RecruitingNot ApplicableNCT06789406

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

Post-Market Clinical Follow-up Study of the Axonics SNM System Model 5101 (R20)

Sponsor

Axonics, Inc.

Enrollment

55 participants

Start Date

Sep 18, 2025

Study Type

INTERVENTIONAL

Conditions

Overactive Bladder (OAB)Urinary Urge Incontinence (UUI)Urinary Frequency (UF)

Summary

Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

years or older
Primary indication of OAB (urinary urgency incontinence (UUI) / urinary frequency (UF) who are not candidates for, or who have failed conservative treatment
Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments

Exclusion Criteria6

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)
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
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)
History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
A female who is breastfeeding
A female with a positive urine pregnancy test

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Interventions

DEVICEAxonics SNM System INS Model 5101 (R20)

Participants treated with the rechargeable Axonics SNM System Model 5101 also referred to as R20. Commercial devices used in this study are within their intended use as described in each geography's approved instructions for use.