Retropubic vs. Transobturator Tension-free Vaginal Tape

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karl Tamussino, MD, Austrian Urogynecology Working Group (AUWG)
ClinicalTrials.gov Identifier:
NCT00441454
First received: February 28, 2007
Last updated: December 9, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Stress Urinary Incontinence
Device: Transobturator Tension-free vaginal tape (TVT-O)
Device: Retropubic Tension-free vaginal tape (TVT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Retropubic vs. Transobturator Tension-free Vaginal Tape (TVT vs. TVT-O): A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Austrian Urogynecology Working Group (AUWG):

Primary Outcome Measures:
  • Continence [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 5 years ]

Enrollment: 564
Study Start Date: September 2004
Study Completion Date: October 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441454

Locations
Austria
Department of OB/GYN, Medical University of Graz
Graz, Austria, 8036
Dept. of Gynecology, Krankenhaus der Barmherzigen Brüder
Graz, Austria, 8020
Dept. OB/GYN, Wilhelminenspital
Vienna, Austria, 1160
Dept. OB/GYN, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Austrian Urogynecology Working Group (AUWG)
Investigators
Principal Investigator: Karl F Tamussino, MD Medical University of Graz, Dept. OB/GYN
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karl Tamussino, MD, PI, Austrian Urogynecology Working Group (AUWG)
ClinicalTrials.gov Identifier: NCT00441454     History of Changes
Other Study ID Numbers: TVT vs. TVT-O
Study First Received: February 28, 2007
Last Updated: December 9, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by Austrian Urogynecology Working Group (AUWG):
stress urinary incontinence
surgery
tension-free vaginal tape
retropubic
transobturator
quality-of-life

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014