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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vaginal Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pelvicol

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Anterior vaginal wall prolapse greater than grade 2 ICS qualifications, International Continence Society Committee for Standardisation of Terminology