Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis (OARS)

Prospective Randomized Trial of Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis

The purpose of this study is to evaluate the success rate of cystocele repair using polypropylene mesh or porcine dermis compared to that of anterior colporrhaphy in a prospective randomized fashion. The study will be performed in a randomized, prospective, single-blinded fashion.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse; Anterior Vaginal Wall Prolapse; Cystocele
• Intervention / Treatment: Device: Polypropylene mesh (Polyform by Boston Scientific); Procedure: Anterior Colporrhaphy; Procedure: Porcine Dermis (Pelvicol by CRBard)

Detailed Description

Study participants will be recruited from the urogynecology clinic at Kaiser Permanente Medical Center Bellflower and San Diego. Clinical evaluation of each patient will include a standardized history, voiding diary, quality of life (UDI-6 & IIQ-7)10 and sexual function (PISQ-12)11-12 questionnaires (Attachment 1), urinalysis, gynecologic and pelvic organ prolapse quantification (POPQ) examinations. Patients will be randomized by a computer-generated randomization schedule, with allocation to either anterior colporrhaphy or site-specific cystocele repair with polypropylene mesh augmentation or site-specific cystocele repair with porcine dermis augmentation. The allocated treatment arm will be concealed in a sealed opaque envelope until the day of surgery. Patients will be given vaginal estrogen cream starting six weeks prior to surgery. Intravenous antibiotic prophylaxis will be given preoperatively and continued postoperatively for 24 hours. Vaginal infiltration will be performed with 0.25% bupivacaine and epinephrine (1:200,000) solution. Anterior colporrhaphy is performed by making a midline incision through the anterior vaginal mucosa, dissecting the vaginal epithelium from the underlying muscularis, and midline plication of the muscularis with No. 2-0 polydioxanone sutures (Ethicon, Somerville, NJ). The excess vaginal mucosa is then excised and the margins of the vagina reapproximated in the midline using No. 2-0 polyglactin (Vicryl) sutures. Patients who are randomized to polypropylene mesh or porcine dermis repair will undergo a site-specific defect repair of the vaginal muscularis with No. 2-0 polydioxanone sutures after midline vaginal incision and lateral dissection. A piece of the assigned material will be fashioned to fit the repaired space and anchored bilaterally to the arcus tendineus fascia pelvis with interrupted No. 2-0 polydioxanone sutures. Other operative procedures will be performed as indicated. TVT or TVT-O procedures (Gynecare Inc., Somerville, NJ) will be performed for stress urinary incontinence as previously described through a separate midurethral vaginal incision. The vagina will be packed for 24 hours. All patients will be discharged when they are able to ambulate and tolerate a solid diet and oral pain medication.

The two groups will be evaluated at 6 weeks, 6 months, 1 and 2 years after surgery. A trained clinical nurse/clinical fellow, whom has been proctored in performance of POP-Q exams, will perform postoperative POPQ staging in all patients. A research nurse blinded to the subject's group assignment will administer preoperative and postoperative quality of life and sexual function questionnaires. The primary outcome of this investigation will be postoperative anterior vaginal support. Anatomic success is defined as point Ba< -1. Secondary outcomes including hospital data, complications, subjective continence, quality of life and sexual function, and overall satisfaction with surgery, will also be compared.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Downey, California, United States, 90242
      • Kaiser Permanente
    • San Diego, California, United States, 92110
      • Kaiser Permanente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Stage 2 or > anterior vaginal prolapse requiring surgical correction.
• >18 years old
• willing to return for follow-up visits.

