Aquarius Pilot Study to Evaluate the New Axonics Trial System

May 11, 2026 updated by: Axonics, Inc.

Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Axonics External Trial System (ETS-02)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The trial system is used to determine if patients are responsive to sacral neuromodulation (SNM) prior to receiving the Axonics implantable neurostimulator (INS) which is approved for the treatment of OAB and FI. This study is evaluating the feasibility and safety of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
        • Recruiting
        • Calvary North Adelaide Hospital/Better Bladders
        • Contact:
          • Darcy Noll, MD
        • Principal Investigator:
          • Ailsa Wilson Edwards, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.
Other Names:
  • Basic or Advanced Trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Feasibility
Time Frame: 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.
Day 5-7
Adverse Events reporting (Safety)
Time Frame: Day 0-7
Device- or procedure-related adverse events as determined by the independent physician adjudicated (IPA).
Day 0-7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axonics, Inc.

Collaborators

Pacific Clinical Research Group

Investigators

  • Principal Investigator: Ailsa Wilson Edwards, MD, Calvary North Adelaide Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105-0179

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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