PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAxonics, Inc.
About this trial
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 criteria
Qualifiers
18 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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Axonics SNM System INS Model 5101 (R20)
Treatment groups
55 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov