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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00442247
Enrollment
60
Registered
2007-03-01
Start date
2004-09-30
Completion date
2008-12-31
Last updated
2007-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Prolapse

Keywords

anterior vaginal wall prolapse, Pelvicol, biomesh, Anterior vaginal wall prolapse

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.

Interventions

DEVICEPelvicol

Sponsors

Zealand University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
55 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
Difference in POP-Q measurements for vaginal prolapse

Secondary

MeasureTime frame
Affect on bladder function after surgery for anterior vaginal wall prolapse

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026