Study Comparing TVT With TVT-SECUR for the Treatment of Stress Urinary Incontinence

Study Overview
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Brief Summary
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The purpoe of this study is to compare the safety and efficacy of the tension-free vaginal tape procedure (TVT) to the TVT-SECUR procedure in the treatment of stress urinary incontinence.

Official Title
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A Randomized Trial Comparing Tension-free Vaginal Tape (TVT) to the TVT-SECUR 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: TVT-SECUR device


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 History of bleeding diathesis or current anti-coagulation therapy 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Tension-free vaginal tape procedure (TVT) | Device: tension-free vaginal tape<br>* Retropubic mid-urethral sling<br>* Other names: TVT;|
| Active Comparator: 2<br>TVT-SECUR device | Device: TVT-SECUR device<br>* Mid-urethral mini-sling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Cure of Urinary Incontinence at 12 Months After Surgery | Composite outcome defined as absence of urinary incontinence as indicated by the Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment of stress urinary incontinence (SUI) after the index surgery. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Complications at 6 Week or Less |  | 6 week | 
| Long Term Complications > 6 Weeks |  | 6 weeks-12 months | 
| Patient Global Impression Improvement |  | 12 months | 
| Incontinence Severity Index Score | The incontinence severity index comprises the following two questions. How often do you experience urine leakage (0=never, 1=less than once a month, 2=one or several times a month, 3=one or several times a week, 4=every day and/or night)? How much urine do you lose each time (1=drops or little, 2=more)? The total score is the score for the first question multiplied by the score for the second question (0=dry, 1-2=slight, 3-4=moderate, 6-8=severe). | 12 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