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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
161
Stanford School of Medicine
Stanford, California, United States
Cleveland Clinic FLorida
Weston, Florida, United States
Female Pelvic Medicine & Urogynecology
Grand Rapids, Michigan, United States
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.
Time frame: 3 years
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.
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Premier Urology Group
Edison, New Jersey, United States
Atlantic Health System
Morristown, New Jersey, United States
Princeton Urogynecology
Princeton, New Jersey, United States
Garden State Urology
Whippany, New Jersey, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
...and 3 more locations