Trial Search Results
Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence
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.
Stanford is currently not accepting patients for this trial.
- Device: Altis Sling
- Device: Transobturator or Retropubic Sling
- 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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study