ACell MatriStem Pelvic Floor Matrix Versus Native Tissue Repair, Comparative Study

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Use of Transvaginal Resorbable Biologic Mesh as Compared to Traditional Non-Mesh Surgical Repair for Treating Pelvic Floor Disorders

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Device: MatriStem Pelvic Floor Matrix
* Procedure: native tissue repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). 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. Subject or subject's legally authorized representative is willing to provide written informed consent. Subject is willing and able to comply with the follow-up regimen. Exclusion Criteria: Subject has a known hypersensitivity to porcine-based materials (relevant to subjects in MatriStem Pelvic Floor Matrix Group only). Subject is pregnant or plans to become pregnant during the study. Subject has an active or chronic systemic infection including any gynecologic infection, urinary tract infection (UTI), or tissue necrosis. Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit). Subject has chronic systemic pain syndrome (e.g. fibromyalgia, painful bladder syndrome). Subject has a systemic connective tissue disease (e.g., scleroderma, systemic lupus erythematous (SLE), Marfans syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatica). Subject has uncontrolled diabetes mellitus (DM). Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical). Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area. Subject has taken systemic steroids (within the last month), immunosuppressive or immunomodulatory treatment (within the last 3 months). Subject is seeking obliterative vaginal surgery as treatment for POP (colpoclesis). Subject is not able to conform to the modified dorsal lithotomy position. Subject is currently participating in or plans to participate in another device or drug study during this study. Subject is to planning to undergo concurrent surgical treatment of prolapse using mesh other than the MatriStem Pelvic Floor Matrix.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MatriStem Pelvic Floor Matrix<br>surgical mesh device | Device: MatriStem Pelvic Floor Matrix<br> <br> |
| Active Comparator: Native Tissue Repair<br>suture repair | Procedure: native tissue repair<br> <br> * Other names: suture repair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety and effectiveness of surgical success/failure. | The composite outcome of surgical success evaluates anatomic outcome, patient reported outcome, and no retreatment pelvic organ prolapse. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The surgical success/failure based on an alternate definition of success. | A composite outcome of surgical success based on an alternate definition of anatomic success, patient reported outcome, and no retreatment for pelvic organ prolapse. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic organ prolapse, MatriStem, pelvic floor matrix, ACell, native tissue repair