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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
- Axonics External Trial System (ETS) (device)
Sponsor: Axonics, Inc. · Participants: 75 · Started: Apr 30, 2026
Contact the study team
- Erum Shaikh · Phone: 657.626.4310
- Gita Ghadimi, OD · Phone: 949-981-4366
Official record on ClinicalTrials.gov — NCT07335484
Locations in the U.S.
| South Carolina | Southern 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.