Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00535301
Recruitment Status : Completed
First Posted : September 26, 2007
Results First Posted : July 28, 2011
Last Update Posted : April 22, 2015
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cystocele Uterine Prolapse Urinary Incontinence Device: grafted anterior prolapse repair Procedure: sutured anterior vaginal prolapse repair Phase 4

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  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Outcome After Anterior Vaginal Prolapse Repair: A Randomized Controlled Trial
Study Start Date : January 2005
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: Perigee Transobturator Prolapse Repair System

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Operative Time [ Time Frame: perioperative ]
    Calculated as time from first incision to time of closure of last incision.

  2. 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.

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00535301

United States, California
Kaiser Permanente
Downey, California, United States, 90242
Sponsors and Collaborators
Kaiser Permanente
Principal Investigator: John N Nguyen, MD Southern California Permanente Medical Group

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kaiser Permanente Identifier: NCT00535301     History of Changes
Other Study ID Numbers: 4348
First Posted: September 26, 2007    Key Record Dates
Results First Posted: July 28, 2011
Last Update Posted: April 22, 2015
Last Verified: April 2015

Keywords provided by Kaiser Permanente:
uterine prolapse
urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Uterine Prolapse
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Pathological Conditions, Anatomical
Urinary Bladder Diseases
Pelvic Organ Prolapse
Uterine Diseases
Genital Diseases, Female