An interventional study of Axonics External Trial System (ETS) in Urinary Urge Incontinence (UUI), Urinary Frequency (UF) and Fecal Incontinence (FI), sponsored by Axonics, Inc.. Recruiting at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Axonics, Inc. (part of Boston Scientific Corporation) · Not applicable, Interventional, and Treatment
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).
242 studies on the registry are indexed under Urinary Incontinence, Urge; 39 are open to participants now.
This study's planned enrollment of 75 is below the median of 86 across 190 interventional studies indexed under Urinary Incontinence, Urge.
Browse Urinary Incontinence, Urge studies →Axonics, Inc. is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
First submitted after Axonics, Inc. became part of Boston Scientific Corporation.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
External trial system used evaluated whether patients with OAB or FI will be responsive to sacral neuromodulation.
Device: 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.
Also known as: Basic or Advanced Trial
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.
Time frame: Day 5-7
Adverse Events reporting (Safety)
Device- or procedure-related adverse events as determined by the independent physician adjudicated (IPA).
Time frame: Day 0-7
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Nov 2026, 7 months after the start.
Of 77 interventional studies with no phase under Urinary Incontinence, Urge, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.