What this study is
Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).
What's being tested
- Axonics External Trial System (ETS)
Intervention · DEVICE
A temporary electrode wire is passed through the S3 foramen with or without fluoroscopic guidance. The wire is then connected to an external pulse generator (EPG) and is worn for a trial period ranging from 3-7 days.
Study details
- Official title
- Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Axonics External Trial System (ETS-02)
- Sponsor
- Axonics, Inc.
- Conditions
- Urinary Urge Incontinence (UUI) · Urinary Frequency (UF) · Fecal Incontinence (FI) · Overactive Bladder (OAB)
- Enrolling
- 75 people
- Starts
- 2026-04-30
- Est. completion
- 2026-12
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 18 years or older
- Provides written informed consent prior to trial procedures
- Primary indication of OAB (UUI/UF) or chronic FI who are considered candidates for an Axonics PNE procedure as assessed by the physician per product IFU
You can't join if
- Any participant that the study Investigator deems to be a poor candidate for any reason, including, but not limited to, inability to complete a baseline bladder or bowel diary or to be compliant with study visits
- Planned changes to current regimen of medications during the trial period that could impact bladder or bowel function
- Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture)
- Current symptomatic urinary tract infection (UTI)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (5)
5 openUniversity of Birmingham, Alabama
Birmingham, Alabama, United States
- Alisha Hitt · Contact
- Adam Baumgarten, MD · Principal investigator
RecruitingAtrium Health - Navicent
Macon, Georgia, United States
- Jennifer Crawford, PhD · Contact
- David Lovejoy, MD · Principal investigator
RecruitingSouthern Urogynecology
West Columbia, South Carolina, United States
- Tina McGready · Contact
- Andrea Pezzella, MD · Principal investigator
Recruiting
2 sites outside the US
Calvary North Adelaide Hospital/Better Bladders
North Adelaide, South Australia, Australia
- Darcy Noll, MD · Contact
- Ailsa Wilson Edwards, MD · Principal investigator
RecruitingEpworth Freemasons Hospital
East Melbourne, Victoria, Australia
- Grace Wood · Contact
- Sandra Elmer, MD · Principal investigator
Recruiting
Study team
Sponsor
Axonics, Inc.
Study ID 105-0179
Principal investigator
Ailsa Wilson Edwards, MD
Calvary North Adelaide Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.