Urinary Urge Incontinence (UUI)Urinary Frequency (UF)Fecal Incontinence (FI)Overactive Bladder (OAB)
Investigational drug(s) / intervention(s)
Axonics External Trial System (ETS)
Axonics 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.
Study summary
Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Overall Feasibility — Day 5-7 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) — Day 0-7 Device- or procedure-related adverse events as determined by the independent physician adjudicated (IPA).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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