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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02021279
• Other study ID #: ACL2012-001
• Status: Completed
• Phase: N/A
• Start date: June 11, 2014
• Est. completion date: April 28, 2021

Study information

• Verified date: February 2022
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: April 28, 2021
• Est. primary completion date: April 28, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Device:
• MatriStem Pelvic Floor Matrix

Procedure:
• native tissue repair

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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