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

Evaluation of the Use of Transvaginal Resorbable Biologic Mesh as Compared to Traditional Non-Mesh Surgical Repair for Treating Pelvic Floor Disorders

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Device: MatriStem Pelvic Floor Matrix; Procedure: native tissue repair

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford School of Medicine
  • Florida
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Female Pelvic Medicine & Urogynecology
  • New Jersey
    • Edison, New Jersey, United States, 08837
      • Premier Urology Group
    • Morristown, New Jersey, United States, 07960
      • Atlantic Health System
    • Princeton, New Jersey, United States, 08540
      • Princeton Urogynecology
    • Whippany, New Jersey, United States, 07981
      • Garden State Urology
  • New York
    • Poughkeepsie, New York, United States, 12601
      • Premier Medical Group of the Hudson Valley
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • The Institute for Female Pelvic Medicine and Reconstructive Surgery
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Center for Pelvic Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MatriStem Pelvic Floor Matrix; surgical mesh device	Device: MatriStem Pelvic Floor Matrix
Active Comparator: Native Tissue Repair; suture repair	Procedure: native tissue repair; Other Names: suture repair

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2014
• Primary Completion (Actual): April 28, 2021
• Study Completion (Actual): April 28, 2021

Study Registration Dates

• First Submitted: December 20, 2013
• First Submitted That Met QC Criteria: December 20, 2013
• First Posted (Estimate): December 27, 2013

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: pelvic organ prolapse; MatriStem; pelvic floor matrix; ACell; native tissue repair
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: ACL2012-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No