Urinary incontinence in the elderly is a major problem with significant medical, psychological, and social consequences. Previous research on urge incontinence, a common form of incontinence, has demonstrated that behavioral interventions and drug treatments are effective for many individuals. However, it is clear that no one method has been 100% effective and all methods have disadvantages. The broad objective of the proposed research is to improve the treatment of urge incontinence 1) by improving the efficacy of individual treatment modalities, 2) by combining treatments that have additive effects, and 3) by improving selection criteria. This project will be a prospective, randomized trial comparing the effects of behavioral training, drug therapy (oxybutynin) and placebo on urge incontinence in ambulatory, community-dwelling women aged 55 years and older. Although the two treatments have been studied individually, their effects have never been compared. Approximately 390 women will be evaluated for participation with the expectation that 195 will complete the protocol. Stratified and blocked randomization procedures will be used to assign subjects to 4 sessions (8 weeks) of biofeedback-assisted behavioral training, 4 sessions (8 weeks) of treatment with oxybutynin, or 4 sessions(8 weeks) of placebo. Bladder diaries completed by subjects prior to randomization and following the last treatment session will be used to calculate reduction in the frequency of incontinence. Urodynamic evaluation conducted prior to and following intervention will be used to objectively document change in bladder or sphincter function. The second purpose of the study is to evaluate the combined effects of the two interventions. Using a conditional cross-over design, patients who do not achieve total continence following one intervention will receive the alternate intervention in addition. Finally, the third purpose of the study is to characterize patients on clinical variables that may influence response to each treatment and eventually aid us in predicting treatment outcome.
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