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NCT Number: NCT07335484

Aquarius Pilot Study to Evaluate the New Axonics Trial System

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

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Key information

Conditions

Urinary Urge Incontinence (UUI) Digestive System Diseases Fecal Incontinence Fecal Incontinence (FI) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Intestinal Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Overactive Bladder (OAB) Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Frequency (UF) Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Calvary North Adelaide Hospital/Better Bladders, North Adelaide, South Australia, Australia

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Axonics External Trial System (ETS)

Device

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

Primary outcomes

  1. 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.

  2. Adverse Events reporting (Safety)

    Time frame: Day 0-7

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

Study contacts

Contact information is provided by the study sponsor or research team.

Erum Shaikh

CONTACT

[email protected]

657.626.4310

Gita Ghadimi, OD

CONTACT

[email protected]

949-981-4366

Sponsors and collaborators

Lead sponsor

Axonics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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