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Clinical Trials/NCT00642109
NCT00642109TerminatedNot Applicable

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

David Scheiner1 site in 1 country160 target enrollmentStarted: January 1, 2006Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
160
Locations
1
Primary Endpoint
Urodynamic stress urinary incontinence measurement

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

TVT

Other

Tension-free Vaginal Tape (TVT)

Intervention: midurethral sling procedure (Procedure)

TOT

Other

Transobturator Tape outside-in (TOT Monarc)

Intervention: midurethral sling procedure (Procedure)

TVT-O

Other

Transobturator Tape inside-out (TVT-O)

Intervention: midurethral sling procedure (Procedure)

Outcomes

Primary Outcomes

Urodynamic stress urinary incontinence measurement

Time Frame: December 2009

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

David Scheiner

PI

University of Zurich

Study Sites (1)

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