a PSC Research Project
Investigators: Carolyn M. Sampselle, Trivellore Raghunathan, Julia Schwartz S Seng, Margaret M. Tolbert, Janis Miriam Miller
More than one in three US women suffer from the distressing, embarrassing, and often unreported problem of urinary incontinence (UI). A key committee of the 2008 International Consultation on Incontinence concluded that pelvic floor muscle training (PFMT) should be offered as first line therapy to all women with stress, urge, or mixed UI and that bladder training (BT) may be preferred to drug therapy. Conservative strategies are low risk and do not prejudice future treatments. We reasoned that such self-management practices should also prevent UI and conducted a RCT to test a prevention behavioral program. A group session presented an array of conservative self-management practices- PFMT, BT and the Knack Maneuver, which is a preemptive contraction to decrease stress UI and/or suppress urge UI. At 12-months post- intervention we found a two-fold UI prevention effect. Moreover, we found high and sustained adherence: 82% at 3 months post intervention and 68% at 12 months. At four years follow-up, sustained adherence of 70% was predicted by early self-efficacy. This intervention is novel because it enables women to adopt and sustain efficacious bladder health practices for incontinence prevention, whereas to date conservative management approaches have focused on treatment. Based on what we now know, these practices should be part of standard well woman care, but it is not realistic to expect busy clinicians to provide this information within the confines of a brief encounter. We have developed a 15-minute DVD that is a condensed version of the prevention behavioral session; it is culturally sensitive and has yielded comparable levels of knowledge and self-efficacy. Using two sites (Michigan and Pennsylvania), we aim to compare the outcomes of the group behavioral program to the DVD version by randomizing 600 women aged 55 years and older to two arms of a comparative effectiveness trial. Follow-up will be at 3-months, 12-months, and 24-months post-intervention. (Aim 1). Controlling for age and BMI, we will test the hypotheses: HO1: There will be no difference in UI incidence demonstrated between groups (PRIMARY HO) HO2: There will be no difference in post-intervention self-management adherence between groups HO3: There will be no difference in post-intervention self-efficacy to adopt strategies between groups We will conduct an economic analysis comparing the two-hour session with the DVD version (Aim 2). Describing the costs and analyzing the willingness to pay and employment data will be the primary focus of this study in order to create the foundation for a future cost-effectiveness analysis, should trial hypotheses be confirmed. At 36-months post-intervention, we will conduct interviews to learn which intervention elements contributed to sustainability of adherence (Aim 3). Our long-range objective is to provide a UI prevention intervention suitable for wide-spread translation at the point of well woman care (annual visit). PUBLIC HEALTH RELEVANCE: More than one of every three women in the United States suffers from the distressing and hidden problem of urinary incontinence, a condition that costs our economy more than $19 billion per year (greater than the combined costs of breast, cervical, and ovarian cancers). Our innovative prevention program teaches women about low-risk, self-management practices and has been shown to cut their risk of urinary incontinence in half. If, as a result of this study, the DVD version yields similar health outcomes for less cost, it would be suitable to give to women at their annual health visits or via the internet with a benefit for untold numbers of women.
|Funding:||National Institure of Nursing Research (5R01NR012011)|
Funding Period: 09/28/2010 to 06/30/2015