Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

Inclusion Criteria:

   - The subject is female and at least 18 years of age.

   - The subject is able and willing to complete all procedures and follow-up visits
   indicated in this protocol.

   - The subject has confirmed stress urinary incontinence (SUI) through cough stress test
   or urodynamics.

   - The subject has failed two non-invasive incontinence therapies (such as Kegel
   exercise, behavior modification, pad use, biofeedback, etc.) for > 6 months.

Exclusion Criteria:

   - The subject has an active urogenital infection or active skin infection in region of
   surgery.

   - The subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as
   determined by POP-Q prolapse grading.

   - The subject is having a concomitant pelvic floor procedure.

   - The subject has incontinence due to neurogenic causes (e.g. multiple sclerosis, spinal
   cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia,
   Parkinson's disease, or similar conditions).

   - The subject had a prior surgical stress urinary incontinence (SUI) treatment.

   - The subject has undergone radiation or brachy therapy to treat pelvic cancer.

   - The subject has urge predominant incontinence by MESA assessment.

   - The subject has an atonic bladder or post void residual (PVR) above 100 cc on ≥ 2
   occasions.

   - The subject is pregnant and/or is planning to get pregnant in the future.

   - The subject has a contraindication to the surgical procedure or the product
   Instructions for Use (IFU).

   - The subject is enrolled in a concurrent clinical trial of any treatment (drug or
   device) that could affect continence function, without the sponsors approval.