Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).
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
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)
Single group
Axonics External Trial System (ETS)
DeviceA 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.
Overall Feasibility
Trial system success rate, defined as the proportion of participants with the Axonics ETS still attached and operable end of the trial period.
Adverse Events reporting (Safety)
Device- or procedure-related adverse events as determined by the independent physician adjudicated (IPA).
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