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

This study has suspended participant recruitment.
(higher incidence of pain related sexual dysfunction in the TO arm)
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00642109
First received: March 17, 2008
Last updated: January 4, 2010
Last verified: October 2009
  Purpose

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

Condition Intervention
Stress Urinary Incontinence
Procedure: midurethral sling procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Urodynamic stress urinary incontinence measurement [ Time Frame: December 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2006
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
TVT
Tension-free Vaginal Tape (TVT)
Procedure: midurethral sling procedure
quality of life, voiding dysfunction
TOT
Transobturator Tape outside-in (TOT Monarc)
Procedure: midurethral sling procedure
quality of life, voiding dysfunction
TVT-O
Transobturator Tape inside-out (TVT-O)
Procedure: midurethral sling procedure
quality of life, voiding dysfunction

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00642109

Locations
Switzerland
University Hospital of Zurich, clinic for gynaecology
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: David Scheiner, University Hospital Zurich
ClinicalTrials.gov Identifier: NCT00642109     History of Changes
Other Study ID Numbers: slingrnd06
Study First Received: March 17, 2008
Last Updated: January 4, 2010
Health Authority: Switzerland: Swissmedic

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 11, 2014