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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Procedure: midurethral sling procedure


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TVT<br>Tension-free Vaginal Tape (TVT) | Procedure: midurethral sling procedure<br>* quality of life, voiding dysfunction<br>|
| Other: TOT<br>Transobturator Tape outside-in (TOT Monarc) | Procedure: midurethral sling procedure<br>* quality of life, voiding dysfunction<br>|
| Other: TVT-O<br>Transobturator Tape inside-out (TVT-O) | Procedure: midurethral sling procedure<br>* quality of life, voiding dysfunction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urodynamic stress urinary incontinence measurement |  | December 2009 |