ACell MatriStem Pelvic Floor Matrix Versus Native Tissue Repair, Comparative Study
Study Details
Study Description
Brief Summary
The primary objective of this study is to assess the safety and effectiveness of MatriStem Pelvic Floor Matrix as compared to native tissue repair for the treatment of pelvic organ prolapse. Patients are evaluated throughout a 3 year follow-up period.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: MatriStem Pelvic Floor Matrix surgical mesh device |
Device: MatriStem Pelvic Floor Matrix
|
Active Comparator: Native Tissue Repair suture repair |
Procedure: native tissue repair
Other Names:
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Outcome Measures
Primary Outcome Measures
- The safety and effectiveness of surgical success/failure. [3 years]
The composite outcome of surgical success evaluates anatomic outcome, patient reported outcome, and no retreatment pelvic organ prolapse.
Secondary Outcome Measures
- The surgical success/failure based on an alternate definition of success. [3 years]
A composite outcome of surgical success based on an alternate definition of anatomic success, patient reported outcome, and no retreatment for pelvic organ prolapse.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject's leading edge of POP is at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba ≥ 0 or Bp ≥ 0 or C ≥ 0 (for prolapse of the apical compartment alone) or C ≥ -½ total vaginal length (for a multi-compartment prolapse that includes the apical compartment).
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Subject is seeking surgical intervention for symptomatic POP, which is defined as experiencing symptoms of vaginal bulging or pelvic heaviness. Vaginal bulge or pelvic heaviness will be considered present if a subject responds "yes" (≥1) to PFDI-20, question 3.
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Subject or subject's legally authorized representative is willing to provide written informed consent.
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Subject is willing and able to comply with the follow-up regimen.
Exclusion Criteria:
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Subject has a known hypersensitivity to porcine-based materials (relevant to subjects in MatriStem Pelvic Floor Matrix Group only).
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Subject is pregnant or plans to become pregnant during the study.
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Subject has an active or chronic systemic infection including any gynecologic infection, urinary tract infection (UTI), or tissue necrosis.
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Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit).
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Subject has chronic systemic pain syndrome (e.g. fibromyalgia, painful bladder syndrome).
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Subject has a systemic connective tissue disease (e.g., scleroderma, systemic lupus erythematous (SLE), Marfans syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatica).
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Subject has uncontrolled diabetes mellitus (DM).
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Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical).
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Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area.
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Subject has taken systemic steroids (within the last month), immunosuppressive or immunomodulatory treatment (within the last 3 months).
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Subject is seeking obliterative vaginal surgery as treatment for POP (colpoclesis).
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Subject is not able to conform to the modified dorsal lithotomy position.
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Subject is currently participating in or plans to participate in another device or drug study during this study.
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Subject is to planning to undergo concurrent surgical treatment of prolapse using mesh other than the MatriStem Pelvic Floor Matrix.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Stanford School of Medicine | Stanford | California | United States | 94305 |
2 | Cleveland Clinic FLorida | Weston | Florida | United States | 33331 |
3 | Female Pelvic Medicine & Urogynecology | Grand Rapids | Michigan | United States | 49503 |
4 | Premier Urology Group | Edison | New Jersey | United States | 08837 |
5 | Atlantic Health System | Morristown | New Jersey | United States | 07960 |
6 | Princeton Urogynecology | Princeton | New Jersey | United States | 08540 |
7 | Garden State Urology | Whippany | New Jersey | United States | 07981 |
8 | Premier Medical Group of the Hudson Valley | Poughkeepsie | New York | United States | 12601 |
9 | The Christ Hospital | Cincinnati | Ohio | United States | 45219 |
10 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
11 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
12 | The Institute for Female Pelvic Medicine and Reconstructive Surgery | Allentown | Pennsylvania | United States | 18103 |
13 | Center for Pelvic Health | Franklin | Tennessee | United States | 37067 |
Sponsors and Collaborators
- Integra LifeSciences Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ACL2012-001