Restorelle® Mesh Versus Native Tissue Repair for Prolapse

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