Clinical Trial: Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Outcome After Anterior Vaginal Prolapse Repair: A Randomized Controlled Trial

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.

Detailed Summary:

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.


Sponsor: Kaiser Permanente

Current Primary Outcome: 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.


Original Primary Outcome: recurrent stage II anterior vaginal prolapse [ Time Frame: three years ]

Current Secondary Outcome:

  • Operative Time [ Time Frame: perioperative ]
    Calculated as time from first incision to time of closure of last incision.
  • 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.


Original Secondary Outcome: - 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 ]

Information By: Kaiser Permanente

Dates:
Date Received: September 24, 2007
Date Started: January 2005
Date Completion:
Last Updated: April 2, 2015
Last Verified: April 2015