A Prospective, Non-Randomized, Parallel Cohort, Multi-center Study of Uphold LITE vs. Native Tissue for the Treatment of Women with Anterior/Apical Pelvic Organ Prolapse (Protocol U8090)

Trial ID:
IRB-13-6287
Bruce Kahn
The purpose of this study is to compare transvaginal mesh repair to traditional native tissue repair in women surgically treated for anterior/apical pelvic organ prolapse with or without concurrent cystocele.

Inclusion Criteria:

  • 1. Subject is female
  • 2. Subject is ≥18 years of age
  • 3. Subject has pelvic organ prolapse with the leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba≥0 or C≥0 (for prolapse of the apical compartment alone) or C≥-1/2 TVL (for a multi-compartment prolapse that includes the apical compartment).
  • 4. Subject reports of 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")
  • 5. Subject or subject's legally authorized representative must be willing to provide written informed consent
  • 6. Subject is willing and able to comply with the follow-up regimen
  • 7. Subject has had a total hysterectomy

Exclusion Criteria:

  • 1. Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis
  • 2. Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, colo-rectal or cervical)
  • 3. Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
  • 4. Subject has taken systemic steroids (within the last month) or immunosuppressive or immunomodulatory treatment (within the last 3 months)
  • 5. Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfans syndrome, Ehlers Danlos collagenosis, polymyositis polymyalgia rheumatica)
  • 6. Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit)
  • 7. Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
  • 8. Subject has a previous prolapse repair with mesh in the target compartment
  • 9. Subject is planning to undergo a concomitant repair with use of mesh in the non-target compartment
  • 10. Subject is not able to conform to the modified dorsal lithotomy position
  • 11. Subject has chronic systemic pain that includes the pelvic area or chronic pain that includes the pelvis
  • 12. Subject has uncontrolled diabetes mellitus (DM)
  • 13. Subject is currently participating in or plans to participate in another device or drug study during this study
  • 14. Subject has a known hypersensitivity to polypropylene mesh