Aquarius Pilot of the New Axonics External System for Bladder and Bowel Control
Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Axonics External Trial System (ETS-02)
This pilot will try the Axonics External Trial System in adults with overactive bladder or fecal incontinence to see if they respond to sacral neuromodulation before getting a permanent implant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Axonics, Inc. Industry-sponsored |
| Locations | 1 site (North Adelaide, South Australia) |
| Trial ID | NCT07335484 on ClinicalTrials.gov |
What this trial studies
The Aquarius Pilot tests the Axonics External Trial System (ETS-02) in adults with overactive bladder (OAB) or chronic fecal incontinence (FI) to evaluate feasibility and safety. Participants undergo a temporary external sacral neuromodulation trial using the ETS-02 to determine symptomatic response prior to consideration of the approved Axonics implantable neurostimulator. The study collects bladder or bowel diaries, tracks symptom changes, and records device-related adverse events with scheduled follow-up visits. Results will inform whether the ETS-02 can reliably identify candidates for permanent sacral neuromodulation.
Who should consider this trial
Good fit: Adults 18 or older with OAB (urinary urgency incontinence or frequency) or chronic fecal incontinence who are considered candidates for a percutaneous nerve evaluation and can complete symptom diaries and follow study visits.
Not a fit: Patients with current urinary tract obstruction or symptomatic UTI, those planning medication changes that affect bladder or bowel function, or anyone unable to complete baseline diaries or comply with study visits may not receive benefit from this external trial.
Why it matters
Potential benefit: If successful, the ETS-02 could help identify which patients will benefit from a permanent Axonics implant while avoiding unnecessary surgery for non-responders.
How similar studies have performed: Sacral neuromodulation with Axonics implants is approved and effective for OAB and FI and external temporary trials are commonly used to identify responders, but the ETS-02 device itself is being piloted for feasibility and safety.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
North Adelaide, South Australia
- Calvary North Adelaide Hospital/Better Bladders — North Adelaide, South Australia, Australia (Recruiting)
Study contacts
- Principal investigator: Ailsa Wilson Edwards, MD — Calvary North Adelaide Hospital
- Study coordinator: Erum Shaikh
- Email: Erum.Shaikh@bsci.com
- Phone: 657.626.4310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.