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
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
Inclusion Criteria3
- 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 Criteria4
- 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)
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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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07335484
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