a PSC Research Project
Investigators: Lisa Kane Low, Trivellore Raghunathan, Carolyn M. Sampselle
Urinary Incontinence (UI) is a prevalent condition that diminishes quality of life in older women at tremendous social and economic costs. Although there are several therapeutic options available, behavioral treatments are recommended by most evidence-based guidelines as an initial approach to therapy for stress, urgency and mixed UI. Behavioral treatments are usually delivered in individualized sessions in medical offices but a group session model of care delivery has been shown to be effective. Based on promising outcomes in our pilot studies using a novel group treatment approach, we were awarded a planning grant to assemble an interdisciplinary team of experts and develop a multi-center randomized control trial (RCT). The proposed study is a three-site RCT to compare the effectiveness and cost-effectiveness of a group-administered behavioral treatment program to no treatment. Women with stress, urgency, or mixed UI will be recruited and screened centrally, evaluated clinically at each of the study sites, and randomly assigned to one of two treatment arms: 1) Group behavioral treatment (GBT) or 2) No treatment. Outcomes will be assessed at 3-, 6-, 9-, and 12-months post treatment. The primary outcome will be self reported UI severity as measured by the International Consultation on Incontinence Questionnaire-UI Short Form, a validated measure for research and practice. Secondary outcome measures will assess frequency of incontinence episodes, volume of urine loss, type of incontinence, pelvic floor muscle strength, patient satisfaction, patient perception of improvement, impact on quality of life, and cost-effectiveness. Once standardized with data to support its clinical effectiveness and cost-effectiveness, group treatment modalities have potential to reach a larger population of older women with UI, not only in medical offices and clinics, but also in community settings, significantly reducing the human and economic burden of UI on patients, healthcare providers, and the health care system as a whole.
|Funding (subcontract):||National Institute on Aging (R01AG043383)|
Funding Period: 09/01/2013 to 05/31/2015