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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

NCT00642109 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2015-07-28

No results posted yet for this study

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

Conditions

  • Stress Urinary Incontinence

Interventions

PROCEDURE

midurethral sling procedure

quality of life, voiding dysfunction

Sponsors & Collaborators

  • University of Zurich

    collaborator OTHER

  • David Scheiner

    lead OTHER

Principal Investigators

  • 01 Studienregister MasterAdmins · UniversitaetsSpital Zuerich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2010-09-30
Completion
2010-10-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00642109 on ClinicalTrials.gov