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

Zealand University Hospital

Status: Unknown

Conditions: Vaginal Prolapse

Treatments: Device: Pelvicol

Study type: Interventional

Funder types: Other

Identifiers

NCT00442247

Feb-UH-2007

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)