PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB
Recruiting now · Not applicable
Conditions studied: Urinary Urge Incontinence (UUI), Urinary Frequency (UF), Overactive Bladder (OAB)
In brief
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.
Key facts
- Study ID
- NCT06789406
- Run by
- Axonics, Inc.
- People needed
- 55
- Starts
- 2025-09-18
- Expected to finish
- 2031-10-01
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Chicago — Chicago, Illinois, United States (enrolling)
- University of Missouri — Columbia, Missouri, United States (enrolling)
- Bradford Royal Infirmary — Bradford, West Yorkshire, United Kingdom (enrolling)
- Pinderfields Hospital — Wakefield, West Yorkshire, United Kingdom (enrolling)
- University College London Hospital — London, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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