Trials / Completed
CompletedNCT00782990
A 3 Year Follow-up Prospective Open Randomized Trial of TVT Versus Colposuspension for Primary Stress Incontinence
A Three Year Follow-up Prospective Open Randomized Trial of Tension-Free Vaginal Tape and Colposuspension for Primary Urodynamic Stress Incontinence
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Hospital Severo Ochoa · Academic / Other
- Sex
- Female
- Age
- 35 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Surgical treatment: TVT | |
| PROCEDURE | Surgical treatment: colposuspension |
Timeline
- Start date
- 2001-01-01
- Primary completion
- 2004-10-01
- Completion
- 2007-06-01
- First posted
- 2008-10-31
- Last updated
- 2008-11-05
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT00782990. Inclusion in this directory is not an endorsement.