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Aquarius Pilot Study to Evaluate the New Axonics Trial System

Recruiting

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

Who can join

Ages 18 and older · All sexes

Full 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)

About the study

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

What is being tested

Sponsor: Axonics, Inc. · Participants: 75 · Started: Apr 30, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07335484

Locations in the U.S.

South CarolinaSouthern Urogynecology, West Columbia

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.