Aquarius Pilot of the New Axonics External System for Bladder and Bowel Control

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Birmingham, Alabama
  Birmingham, Alabama, United States Recruiting
• Atrium Health - Navicent
  Macon, Georgia, United States Recruiting
• Southern Urogynecology
  West Columbia, South Carolina, United States Recruiting
• Calvary North Adelaide Hospital/Better Bladders
  North Adelaide, South Australia, Australia Recruiting
• Epworth Freemasons Hospital
  East Melbourne, Victoria, 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.