TOMUS-Trial Of Mid-Urethral Slings

Study Overview
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Brief Summary
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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.

Official Title
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TOMUS-Trial Of Mid-Urethral Slings

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Procedure: retropubic mid-urethral sling (TVT)
* Procedure: transobturator mid-urethral sling (TVT-O and the Monarc)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>retropubic mid-urethral sling (TVT) The specific TVT used was the Tension-free Vaginal Tape (Gynecare) | Procedure: retropubic mid-urethral sling (TVT)<br>* 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.<br>|
| Active Comparator: 2<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Subjective Treatment Success at 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction at 12 Months | 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. | Follow-Up | 
| Change in Quality of Life From Baseline to 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). | Baseline - 12 months | 
| Bother as Measured by the Urogenital Distress Inventory (UDI) at 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) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Incontinence, Stress, Surgery