The long-term goal is to develop an effective behavioral therapy for stress urinary incontinence (SUI). Estimated prevalence rates of urinary incontinence range from 15-43% of women, with SUI as the most prevalent. The project will test Knack therapy, a self-help treatment for SUI that teaches women a pelvic floor muscle contractions simultaneously with a event known to trigger leakage. By doing so, momentary closure pressure is imposed on the urethra and risk for leakage is immediately reduced. This proposal aims to develop and test, in a general population of women with SUI, a model for predicting who will succeed in a costly surgery and time consuming Kegel's exercises).
Specific Aims are to: (1) develop a logistic regression model to predict success with the Knack, (2) validate the model by determining the proportion of people who succeed according to who is predicted to succeed, and (3) develop long-term effectiveness of the Knack (1-year). The project will be implemented in three phases: model development (n=160 women), model validation (n approximately 160), and long-term follow-up of women who demonstrate response. The short-term outcome of """"""""positive response"""""""" is defined as able to reduce leakage during coughing to under 2 ml or 50% decrease from baseline (whichever is more stringent). This will be evaluated immediately and at 1 month. Leakage is evaluated in simple fashion with a paper towel test in the clinic. Long-term success (3-month and 1-year) is defined both by the paper towel test criteria and by documentation of at least 50% reduction of leakage in diary to reflect success at home. ROC curve analysis will be used to analyze model data, t-test and descriptives to analyze response. Anticipated results include that 1) the treatment group will demonstrate significantly less urine leakage than a control group immediately post-instruction and at 1-month follow-up; and 2) over time (1-, 3-, and 12-months) at least 80% of women selected by the predictive model who receive the Knack intervention will reach and sustain a greater than 50% reduction in urine loss from baseline.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Specialized Center (P50)
Project #
1P50HD044406-01
Application #
6582292
Study Section
Special Emphasis Panel (ZAR1)
Project Start
2002-09-01
Project End
2007-08-31
Budget Start
Budget End
Support Year
1
Fiscal Year
2002
Total Cost
Indirect Cost
Name
University of Michigan Ann Arbor
Department
Type
DUNS #
791277940
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109
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