Study Comparing Tension-free Vaginal Tape With the Monarc Procedure for Stress Urinary Incontinence

Study Overview
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Brief Summary
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Urinary incontinence is a major health issue in women. It is estimated to affect 30 - 40% of older women. Stress urinary incontinence, the most common form of this disease, is treated primarily with surgery. A woman's lifetime risk of surgery for SUI is 4%, with nearly 1/3 of surgery being performed for recurrences. Many different surgical procedures have been described for the treatment of SUI and there is no general agreement as to the most effective. This study compares the safety and efficacy of the tension-free vaginal tape procedure to the Monarc subfascial hammock procedure in the treatment of stress urinary incontinence.

Official Title
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A Randomized Trial Comparing the Monarc Subfascial Hammock Procedure With Tension-free Vaginal Tape Procedure for the Surgical Treatment of Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Tension-free Vaginal Tape
* Device: Monarc sub-fascial hammock


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Urinary incontinence symptoms Urodynamic stress incontinence confirmed with multichannel urodynamic testing Age of at least 21 years Desires surgical correction of stress urinary incontinence Exclusion Criteria: Post-void residual volume >100cc Detrusor overactivity on preoperative multichannel urodynamic testing History of previous synthetic, biologic or fascial sub-urethral sling Desires future childbearing Chronic inguinal or vulvar abscess or history of Hidradenitis Suppurativa History of bleeding diathesis or current anti-coagulation therapy Inguinal lymphadenopathy or inguinal/vulvar mass Current genitourinary fistula or urethral diverticulum Reversible cause of incontinence (i.e. drug effect) Contraindication to surgery

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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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tension-free Vaginal Tape<br> | Device: Tension-free Vaginal Tape<br> <br> |
| Active Comparator: Monarc Sub-fascial hammock<br> | Device: Monarc sub-fascial hammock<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of abnormal bladder function, defined as the sign or symptom of urinary incontinence or urinary retention |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications |  |  | 
| Postoperative pain |  | 2 weeks, 6 weeks | 
| HRQOL |  | 6 months, 12 months, 18 months, 24 months | 
| Sexual function |  | 12 months, 24 months | 
| Global improvement in bladder function |  | 6 months, 12 months, 18 months, 24 months | 
| Development of anterior vaginal prolapse |  | 12 months, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress urinary incontinence, sling procedures, tension-free vaginal tape, transobturator