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.
This research study is led by Dr. Keisha Jones.
Contact: Reva Kleppel, 413-794-2415
January 01, 2015
Baystate Medical Center, 759 Chestnut St, Springfield, MA
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
- 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 urodynamics.
- 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 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 neurological causes (e.g. multiple sclerosis, spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia, Parkinsons disease, or similar conditions).
Subjects will be followed for a total of 36 months with scheduled visits at 6, 12, 18, 24 and 36 months.