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

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.