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A Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse

Not Applicable
Conditions
Vaginal Prolapse
Registration Number
NCT00442247
Lead Sponsor
Zealand University Hospital
Brief Summary

Anterior vaginal wall prolapse is a common problem. Until now many different surgical techniques have been evaluated but so far recurrence is often still observed. Therefore, synthetic mesh or biomesh for vaginal prolapse reconstruction have been introduced.

Detailed Description

Anterior vaginal wall prolapse is a common problem. Until now many different surgical techniques have been evaluated but so far recurrence is often still observed. Therefore, synthetic mesh or biomesh for vaginal prolapse reconstruction have been introduced. However, is is now known whether these methods are superior to the replication of the pubocervicale fascia, a method which is well described and have been used for many years. Furthermore, most studies evaluating the used of mesh for anterior vaginal wall prolapse have not been controlled studies and been irrespective to whether the repair was a primary or secondary operation.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
60
Inclusion Criteria
  • Anterior vaginal wall prolapse greater than grade 2 ICS qualifications, International Continence Society Committee for Standardisation of Terminology
Exclusion Criteria
  • Recurrent vaginal prolapse, wault prolapse

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Difference in POP-Q measurements for vaginal prolapse
Secondary Outcome Measures
NameTimeMethod
Affect on bladder function after surgery for anterior vaginal wall prolapse

Trial Locations

Locations (1)

Dept. of Obstetrics and Gynecology

🇩🇰

Roskilde, Denmark

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