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To assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s).
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Inclusion criteria
Exclusion criteria
For all indications:
Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints
Any psychiatric or personality disorder at the discretion of the study physician
History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
A female who is breastfeeding
A female with a positive urine pregnancy test
For OAB & UR:
Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
Current symptomatic urinary tract infection (UTI)
For FI only:
Rectomucosal prolapse or congenital anorectal malformation
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Data sourced from clinicaltrials.gov
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