Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis

NCT01393171 | Completed Results

• 2 other identifiers: IRB4358KPSC IRB 4358
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Anterior Vaginal Wall Prolapse; Cystocele; Pelvic Organ Prolapse

Keywords

Anterior Vaginal Prolapse; Cystocele; Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants With One or More Adverse Events at Two Years

  2 years

• Number of Participants With Overall Failure

  2 year

• Change in Quality of Life Measured by the Pelvic Floor Distress Inventory 20 and Pelvic Floor Impact Questionnaire 7

  2-year compared to baseline scores

• Change in Postoperative Sexual Function Measured by Pelvic Organ Prolapse/Urinary Incontinence Questionnaire 12

  2 year

Study Arms (3)

Polypropylene Mesh

ACTIVE COMPARATOR

Site-specific cystocele repair with polypropylene mesh augmentation

Device: Polypropylene mesh (Polyform by Boston Scientific)

Anterior Colporrhaphy

PLACEBO COMPARATOR

Anterior vaginal prolapse repair with anterior colporrhaphy with no graft.

Procedure: Anterior Colporrhaphy

Porcine Dermis

ACTIVE COMPARATOR

Site-specific cystocele repair with porcine dermis augmentation

Procedure: Porcine Dermis (Pelvicol by CRBard)

Interventions

Polypropylene mesh (Polyform by Boston Scientific) DEVICE

Site-specific cystocele repair with polypropylene mesh augmentation

Also known as: Polyform by Boston Scientific

Polypropylene Mesh

Porcine Dermis (Pelvicol by CRBard) PROCEDURE

Site-specific cystocele repair with porcine dermis augmentation

Also known as: Pelvicol by CRBard

Porcine Dermis

Anterior Colporrhaphy PROCEDURE

Anterior vaginal prolapse repair with suture.

Also known as: Cystocele repair

Anterior Colporrhaphy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (2)

Kaiser Permanente

Downey, California, 90242, United States

Location

Kaiser Permanente

San Diego, California, 92110, United States

Location

Related Publications (4)

• 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.

  PMID: 11744900 BACKGROUND

• 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.

  PMID: 21561348 BACKGROUND

• 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.

  PMID: 17010297 BACKGROUND

• 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.

  PMID: 22067717 RESULT

MeSH Terms

Conditions

Cystocele; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Small sample size that did not permit evaluation of differences between permanent mesh and xenografts.

Results Point of Contact

• Title: Dr John Nguyen
• Organization: Kaiser Permanente

john.n.nguyen@kp.org

562-657-2642

Study Officials

• John N. Nguyen, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: July 13, 2011
• Study Start: January 1, 2006
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2018
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)