A Comparison of the Retropubic (TVT) With the Transobturator Sling Operation in the Treatment of Female Stress Urinary Incontinence or Stress Dominated Mixed Urinary Incontinence

July 25, 2015 updated by: David Scheiner

A Prospective Randomized Clinical Trial: Comparison of the Retropubic (TVT) With the Transobturator (outside-in T.O.T. Monarc or Inside-out TVT-O) Sling Operation in the Treatment of Female Stress Urinary Incontinence or Stress Dominated Mixed Urinary Incontinence

The midurethral tension-free vaginal tape (a macroporous polypropylene mesh) procedure is a well established technique for treating female stress urinary incontinence in patients with (hyper)mobile urethra. Postoperative continence rates are achieved in up to 95%. Currently, several anatomical approaches are developed and investigated to simplify this minimal invasive technique and make it safer. While the retropubic approach consists of the passage of the needles from under the midurethra up behind the pubic bone through the cavum retzii, the transobturator technique traverses the foramina obturatoria. Intraoperative complications like bladder perforation (in 4%) can be treated conservatively, while postoperative complications like voiding dysfunction (urinary outlet obstruction in up to 16% or urinary retention) are troublesome, impair the quality of life and require occasionally surgical sling release (transection of the sling). The aim of this study is to compare quality of life, postoperative voiding dysfunction, success rates and tape position after retropubic and transobturator sling procedure.

  • Trial with surgical intervention

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

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

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital of Zurich, Clinic for Gynaecology

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion criteria:

  • Urodynamic stress urinary incontinence or stress dominated mixed urinary incontinence with mobile urethra
  • With or without concomitant surgery for pelvic organ prolapse
  • With or without hysterectomy

Exclusion criteria:

  • No informed consent
  • No preoperative urodynamic investigation
  • Mixed urinary incontinence with predominant overactive bladder
  • Recurrent stress urinary incontinence after sling procedure
  • Begin of treatment of overactive bladder less then a month ago or non stable condition
  • Pregnancy
  • Desires future childbearing
  • Concomitant incontinence procedure like intravesikal injection of Botulinumtoxin
  • Preoperative postvoid residual urinary volume exceeding 100cc
  • Coagulopathies

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: TVT
Tension-free Vaginal Tape (TVT)
Procedure: midurethral sling procedure
quality of life, voiding dysfunction
Other: TOT
Transobturator Tape outside-in (TOT Monarc)
Procedure: midurethral sling procedure
quality of life, voiding dysfunction
Other: TVT-O
Transobturator Tape inside-out (TVT-O)
Procedure: midurethral sling procedure
quality of life, voiding dysfunction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urodynamic stress urinary incontinence measurement
Time Frame: December 2009
December 2009

Collaborators and Investigators

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

Sponsor

David Scheiner

Collaborators

University of Zurich

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

January 1, 2006

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

March 17, 2008

First Submitted That Met QC Criteria

March 21, 2008

First Posted (Estimate)

March 24, 2008

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 25, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • slingrnd06

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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