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

Completed · Not applicable

Conditions studied: Pelvic Organ Prolapse

In brief

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.

Key facts

Study ID

NCT02021279

Run by

Integra LifeSciences Corporation

People needed

161

Starts

2014-06-11

Expected to finish

2021-04-28

Last updated by the study team

2022-02-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford School of Medicine — Stanford, California, United States
• Cleveland Clinic FLorida — Weston, Florida, United States
• Female Pelvic Medicine & Urogynecology — Grand Rapids, Michigan, United States
• Premier Urology Group — Edison, New Jersey, United States
• Atlantic Health System — Morristown, New Jersey, United States
• Princeton Urogynecology — Princeton, New Jersey, United States
• Garden State Urology — Whippany, New Jersey, United States
• Premier Medical Group of the Hudson Valley — Poughkeepsie, New York, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• The Institute for Female Pelvic Medicine and Reconstructive Surgery — Allentown, Pennsylvania, United States
• Center for Pelvic Health — Franklin, Tennessee, United States

Full record on ClinicalTrials.gov

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