Overview

This trial is active, not recruiting.

Condition vaginal prolapse
Treatment pelvicol
Sponsor Roskilde County Hospital
Start date September 2004
End date December 2008
Trial size 60 participants
Trial identifier NCT00442247, Feb-UH-2007

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Difference in POP-Q measurements for vaginal prolapse
time frame:

Secondary Outcomes

Measure
Affect on bladder function after surgery for anterior vaginal wall prolapse
time frame:

Eligibility Criteria

Female participants from 55 years up to 75 years old.

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

Additional Information

Official title A Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse
Principal investigator Ulla Hviid, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2007.
Information provided to ClinicalTrials.gov by Roskilde County Hospital.