TOMUS-Trial Of Mid-Urethral Slings (TOMUS)
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|ClinicalTrials.gov Identifier: NCT00325039|
Recruitment Status : Completed
First Posted : May 11, 2006
Results First Posted : September 27, 2012
Last Update Posted : January 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence||Procedure: retropubic mid-urethral sling (TVT) Procedure: transobturator mid-urethral sling (TVT-O and the Monarc)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||597 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||TOMUS-Trial Of Mid-Urethral Slings|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2013|
Active Comparator: 1
retropubic mid-urethral sling (TVT) The specific TVT used was the Tension-free Vaginal Tape (Gynecare)
Procedure: retropubic mid-urethral sling (TVT)
This trial is a comparison of two types of mid-urethral slings. The retropubic mid-urethral mesh sling is used for treatment of stress incontinence; this procedure was less invasive than the fascial sling procedures that were reference standards at the start of the study. Specifically, a synthetic tape is passed transvaginally at the midurethral level through the retropubic space.
Active Comparator: 2
transobturator mid-urethral sling (TVT-O and the Monarc) Two transobturator slings were used: the Tension-free Vaginal Tape Obturator (Gynecare), which is placed starting inside the vagina and coming out through the obturator foramen ("in-to-out") or the Monarc (American Medical System), which is placed starting in the groin area, passing through the obturator foramen, and then into the vagina ("out-to-in").
Procedure: transobturator mid-urethral sling (TVT-O and the Monarc)
This trial is a comparison of two types of mid-urethral slings. The transobturator mid-urethral sling is used for treatment of stress incontinence; this procedure was developed to minimize the potential for bladder and bowel injuries associated with the retropubic sling, since the sling is passed through the obturator canal, avoiding the pelvic organs in the retropubic space.
- Objective Treatment Success at 12 Months [ Time Frame: 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.
- Subjective Treatment Success at 12 Months [ Time Frame: 12 months ]Absence of self-reported symptoms of stress-type urinary incontinence, as assessed with the use of the Medical, Epidemiological and Social Aspects of Aging (MESA) questionnaire (responded never to all 9 MESA questions), no leakage recorded in a 3-day voiding diary and no retreatment for stress incontinence including behavioral, pharmacologic or surgical treatment.
- Patient Satisfaction at 12 Months [ Time Frame: Follow-Up ]Patient satisfaction was assessed at the 12 month visit with the questions, "how satisfied or dissatisfied are you with the result of bladder surgery related to urine leakage?" Possible responses were completely satisfied, mostly satisfied, neutral, mostly dissatisfied, and completely dissatisfied. Completely and mostly satisfied were reported as "satisfied" and neutral, most dissatisfied and completely dissatisfied as "not satisfied".
- Change in Quality of Life From Baseline to 12 Months [ Time Frame: Baseline - 12 months ]Scores on the Incontinence Impact Questionnaire range from 0 to 400 with higher scores indicating greater impact. The scores are changes from baseline to the 12 month visit (baseline - 12 months).
- Bother as Measured by the Urogenital Distress Inventory (UDI) at 12 Months [ Time Frame: 12 months ]Urogenital Distress Inventory (UDI) scores range from 0 to 300 with higher scores indicating greater distress. Scores are changes from baseline to the 12 month visit (baseline - 12 months)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325039
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|University of California|
|San Diego, California, United States, 92103|
|San Diego, California, United States, 92110|
|United States, Illinois|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|United States, Maryland|
|University of Maryland|
|Baltimore, Maryland, United States, 21201|
|United States, Michigan|
|Oakwood Hospital/Cancer Center|
|Dearborn, Michigan, United States, 48123|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48123|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Texas|
|University of Texas Southwestern|
|Dallas, Texas, United States, 75390|
|University of Texas Health Sciences Center|
|San Antonio, Texas, United States, 78229-3900|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Study Chair:||Ann Gormley, M.D.||Dartmouth-Hitchcock Medical Center|