RecruitingNot ApplicableNCT07335484

Aquarius Pilot Study to Evaluate the New Axonics Trial System

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

Sponsor

Axonics, Inc.

Enrollment

75 participants

Start Date

Apr 30, 2026

Study Type

INTERVENTIONAL

Conditions

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

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Axonics External Trial System (ETS) for people with fecal incontinence (fi), overactive bladder (oab), and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.