A 3 Year Follow-up Prospective Open Randomized Trial of TVT Versus Colposuspension for Primary Stress Incontinence

Study Overview
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Brief Summary
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Objective: To compare TVT with COLPOSUSPENSION (CS) as primary treatment for stress incontinence (SUI). Design: Randomised, open, comparative trial 3-years follow-up. Participants: 49 consecutive 35 to 70 years old women with urodynamic SUI. Setting: Urology department of a district general hospital at Leganés (Madrid), Spain. Intervention: 24 patients randomised to TVT and 25 to CS.

Detailed Description
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Background: Evidence comparing effectiveness of tension-free vaginal tape (TVT) and Burch's colposuspension (CS) in the long term follow-up is weak. Objective: To compare TVT with CS as primary treatment for stress incontinence (SUI). Design: Randomised, open, comparative trial 3-years follow-up. Participants: 49 consecutive 35 to 70 years old women with urodynamic SUI. Setting: Urology department of a district general hospital at Leganés (Madrid), Spain. Intervention: 24 patients randomised to TVT and 25 to CS. Measurements: Main outcome: Assessment before treatment and at 6-months, 1-year and 3-years postoperatively with the incontinence severity symptoms index (ISS) and the incontinence impact symptoms index (IIS) Secondary outcome: 3 groups to asses cure rates: cured, improved and failure.

Official Title
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A Three Year Follow-up Prospective Open Randomized Trial of Tension-Free Vaginal Tape and Colposuspension for Primary Urodynamic Stress Incontinence

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Procedure: Surgical treatment: TVT
* Procedure: Surgical treatment: colposuspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between the ages of 35 and 70 who had completed their family with a clinical (Booney test positive) and urodynamic diagnosis of Stress Urinary Incontinence Previous surgery for prolapse, incontinence or bladder disease, urodynamic diagnosis of detrusor overactivity, or voiding difficulty (defined as maximum flow less than 15 ml/second or voiding pressure greater than 50 cm H2O or residual volume greater than 100 ml) Cystocele over grade I Previous hysterectomy Body mass index (BMI) of 40 or more Uncontrolled diabetes Neurological disease Recurrent urinary tract infections Genital atrophy precluding vaginal surgery Known bleeding diathesis or current anticoagulant therapy

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tvt group<br>Surgical treatment for incontinence: TVT | Procedure: Surgical treatment: TVT<br> <br> |
| Active Comparator: Burch group<br>Surgical treatment for incontinence: Colposuspension | Procedure: Surgical treatment: colposuspension<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective SUI cure evaluated with incontinence severity symptoms (ISS) and incontinence impact symptoms (IIS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Criteria were established to include patients in one of three groups: cure, improved and treatment failure |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress urinary incontinence, female incontinence, surgical treatment, Female stress urinary incontinence