Introduction and Objectives
Women with urge urinary incontinence are commonly treated with antimuscarinic medications, but many discontinue therapy.
The objective of this study was 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 sustain these improvements after discontinuing medication.
Methods
The BE-DRI trial was a two-stage, multi-center, randomized clinical trial conducted between July 2004 and January 2006 in outpatient clinics at the nine university-affiliated clinical centers of the Urinary Incontinence Treatment Network (NIDDK). Participants were 307 women with urge predominant incontinence. The study interventions were ten weeks of open-label, extended-release tolterodine alone (N = 153) or tolterodine combined with behavioral training (N = 154) (Stage 1). The behavioral intervention included teaching pelvic floor muscle control and exercises (using vaginal palpation); behavioral strategies to diminish urgency, suppress bladder contractions, and prevent both stress and urge incontinence; delayed voiding to increase voiding intervals for those who voided >8 times per day; and individualized fluid management for those with excessive urine output (> 70 oz. per day). Interventions were followed by discontinuation of therapy and follow-up at 8 months (Stage 2). 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 the frequency of incontinence episodes on bladder diary. Secondary outcomes were reduction in incontinence, self-reported satisfaction and improvement, and scores on validated questionnaires measuring symptom distress/bother and health-related qualityof- life. Study staff who performed outcome evaluations were blinded to group assignment, but participants and interventionists were not.
Results
Assigned treatment was completed by 68% of participants and 8 month outcome status was assessed on 77%. At 8 months, there was no difference in successful discontinuation of drug therapy between combined therapy and drug therapy 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%; 95% confidence interval of difference: -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 (both P = 0.02) and perceived improvement (P = 0.008, P<0.001), but not health-related quality-of-life. Adverse events were uncommon in both groups (12 events in 6 participants, 3 in each group).
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.
Keywords
urinary urge incontinence, drug therapy, behavioral therapy, combined modality therapy, quality of life, pelvic floor muscle exercises