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 are effective for many individuals. Preliminary data indicate that this behavioral training administered by nurse practitioners is at least as effective as drug therapy. If is safe, practical, and yields high levels of patient satisfaction. Behavioral training has several components, one of which is biofeedback. Biofeedback technology requires specialized equipment and expertise, yet it has not been established whether biofeedback is an essential component that heightens therapeutic efficacy. The primary purpose of this continuation project is to test whether biofeedback enhances the outcome of behavioral training in the treatment of urge incontinence in ambulatory, community-dwelling, older women. This project will be a prospective randomized clinical trial comparing the effects of behavioral training with and without biofeedback against a """"""""minimal treatment"""""""" control condition. Approximately 480 women will be evaluated for participation with the expectation that 159 will complete the protocol. Stratified and blocked randomization procedures will be used to assign subjects to four sessions (8 weeks) of biofeedback-assisted behavioral training, four sessions (8 weeks) of behavioral training without biofeedback, or four sessions (8 weeks) of a self-administered behavioral program. 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. Secondary outcome measures will include patient satisfaction and changes in psychological symptoms associated with each intervention.
The second aim of the study is to explore four possible mechanisms by which behavioral training reduces incontinence: increased pelvic muscle strength, increased use of pelvic muscles in response to the sensation of urgency, reduced frequency of urination, and increased bladder capacity.
The third aim i s to characterize patients on a number of variables with potential predictive value in order to identify useful selection criteria.
The fourth aim i s to study the long-term durability of behavior training in patients enrolled in the current clinical trial as well as the proposed clinical trial.
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