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 treatment for stress, urgency, and mixed UI. Behavioral treatments are usually delivered in individualized visits 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 controlled 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 three 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-randomization. The primary outcome will be self- reported UI severity as measured by the International Consultation on Incontinence Questionnaire-UI Short Form (ICI-Q), 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 traditional medical settings, but also in community settings, significantly reducing the human and economic burden of UI on patients, health care providers, and the health care system as a whole. PHS 398/2590 (Rev. 06/09) Page Continuation Format Page

Public Health Relevance

The Group Behavioral Treatment (GBT) is a novel group-administered intervention developed by the investigators to treat urinary incontinence (UI). 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 traditional medical settings, but also in community settings, significantly reducing the human and economic burden of UI on patients, health care providers, and the health care system as a whole.

Agency
National Institute of Health (NIH)
Institute
National Institute on Aging (NIA)
Type
Research Project (R01)
Project #
1R01AG043383-01A1
Application #
8578633
Study Section
National Institute on Aging Initial Review Group (NIA)
Program Officer
Romashkan, Sergei
Project Start
2013-09-01
Project End
2016-05-31
Budget Start
2013-09-01
Budget End
2014-05-31
Support Year
1
Fiscal Year
2013
Total Cost
$1,437,560
Indirect Cost
$222,296
Name
William Beaumont Hospital
Department
Type
DUNS #
076362110
City
Royal Oak
State
MI
Country
United States
Zip Code
48073