Pelvic Organ Prolapse
Conditions
Keywords
pelvic organ prolapse, MatriStem, pelvic floor matrix, ACell, native tissue repair
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.
Interventions
DEVICEMatriStem Pelvic Floor Matrix
PROCEDUREnative tissue repair
Sponsors
Integra LifeSciences Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed