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Clinical Trials/NCT00642109
NCT00642109
Terminated
Not Applicable

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

David Scheiner1 site in 1 country160 target enrollmentJanuary 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress Urinary Incontinence
Sponsor
David Scheiner
Enrollment
160
Locations
1
Primary Endpoint
Urodynamic stress urinary incontinence measurement
Status
Terminated
Last Updated
10 years ago

Overview

Brief Summary

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
Registry
clinicaltrials.gov
Start Date
January 2006
End Date
October 2010
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

David Scheiner

PI

University of Zurich

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Urodynamic stress urinary incontinence measurement

Time Frame: December 2009

Study Sites (1)

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