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Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence
Trial ID: NCT02348112
The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.
A Post-Market Evaluation of the Altis® Single Incision Sling System Versus Transobturator or Retropubic Mesh Sling in the Treatment of Female Stress Urinary Incontinence
- 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 through cough stress test or
- The subject has failed two non-invasive incontinence therapies (such as Kegal
exercise, behavior modification, pad use, biofeedback, etc.) for > 6 months.
- The subject has an active urogenital infection or active skin infection in region of
- 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 neurological causes (e.g. multiple sclerosis,
spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter
dyssynergia, Parkinsons disease, or similar conditions).
- The subject had a prior surgical stress urinary incontinence 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
- The subject is pregnant and/or is planning to get pregnant in the future.
- The subject has a contraindication to the surgical procedure of 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.
device: Altis Sling
device: Transobturator or Retropubic Sling