Axonics SacRal NeuromodulaTIon System RegisTRY Study

Completed

Conditions studied: Urinary Retention, Urinary Urge Incontinence, Urgency-Frequency, Fecal Incontinence

In brief

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

Key facts

Study ID

NCT05064384

Run by

Axonics, Inc.

People needed

272

Starts

2020-11-30

Expected to finish

2024-03-31

Last updated by the study team

2025-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Willing and capable of providing informed consent
• Capable of participating in all testing associated with this clinical investigation

You may not qualify if…

• 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

Where it is running

• Arkansas Urology Research Center — Little Rock, Arkansas, United States
• University of California, Irvine — Irvine, California, United States
• Stanford Medicine — Redwood City, California, United States
• Sansum Clinic Urology — Santa Barbara, California, United States
• Manatee Medical Research Institute — Bradenton, Florida, United States
• Urologic Solutions — Fort Myers, Florida, United States
• Florida Urology Partners — North Redington Beach, Florida, United States
• Pinellas Urology — St. Petersburg, Florida, United States
• Florida Urology Partners — Tampa, Florida, United States
• Northwestern — Chicago, Illinois, United States
• LSU Health — New Orleans, Louisiana, United States
• Ochsner Health — New Orleans, Louisiana, United States
• Chesapeake Urology — Hanover, Maryland, United States
• Comprehensive Urology — Royal Oak, Michigan, United States
• Adult Pediatric Urology & Urogynecology — Omaha, Nebraska, United States
• The Urology Center PC — Omaha, Nebraska, United States
• New Jersey Urology — Englewood, New Jersey, United States
• Stony Brook University — Stony Brook, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Urologic Specialists Oklahoma — Tulsa, Oklahoma, United States
• Institute for Female Pelvic Medicine and Reconstructive Surgery — Allentown, Pennsylvania, United States
• Penn State University — Hershey, Pennsylvania, United States
• The Female Pelvic Health Center — Newtown, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Southern Urogynecology — West Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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