Mixed Incontinence: Medical Or Surgical Approach?
The purpose of this study is to compare treatment outcomes for patients with mixed urinary
incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is
initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and
urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery
for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach.
Follow-up will be a minimum of 12 Months.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Optimal Outcome of Treatment at 6 Months
Composite measure defined as "much better" or "very much better" on Patient Global Impression of Improvement (PGI-I) and "normal" or "mild" on Patient Global Impression of Symptoms (PGI-S). PGI-I is a single item: "Circle the one answer that best describes your urinary tract condition now, compared to how it was before your incontinence treatment" with responses ranging from 1= "Very much better" to 7= "Very much worse." The PGI-S is a single item:; "Circle the one number that best describes how your urinary tract condition is now" with responses ranging from 1 = "Normal" to 4 "Severe".
Ann Gormley, MD
Dartmouth-Hitchcock Medical Center
United States: Federal Government
|University of Alabama||Birmingham, Alabama|
|Loyola University Medical Center||Maywood, Illinois 60153|
|University of Pittsburgh||Pittsburgh, Pennsylvania 15261|
|University of Utah||Salt Lake City, Utah|
|University of Maryland||Baltimore, Maryland 21201|
|University of California||San Francisco, California 94108|
|University of Texas Health Sciences Center||San Antonio, Texas|
|Oakwood Hospital/Cancer Center||Dearborn, Michigan 48123|
|University of Texas Southwestern||Dallas, Texas 75390|
|Beaumont Hospital||Royal Oak, Michigan 48073|