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Aquarius Pilot Study to Evaluate the New Axonics Trial System

NCT07335484 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-05-12

No results posted yet for this study

Summary

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

Conditions

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

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.

Sponsors & Collaborators

  • Axonics, Inc.

    lead INDUSTRY

Principal Investigators

  • Ailsa Wilson Edwards, MD · Calvary North Adelaide Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-09-30
Completion
2026-12-31
FDA Device
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07335484 on ClinicalTrials.gov