Retropubic vs. Transobturator Tension-free Vaginal Tape

December 9, 2012 updated by: Karl Tamussino, MD, Austrian Urogynecology Working Group (AUWG)

Retropubic vs. Transobturator Tension-free Vaginal Tape (TVT vs. TVT-O): A Randomized Trial

The so-called tension-free vaginal tape (TVT), first described in Sweden in 1996, has become a standard operation worldwide for the treatment of women with stress urinary incontinence. This tape is placed from the vagina behind the pubic bone and exits through the skin of the lower abdomen, just above the pubic bone. In 2001 a urologist in France proposed passing a similar tape laterally (as opposed to behind the pubic bone). This tape is passed through a window of the pelvic bones (the so-called obturator foramen), by what is called a transobturator approach. It is passed through the skin of the thigh (as opposed to the lower abdomen). The reason for this modification was to avoid injuring the bladder and, possibly, provide a more physiologic restoration of the continence mechanism. However, it is unclear whether the lateral (so-called transobturator approach) is as good as or better than the initial approach behind the pubic bone.

The purpose of the present study is to compare the standard (retropubic) and the newer (transobturator) approach for the placement of a tape for treating women with stress urinary incontinence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After informed consent women scheduled for surgery for stress urinary incontinence are randomized to receive a tension-free vaginal tape either by the retropubic or the transobturator approach.

Study Type

Interventional

Enrollment (Actual)

564

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8020
        • Dept. of Gynecology, Krankenhaus der Barmherzigen Brüder
      • Graz, Austria, 8036
        • Department of OB/GYN, Medical University of Graz
      • Vienna, Austria, 1090
        • Dept. OB/GYN, Medical University of Vienna
      • Vienna, Austria, 1160
        • Dept. OB/GYN, Wilhelminenspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Planned surgery for primary stress incontinence (positive stress test at bladder filling of 300 ml) without concomitant prolapse surgery or hysterectomy
  • Patient able and willing to participate in follow-up
  • Informed consent

Exclusion Criteria:´

  • Detrusor overactivity, predominant complaint overactive bladder (OAB)
  • Major concomitant surgery
  • Prolapse beyond introitus or any prolapse necessitating surgery
  • Previous incontinence surgery other than colporrhaphy
  • Residual urine >100 ml
  • Neurologic disease
  • Allergy to local anesthetic agents
  • Coagulation disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Retropubic Tension-free Vaginal Tape (TVT)
Device: Retropubic Tension-free vaginal tape (TVT)
Retropubic Tension-free vaginal tape (TVT)
Active Comparator: B
Transobturator Tension-free Vaginal Tape (TVT-O)
Device: Transobturator Tension-free vaginal tape (TVT-O)
tension-free vaginal tape (TVT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Continence
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Austrian Urogynecology Working Group (AUWG)

Investigators

  • Principal Investigator: Karl F Tamussino, MD, Medical University of Graz, Dept. OB/GYN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

February 28, 2007

First Submitted That Met QC Criteria

February 28, 2007

First Posted (Estimate)

March 1, 2007

Study Record Updates

Last Update Posted (Estimate)

December 11, 2012

Last Update Submitted That Met QC Criteria

December 9, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TVT vs. TVT-O

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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