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Axonics SacRal NeuromodulaTIon System RegisTRY Study (ARTISTRY)

A

Axonics

Status

Completed

Conditions

Urinary Retention
Urgency-Frequency
Urinary Urge Incontinence
Fecal Incontinence

Study type

Observational

Funder types

Industry

Identifiers

NCT05064384
105-0076

Details and patient eligibility

About

To assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s).

Enrollment

272 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients scheduled to be trialed with the Axonics External Trial System (ETS), or patients scheduled to receive an Axonics Implantable neurostimulator (INS) or Axonics FS implant
  2. Willing and capable of providing informed consent
  3. Capable of participating in all testing associated with this clinical investigation

Exclusion criteria

For all indications:

  1. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints

  2. Any psychiatric or personality disorder at the discretion of the study physician

  3. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone

  4. A female who is breastfeeding

  5. A female with a positive urine pregnancy test

    For OAB & UR:

  6. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)

  7. Current symptomatic urinary tract infection (UTI)

    For FI only:

  8. Rectomucosal prolapse or congenital anorectal malformation

Trial contacts and locations

26

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Data sourced from clinicaltrials.gov

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