Exclusion Criteria:

• Less than stage II or > anterior vaginal prolapse,
• decline to participate,
• pregnant or contemplating future pregnancy,
• anti-incontinence procedure other than midurethral sling (ie, Burch colposuspension, pubovaginal sling, or needle suspension) is planned as part of their surgical procedures,
• any contra-indication to receiving mesh or porcine dermis.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Polypropylene Mesh; Site-specific cystocele repair with polypropylene mesh augmentation	Device: Polypropylene mesh (Polyform by Boston Scientific); Site-specific cystocele repair with polypropylene mesh augmentation; Other Names: Polyform by Boston Scientific
Placebo Comparator: Anterior Colporrhaphy; Anterior vaginal prolapse repair with anterior colporrhaphy with no graft.	Procedure: Anterior Colporrhaphy; Anterior vaginal prolapse repair with suture.; Other Names: Cystocele repair
Active Comparator: Porcine Dermis; Site-specific cystocele repair with porcine dermis augmentation	Procedure: Porcine Dermis (Pelvicol by CRBard); Site-specific cystocele repair with porcine dermis augmentation; Other Names: Pelvicol by CRBard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis	The primary outcome as the number of participants with optimal anterior vaginal support at two year defined as POPQ point Ba < -1.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With One or More Adverse Events at Two Years	Number of participants with one or more adverse events at two years will also be compared between the three groups.	2 years
Number of Participants With Overall Failure	Secondary Outcome Include: The number of participants with Overall Failure which includes subjective symptoms of vaginal bulge and POP-Q point of Ba > -1 on exam. This secondary outcome represents a composite outcome.	2 year
Change in Quality of Life Measured by the Pelvic Floor Distress Inventory 20 and Pelvic Floor Impact Questionnaire 7	The difference in the Pelvic Floor Distress Inventory 20 (PFDI-20) and Pelvic Floor Impact Questionnaire 7 (PFIQ-7) score at 2 years compared to baseline values. The total score of each instrument ranges from 0 to 300 with higher scores indicating a greater degree of bother (ie, worse quality of life). The difference between baseline and 2-year scores were measured to account for differences in baseline scores among participants. A negative change in score indicates decreased bother after surgery and thus improved outcome; the greater the reduction in score, the greater reduction in bother and thus the better the outcome.	2-year compared to baseline scores
Change in Postoperative Sexual Function Measured by Pelvic Organ Prolapse/Urinary Incontinence Questionnaire 12	The difference in Pelvic Organ Prolapse/Urinary Incontinence Questionnaire 12 (PISQ-12) scores at 24 months compared to baseline scores. The total score ranges from 0 to 48 with higher scores indicating better sexual function. The difference in PISQ-12 score was calculated to account for baseline variation in scores among participants. A positive change indicates improved sexual function while a negative change indicates worsened sexual function after surgery.	2 year

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: John N. Nguyen, MD, Kaiser Permanente

Publications and helpful links

General Publications

• Weber AM, Walters MD, Piedmonte MR, Ballard LA. Anterior colporrhaphy: a randomized trial of three surgical techniques. Am J Obstet Gynecol. 2001 Dec;185(6):1299-304; discussion 1304-6. doi: 10.1067/mob.2001.119081.
• Altman D, Vayrynen T, Engh ME, Axelsen S, Falconer C; Nordic Transvaginal Mesh Group. Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. N Engl J Med. 2011 May 12;364(19):1826-36. doi: 10.1056/NEJMoa1009521. Erratum In: N Engl J Med. 2013 Jan 24;368(4):394.
• Simsiman AJ, Luber KM, Menefee SA. Vaginal paravaginal repair with porcine dermal reinforcement: correction of advanced anterior vaginal prolapse. Am J Obstet Gynecol. 2006 Dec;195(6):1832-6. doi: 10.1016/j.ajog.2006.07.005. Epub 2006 Sep 28.
• Menefee SA, Dyer KY, Lukacz ES, Simsiman AJ, Luber KM, Nguyen JN. Colporrhaphy compared with mesh or graft-reinforced vaginal paravaginal repair for anterior vaginal wall prolapse: a randomized controlled trial. Obstet Gynecol. 2011 Dec;118(6):1337-1344. doi: 10.1097/AOG.0b013e318237edc4.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2006
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: June 28, 2011
• First Submitted That Met QC Criteria: July 12, 2011
• First Posted (Estimated): July 13, 2011

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Anterior Vaginal Prolapse; Cystocele; Pelvic Organ Prolapse
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hernia; Prolapse; Pelvic Organ Prolapse; Cystocele
• Other Study ID Numbers: IRB4358; KPSC IRB 4358 (Other Identifier: Kaiser Permanente)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No