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)

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

The trial system is used to determine if patients are responsive to sacral neuromodulation (SNM) prior to receiving the Axonics implantable neurostimulator (INS) which is approved for the treatment of OAB and FI. This study is evaluating the feasibility and safety of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).

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)