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Trial ID: NCT02021279
Evaluation of the Use of Transvaginal Resorbable Biologic Mesh as Compared to Traditional Non-Mesh Surgical Repair for Treating Pelvic Floor Disorders
Associate Professor of Obstetrics and Gynecology (Gynecology-Urogynecology) and, by courtesy, of Urology
- 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
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