Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair

This study has been completed.
Sponsor:
Information provided by:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00535301
First received: September 24, 2007
Last updated: August 1, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Cystocele
Uterine Prolapse
Urinary Incontinence
Device: grafted anterior prolapse repair
Procedure: sutured anterior vaginal prolapse repair
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Outcome After Anterior Vaginal Prolapse Repair: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Recurrent Stage II or Greater Anterior Vaginal Prolapse [ Time Frame: three years ] [ Designated as safety issue: No ]
    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:
  • Operative Time - From First Incision to Closure of Last Incision [ Time Frame: perioperative ] [ Designated as safety issue: No ]
    (from first incision to closure of last incision)

  • Vaginal Mesh Exposure [ Time Frame: perioperative ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 75
Study Start Date: January 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Anterior Colporrhaphy
Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
Procedure: sutured anterior vaginal prolapse repair
anterior vaginal prolapse repair with suture
Other Name: cystocele repair
Active Comparator: Perigee
Anterior vaginal prolapse repair with graft
Device: grafted anterior prolapse repair
anterior vaginal prolapse repair with graft
Other Name: Perigee Transobturator Prolapse Repair System

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535301

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John N. Nguyen, MD, SCPMG
ClinicalTrials.gov Identifier: NCT00535301     History of Changes
Other Study ID Numbers: 4348
Study First Received: September 24, 2007
Results First Received: May 4, 2011
Last Updated: August 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
cystocele
uterine prolapse
urinary incontinence

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

ClinicalTrials.gov processed this record on October 19, 2014