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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 because the information has not been verified recently.
Verified April 2007 by Hopital Antoine Beclere.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hopital Antoine Beclere
ClinicalTrials.gov Identifier:
NCT00135616
First received: August 25, 2005
Last updated: April 27, 2007
Last verified: April 2007
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Study Comparing Two Types of Suburethral Slings for the Surgical Treatment of Female Stress Incontinence : TVT and TVT-O.

Resource links provided by NLM:

U.S. FDA Resources

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
CHU Amiens
Amiens, France, 80000
Centre Hospitalier Universitaire
Angers, France, 49000
CHU Pellegrin
Bordeaux, France, 33000
Hopital Saint Andre
Bordeaux, France, 33000
CH Chambery
Chambery, France, 73000
Hopital Antoine Beclere
Clamart, France, 92140
Hôtel Dieu
Clermont-Ferrand, France, 63058
CH Dunkerque
Dunkerque, France, 59000
Centre Hospitalier Paul Ardier
Issoire, France, 63500
Chu Nancy
Nancy, France
CH Caremeau
Nimes, France, 30000
Hopital Diaconesses Croix Saint Simon
Paris, France, 75012
CH Rennes
Rennes, France, 35000
CH Rouen
Rouen, France, 76000
Sponsors and Collaborators
Hopital Antoine Beclere
Investigators
Principal Investigator: Xavier Deffieux, MD Hopital Antoine Beclere, Clamart, France
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00135616     History of Changes
Other Study ID Numbers: xd01
Study First Received: August 25, 2005
Last Updated: April 27, 2007
Health Authority: France: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013