Axonics SacRal NeuromodulaTIon System RegisTRY Study

Completed

• Conditions: Urinary Urge Incontinence; Urgency-Frequency; Urinary Retention; Fecal Incontinence

• Registration Number: NCT05064384
• Lead Sponsor: Axonics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-30
• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-09-22
• Study First Posted: 2021-10-01
• Primary Completion: 2023-10-06
• Study Completion: 2023-10-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Therapy Responder Rate	1 year	Participants with the External Trial Stimulator and received the Axonics System

Trial Locations

Locations (25)

Northwestern; 🇺🇸 Chicago, Illinois, United States

Urologic Research and Consulting; 🇺🇸 Englewood, New Jersey, United States

Center for Pelvic Health; 🇺🇸 Franklin, Tennessee, United States

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Arizona State Urological Institute; 🇺🇸 Phoenix, Arizona, United States

Arkansas Urology Research Center; 🇺🇸 Little Rock, Arkansas, United States

Sansum Clinic Urology; 🇺🇸 Santa Barbara, California, United States

Urologic Solutions; 🇺🇸 Fort Myers, Florida, United States

Florida Urogynecology and Reconstructive Surgery; 🇺🇸 Jacksonville, Florida, United States

Florida Urology Partners; 🇺🇸 Tampa, Florida, United States

Pinellas Urology; 🇺🇸 Saint Petersburg, Florida, United States

Georgia Urology; 🇺🇸 McDonough, Georgia, United States

Chesapeake Urology; 🇺🇸 Hanover, Maryland, United States

Adult Pediatric Urology & Urogynecology; 🇺🇸 Omaha, Nebraska, United States

Comprehensive Urology; 🇺🇸 Royal Oak, Michigan, United States

The Urology Center PC; 🇺🇸 Omaha, Nebraska, United States

Atrium Health; 🇺🇸 Charlotte, North Carolina, United States

Urologic Specialists Oklahoma; 🇺🇸 Tulsa, Oklahoma, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

The Female Pelvic Health Center; 🇺🇸 Newtown, Pennsylvania, United States

Southern Urogynecology; 🇺🇸 West Columbia, South Carolina, United States

Institute for Female Pelvic Medicine and Reconstructive Surgery; 🇺🇸 Allentown, Pennsylvania, United States

Ochsner Health; 🇺🇸 New Orleans, Louisiana, United States

LSU Health; 🇺🇸 New Orleans, Louisiana, United States