Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Axonics External Trial System (ETS-02)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Australia
Epworth Freemasons Hospital
RECRUITING
East Melbourne
Calvary North Adelaide Hospital/Better Bladders
RECRUITING
North Adelaide
Contact Information
Primary
Erum Shaikh
Erum.Shaikh@bsci.com
657.626.4310
Backup
Gita Ghadimi, OD
Gita.Ghadimi@bsci.com
949-981-4366
Time Frame
Start Date: 2026-04-30
Estimated Completion Date: 2026-12
Participants
Target number of participants: 75
Treatments
Experimental: Patients diagnosed with OAB and/or FI who are candidates for Axonics SNM (PNE) procedure
External trial system used evaluated whether patients with OAB or FI will be responsive to sacral neuromodulation.
Related Therapeutic Areas
Sponsors
Leads: Axonics, Inc.