©2022 Stanford Medicine
Restorelle® Mesh Versus Native Tissue Repair for Prolapse
Recruiting
Trial ID: NCT02162615
Purpose
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
Associate Professor of Obstetrics and Gynecology (Gynecology-Urogynecology) and, by courtesy, of Urology
Eligibility
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
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)
- Subject is planning to undergo a concomitant prolapse repair in a non-target
compartment with anything other than native tissue repair
Intervention(s):
device: Restorelle Direct Fix A
device: Restorelle Direct Fix P
procedure: Native Tissue Repair Anterior
procedure: Native Tissue Repair Posterior
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305