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

This study is ongoing, but not recruiting participants.

First Received: September 19, 2006 Last Updated: October 31, 2006 History of Changes

Sponsored by:	Helsinki University
Information provided by:	Helsinki University
ClinicalTrials.gov Identifier:	NCT00379314

Purpose

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	Intervention	Phase
Urinary Stress Incontinence	Procedure: TVT and TVT-O minimally invasive surgical procedures Procedure: Surgery for female stress urinary incontinence	Phase III

MedlinePlus related topics: Pelvic Support Problems Surgery Urinary Incontinence

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Prospective, Multicenter Trial Comparing TVT With TVT-O Procedures in Treatment of Female Primary Urinary Stress Incontinence

Further study details as provided by Helsinki University:

Primary Outcome Measures:

Complications
Objective cure rate by stress test and pad weighing test

Secondary Outcome Measures:

Quality of life questionnaires

Estimated Enrollment:	260
Study Start Date:	April 2004
Estimated Study Completion Date:	December 2010

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379314

Locations

Finland
Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital
Helsinki, Finland, 00029 HUS

Sponsors and Collaborators

Helsinki University

Investigators

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

More Information

Additional Information:

International urogynecological association This link exits the ClinicalTrials.gov site

Publications:

Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand. 2002 Jan;81(1):72-7.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Laurikainen E, Valpas A, Kivela A, Kalliola T, Rinne K, Takala T, Nilsson CG. Retropubic compared with transobturator tape placement in treatment of urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2007 Jan;109(1):4-11.

Study ID Numbers:	42/E8/04
Study First Received:	September 19, 2006
Last Updated:	October 31, 2006
ClinicalTrials.gov Identifier:	NCT00379314 History of Changes
Health Authority:	Finland: Ethics Committee

Keywords provided by Helsinki University:

Incontinence
Urinary
Female
Surgery
Complications

Study placed in the following topic categories:

Signs and Symptoms
Urinary Incontinence, Stress
Urologic Diseases

Urination Disorders
Stress
Urinary Incontinence

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Urinary Incontinence, Stress

Urologic Diseases
Urination Disorders
Urinary Incontinence

ClinicalTrials.gov processed this record on May 07, 2009