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


Trial ID: NCT02123992


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.

Official Title

A Prospective, Safety and Efficacy Cohort Study of Elevate® Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse Repair

Stanford Investigator(s)

Eric R. Sokol, MD
Eric R. Sokol, MD

Professor of Obstetrics and Gynecology (Gynecology-Urogynecology) and, by courtesy, of Urology


Inclusion Criteria:

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

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 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

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


procedure: Native Tissue Repair for pelvic organ prolapse

device: Elevate Apical and Posterior


Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305