CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 65 enrolled
Drug / intervention
synthetic polypropylene meshdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00557882
NCT00557882Phase 4Completed
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A Randomized Clinical Trial of Vaginal Mesh for Anterior Prolapse

Medstar Health Research Institute·interventional·Posted Nov 14, 2007·Updated Oct 30, 2020

In Brief

A Phase 4 clinical trial evaluating synthetic polypropylene mesh for Vaginal Prolapse and 3 related conditions. Completed, enrolled 65 participants across 1 site.

Detailed 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 anterior prolapse compared to traditional vaginal reconstructive surgery without mesh.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaginal Prolapse, Uterine Prolapse, Cystocele, Pelvic Organ Prolapse
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 14, 2007
Enrollment StartJun 1, 2007
Primary CompletionOct 1, 2009
Study CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.6 years ago

Interventions

synthetic polypropylene meshdevice

Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine.