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Clinical Trials/NCT00442247
NCT00442247
Unknown
Not Applicable

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

Zealand University Hospital1 site in 1 country60 target enrollmentSeptember 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vaginal Prolapse
Sponsor
Zealand University Hospital
Enrollment
60
Locations
1
Primary Endpoint
Difference in POP-Q measurements for vaginal prolapse
Last Updated
19 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2004
End Date
December 2008
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Difference in POP-Q measurements for vaginal prolapse

Secondary Outcomes

  • Affect on bladder function after surgery for anterior vaginal wall prolapse

Study Sites (1)

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