Aquarius Pilot Study to Evaluate the New Axonics Trial System

Recruiting now · Not applicable

Conditions studied: Urinary Urge Incontinence (UUI), Urinary Frequency (UF), Fecal Incontinence (FI), Overactive Bladder (OAB)

In brief

Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).

Key facts

Study ID

NCT07335484

Run by

Axonics, Inc.

People needed

75

Starts

2026-04-30

Expected to finish

2026-12-01

Last updated by the study team

2026-07-13

Who can join

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

You 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 may not qualify 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)

Where it is running

• Calvary North Adelaide Hospital/Better Bladders — North Adelaide, South Australia, Australia (enrolling)
• Epworth Freemasons Hospital — East Melbourne, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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