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Efficacy Study of Vaginal Mesh for Prolapse — VAMP  

Pelvic Organ Prolapse Clinical Trial

Official title:
A Randomized Clinical Trial of Vaginal Mesh for Prolapse

Clinical Trial Summary

The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for pelvic organ prolapse compared to traditional vaginal reconstructive surgery without mesh.

Clinical Trial Description

Minimally invasive surgical procedures using mesh have rapidly developed in the field of pelvic floor reconstruction. Unfortunately, safety and efficacy data have lagged behind the technical advancements. No randomized controlled trials of different vaginal apical suspension procedures have been reported. The use of synthetic vaginal mesh has evolved due to the 20-30% recurrence rate for conventional pelvic reconstructive surgeries. This trial will examine synthetic monofilament polypropylene mesh use in vaginal reconstructive surgery for vaginal Stage II-IV prolapse. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00475540
Study type Interventional
Source Medstar Health Research Institute
Contact
Status Completed
Phase N/A
Start date January 2007
Completion date August 2013
View Details
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