Urinary incontinence in the elderly is a major problem with significant medical, psychological, and social consequences. Previous research on stress incontinence, a common form of incontinence, has demonstrated that behavioral interventions and electrical stimulation 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 stress incontinence 1) by improving the efficacy of individual treatment modalities, 2) by combining treatments that may have additive affects, 3) by studying further the mechanisms by which therapies reduce incontinence, and 4) by improving selection criteria. This project will be a prospective, randomized trial comparing the effects of biofeedback-assisted pelvic muscle training, biofeedback-assisted pelvic muscle training enhanced with electrical stimulation, and a minimal treatment control condition on stress incontinence in ambulatory, community-dwelling woman aged 55 years and older (specific aim #1). Although the two treatments have been studied individually, their combined effects have not been investigated. 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 4 sessions (8 weeks) of biofeedback-assisted pelvic muscle training, 4 sessions (8 weeks) of biofeedback-assisted pelvic muscle training enhanced with maximal electrical stimulation, or 4 sessions (8 weeks) of a self-help behavioral program. Bladder diaries and 24-hour home pad tests completed by subjects prior to randomization and following last treatment session will be used to calculate reduction in the frequency and volume of incontinence.
The second aim of the study is to explore two possible mechanisms of clinical improvement: increased leak point pressure and increased pelvic muscle strength. Urodynamic evaluation, including leak point pressure, and assessment of vaginal and anal sphincter strength, conducted prior to and following intervention, will be used to document objective change in these variables.
The third aim of the study is to characterize patients on clinical variables that may influence response to each treatment and aid in predicting treatment outcome.
