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

Phase 4

Completed

• Conditions: Urinary Incontinence

• Registration Number: NCT00782990
• Lead Sponsor: Hospital Severo Ochoa

Brief Summary

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

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.

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2004-10
• Study Completion: 2007-06
• Study First Submitted: 2008-10-30
• Study First Submitted QC: 2008-10-30
• Study First Posted: 2008-10-31
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-04
• Last Update Posted: 2008-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Subjective SUI cure evaluated with incontinence severity symptoms (ISS) and incontinence impact symptoms (IIS)

Secondary Outcome Measures

Name	Time	Method
Criteria were established to include patients in one of three groups: cure, improved and treatment failure

Trial Locations

Locations (1)

Hospital Severo Ochoa; 🇪🇸 Leganes, Madrid, Spain