Planning a RCT of Group-Session BMP to Treat Older Adult Women with Incontinence

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DESCRIPTION (provided by applicant): Urinary incontinence (UI) affects more than one in three adult women in the United States, costs as much as $16 to $32 billion yearly, and contributes significantly to dependency, social isolation, and depression in older women. Individualized teaching of behavior modification program (BMP) is known as one of the standard treatments for UI but is costly and time consuming for patients and providers. Group-Session Teaching of a Behavioral Modification Program (GST-BMP) has significant potential to deliver effective UI prevention and treatment to larger groups of women from all geographic and socioeconomic strata. Our preliminary studies of GST-BMP have demonstrated that not only is the ability to teach effectively transferable to other instructors but GST-BMP is also effective in treating incontinence in adult ambulatory women =55 years old. Treatment group paired analysis in our pilot study showed statistically and clinically significant improvements in voiding frequency, leak diameter in cough test, and vaginal digital pressure, displacement, and duration scores. Overall, UI symptom severity was statistically significantly reduced among the treatment group (52.2%) compared to the control group (16.7%), p=0.025. Given the magnitude of the problem of UI, there is a need to expand this preliminary work to evaluate long-term clinical and economic outcomes of GST-BMP, and to test whether outcomes achieved in our pilot study can be replicated by other providers at centers throughout the US. If so, this could lead to widespread implementation of community-based programs that may be more convenient and cost-effective for vulnerable populations with limited access to health care services. Therefore, we are seeking planning grant support to develop a Phase III multi-center randomized control trial testing the clinical and economic outcomes of GST-BMP compared to individualized BMP. Under this planning grant we will assemble a multidisciplinary team of experts in urology, urogynecology, urology nursing, geriatric urology, geriatric medicine, behavioral science, health economics, and outcomes research. The major goal of this team is to prepare a Phase III randomized clinical trial ready for multi-site implementation upon conclusion of this planning grant. We will develop a detailed Manual of Procedures (MOP) and prepare and submit to the National Institute on Aging (NIA) an investigator-initiated research proposal using an R01 mechanism and a clinical trial methodology to test two hypotheses: 1) GST-BMP is clinically as effective in the treatment of stress, urge, and mixed UI as individualized BMP; and 2) GST-BMP is cost-effective compared to individualized BMP in treating stress, urge, and mixed UI.