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ACell MatriStem Pelvic Floor Matrix Versus Native Tissue Repair, Comparative Study
Trial ID: NCT02021279
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.
Evaluation of the Use of Transvaginal Resorbable Biologic Mesh as Compared to Traditional Non-Mesh Surgical Repair for Treating Pelvic Floor Disorders
- 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,
- Subject or subject's legally authorized representative is willing to provide written
- Subject is willing and able to comply with the follow-up regimen.
- 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
- Subject has a systemic connective tissue disease (e.g., scleroderma, systemic lupus
erythematous (SLE), Marfans syndrome, Ehlers Danhlos, collagenosis, polymyositis or
- Subject has uncontrolled diabetes mellitus (DM).
- Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or
- 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.
device: MatriStem Pelvic Floor Matrix
procedure: native tissue repair