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

This study is ongoing, but not recruiting participants.

Sponsored by: Hopital Antoine Beclere
Information provided by: Hopital Antoine Beclere
ClinicalTrials.gov Identifier: NCT00135616
  Purpose

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.


Condition Intervention Phase
Urinary Incontinence, Stress
Device: surgical placement of a suburethral sling tvt or tvt-o
Phase IV

MedlinePlus related topics:   Pelvic Support Problems    Stress    Urinary Incontinence   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Randomized Controlled Study Comparing Two Types of Suburethral Slings for the Surgical Treatment of Female Stress Incontinence : TVT and TVT-O.

Further study details as provided by Hopital Antoine Beclere:

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

Estimated Enrollment:   180
Study Start Date:   March 2005
Estimated Study Completion Date:   March 2008

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.

  Eligibility
Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135616

Locations
France
Hopital Antoine Beclere    
      Clamart, France, 92140
CH Dunkerque    
      Dunkerque, France, 59000
Centre Hospitalier Paul Ardier    
      Issoire, France, 63500
Hôtel Dieu    
      Clermont-Ferrand, France, 63058
Centre Hospitalier Universitaire    
      Angers, France, 49000
Hopital Saint Andre    
      Bordeaux, France, 33000
CHU Amiens    
      Amiens, France, 80000
CHU NANCY    
      Nancy, France
CH Caremeau    
      Nimes, France, 30000
CH Rouen    
      Rouen, France, 76000
CH Rennes    
      Rennes, France, 35000
CHU Pellegrin    
      Bordeaux, France, 33000
Hopital Diaconesses Croix Saint Simon    
      Paris, France, 75012
CH Chambery    
      Chambery, France, 73000

Sponsors and Collaborators
Hopital Antoine Beclere

Investigators
Principal Investigator:     Xavier Deffieux, MD     Hopital Antoine Beclere, Clamart, France    
  More Information


Study ID Numbers:   xd01
First Received:   August 25, 2005
Last Updated:   April 27, 2007
ClinicalTrials.gov Identifier:   NCT00135616
Health Authority:   France: Ministry of Health;   France: Afssaps - French Health Products Safety Agency

Keywords provided by Hopital Antoine Beclere:
urinary incontinence  
stress incontinence  
urethra  
gynaecologic surgical procedures  
suburethral sling  

Study placed in the following topic categories:
Signs and Symptoms
Urinary Incontinence, Stress
Urologic Diseases
Urination Disorders
Stress
Urinary Incontinence

Additional relevant MeSH terms:
Urological Manifestations
Pathologic Processes

ClinicalTrials.gov processed this record on October 17, 2008




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