The purpose of this study is to compare safety and effectiveness of the Exair Prolapse Repair System for treatment of pelvic organ prolapse to traditional native tissue repair through 36 months of follow-up.
Study Type
OBSERVATIONAL
Enrollment
79
Progressive GYN Center
Savannah, Georgia, United States
Women's Health Advantage
Fort Wayne, Indiana, United States
Advanced Urogynecology of Michigan
Recurrence of Prolapse
Recurrent prolapse is measured anatomically at the target compartment by leading edge of prolapse beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging.
Time frame: 36 Month
Rate of device and procedure related adverse events
Time frame: 36 Month
Recurrence of prolapse
Recurrent prolapse is measured anatomically by leading edge of prolapse in the target compartment at or beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging.
Time frame: 36 Month
Rates of other adverse events
Time frame: 36 months
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Dearborn, Michigan, United States
Minnesota Women's Care
Maplewood, Minnesota, United States
Atlantic Urogynecology Associates
Morristown, New Jersey, United States
Princeton Urogynecology
Princeton, New Jersey, United States
Albany Medical Center
Albany, New York, United States
United Health Services
Johnson City, New York, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
Novant Health Clinical Research
Winston-Salem, North Carolina, United States
...and 4 more locations