Axonics SacRal NeuromodulaTIon System RegisTRY Study

Fecal Incontinence Clinical Trial

— ARTISTRY  

Official title:

Axonics SacRal NeuromodulaTIon System RegisTRY Study : ARTISTRY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05064384
• Other study ID #: 105-0076
• Status: Completed
• Start date: November 30, 2020
• Est. completion date: October 6, 2023

Study information

• Verified date: April 2024
• Source: Axonics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: October 6, 2023
• Est. primary completion date: October 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fecal Incontinence
• Urgency-Frequency
• Urinary Incontinence, Urge
• Urinary Retention
• Urinary Urge Incontinence

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
United States	Institute for Female Pelvic Medicine and Reconstructive Surgery	Allentown	Pennsylvania
United States	Atrium Health	Charlotte	North Carolina
United States	Northwestern	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Urologic Research and Consulting	Englewood	New Jersey
United States	Urologic Solutions	Fort Myers	Florida
United States	Center for Pelvic Health	Franklin	Tennessee
United States	Chesapeake Urology	Hanover	Maryland
United States	Florida Urogynecology and Reconstructive Surgery	Jacksonville	Florida
United States	Arkansas Urology Research Center	Little Rock	Arkansas
United States	Georgia Urology	McDonough	Georgia
United States	Florida Urology Partners	N. Redington Beach	Florida
United States	LSU Health	New Orleans	Louisiana
United States	Ochsner Health	New Orleans	Louisiana
United States	The Female Pelvic Health Center	Newtown	Pennsylvania
United States	Adult Pediatric Urology & Urogynecology	Omaha	Nebraska
United States	The Urology Center PC	Omaha	Nebraska
United States	Arizona State Urological Institute	Phoenix	Arizona
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Comprehensive Urology	Royal Oak	Michigan
United States	Pinellas Urology	Saint Petersburg	Florida
United States	Sansum Clinic Urology	Santa Barbara	California
United States	Florida Urology Partners	Tampa	Florida
United States	Urologic Specialists Oklahoma	Tulsa	Oklahoma
United States	Southern Urogynecology	West Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Axonics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapy Responder Rate	Participants with the External Trial Stimulator and received the Axonics System	1 year