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
About this trial
This is an interventional treatment trial for Cystocele focused on measuring cystocele, uterine prolapse, urinary incontinence
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
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
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
Learn more about this trial
Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair
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