CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 99 enrolled
Drug / intervention
Polypropylene mesh (Polyform by Boston Scientific) +2 moredevice
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/NCT01393171
NCT01393171N/ACompleted
CompareCT.gov

Prospective Randomized Trial of Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis

Kaiser Permanente·interventional·Posted Jul 13, 2011·Updated Nov 13, 2023

In Brief

A clinical study evaluating Polypropylene mesh (Polyform by Boston Scientific), Porcine Dermis (Pelvicol by CRBard), and 1 other intervention for Anterior Vaginal Wall Prolapse and 2 related conditions. Completed, enrolled 99 participants across 2 sites.

Detailed Summary

The purpose of this study is to evaluate the success rate of cystocele repair using polypropylene mesh or porcine dermis compared to that of anterior colporrhaphy in a prospective randomized fashion. The study will be performed in a randomized, prospective, single-blinded fashion.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnterior Vaginal Wall Prolapse, Cystocele, Pelvic Organ Prolapse
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 13, 2011
Enrollment StartJan 1, 2006
Primary CompletionDec 1, 2015
Study CompletionApr 1, 2018
TodayJul 2, 2026
Enrollment to primary: 9.9 yearsPosted 15.0 years ago

Interventions

Polypropylene mesh (Polyform by Boston Scientific)device

Site-specific cystocele repair with polypropylene mesh augmentation

Porcine Dermis (Pelvicol by CRBard)procedure

Site-specific cystocele repair with porcine dermis augmentation

Anterior Colporrhaphyprocedure

Anterior vaginal prolapse repair with suture.