Study of the Elevate Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse

Stopped early · Phase 4

Conditions studied: Pelvic Organ Prolapse

In brief

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.

Key facts

Study ID

NCT02123992

Run by

ASTORA Women's Health

People needed

99

Starts

2014-04-01

Expected to finish

2019-04-01

Last updated by the study team

2016-09-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Urological Associates of Southern Arizona — Tucson, Arizona, United States
• The Clark Center for Urogynecology — Newport Beach, California, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• National Center for Advanced Pelvic Surgery — Washington D.C., District of Columbia, United States
• Women's Health Advantage — Fort Wayne, Indiana, United States
• Metro Urology — Woodbury, Minnesota, United States
• Adult & Pediatric Urology and Urogynecology — Omaha, Nebraska, United States
• Women's Cancer Center of Nevada — Las Vegas, Nevada, United States
• Delaware Valley Urology — Mount Laurel, New Jersey, United States
• Princeton Medical Center — Princeton, New Jersey, United States
• The Center for Specialized Women's Health — Whippany, New Jersey, United States
• North Shore Women's Health Clinic — Great Neck, New York, United States
• Premier Medical Group — Poughkeepsie, New York, United States
• The Institute for Female Pelvic Medicine - St. Luke's Hospital — Allentown, Pennsylvania, United States
• Center for Women's Health of Lansdale — Lansdale, Pennsylvania, United States
• The Female Pelvic Health Center — Newtown, Pennsylvania, United States
• Swan Urogynecology — Nashville, Tennessee, United States
• The Womens Centre — Denton, Texas, United States
• University of Texas at Galveston — Galveston, Texas, United States
• Lone Star Urogynecology and Continence Center — Round Rock, Texas, United States
• Female Pelvic Medicine Institute of Virginia — North Chesterfield, Virginia, United States
• Athena Women's Health — Issaquah, Washington, United States
• University of Washington Pelvic Health Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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