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.