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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Hopital Antoine Beclere.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00135616
First Posted: August 26, 2005
Last Update Posted: April 30, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hopital Antoine Beclere
August 25, 2005
August 26, 2005
April 30, 2007
March 2005
Not Provided
  • pre operative complication: rate of bladder perforation
  • post operative complication: rate of post-operative pain
  • per operative complication : rate of bladder perforation
  • post operative complication: rate of post-operative pain
Complete list of historical versions of study NCT00135616 on ClinicalTrials.gov Archive Site
  • efficacy: disparation of urinary incontinence
  • safety: sexual behaviour
Same as current
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Not Provided
 
Treatment of Female Stress Urinary Incontinence: Study Comparing Two Suburethral Slings, Retropubic Approach (TVT) and Trans-Obturator (TVT-O) Approach
Randomized Controlled Study Comparing Two Types of Suburethral Slings for the Surgical Treatment of Female Stress Incontinence : TVT and TVT-O.
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Urinary Incontinence, Stress
Device: surgical placement of a suburethral sling tvt or tvt-o
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
180
March 2008
Not Provided

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
Sexes Eligible for Study: Female
18 Years to 95 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00135616
xd01
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Hopital Antoine Beclere
Not Provided
Principal Investigator: Xavier Deffieux, MD Hopital Antoine Beclere, Clamart, France
Hopital Antoine Beclere
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP