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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00642109
• Other study ID #: slingrnd06
• Status: Terminated
• Phase: N/A
• First received: March 17, 2008
• Last updated: July 25, 2015
• Start date: January 2006
• Est. completion date: October 2010

Study information

• Verified date: July 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 160
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion criteria:

• Urodynamic stress urinary incontinence or stress dominated mixed urinary incontinence with mobile urethra

• With or without concomitant surgery for pelvic organ prolapse

• With or without hysterectomy

Exclusion criteria:

• No informed consent

• No preoperative urodynamic investigation

• Mixed urinary incontinence with predominant overactive bladder

• Recurrent stress urinary incontinence after sling procedure

• Begin of treatment of overactive bladder less then a month ago or non stable condition

• Pregnancy

• Desires future childbearing

• Concomitant incontinence procedure like intravesikal injection of Botulinumtoxin

• Preoperative postvoid residual urinary volume exceeding 100cc

• Coagulopathies

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• midurethral sling procedure
quality of life, voiding dysfunction

Locations

Country	Name	City	State
Switzerland	University Hospital of Zurich, clinic for gynaecology	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
David Scheiner	University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urodynamic stress urinary incontinence measurement		December 2009	No