A Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Zealand University Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Difference in POP-Q measurements for vaginal prolapse
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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