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Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair

Primary Purpose

Cystocele, Uterine Prolapse, Urinary Incontinence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
grafted anterior prolapse repair
sutured anterior vaginal prolapse repair
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystocele focused on measuring cystocele, uterine prolapse, urinary incontinence

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Kaiser Permanente

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Anterior Colporrhaphy (sutured repair)

Perigee (grafted repair)

Arm Description

Anterior vaginal prolapse repair with anterior colporrhaphy (no graft) using sutures.

Anterior vaginal prolapse repair with graft

Outcomes

Primary Outcome Measures

Recurrent Stage II or Greater Anterior Vaginal Prolapse
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
Calculated as time from first incision to time of closure of last incision.
Vaginal Mesh Exposure
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.

Full Information

First Posted
September 24, 2007
Last Updated
April 2, 2015
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT00535301
Brief Title
Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair
Official Title
Outcome After Anterior Vaginal Prolapse Repair: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystocele, Uterine Prolapse, Urinary Incontinence
Keywords
cystocele, uterine prolapse, urinary incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anterior Colporrhaphy (sutured repair)
Arm Type
Placebo Comparator
Arm Description
Anterior vaginal prolapse repair with anterior colporrhaphy (no graft) using sutures.
Arm Title
Perigee (grafted repair)
Arm Type
Active Comparator
Arm Description
Anterior vaginal prolapse repair with graft
Intervention Type
Device
Intervention Name(s)
grafted anterior prolapse repair
Other Intervention Name(s)
Perigee Transobturator Prolapse Repair System
Intervention Description
anterior vaginal prolapse repair with graft
Intervention Type
Procedure
Intervention Name(s)
sutured anterior vaginal prolapse repair
Other Intervention Name(s)
cystocele repair
Intervention Description
anterior vaginal prolapse repair with suture
Primary Outcome Measure Information:
Title
Recurrent Stage II or Greater Anterior Vaginal Prolapse
Description
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.
Time Frame
three years
Secondary Outcome Measure Information:
Title
Operative Time
Description
Calculated as time from first incision to time of closure of last incision.
Time Frame
perioperative
Title
Vaginal Mesh Exposure
Description
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.
Time Frame
perioperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John N Nguyen, MD
Organizational Affiliation
Southern California Permanente Medical Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17219252
Citation
Gauruder-Burmester A, Koutouzidou P, Rohne J, Gronewold M, Tunn R. Follow-up after polypropylene mesh repair of anterior and posterior compartments in patients with recurrent prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Sep;18(9):1059-64. doi: 10.1007/s00192-006-0291-7. Epub 2007 Jan 12.
Results Reference
background
PubMed Identifier
18378748
Citation
Nguyen JN, Burchette RJ. Outcome after anterior vaginal prolapse repair: a randomized controlled trial. Obstet Gynecol. 2008 Apr;111(4):891-8. doi: 10.1097/AOG.0b013e31816a2489.
Results Reference
derived

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Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair

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