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Treatment of Female Stress Urinary Incontinence: Study Comparing Two Suburethral Slings, Retropubic Approach (TVT) and Trans-Obturator (TVT-O) Approach

Primary Purpose

Urinary Incontinence, Stress

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
surgical placement of a suburethral sling tvt or tvt-o
Sponsored by
Hopital Antoine Beclere
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence, Stress focused on measuring urinary incontinence, stress incontinence, urethra, gynaecologic surgical procedures, suburethral sling

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Woman over 18 years old Clinical diagnosis of stress urinary incontinence requiring surgical management Must be able to read and sign the consent Exclusion Criteria: Pregnancy Anti-coagulant treatment Isolated overactive bladder syndrome Genital prolapse requiring surgical treatment Concomitant hysterectomy

Sites / Locations

  • CHU Amiens
  • Centre Hospitalier Universitaire
  • CHU Pellegrin
  • Hopital Saint Andre
  • CH Chambery
  • Hopital Antoine Beclere
  • Hôtel Dieu
  • CH Dunkerque
  • Centre Hospitalier Paul Ardier
  • Chu Nancy
  • CH Caremeau
  • Hopital Diaconesses Croix Saint Simon
  • CH Rennes
  • CH Rouen

Outcomes

Primary Outcome Measures

pre operative complication: rate of bladder perforation
post operative complication: rate of post-operative pain

Secondary Outcome Measures

efficacy: disparation of urinary incontinence
safety: sexual behaviour

Full Information

First Posted
August 25, 2005
Last Updated
April 27, 2007
Sponsor
Hopital Antoine Beclere
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1. Study Identification

Unique Protocol Identification Number
NCT00135616
Brief Title
Treatment of Female Stress Urinary Incontinence: Study Comparing Two Suburethral Slings, Retropubic Approach (TVT) and Trans-Obturator (TVT-O) Approach
Official Title
Randomized Controlled Study Comparing Two Types of Suburethral Slings for the Surgical Treatment of Female Stress Incontinence : TVT and TVT-O.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hopital Antoine Beclere

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O.
Detailed Description
Urinary stress incontinence (USI) is a frequent pathology in women. Surgical treatment is required in 30 to 50% of women presenting with USI. Several surgical techniques are currently available. At the present time, the placement of suburethral slings is one of the most efficient techniques. Furthermore, the placement of a suburethral sling is known to be associated with a low rate of complications. Currently, two approaches are available for the placement of a suburethral sling: retropubic approach (TVT) and trans-obturator approach (TVT-O). The efficacy of these two approaches seem equivalents. However, the morbidity related to these two techniques is probably different. In retrospective studies, the retropubic approach is associated with a higher rate of bladder perforation. On the other hand, the trans-obturator approach is supposed to be associated with a higher rate of post-operative pain. Thus, the purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress
Keywords
urinary incontinence, stress incontinence, urethra, gynaecologic surgical procedures, suburethral sling

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
surgical placement of a suburethral sling tvt or tvt-o
Primary Outcome Measure Information:
Title
pre operative complication: rate of bladder perforation
Title
post operative complication: rate of post-operative pain
Secondary Outcome Measure Information:
Title
efficacy: disparation of urinary incontinence
Title
safety: sexual behaviour

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Woman over 18 years old Clinical diagnosis of stress urinary incontinence requiring surgical management Must be able to read and sign the consent Exclusion Criteria: Pregnancy Anti-coagulant treatment Isolated overactive bladder syndrome Genital prolapse requiring surgical treatment Concomitant hysterectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Deffieux, MD
Organizational Affiliation
Hopital Antoine Beclere, Clamart, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80000
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
CHU Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hopital Saint Andre
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
CH Chambery
City
Chambery
ZIP/Postal Code
73000
Country
France
Facility Name
Hopital Antoine Beclere
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
Hôtel Dieu
City
Clermont-Ferrand
ZIP/Postal Code
63058
Country
France
Facility Name
CH Dunkerque
City
Dunkerque
ZIP/Postal Code
59000
Country
France
Facility Name
Centre Hospitalier Paul Ardier
City
Issoire
ZIP/Postal Code
63500
Country
France
Facility Name
Chu Nancy
City
Nancy
Country
France
Facility Name
CH Caremeau
City
Nimes
ZIP/Postal Code
30000
Country
France
Facility Name
Hopital Diaconesses Croix Saint Simon
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
CH Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
CH Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Treatment of Female Stress Urinary Incontinence: Study Comparing Two Suburethral Slings, Retropubic Approach (TVT) and Trans-Obturator (TVT-O) Approach

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