AXONICS: Prospective, multicenter clinical evaluation of the recharge free Axonics SNM System (INS Model 4101)
Sponsor: |
Axonics, Inc |
Enrolling: |
Male and Female Patients |
Study Length: |
1 Years |
Clinic Visits: |
7 |
IRB Number: |
AAAV3913 |
U.S. Govt. ID: |
NCT06186765 |
Contact: |
Claudia Musat: 212-342-4102 / cm2065@cumc.columbia.edu |
The purpose of this study is to evaluate the safety and effectiveness of a device called the Axonics SNM System in reducing symptoms for people who have Overactive Bladder (OAB) and/or Fecal Incontinence (FI). The study will enroll up to 130 participants at up to 20 sites in the United States and Western Europe. The Axonics System delivers mild electric pulses (stimulation) to the area of the sacral nerve, which is located in the lower back. This Sacral Neuromodulation (SNM) therapy treats bladder and bowel dysfunction such as urinary urgency incontinence (UUI), urinary frequency (UF) and fecal incontinence (FI). This therapy is expected to lower your symptoms and improve your day-to-day life. The device and procedure are both approved by the United States Food and Drug Administration. The F15 device (Model 4101) is a non-rechargeable device, which means it does not need charging. The non-rechargeable F15 device is approved to be used in the United States and Canada but not yet in Europe. This trial is being conducted to collect additional information for the non-rechargeable F15 device for approval in Europe.If you decide to participate in this study, you will be one of the subjects at Columbia University Irving Medical Center (CUIMC), who will receive a medical device to control your bowel symptoms. CUIMC is not treating patients with OAB and urinary incontinence symptoms. You will return to your doctor's office for several follow-up visits after your standard of care device implant. They are scheduled at 1 month, 3 months, 6 months, 9 months (phone call only) and 1 year.
Investigator
Marco Bertucci Zoccali, MD
1.Chronic Fecal Incontinence who are not candidates for or who have failed conservative treatment |
Yes |
No |
1.Chronic Fecal Incontinence who are not candidates for or who have failed conservative treatment |
Yes |
No |
3.Not previously implanted with a sacral neuromodulation device |
Yes |
No |