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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00642109
Enrollment
160
Registered
2008-03-24
Start date
2006-01-31
Completion date
2010-10-31
Last updated
2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

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

Interventions

PROCEDUREmidurethral sling procedure

quality of life, voiding dysfunction

Sponsors

University of Zurich
CollaboratorOTHER
David Scheiner
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
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

Design outcomes

Primary

MeasureTime frame
Urodynamic stress urinary incontinence measurementDecember 2009

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026