Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

January 01, 2015
794700
OB Gyn
Keisha Jones, MD
Baystate Medical Center, 759 Chestnut St, Springfield, MA
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.

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

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 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.

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 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 occasions.
• 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.


Subjects will be followed for a total of 36 months with scheduled visits at 6, 12, 18, 24 and 36 months.
Active
Observational
Reva Kleppel
413-794-2415