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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
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Purpose
| 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.
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
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
France
Hopital Antoine Beclere, Clamart, 92140, France; Recruiting
hervé fernandez, md, Principal Investigator
xavier deffieux, md, Sub-Investigator
karen bonnet, md, Sub-Investigator
CH Dunkerque, Dunkerque, 59000, France; Recruiting
philippe debodinance, md, Principal Investigator
Centre Hospitalier Paul Ardier, Issoire, 63500, France; Recruiting
aslam mansoor, md, Principal Investigator
Hôtel Dieu, Clermont-Ferrand, 63058, France; Recruiting
bernard jacquetin, md, Principal Investigator
brigitte fatton, md, Sub-Investigator
Centre Hospitalier Universitaire, Angers, 49000, France; Recruiting
philippe descamps, md, Principal Investigator
Hopital Saint Andre, Bordeaux, 33000, France; Recruiting
claude hocke, md, Principal Investigator
CHU Lille, Lille, 59000, France; Not yet recruiting
michel cosson, md, phd, Principal Investigator
jean philippe lucot, md, Sub-Investigator
CHU Amiens, Amiens, 80000, France; Recruiting
philippe merviel, md, Principal Investigator
CH Chambery, Chambery, 73000, France; Recruiting
gilles pennehouat, md, Principal Investigator
CH Caremeau, Nimes, 30000, France; Recruiting
renaud de tayrac, md, Principal Investigator
CH Rouen, Rouen, 76000, France; Recruiting
loic marpeau, md, Sub-Investigator
fabrice sergent, md, Principal Investigator
CH Rennes, Rennes, 35000, France; Recruiting
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, Principal Investigator
jean luc brun, md, Sub-Investigator
Hopital Diaconesses Croix Saint Simon, Paris, 75012, France; Recruiting
delphine Salt-Lizee, md, Sub-Investigator
richard villet, md, Principal Investigator
xavier deffieux, md, Principal Investigator, Hopital Antoine Beclere, Clamart, France
More Information
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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