TOMUS-Trial Of Mid-Urethral Slings

Phase 4

Completed

Interventions: Procedure: retropubic mid-urethral sling (TVT)
Procedure: transobturator mid-urethral sling (TVT-O and the Monarc)

Brief Summary: The primary aim of this clinical trial is to compare treatment success for two minimally invasive surgical procedures to treat stress urinary incontinence in women. These procedures are called mid-urethral slings. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and the need for other treatments(s) after surgery. Follow-up will be a minimum of two years.

Recruitment & Eligibility

Inclusion Criteria

Female
Stress urinary incontinence (SUI) as evidenced by all of the following:
Self-reported stress-type urinary incontinence symptoms, of duration ≥ 3 months
Medical, Epidemiological and Social Aspects of Aging (MESA) stress symptom score (percent of total possible stress score) greater than MESA urge symptom score (percent of total possible urge score)
Observation of leakage by provocative stress test at a bladder volume ≤ 300ml
Bladder capacity ≥ 200ml by stress test
Post-void residual (PVR) ≤ 100cc with pelvic organ prolapse (POP) Stage I or lower. If POP is Stage II-IV, PVR >100cc but ≤ 500cc is allowed
Eligible for both retropubic and transobturator procedures
No medical contraindications, e.g., current urinary tract infection (UTI), history of pelvic irradiation, history of lower urinary tract cancer
American Society of Anesthesiologists (ASA) class I, II, or III
No current intermittent catheterization
Available for 24-months of follow-up and able to complete study assessments, per clinician judgment
Signed consent form

Exclusion Criteria

Age <21 years
Non-ambulatory (ambulatory with assistive devices does not exclude the patient)
Pregnancy by self-report or positive pregnancy test, or self-reported intention to ever become pregnant
Current chemotherapy or current or history of pelvic radiation therapy
Systemic disease known to affect bladder function (i.e., Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma)
Urethral diverticulum, current or previous (i.e. repaired)
Prior augmentation cystoplasty or artificial sphincter
Implanted nerve stimulators for urinary symptoms
History of synthetic sling for stress urinary incontinence
<12 months post-partum
Laparoscopic or open pelvic surgery <3 months*
Current evaluation or treatment for chronic pelvic pain (painful bladder syndrome)
Participation in another treatment intervention trial that might influence the results of this trial
Need for concomitant surgery requiring an abdominal incision, use of graft material in the anterior compartment, or any use of synthetic graft material
Enrollment in other urinary incontinence trials including SISTEr/E-SISTEr or BE-DRI/E-BE-DRI

Arm && Interventions

Group	Intervention	Description
1	retropubic mid-urethral sling (TVT)	retropubic mid-urethral sling (TVT) The specific TVT used was the Tension-free Vaginal Tape (Gynecare)
2	transobturator mid-urethral sling (TVT-O and the Monarc)	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").

Primary Outcome Measures

Name	Time	Method
Objective Treatment Success at 12 Months	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	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.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction at 12 Months	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	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	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)

Locations (11): Loyola University Medical Center
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Maywood, Illinois, United States
University of Maryland
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Baltimore, Maryland, United States
William Beaumont Hospital
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Royal Oak, Michigan, United States
University of Pittsburgh
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Pittsburgh, Pennsylvania, United States
Oakwood Hospital/Cancer Center
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Dearborn, Michigan, United States
University of Texas Southwestern
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Dallas, Texas, United States
University of Alabama
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Birmingham, Alabama, United States
University of California
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San Diego, California, United States
Kaiser Permanente
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San Diego, California, United States
University of Texas Health Sciences Center
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San Antonio, Texas, United States
University of Utah
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Salt Lake City, Utah, United States