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

NCT02021279 | Completed DMC

• 1 other identifier: ACL2012-001
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 13

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.

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapse; MatriStem; pelvic floor matrix; ACell; native tissue repair

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The surgical success/failure based on an alternate definition of success.

  3 years

Study Arms (2)

MatriStem Pelvic Floor Matrix

EXPERIMENTAL

surgical mesh device

Device: MatriStem Pelvic Floor Matrix

Native Tissue Repair

ACTIVE COMPARATOR

suture repair

Procedure: native tissue repair

Interventions

MatriStem Pelvic Floor Matrix DEVICE

MatriStem Pelvic Floor Matrix

native tissue repair PROCEDURE

Also known as: suture repair

Native Tissue Repair

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (13)

Stanford School of Medicine

Stanford, California, 94305, United States

Location

Cleveland Clinic FLorida

Weston, Florida, 33331, United States

Location

Female Pelvic Medicine & Urogynecology

Grand Rapids, Michigan, 49503, United States

Location

Premier Urology Group

Edison, New Jersey, 08837, United States

Location

Atlantic Health System

Morristown, New Jersey, 07960, United States

Location

Princeton Urogynecology

Princeton, New Jersey, 08540, United States

Location

Garden State Urology

Whippany, New Jersey, 07981, United States

Location

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, 12601, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

The Institute for Female Pelvic Medicine and Reconstructive Surgery

Allentown, Pennsylvania, 18103, United States

Location

Center for Pelvic Health

Franklin, Tennessee, 37067, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: December 27, 2013
• Study Start: June 11, 2014
• Primary Completion: April 28, 2021
• Study Completion: April 28, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)