F15 Recharge Free Axonics SNM System Clinical Study

Launched by AXONICS, INC. · Dec 28, 2023

Keywords

ClinConnect Summary

The F15 Recharge Free Axonics SNM System Clinical Study is looking at a new treatment option for people experiencing urinary urge incontinence (the sudden, strong urge to urinate), urinary frequency (needing to urinate often), and fecal incontinence (involuntary loss of bowel control). This study involves patients who have tried other treatments without success and are at least 18 years old. The goal is to see how well the Axonics rechargeable neuromodulation system works for these conditions.

To participate, individuals need to be willing to provide consent and attend regular follow-up visits for up to a year. However, some people may not qualify if they have certain medical conditions, like neurological disorders, or if they've tried a similar treatment before without success. Throughout the study, participants can expect to be closely monitored to assess the effectiveness of the new device, helping doctors better understand its benefits for managing these challenging conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18 years or older
• • 2. Primary indication of overactive bladder (OAB) (urinary urgency incontinence (UUI)/ urinary frequency (UF)) or fecal incontinence (FI) who are not candidates for, or who have failed conservative treatment
• • 3. Willing and capable to provide written informed consent and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year.
• Exclusion Criteria:
• • 1. Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (exclusion of 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