This three-site randomized controlled trial compares the effectiveness and cost-effectiveness of a group-administered behavioral treatment program to no treatment. Women with stress, urgency, or mixed urinary incontinence will be recruited and screened centrally, evaluated clinically at each of three study sites, and random assigned to one of two treatment arms: 1. Group behavioral treatment or 2. No treatment. Group treatment modalities have the potential to reach a larger population of older women with urinary incontinence, not only in the traditional medical settings, but also in community settings. The investigators hypothesize that group behavioral treatment will be more effective than no treatment. The investigators hypothesize that the group treatment will be cost-effective compared to no treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
463
Group Behavioral Treatment class is a two hour class taught by certified interventionist covering urinary system anatomy, bladder health and self management strategies, pelvic floor training, pelvic floor muscle contracting techniques, and bladder training. Slides and handouts supplement the content of the class.
Birmingham VA Medical Cnter
Birmingham, Alabama, United States
University of Michigan
Ann Arbor, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
University of Pennsylvania Health System, Urology
Philadelphia, Pennsylvania, United States
Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity.
The primary outcome is the self-reported urinary incontinence severity as measured by the International Consultation on Incontinence questionnaire-short form (ICI-Q). This short and simple questionnaire is used to screen for incontinence (urine leakage) to obtain a brief yet comprehensive summary of the level, impact and perceived cause of symptoms of incontinence. The ICI-Q consists of four questions and numeric scales: 1. How much do you leak urine? (0-5); never - all the time, 2. How much urine do you usually leak? (0-6); none - large amount, 3. Overall, how much does leaking urine interfere with your everyday life? (0-10); not at all - a great deal, 4. When does urine leak? Multiple choices. The ICI-Q score is the sum of questions 1-3 and ranges from 0-21. The higher the score, the greater severity of incontinence. Baseline data is compared to the 3 month data for the primary outcome.
Time frame: Baseline and 3 months
Group Behavioral Treatment Cost-effectiveness
Measure resource use and utilities and compare the difference in incontinence management costs and utilities between treatment and control group.
Time frame: 12 months
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