Axonics SacRal NeuromodulaTIon System RegisTRY Study (ARTISTRY)

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).

Full description

The study will be a prospective, multi-center, single-arm, post-market registry study. Participant outcomes will be compared to their baseline, with participants serving as their own control.

The study is expected to complete enrollment in approximately 24 months and follow the patients per protocol for 1 year. The study was conducted at approximately 30 centers in the United States and Canada.

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 design