Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair

April 2, 2015 updated by: Kaiser Permanente

Outcome After Anterior Vaginal Prolapse Repair: A Randomized Controlled Trial

The purpose of this study is determine whether grafted anterior vaginal prolapse repair is more effective and associated with less complications than prolapse repair with suture.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Successful correction of anterior vaginal prolapse remains one of the most challenging aspects of pelvic reconstructive surgery. Up to 70% have recurrent prolapse following anterior colporrhaphy. The low success rate has consequently led to widespread use of grafts in anterior vaginal prolapse repair. While both biologic grafts and polyglactin 910 mesh have yielded disappointing results, uncontrolled studies have demonstrated low recurrence rates with polypropylene mesh reinforcement.

The Perigee Transobturator Prolapse Repair System (Perigee TPRS) (American Medical Systems, Minnetonka, Minnesota) is used to repair anterior vaginal prolapse via a transobturator approach. Specially-designed helical needles are utilized to attach either a porcine dermal (InteXenTM) or soft polypropylene (InteProTM) graft to the pelvic sidewall at four points. We designed this randomized control trial to compare the anatomic success rates, effect on quality of life and sexual symptom scores, and rates of adverse events of the Perigee TPRS with polypropylene mesh to that of anterior colporrhaphy.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Downey, California, United States, 90242
        • Kaiser Permanente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • stage II or greater anterior vaginal prolapse requiring surgical correction
  • age 21 years and older

Exclusion Criteria:

  • less than Stage II anterior vaginal prolapse
  • decline participation
  • pregnant or contemplating future pregnancy
  • prior anterior vaginal prolapse repair with biologic or synthetic graft
  • active or latent systemic infection
  • compromised immune system
  • previous pelvic irradiation or cancer
  • known hypersensitivity to polypropylene
  • uncontrolled diabetes mellitus
  • unable or unwilling to give valid informed consent
  • unable or unwilling to comply with the protocol
  • scheduled to undergo concomitant Burch colposuspension or pubovaginal sling

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Anterior Colporrhaphy (sutured repair)
Anterior vaginal prolapse repair with anterior colporrhaphy (no graft) using sutures.
Procedure: sutured anterior vaginal prolapse repair
anterior vaginal prolapse repair with suture
Other Names:
  • cystocele repair
Active Comparator: Perigee (grafted repair)
Anterior vaginal prolapse repair with graft
Device: grafted anterior prolapse repair
anterior vaginal prolapse repair with graft
Other Names:
  • Perigee Transobturator Prolapse Repair System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent Stage II or Greater Anterior Vaginal Prolapse
Time Frame: three years
Pelvic Organ Prolapse Quantification Point Ba is the most distal position of any part of the anterior vagina between point Aa and the vaginal cuff or anterior vaginal fornix. Better vaginal support is assigned a negative value (ie, if there is no prolapse, point Ba is -3 cm by definition). Vaginal prolapse beyond the hymen, indicating worse vaginal support, is assigned a positive value (this may be equal to the total vaginal length at the maximum). Recurrent stage II or greater anterior vaginal prolapse is defined as POPQ Point Ba measurement equal to or greater (more positive) than -1.
three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative Time
Time Frame: perioperative
Calculated as time from first incision to time of closure of last incision.
perioperative
Vaginal Mesh Exposure
Time Frame: perioperative
Vaginal mesh exposure defined as appearance of mesh, placed during the index surgery, not covered by overlying vaginal epithelium on postoperative pelvic exams subsequent to the first postoperative exam. May be either symptomatic or asymptomatic. This was not differentiated in the statistical analysis.
perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Investigators

  • Principal Investigator: John N Nguyen, MD, Southern California Permanente Medical Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

September 24, 2007

First Submitted That Met QC Criteria

September 24, 2007

First Posted (Estimate)

September 26, 2007

Study Record Updates

Last Update Posted (Estimate)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4348

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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