TOMUS-Trial Of Mid-Urethral Slings
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Treatment Success at 12 Months
Objective treatment success: negative stress test, negative pad test, and no retreatment for stress urinary incontinence (SUI) including behavioral, pharmacologic or surgical procedures A provocative stress test standardized to volume and position is performed for direct observation of urine leakage. Observed urine loss from the urethra coincidental with the Valsalva maneuver or cough is a positive test; a negative test indicates no urine loss. Pad testing quantifies the amount of urine involuntarily lost and is used to reflect everyday incontinence; it is negative if loss is <15g/24 hrs.
12 months
No
Ann Gormley, M.D.
Study Chair
Dartmouth-Hitchcock Medical Center
United States: Federal Government
DK58229
NCT00325039
April 2006
June 2013
Name | Location |
---|---|
University of Alabama | Birmingham, Alabama |
Loyola University Medical Center | Maywood, Illinois 60153 |
William Beaumont Hospital | Royal Oak, Michigan 48073 |
University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |
University of Utah | Salt Lake City, Utah |
University of Maryland | Baltimore, Maryland 21201 |
Kaiser Permanente | Sacramento, California |
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 |