Menu
Recruiting NCT07335484

Aquarius Pilot Study to Evaluate the New Axonics Trial System

No phase Interventional Urinary Urge Incontinence (UUI) Urinary Frequency (UF) Fecal Incontinence (FI) Overactive Bladder (OAB)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Axonics External Trial System (ETS).
Who it may be relevant to
Registry conditions: Urinary Urge Incontinence (UUI), Urinary Frequency (UF), Fecal Incontinence (FI), Overactive Bladder (OAB). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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).

Interventions

  • 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.

Primary outcome measures

  • Overall Feasibility [Time frame: Day 5-7]
  • Adverse Events reporting (Safety) [Time frame: Day 0-7]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Australia · 2 centers
  • Calvary North Adelaide Hospital/Better Bladders — North Adelaide
  • Epworth Freemasons Hospital — East Melbourne

Identifiers

NCT: NCT07335484 · 105-0179

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