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

September 24, 2007
August 1, 2011
January 2005
April 2008   (final data collection date for primary outcome measure)
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.
recurrent stage II anterior vaginal prolapse [ Time Frame: three years ]
Complete list of historical versions of study NCT00535301 on ClinicalTrials.gov Archive Site
  • 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.
- operative time (from first incision to closure of last incision) - blood loss (preoperative minus postoperative day one hemoglobin) - length of hospitalization - adverse events - PFDI-20, PFIQ-7 and PISQ-12 scores [ Time Frame: three years ]
Not Provided
Not Provided
 
Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Cystocele
  • Uterine Prolapse
  • Urinary Incontinence
  • Device: grafted anterior prolapse repair
    anterior vaginal prolapse repair with graft
    Other Name: Perigee Transobturator Prolapse Repair System
  • Procedure: sutured anterior vaginal prolapse repair
    anterior vaginal prolapse repair with suture
    Other Name: cystocele repair
  • Placebo Comparator: Anterior Colporrhaphy
    Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
    Intervention: Procedure: sutured anterior vaginal prolapse repair
  • Active Comparator: Perigee
    Anterior vaginal prolapse repair with graft
    Intervention: Device: grafted anterior prolapse repair

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Female
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00535301
4348
No
John N. Nguyen, MD, SCPMG
Kaiser Permanente
Not Provided
Principal Investigator: John N Nguyen, MD Southern California Permanente Medical Group
Kaiser Permanente
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP