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

Sponsor

David Scheiner (Other)

Overall Status

Terminated

CT.gov ID

NCT00642109

Collaborator

University of Zurich (Other)

160

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Procedure: midurethral sling procedure	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Other: TVT

Tension-free Vaginal Tape (TVT)

Procedure: midurethral sling procedure

quality of life, voiding dysfunction

Other: TOT

Transobturator Tape outside-in (TOT Monarc)

Procedure: midurethral sling procedure

quality of life, voiding dysfunction

Other: TVT-O

Transobturator Tape inside-out (TVT-O)

Procedure: midurethral sling procedure

quality of life, voiding dysfunction

Outcome Measures

Primary Outcome Measures

Urodynamic stress urinary incontinence measurement [December 2009]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Zurich, clinic for gynaecology	Zurich		Switzerland	8091

Sponsors and Collaborators

David Scheiner
University of Zurich

Investigators

Study Director: 01 Studienregister MasterAdmins, UniversitaetsSpital Zuerich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Scheiner, PI, University of Zurich

ClinicalTrials.gov Identifier:

NCT00642109

Other Study ID Numbers:

slingrnd06

First Posted:

Mar 24, 2008

Last Update Posted:

Jul 28, 2015

Last Verified:

Jul 1, 2015

Additional relevant MeSH terms:

Urinary Incontinence

Enuresis

Urinary Incontinence, Stress

Study Results

No Results Posted as of Jul 28, 2015