Clinical Trial: Treatment of Female Stress Urinary Incontinence : Randomized Study Comparing Two Suburethral Slings, TVT and TVT-O

This study is currently recruiting patients.
Verified by Hopital Antoine Beclere January 2005

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 Incontinence
 Device: surgical placement of a suburethral sling tvt or tvt-o
Phase IV

MedlinePlus related topics:  Pelvic Support Problems;   Urinary Incontinence

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: 
Primary Outcomes: per operative complication : rate of bladder perforation; post operative complication : rate of post-operative pain
Secondary Outcomes: efficacy : disparation of urinary incontinence; safety : sexual behaviour
Expected Total Enrollment:  180

Study start: March 2005;  Expected completion: March 2008
Last follow-up: March 2008;  Data entry closure: March 2008

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 a 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 approach 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   -   95 Years,  Genders Eligible for Study:  Female
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00135616

xavier deffieux, dr      33 1 45 37 44 69    x.deffieux@free.fr

France
      Hopital Antoine Beclere, Clamart,  92140,  France; Recruiting
xavier deffieux, dr  33 1 45 37 44 69 
hervé fernandez, md,  Principal Investigator
xavier deffieux, md,  Sub-Investigator
karen bonnet, md,  Sub-Investigator

      CH Dunkerque, Dunkerque,  59000,  France; Recruiting
philippe debodinance, md
philippe debodinance, md,  Principal Investigator

      Centre Hospitalier Paul Ardier, Issoire,  63500,  France; Recruiting
aslam mansoor, md
aslam mansoor, md,  Principal Investigator

      Hôtel Dieu, Clermont-Ferrand,  63058,  France; Recruiting
bernard jacquetin, md
bernard jacquetin, md,  Principal Investigator
brigitte fatton, md,  Sub-Investigator

      Centre Hospitalier Universitaire, Angers,  49000,  France; Recruiting
Philippe descamps, md
philippe descamps, md,  Principal Investigator

      Hopital Saint Andre, Bordeaux,  33000,  France; Recruiting
claude hocke, md
claude hocke, md,  Principal Investigator

      CHU Lille, Lille,  59000,  France; Not yet recruiting
michel cosson, md, phd
michel cosson, md, phd,  Principal Investigator
jean philippe lucot, md,  Sub-Investigator

      CHU Amiens, Amiens,  80000,  France; Recruiting
philippe merviel, md
philippe merviel, md,  Principal Investigator

      CH Chambery, Chambery,  73000,  France; Recruiting
Gilles Pennehouat, md
gilles pennehouat, md,  Principal Investigator

      CH Caremeau, Nimes,  30000,  France; Recruiting
renaud de tayrac, md
renaud de tayrac, md,  Principal Investigator

      CH Rouen, Rouen,  76000,  France; Recruiting
loic marpeau, md
loic marpeau, md,  Sub-Investigator
fabrice sergent, md,  Principal Investigator

      CH Rennes, Rennes,  35000,  France; Recruiting
jean leveque, md
jean leveque, md,  Principal Investigator
jean philippe harlicot, md,  Sub-Investigator
jerry coiffic, md,  Sub-Investigator

      CHU Pellegrin, Bordeaux,  33000,  France; Recruiting
philippe dallay, md
philippe dallay, md,  Principal Investigator
jean luc brun, md,  Sub-Investigator

      Hopital Diaconesses Croix Saint Simon, Paris,  75012,  France; Recruiting
richard villet, md
delphine Salt-Lizee, md,  Sub-Investigator
richard villet, md,  Principal Investigator

Study chairs or principal investigators

xavier deffieux, md,  Principal Investigator,  Hopital Antoine Beclere, Clamart, France   

More Information

Study ID Numbers:  xd01
Last Updated:  August 25, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00135616
Health Authority: France: Ministry of Health; France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-08-30



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