Restorelle® Mesh Versus Native Tissue Repair for Prolapse


Trial ID: NCT02162615


The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle. These results will be compared to the safety and effectiveness results in patients who have native tissue repair (without mesh) as their pelvic organ prolapse treatment.

Official Title

Restorelle® Transvaginal Mesh Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Restorelle 522 Study

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:

   - 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 C≥ -1/2 tvl or 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

   - 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

   - 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)

   - Subject is planning to undergo a concomitant prolapse repair in a non-target
   compartment with anything other than native tissue repair


device: Restorelle Direct Fix A

device: Restorelle Direct Fix P

procedure: Native Tissue Repair Anterior

procedure: Native Tissue Repair Posterior


Contact Information

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