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
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
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
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
NCT ID
NCT00642109
First Posted
March 17, 2008
Last Updated
July 25, 2015
Sponsor
David Scheiner
Collaborators
University of Zurich
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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