Altis 522 Study
September 20, 2016
Keisha Jones, MD
Baystate Medical Center, 759 Chestnut Street, Springfield, MA
The aim of this FDA directed postmarket study is to compare the safety and effectiveness of the Altis Single Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic mesh sling through 36
Note: Baystate will be in the comparator arm of the trial; we will continue to use the device/procedures we normally use for the treatment of female stress urinary incontinence, and not the device under study (Altis Single Incision Sling System).
To be included in the study, subjects must meet all of the following inclusion criteria:
1. The subject is female and at least 18 years of age.
2. The subject is able and willing to complete all procedures and follow-up visits indicated in this protocol.
3. The subject has confirmed stress urinary incontinence (SUI) through cough stress test or urodynamics.
4. The subject has failed two non-invasive incontinence therapies (such as Kegel exercise, behavior modification, pad use, biofeedback, etc.) for > 6 months.
To be included in this clinical study subjects must not meet any of the following exclusion criteria:
1. The subject has an active urogenital infection or active skin infection in region of surgery.
2. The subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading.
3. The subject is having a concomitant pelvic floor procedure.
4. 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).
5. The subject had a prior surgical SUI treatment.
6. The subject has undergone radiation or brachy therapy to treat pelvic cancer.
7. The subject has urge predominant incontinence by MESA assessment.
8. The subject has an atonic bladder or post void residual (PVR) above 100 cc on ≥ 2 occasions.
9. The subject is pregnant and/or is planning to get pregnant in the future.
10. The subject has a contraindication to the surgical procedure or the product IFU.
11. 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 months, 12 months, 18 months, 24 months, and 36 months.