Restorelle® Transvaginal Mesh versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 123

Inclusion Criteria

1. Subject is female
2. Subject is at least 18 years of age
3. 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
4. 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*)
5. Subject is willing to provide written informed consent
6. Subject is willing and able to comply with the follow-up regimen

Exclusion Criteria

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