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Clinical Trials in Australia / NCT07335484
Recruiting Not applicable

Aquarius Pilot Study to Evaluate the New Axonics Trial System

NCT07335484 · tracked via the Priya Life Science Australia tracker
Sponsor
Axonics, Inc
Phase
Not applicable
Started
2026-04-30
Last updated
2026-09-14

Condition(s) studied

Urinary Urge Incontinence (UUI)Urinary Frequency (UF)Fecal Incontinence (FI)Overactive Bladder (OAB)

Investigational drug(s) / intervention(s)

Axonics External Trial System (ETS)

Axonics External Trial System (ETS): 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 summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Primary outcome measure(s)

  • Overall Feasibility — Day 5-7
    Trial system success rate, defined as the proportion of participants with the Axonics ETS still attached and operable end of the trial period.
  • Adverse Events reporting (Safety) — Day 0-7
    Device- or procedure-related adverse events as determined by the independent physician adjudicated (IPA).

Trial sites (3)

FacilityCityRegionStatus
Southern Urogynecology West Columbia South Carolina Recruiting
Calvary North Adelaide Hospital/Better Bladders North Adelaide South Australia Recruiting
Epworth Freemasons Hospital East Melbourne Victoria Recruiting

Other trials for the same condition

INOPASE - Performance and Safety Study of a Personalised SNM System Recruiting
Non-invasive Saphenous Nerve Stimulation Therapy for Overactive Bladder Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07335484 on ClinicalTrials.gov ↗ ← All trials in Australia