BACKGROUND-Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications.

BACKGROUND Urodynamic studies are commonly performed in women before surgery for stress urinary incontinence, but there is no good evidence that they improve outcomes. METHODS We performed a multicenter, randomized, noninferiority trial involving women with uncomplicated, demonstrable stress urinary incontinence to compare outcomes after preoperative office evaluation and urodynamic tests or evaluation only. The primary outcome was treatment success at 12 months, defined as a reduction in the score on the Urogenital Distress Inventory of 70% or more and a response of “much better” or “very much better” on the Patient Global Impression of Improvement. The predetermined noninferiority margin was 11 percentage points. RESULTS A total of 630 women were randomly assigned to undergo office evaluation with urodynamic tests or evaluation only (315 per group); the proportion in whom treatment was successful was 76.9% in the urodynamic-testing group versus 77.2% in the evaluation-only group (difference, −0.3 percentage points; 95% confidence interval, −7.5 to 6.9), which was consistent with noninferiority. There were no significant between-group differences in secondary measures of incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events. Women who underwent urodynamic tests were significantly less likely to receive a diagnosis of overactive bladder and more likely to receive a diagnosis of voiding-phase dysfunction, but these changes did not lead to significant between-group differences in treatment selection or outcomes. CONCLUSIONS For women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior to evaluation with urodynamic testing for outcomes at 1 year. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT00803959.)

BACKGROUND Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinary incontinence, but data directly comparing the two types of therapy are needed. METHODS We performed a double-blind, double-placebo–controlled, randomized trial involving women with idiopathic urgency urinary incontinence who had five or more episodes of urgency urinary incontinence per 3-day period, as recorded in a diary. For a 6-month period, participants were randomly assigned to daily oral anticholinergic medication (solifenacin, 5 mg initially, with possible escalation to 10 mg and, if necessary, subsequent switch to trospium XR, 60 mg) plus one intradetrusor injection of saline or one intradetrusor injection of 100 U of onabotulinumtoxinA plus daily oral placebo. The primary outcome was the reduction from baseline in mean episodes of urgency urinary incontinence per day over the 6-month period, as recorded in 3-day diaries submitted monthly. Secondary outcomes included complete resolution of urgency urinary incontinence, quality of life, use of catheters, and adverse events. RESULTS Of 249 women who underwent randomization, 247 were treated, and 241 had data available for the primary outcome analyses. The mean reduction in episodes of urgency urinary incontinence per day over the course of 6 months, from a baseline average of 5.0 per day, was 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxinA group (P = 0.81). Complete resolution of urgency urinary incontinence was reported by 13% and 27% of the women, respectively (P = 0.003). Quality of life improved in both groups, without significant between-group differences. The anticholinergic group had a higher rate of dry mouth (46% vs. 31%, P = 0.02) but lower rates of catheter use at 2 months (0% vs. 5%, P = 0.01) and urinary tract infections (13% vs. 33%, P<0.001). CONCLUSIONS Oral anticholinergic therapy and onabotulinumtoxinA by injection were associated with similar reductions in the frequency of daily episodes of urgency urinary incontinence. The group receiving onabotulinumtoxinA was less likely to have dry mouth and more likely to have complete resolution of urgency urinary incontinence but had higher rates of transient urinary retention and urinary tract infections. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health; ClinicalTrials.gov number, NCT01166438.)

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.

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