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.