Design of the Behavior Enhances Drug Reduction of Incontinence (BE-DRI) study.

PURPOSE: To describe the design of a multi-center randomized clinical trial of behavioral training combined with drug therapy for the treatment of urge incontinence. The study aims are to determine whether adding behavioral training will increase the number of women who can discontinue drug therapy and sustain a significant reduction of incontinence; to test whether the short-term effectiveness of drug therapy can be enhanced by combining it with behavioral training; and to determine the cost-effectiveness of combined therapy.

DESIGN: Two-stage randomized clinical trial currently being conducted by the Urinary Incontinence Treatment Network, a clinical trials network established by the National Institutes of Health.

METHODS: Participants are 307 community-dwelling women with pure or predominant urge incontinence. Stage 1 consists of 10 weeks of drug therapy with sustained-release tolterodine alone or combined with behavioral training (pelvic floor muscle exercise training, bladder control techniques, fluid management). In stage 2, drug is withdrawn and behavioral training stopped. The primary outcome, measured at 8 months, is a composite of two endpoints (1) successful drug withdrawal (i.e. not requesting any other treatment for incontinence) and (2) achieving and maintaining > or =70% reduction in the frequency of incontinence episodes on bladder diary. The effects of treatment and drug withdrawal are measured at week 10 and months 4, 6, 8, 14, 20, and 26. Assessments include: the Medical Epidemiological and Social Aspects of Aging (MESA) incontinence questionnaire, pelvic floor muscle strength assessment, Incontinence Impact Questionnaire, Urogenital Distress Inventory, Overactive Bladder Questionnaire, Short-Form Health Survey (SF-12), costs associated with incontinence care, Health Utility Index Mark 3, Willingness to Pay Scale, and Patient Satisfaction Questionnaire.

SIGNIFICANCE: The BE-DRI study is the first clinical trial to investigate the use of drug therapy combined with behavioral therapy with the pre-established goal of discontinuing the medication. The concept of drug cessation represents a new paradigm in this field of research and has important implications for future treatment approaches to urge incontinence.