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

Phase 3

• Conditions: Urinary Stress Incontinence

• Registration Number: NCT00379314
• Lead Sponsor: University of Helsinki

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Status Verified: 2006-09
• Study First Submitted: 2006-09-19
• Study First Submitted QC: 2006-09-19
• Study First Posted: 2006-09-21
• Last Update Submitted: 2006-10-31
• Last Update Posted: 2006-11-01
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 260

Inclusion Criteria

• history of stress incontinence
• indications for surgical treatment
• positive cough stress test
• urgency score < 7

Exclusion Criteria

• prior incontinence surgery
• need of concomitant surgery
• post void residual urine volume < 100 ml
• urinary tract anomalies
• urinary tract infection
• more than 3 urinary tract infection within last year
• more than grade 2 urogenital prolapse
• Body mass index > 35
• Radiotherapy of the pelvic region
• active malignancy
• hemophilia
• anticoagulant treatment
• neurological disorder or other disease which affects bladder function
• anticholinergic treatment
• use of duloxetine
• do not understand the purpose of the trial
• immobility

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Objective cure rate by stress test and pad weighing test
Complications

Secondary Outcome Measures

Name	Time	Method
Quality of life questionnaires

Trial Locations

Locations (1)

Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland