CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 564 enrolled
Drug / intervention
Transobturator Tension-free vaginal tape (TVT-O) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00441454
NCT00441454N/ACompleted

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

Austrian Urogynecology Working Group (AUWG)·interventional·Posted Mar 1, 2007·Updated Dec 11, 2012

In Brief

A clinical study evaluating Transobturator Tension-free vaginal tape (TVT-O) and Retropubic Tension-free vaginal tape (TVT) for Stress Urinary Incontinence. Completed, enrolled 564 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 1, 2007
Enrollment StartSep 1, 2004
Primary CompletionJun 1, 2012
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 19.3 years ago

Interventions

Transobturator Tension-free vaginal tape (TVT-O)device

tension-free vaginal tape (TVT)

Retropubic Tension-free vaginal tape (TVT)device

Retropubic Tension-free vaginal tape (TVT)