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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

Primary Purpose

Stress Urinary Incontinence

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
midurethral sling procedure
Sponsored by
David Scheiner
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University Hospital of Zurich, clinic for gynaecology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

TVT

TOT

TVT-O

Arm Description

Tension-free Vaginal Tape (TVT)

Transobturator Tape outside-in (TOT Monarc)

Transobturator Tape inside-out (TVT-O)

Outcomes

Primary Outcome Measures

Urodynamic stress urinary incontinence measurement

Secondary Outcome Measures

Full Information

First Posted
March 17, 2008
Last Updated
July 25, 2015
Sponsor
David Scheiner
Collaborators
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT00642109
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
higher incidence of pain related sexual dysfunction in the TO arm
Study Start Date
January 2006 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Scheiner
Collaborators
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TVT
Arm Type
Other
Arm Description
Tension-free Vaginal Tape (TVT)
Arm Title
TOT
Arm Type
Other
Arm Description
Transobturator Tape outside-in (TOT Monarc)
Arm Title
TVT-O
Arm Type
Other
Arm Description
Transobturator Tape inside-out (TVT-O)
Intervention Type
Procedure
Intervention Name(s)
midurethral sling procedure
Intervention Description
quality of life, voiding dysfunction
Primary Outcome Measure Information:
Title
Urodynamic stress urinary incontinence measurement
Time Frame
December 2009

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
01 Studienregister MasterAdmins
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Zurich, clinic for gynaecology
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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