Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cystocele Uterine Prolapse Urinary Incontinence |
Device: grafted anterior prolapse repair Procedure: sutured anterior vaginal prolapse repair |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Outcome After Anterior Vaginal Prolapse Repair: A Randomized Controlled Trial |
- Recurrent Stage II or Greater Anterior Vaginal Prolapse [ Time Frame: three years ] [ Designated as safety issue: No ]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.
- Operative Time - From First Incision to Closure of Last Incision [ Time Frame: perioperative ] [ Designated as safety issue: No ](from first incision to closure of last incision)
- Vaginal Mesh Exposure [ Time Frame: perioperative ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 75 |
| Study Start Date: | January 2005 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Anterior Colporrhaphy
Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
|
Procedure: sutured anterior vaginal prolapse repair
anterior vaginal prolapse repair with suture
Other Name: cystocele repair
|
|
Active Comparator: Perigee
Anterior vaginal prolapse repair with graft
|
Device: grafted anterior prolapse repair
anterior vaginal prolapse repair with graft
Other Name: Perigee Transobturator Prolapse Repair System
|
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, California | |
| Kaiser Permanente | |
| Downey, California, United States, 90242 | |
| Principal Investigator: | John N Nguyen, MD | Southern California Permanente Medical Group |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | John N. Nguyen, MD, SCPMG |
| ClinicalTrials.gov Identifier: | NCT00535301 History of Changes |
| Other Study ID Numbers: | 4348 |
| Study First Received: | September 24, 2007 |
| Results First Received: | May 4, 2011 |
| Last Updated: | August 1, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Kaiser Permanente:
|
cystocele uterine prolapse urinary incontinence |
Additional relevant MeSH terms:
|
Cystocele Prolapse Urinary Incontinence Uterine Prolapse Urinary Bladder Diseases Urologic Diseases Pelvic Organ Prolapse |
Pathological Conditions, Anatomical Urination Disorders Urological Manifestations Signs and Symptoms Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on June 18, 2013