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

Not Applicable

Terminated

• Conditions: Stress Urinary Incontinence
• Interventions: Procedure: midurethral sling procedure

• Registration Number: NCT00642109
• Lead Sponsor: David Scheiner

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2008-03-17
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-24
• Primary Completion: 2010-09
• Study Completion: 2010-10
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-25
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TOT	midurethral sling procedure	Transobturator Tape outside-in (TOT Monarc)
TVT-O	midurethral sling procedure	Transobturator Tape inside-out (TVT-O)
TVT	midurethral sling procedure	Tension-free Vaginal Tape (TVT)

Primary Outcome Measures

Name	Time	Method
Urodynamic stress urinary incontinence measurement	December 2009

Trial Locations

Locations (1)

University Hospital of Zurich, clinic for gynaecology; 🇨🇭 Zurich, Switzerland