NCT02021279CompletedNot Applicable
Evaluation of the Use of Transvaginal Resorbable Biologic Mesh as Compared to Traditional Non-Mesh Surgical Repair for Treating Pelvic Floor Disorders
Integra LifeSciences Corporation13 sites in 1 country161 target enrollmentStarted: June 11, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 161
- Locations
- 13
- Primary Endpoint
- The safety and effectiveness of surgical success/failure.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •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.
Arms & Interventions
MatriStem Pelvic Floor Matrix
Experimental
surgical mesh device
Intervention: MatriStem Pelvic Floor Matrix (Device)
Native Tissue Repair
Active Comparator
suture repair
Intervention: native tissue repair (Procedure)
Outcomes
Primary Outcomes
The safety and effectiveness of surgical success/failure.
Time Frame: 3 years
The composite outcome of surgical success evaluates anatomic outcome, patient reported outcome, and no retreatment pelvic organ prolapse.
Secondary Outcomes
- The surgical success/failure based on an alternate definition of success.(3 years)
Investigators
Study Sites (13)
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