NCT00642109

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: David Scheiner · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
PROCEDURE	midurethral sling procedure	quality of life, voiding dysfunction

Timeline

• Start date: 2006-01-01
• Primary completion: 2010-09-01
• Completion: 2010-10-01
• First posted: 2008-03-24
• Last updated: 2015-07-28

Locations

1 site across 1 country: Switzerland