Overview

This trial is active, not recruiting.

Condition urinary stress incontinence
Treatments tvt and tvt-o minimally invasive surgical procedures, surgery for female stress urinary incontinence
Phase phase 3
Sponsor Helsinki University
Start date April 2004
End date December 2010
Trial size 260 participants
Trial identifier NCT00379314, 42/E8/04

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Complications
time frame:
Objective cure rate by stress test and pad weighing test
time frame:

Secondary Outcomes

Measure
Quality of life questionnaires
time frame:

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title A Randomized, Prospective, Multicenter Trial Comparing TVT With TVT-O Procedures in Treatment of Female Primary Urinary Stress Incontinence
Principal investigator Carl G Nilsson, MD,PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2006.
Information provided to ClinicalTrials.gov by Helsinki University.