Exair® Versus Native Tissue Repair for Prolapse
- Conditions
- Pelvic Organ Prolapse
- Interventions
- Procedure: Total Native Tissue RepairDevice: Exair Prolapse Repair System
- Registration Number
- NCT02162628
- Lead Sponsor
- Coloplast A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 79
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Total Native Tissue Repair Total Native Tissue Repair Total repair with native tissue only Exair for Total Repair Exair Prolapse Repair System Total repair with Exair Prolapse Repair System alone or in combination with native tissue repair
- Primary Outcome Measures
Name Time Method Rate of device and procedure related adverse events 36 Month Recurrence of Prolapse 36 Month 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.
- Secondary Outcome Measures
Name Time Method Recurrence of prolapse 36 Month 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.
Rates of other adverse events 36 months
Trial Locations
- Locations (14)
CHUS-CRC
🇨🇦Sherbrooke, Quebec, Canada
Princeton Urogynecology
🇺🇸Princeton, New Jersey, United States
Novant Health Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Vermont Urogynecology Associates, P.C.
🇺🇸Williston, Vermont, United States
Albany Medical Center
🇺🇸Albany, New York, United States
The Institute for Female Pelvic Medicine and Reconstructive Surgery
🇺🇸Allentown, Pennsylvania, United States
Carillion Clinic OB/GYN
🇺🇸Christiansburg, Virginia, United States
United Health Services
🇺🇸Johnson City, New York, United States
Progressive GYN Center
🇺🇸Savannah, Georgia, United States
Women's Health Advantage
🇺🇸Fort Wayne, Indiana, United States
Advanced Urogynecology of Michigan
🇺🇸Dearborn, Michigan, United States
Minnesota Women's Care
🇺🇸Maplewood, Minnesota, United States
Atlantic Urogynecology Associates
🇺🇸Morristown, New Jersey, United States
Lyndhurst Clinical Research
🇺🇸Winston-Salem, North Carolina, United States