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

Sponsor

University of Helsinki (Other)

Overall Status

Unknown status

CT.gov ID

NCT00379314

Collaborator

(none)

260

Enrollment

Location

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Stress Incontinence	Procedure: TVT and TVT-O minimally invasive surgical procedures Procedure: Surgery for female stress urinary incontinence	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2004

Study Completion Date :

Dec 1, 2010

Outcome Measures

Primary Outcome Measures

Complications []
Objective cure rate by stress test and pad weighing test []

Secondary Outcome Measures

Quality of life questionnaires []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital	Helsinki		Finland	00029 HUS

Sponsors and Collaborators

University of Helsinki

Investigators

Principal Investigator: Carl G Nilsson, MD,PhD, Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital
Principal Investigator: Carl G Nilsson, MD,PhD, University of Helsinki