At a glance
ClinicalIndex Comparison RecordN/ACompleted· 65 enrolled
Drug / intervention
synthetic monofilament 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.
A Randomized Clinical Trial of Vaginal Mesh for Prolapse
In Brief
A clinical study evaluating synthetic monofilament polypropylene mesh for Pelvic Organ Prolapse and 4 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 pelvic organ prolapse compared to traditional vaginal reconstructive surgery without mesh.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPelvic Organ Prolapse, Uterine Prolapse, Vaginal Prolapse, Cystocele, Rectocele
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
First PostedMay 2007
Primary CompletionAug 2012
Study CompletionAug 2013
TodayJul 2026
First PostedMay 21, 2007
Enrollment StartJan 1, 2007
Primary CompletionAug 1, 2012
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 19.1 years ago
Interventions
synthetic monofilament polypropylene meshdevice
Vaginal prolapse repair with mesh