Exair® Versus Native Tissue Repair for Prolapse

Exair® Prolapse Repair System Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Exair 522 Study

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.

Inclusion Criteria:

• Female at least 18 years of age
• Subject has pelvic organ prolapse with leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba ≥0 and Bp ≥0 and C≥ -1/2 tvl
• Subject reports a bothersome bulge they can see or feel per PFDI-20 question 3, response of 2 or higher (i.e. responses of "somewhat", "moderately" or "quite a bit")
• Subject is willing to provide written informed consent
• Subject is willing and able to comply with the follow-up regimen

Exclusion Criteria:

• Subject is pregnant or intends to become pregnant during the study
• Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI), or tissue necrosis
• 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), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
• Subject has a systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis or polymyalgia rheumatica)
• Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
• Subject has uncontrolled diabetes mellitus (DM)
• 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 is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
• 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 has a known sensitivity to polypropylene
• Subject has had previous prolapse repair with mesh in the target compartment(s)