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Clinical Trials/NCT00135616
NCT00135616
Unknown
Phase 4

Randomized Controlled Study Comparing Two Types of Suburethral Slings for the Surgical Treatment of Female Stress Incontinence : TVT and TVT-O.

Hopital Antoine Beclere14 sites in 1 country180 target enrollmentMarch 2005

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Urinary Incontinence, Stress
Sponsor
Hopital Antoine Beclere
Enrollment
180
Locations
14
Primary Endpoint
pre operative complication: rate of bladder perforation
Last Updated
19 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
March 2005
End Date
March 2008
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility 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

Outcomes

Primary Outcomes

pre operative complication: rate of bladder perforation

post operative complication: rate of post-operative pain

Secondary Outcomes

  • efficacy: disparation of urinary incontinence
  • safety: sexual behaviour

Study Sites (14)

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