Clinical trial NCT02021279: ACell MatriStem Pelvic Floor Matrix Versus Native Tissue Repair, Comparative Study
Official title: Evaluation of the Use of Transvaginal Resorbable Biologic Mesh as Compared to Traditional Non-Mesh Surgical Repair for Treating Pelvic Floor Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: pelvic organ prolapse
MatriStem
pelvic floor matrix
ACell
native tissue repair
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2013-12-27
Enrollment: 161
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The safety and effectiveness of surgical success/failure.
timeFrame: 3 years
Secondary outcomes:
measure: The surgical success/failure based on an alternate definition of success.
timeFrame: 3 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford School of Medicine
state: California
city: Weston
country: United States
facility: Cleveland Clinic FLorida
state: Florida
city: Grand Rapids
country: United States
facility: Female Pelvic Medicine & Urogynecology
state: Michigan
city: Edison
country: United States
facility: Premier Urology Group
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Health System
state: New Jersey
city: Princeton
country: United States
facility: Princeton Urogynecology
state: New Jersey
city: Whippany
country: United States
facility: Garden State Urology
state: New Jersey
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Allentown
country: United States
facility: The Institute for Female Pelvic Medicine and Reconstructive Surgery
state: Pennsylvania
city: Franklin
country: United States
facility: Center for Pelvic Health
state: Tennessee
Study officials:
References: