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RecruitingNCT07335484Updated Sep 14, 2026

Aquarius Pilot Study to Evaluate the New Axonics Trial System

An interventional study of Axonics External Trial System (ETS) in Urinary Urge Incontinence (UUI), Urinary Frequency (UF) and Fecal Incontinence (FI), sponsored by Axonics, Inc.. Recruiting at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Axonics, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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).

02

Conditions studied

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

Keywords

  • Peripheral nerve evaluation
  • External trial system
  • Pilot study
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • 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)

Interventions

  • DeviceAxonics 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.

    Also known as: Basic or Advanced Trial

05

What researchers measure

Primary outcomes

  1. Overall Feasibility

    Trial system success rate, defined as the proportion of participants with the Axonics ETS still attached and operable end of the trial period.

    Time frame: Day 5-7

  2. Adverse Events reporting (Safety)

    Device- or procedure-related adverse events as determined by the independent physician adjudicated (IPA).

    Time frame: Day 0-7

06

Study locations

3 of 3 sites recruiting
  • Southern Urogynecology
    West Columbia, South Carolina 29169, United States
    • Tina McGready · Contact
    • Andrea Pezzella, MD · Principal investigator
    Recruiting
  • Calvary North Adelaide Hospital/Better Bladders
    North Adelaide, South Australia 5006, Australia
    • Darcy Noll, MD · Contact
    • Ailsa Wilson Edwards, MD · Principal investigator
    Recruiting
  • Epworth Freemasons Hospital
    East Melbourne, Victoria 3002, Australia
    • Grace Wood · Contact
    • Sandra Elmer, MD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07335484
Lead sponsor
Axonics, Inc.
Responsible party
Sponsor
First posted
Jan 13, 2026
Start date
Apr 30, 2026
Primary completion
Nov 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 14, 2026

Study contacts

Erum Shaikh
Contact
Erum.Shaikh@bsci.com
657.626.4310
Gita Ghadimi, OD
Contact
Gita.Ghadimi@bsci.com
949-981-4366
Ailsa Wilson Edwards, MD
principal investigator · Calvary North Adelaide Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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