NCT00379314

Randomized, Multicenter Trial Comparing TVT With TVT-O for Treatment of Female Urinary Incontinence

A Randomized, Prospective, Multicenter Trial Comparing TVT With TVT-O Procedures in Treatment of Female Primary Urinary Stress Incontinence

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (planned)
• Sponsor: University of Helsinki · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Tensionfree Vaginal Tape (TVT) procedure is a minimally invasive surgical procedure for treatment of female urinary stress incontinence. The TVT procedure has a documented efficacy and safety but is still associated with the risk of intra- and post-operative complications. A modification of the TVT procedure called TVT-O (Tensionfree Vaginal Tape Obturator), which utilises the obturator foramen for passage of the tape, is thought to lower the risk of complications. The trial compares the TVT procedure with the TVT-O procedure in a randomized fashion in order to detect differences in the rate of complications and in cure rate.

Conditions

• Urinary Stress Incontinence

Interventions

Type	Name	Description
PROCEDURE	TVT and TVT-O minimally invasive surgical procedures
PROCEDURE	Surgery for female stress urinary incontinence

Timeline

• Start date: 2004-04-01
• Completion: 2010-12-01
• First posted: 2006-09-21
• Last updated: 2006-11-01

Locations

1 site across 1 country: Finland