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

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: native tissue repair; Device: MatriStem Pelvic Floor Matrix

• Registration Number: NCT02021279
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-20
• Study First Submitted QC: 2013-12-20
• Study First Posted: 2013-12-27
• Study Start: 2014-06-11
• Primary Completion: 2021-04-28
• Study Completion: 2021-04-28
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 161

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Native Tissue Repair	native tissue repair	suture repair
MatriStem Pelvic Floor Matrix	MatriStem Pelvic Floor Matrix	surgical mesh device

Primary Outcome Measures

Name	Time	Method
The safety and effectiveness of surgical success/failure.	3 years	The composite outcome of surgical success evaluates anatomic outcome, patient reported outcome, and no retreatment pelvic organ prolapse.

Secondary Outcome Measures

Name	Time	Method
The surgical success/failure based on an alternate definition of success.	3 years	A composite outcome of surgical success based on an alternate definition of anatomic success, patient reported outcome, and no retreatment for pelvic organ prolapse.

Trial Locations

Locations (13)

Garden State Urology; 🇺🇸 Whippany, New Jersey, United States

Princeton Urogynecology; 🇺🇸 Princeton, New Jersey, United States

Cleveland Clinic FLorida; 🇺🇸 Weston, Florida, United States

Stanford School of Medicine; 🇺🇸 Stanford, California, United States

Atlantic Health System; 🇺🇸 Morristown, New Jersey, United States

Premier Urology Group; 🇺🇸 Edison, New Jersey, United States

Female Pelvic Medicine & Urogynecology; 🇺🇸 Grand Rapids, Michigan, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Premier Medical Group of the Hudson Valley; 🇺🇸 Poughkeepsie, New York, 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

The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

Center for Pelvic Health; 🇺🇸 Franklin, Tennessee, United States