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Retropubic vs. Transobturator Tension-free Vaginal Tape

NCT00441454 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 564

Last updated 2012-12-11

No results posted yet for this study

Summary

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.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Transobturator Tension-free vaginal tape (TVT-O)

tension-free vaginal tape (TVT)

DEVICE

Retropubic Tension-free vaginal tape (TVT)

Retropubic Tension-free vaginal tape (TVT)

Sponsors & Collaborators

  • Austrian Urogynecology Working Group (AUWG)

    lead OTHER

Principal Investigators

  • Karl F Tamussino, MD · Medical University of Graz, Dept. OB/GYN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2012-06-30
Completion
2012-10-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00441454 on ClinicalTrials.gov