical and demographic factors associated with incontinence-related quality of life (QoL) in 655 women with stress urinary incontinence who elected surgical treatment. The following factors were examined for their association with QoL as measured with the Incontinence Impact Questionnaire (IIQ): number of incontinence (UI) episodes/day; self-reported type of UI symptoms (stress and urge); sexual function as measured by the Prolapse/Urinary Incontinence Sexual Questionnaire; symptom bother as measured by the Urogenital Distress Inventory; as well as other clinical and sociodemographic factors. A stepwise least-squares regression analysis was used to identify factors significantly associated with QoL. Lower QoL was related to the greater frequency of stress UI symptoms, increasing severity, greater symptom bother, prior UI surgery or treatment, and sexual dysfunction (if sexually active). Health and sociodemographic factors associated with lower incontinence-related QoL included current tobacco use, younger age, lower socioeconomic status, and Hispanic ethnicity.