The broad, long-term aims of our research team are to determine the effectiveness of behavioral and pharmacological interventions in the treatment of urinary incontinence in older women. Poor bladder control is a serious health problem that can have severe consequences on the independence and quality of life of older women.
The aims of the 1 year pilot study are to collect critical pilot data and experience prior to a larger, more complex clinical trial. This pilot study aims to: Assess our ability to recruit participants to participate in a randomized clinical trial of the efficacy of biofeedback in treating urinary incontinence; provide experience with intervention materials, data collection procedures, and participant management related to the proposed clinical trial; provide confidence in the hypothesis that our regimens of biofeedback are associated with clinically meaningful treatment effects. Thirty women aged 50-65 will be randomized to one of three conditions: 6 treatments of biofeedback-assisted behavioral therapy, 3 treatments of biofeedback-assisted behavioral therapy, and control (pelvic floor exercise, self-monitoring, and urge strategy instruction). Subjective self-report data and objective incontinence severity measures will be used. In addition, data will be collected on: generic and incontinence-specific quality of life, adherence to pelvic floor exercises, adherence to biofeedback, patient satisfaction and treatment preferences. Descriptive statistics, such as counts, frequencies, and means will be calculated for all variables. Analyses will be conducted primarily using SAS software.
