Skip to main content
OpenTrials
Completed

NCT Number: NCT00441454

Retropubic vs. Transobturator Tension-free Vaginal Tape

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of OB/GYN, Medical University of Graz, Graz, Austria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Continence

    Time frame: 5 years

Secondary outcomes

  1. Quality of life

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Austrian Urogynecology Working Group (AUWG)

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2012
Study completion
2012
First posted
Mar 1, 2007
Registry last updated
Dec 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.