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

Sponsor
Integra LifeSciences Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT02021279
Collaborator
(none)
161
13
2
82.6
12.4
0.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: MatriStem Pelvic Floor Matrix
  • Procedure: native tissue repair
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
161 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Use of Transvaginal Resorbable Biologic Mesh as Compared to Traditional Non-Mesh Surgical Repair for Treating Pelvic Floor Disorders
Actual Study Start Date :
Jun 11, 2014
Actual Primary Completion Date :
Apr 28, 2021
Actual Study Completion Date :
Apr 28, 2021

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford School of Medicine Stanford California United States 94305
    2 Cleveland Clinic FLorida Weston Florida United States 33331
    3 Female Pelvic Medicine & Urogynecology Grand Rapids Michigan United States 49503
    4 Premier Urology Group Edison New Jersey United States 08837
    5 Atlantic Health System Morristown New Jersey United States 07960
    6 Princeton Urogynecology Princeton New Jersey United States 08540
    7 Garden State Urology Whippany New Jersey United States 07981
    8 Premier Medical Group of the Hudson Valley Poughkeepsie New York United States 12601
    9 The Christ Hospital Cincinnati Ohio United States 45219
    10 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    11 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    12 The Institute for Female Pelvic Medicine and Reconstructive Surgery Allentown Pennsylvania United States 18103
    13 Center for Pelvic Health Franklin Tennessee United States 37067

    Sponsors and Collaborators

    • Integra LifeSciences Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Integra LifeSciences Corporation
    ClinicalTrials.gov Identifier:
    NCT02021279
    Other Study ID Numbers:
    • ACL2012-001
    First Posted:
    Dec 27, 2013
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Integra LifeSciences Corporation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 8, 2022