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โ† Trials
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PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB

RecruitingNAAges 18 Years - anyAllAxonics, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. 18 years or older 2. Primary indication of OAB (urinary urgency incontinence (UUI) / urinary frequency (UF) who are not candidates for, or who have failed conservative treatment 3. Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments Exclusion Criteria: 1. 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) 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
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What it tests

  • Axonics SNM System INS Model 5101 (R20)
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Where

6 sites
University of Chicago
Chicago, United States
University of Missouri
Columbia, United States
Bradford Royal Infirmary
Bradford, United Kingdom
Pinderfields Hospital
Wakefield, United Kingdom
St James's University Hospital
Leeds, United Kingdom
University College London Hospital
London, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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