PMCF Study of the Axonics SNM System Model 5101 (R20)

Launched by AXONICS, INC. · Jan 17, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the Axonics SNM System, which is a treatment designed to help people with conditions like urinary urge incontinence, urinary frequency, and overactive bladder. The study aims to gather more information about the safety and effectiveness of this device over a longer period of time, and it will take place after the device has already been approved for use.

To participate, you need to be at least 18 years old and have issues with overactive bladder that haven't improved with other treatments. You'll also need to be able to provide written consent and attend follow-up appointments at a clinical center. However, there are some people who won't be eligible, such as those with certain medical conditions that could interfere with the study or individuals who had a previous trial with a similar device without success. If you qualify, you can expect to have regular check-ins to assess how well the device is working for you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18 years or older
• • 2. Primary indication of OAB (urinary urgency incontinence (UUI) / urinary frequency (UF) who are not candidates for, or who have failed conservative treatment
• • 3. Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments
• Exclusion Criteria:
• • 1. Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (i.e., neurological conditions such as multiple sclerosis)
• • 2. Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements
• • 3. Previously underwent an external sacral neuromodulation SNM trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder)
• • 4. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
• • 5. A female who is breastfeeding
• • 6. A female with a positive urine pregnancy test