About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Axonics External Trial System (ETS)

Treatment groups

75 Participants
are divided into 1 treatment group

Locations

2
Calvary North Adelaide Hospital/Better Bladders5006, North AdelaideSouth Australia, Australia
Epworth Freemasons Hospital3002, East MelbourneVictoria, Australia

Sponsors and collaborators

Axonics, Inc.

Lead sponsor