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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 is currently recruiting participants.
Verified by University of Zurich, March 2008
First Received: March 17, 2008   Last Updated: April 10, 2008   History of Changes
Sponsored by: University of Zurich
Information provided by: University of Zurich
ClinicalTrials.gov Identifier: NCT00642109
  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

MedlinePlus related topics: Pelvic Support Problems Surgery Urinary Incontinence Urine and Urination
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Urodynamic stress urinary incontinence measurement [ Time Frame: December 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2006
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642109

Contacts
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11

Locations
Switzerland
Recruiting
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: University Hospital Zurich ( David Scheiner )
Study ID Numbers: slingrnd06
Study First Received: March 17, 2008
Last Updated: April 10, 2008
ClinicalTrials.gov Identifier: NCT00642109     History of Changes
Health Authority: Switzerland: Swissmedic

Study placed in the following topic categories:
Signs and Symptoms
Urinary Incontinence, Stress
Urologic Diseases
Urination Disorders
Stress
Urinary Incontinence

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

ClinicalTrials.gov processed this record on May 07, 2009