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Sponsored by: |
University of Zurich |
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Information provided by: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT00642109 |
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.
Condition | Intervention |
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Stress Urinary Incontinence |
Procedure: midurethral sling procedure |
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 |
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 |
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TVT
Tension-free Vaginal Tape (TVT)
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Procedure: midurethral sling procedure
quality of life, voiding dysfunction
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TOT
Transobturator Tape outside-in (TOT Monarc)
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Procedure: midurethral sling procedure
quality of life, voiding dysfunction
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TVT-O
Transobturator Tape inside-out (TVT-O)
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Procedure: midurethral sling procedure
quality of life, voiding dysfunction
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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contact: 01 Studienregister MasterAdmins | +41 (0)44 255 11 11 |
Switzerland | |
Recruiting | |
Zurich, Switzerland |
Study Director: | 01 Studienregister MasterAdmins | UniversitaetsSpital Zuerich |
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 |
Signs and Symptoms Urinary Incontinence, Stress Urologic Diseases |
Urination Disorders Stress Urinary Incontinence |
Signs and Symptoms Urological Manifestations Pathologic Processes Urinary Incontinence, Stress |
Urologic Diseases Urination Disorders Stress Urinary Incontinence |