Study of the Elevate Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse
- Conditions
- Pelvic Organ Prolapse
- Interventions
- Procedure: Native Tissue Repair for pelvic organ prolapseDevice: Elevate Apical and Posterior
- Registration Number
- NCT02123992
- Lead Sponsor
- ASTORA Women's Health
- Brief Summary
The aim of this study is to further evaluate the safety and efficacy of the Elevate® Apical and Posterior Prolapse Repair System for repair of apical/posterior pelvic organ prolapse in a controlled, post-market cohort study.
- Detailed Description
The Harmony 522 study has been terminated due to the closing of the Astora Women's Health business. No other entity will be taking responsibility for this study. The study was terminated with partial subject enrollment complete and therefore no primary or secondary data analysis can be performed. The data from this study resides in a national data base which Astora no longer has access and therefore is another reason why no data analysis can be performed. The national database is owned and managed by the American Urogynecology Society (AUGS). AUGS has access to Astora's data and will at some time in the near future publish results to physicians who are active participants in the registry. Full public disclosure of this data may not occur for a number of years and will be aggregated with data from other study sponsors.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 99
Subject is female
Subject is at least 18 years of age
Subject must have documented diagnosis of posterior or posterior and apical vaginal prolapse with leading edge of pelvic organ prolapse at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Bp ≥ 0; or Bp ≥ 0 and C ≥ -1/2 TVL (for a multi-compartment posterior prolapse that includes the apical compartment)
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 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
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 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 systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan's syndrome, Ehlers Danhlos, 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
Subject is planning to undergo a concomitant repair with use of mesh in the non-target compartment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Native Tissue Repair Native Tissue Repair for pelvic organ prolapse The control arm of the study will include the treatment of posterior vaginal prolapse using standard surgical sutures Elevate Apical and Posterior Elevate Apical and Posterior The experimental arm of the study will include the implantation of the Elevate Posterior surgical mesh for the treatment of posterior vaginal prolapse
- Primary Outcome Measures
Name Time Method Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures 36 months Rate of device or procedure related serious adverse events 36 months
- Secondary Outcome Measures
Name Time Method Changes in Quality of Life measured through the following questionaires: PFDI- 20,PFIQ-7, PISQ-12 36 months Rate of repeat surgery/revision for prolapse arising from the same site/target compartment 36 months Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures 36 months
Trial Locations
- Locations (23)
University of Texas at Galveston
🇺🇸Galveston, Texas, United States
Metro Urology
🇺🇸Woodbury, Minnesota, United States
North Shore Women's Health Clinic
🇺🇸Great Neck, New York, United States
The Institute for Female Pelvic Medicine - St. Luke's Hospital
🇺🇸Allentown, Pennsylvania, United States
Lone Star Urogynecology and Continence Center
🇺🇸Round Rock, Texas, United States
University of Washington Pelvic Health Center
🇺🇸Seattle, Washington, United States
Swan Urogynecology
🇺🇸Nashville, Tennessee, United States
The Clark Center for Urogynecology
🇺🇸Newport Beach, California, United States
Urological Associates of Southern Arizona
🇺🇸Tucson, Arizona, United States
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
Women's Health Advantage
🇺🇸Fort Wayne, Indiana, United States
National Center for Advanced Pelvic Surgery
🇺🇸Washington, District of Columbia, United States
Adult & Pediatric Urology and Urogynecology
🇺🇸Omaha, Nebraska, United States
Delaware Valley Urology
🇺🇸Mt. Laurel, New Jersey, United States
Women's Cancer Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Princeton Medical Center
🇺🇸Princeton, New Jersey, United States
The Center for Specialized Women's Health
🇺🇸Whippany, New Jersey, United States
Premier Medical Group
🇺🇸Poughkeepsie, New York, United States
Center for Women's Health of Lansdale
🇺🇸Lansdale, Pennsylvania, United States
The Female Pelvic Health Center
🇺🇸Newtown, Pennsylvania, United States
The Womens Centre
🇺🇸Denton, Texas, United States
Female Pelvic Medicine Institute of Virginia
🇺🇸North Chesterfield, Virginia, United States
Athena Women's Health
🇺🇸Issaquah, Washington, United States