RecruitingNot Applicable

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

United States, United Kingdom55 participantsStarted 2025-09-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB)

Timeframe: 3 months

Adverse event reporting (Safety)

Timeframe: 3 months

Trial details

NCT IDNCT06789406

SponsorAxonics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Anna Selverian

714-262-1787 anna.selverian@bsci.com

View on ClinicalTrials.gov More Urinary Urge Incontinence (UUI) trials