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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- David Scheiner
- 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
Tension-free Vaginal Tape (TVT)
Intervention: midurethral sling procedure (Procedure)
TOT
Transobturator Tape outside-in (TOT Monarc)
Intervention: midurethral sling procedure (Procedure)
TVT-O
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
David Scheiner
PI
University of Zurich
