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Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis

NCT01393171 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2023-11-13

Study results available
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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.

Conditions

  • Anterior Vaginal Wall Prolapse
  • Cystocele
  • Pelvic Organ Prolapse

Interventions

DEVICE

Polypropylene mesh (Polyform by Boston Scientific)

Site-specific cystocele repair with polypropylene mesh augmentation

PROCEDURE

Porcine Dermis (Pelvicol by CRBard)

Site-specific cystocele repair with porcine dermis augmentation

PROCEDURE

Anterior Colporrhaphy

Anterior vaginal prolapse repair with suture.

Sponsors & Collaborators

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • John N. Nguyen, MD · Kaiser Permanente

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2015-12-31
Completion
2018-04-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01393171 on ClinicalTrials.gov