Women with urge urinary incontinence are commonly treated with antimuscarinic medications, but many discontinue therapy.
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.
Two-stage, multi-center, randomized clinical trial (BE-DRI trial) (July 2004 – January 2006).
Nine university-affiliated outpatient clinics.
307 women with urge predominant incontinence.
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.
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.
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).
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%.
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.