OARS: Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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:
|
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis [5 years]
The primary outcome of this investigation will be postoperative anterior vaginal support measured by the validated scale(POP-Q, POP-Q point Ba performed by blinded examiner. Anatomic support will be considered optimal when Ba by POP-Q being at stage 0 or 1 (Ba=-2,-3).
Secondary Outcome Measures
- Adverse events [5 years]
Secondary outcomes include *hospital data including intra-operative data complications (genito-urinary tract injury) and estimated blood loss. Postoperative length of stay.
- Overall failure rate [5 year]
Secondary Outcome Include: *Overall Failure rate which includes subjective symptoms of vaginal bulge and anatomic/objective measure, POP-Q point of Ba. This secondary outcome represents a composite outcome.
- Postoperative quality of life [5 Year]
Secondary Outcome include: *Quality Of Life- A secondary outcome on subjective bother involving pelvic floor disorders using several validated scales including PFDI-20 and PFIQ-7 will be measured at 6 months, 12 months and 24 months.
- Postoperative sexual function [5 year]
Secondary Outcome Include: *Sexual Function: A secondary outcome on subjective bother involving pelvic floor disorders using a validated scale, PISQ-12 questionnaire,will be measured at 6 months, 12 months and 24 months.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Stage 2 or > anterior vaginal prolapse requiring surgical correction.
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18 years old
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willing to return for follow-up visits.
Exclusion Criteria:
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Less than stage II or > anterior vaginal prolapse,
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decline to participate,
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pregnant or contemplating future pregnancy,
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anti-incontinence procedure other than midurethral sling (ie, Burch colposuspension, pubovaginal sling, or needle suspension) is planned as part of their surgical procedures,
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any contra-indication to receiving mesh or porcine dermis.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaiser Permanente | Downey | California | United States | 90242 |
| 2 | Kaiser Permanente | San Diego | California | United States | 92110 |
Sponsors and Collaborators
- Kaiser Permanente
Investigators
- Principal Investigator: John N. Nguyen, MD, Kaiser Permanente
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB4358
- KPSC IRB 4358