Uphold LITE Post-Market Surveillance Study

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 focal 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
• •15. Subject is pregnant or intends to become pregnant during the study