Urinary Urge Incontinence (UUI)NCT07335484
Aquarius Pilot Study to Evaluate the New Axonics Trial System
A study testing Axonics External Trial System (ETS) in people with Urinary Urge Incontinence (UUI) and Urinary Frequency (UF), run by Axonics, Inc. at 5 sites in 2 countries.
Trial summary
Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Urge Incontinence (UUI), Urinary Frequency (UF), Fecal Incontinence (FI)
- What is being tested?
- Axonics External Trial System (ETS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 30 Apr 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
University of Birmingham, Alabama
Birmingham, Alabama, 35294
Alisha Hitt
Adam Baumgarten, MD
- Recruiting
Atrium Health - Navicent
Macon, Georgia, 31201
Jennifer Crawford, PhD
David Lovejoy, MD
- Recruiting
Southern Urogynecology
West Columbia, South Carolina, 29169
Tina McGready
Andrea Pezzella, MD
Australia2 sites, 2 recruiting
- Recruiting
Epworth Freemasons Hospital
East Melbourne, Victoria, 3002
Grace Wood
Sandra Elmer, MD
- Recruiting
Calvary North Adelaide Hospital/Better Bladders
North Adelaide, South Australia, 5006
Darcy Noll, MD
Ailsa Wilson Edwards, MD
About this study
Official title: 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).
Read the detailed description
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).
- Conditions
- Urinary Urge Incontinence (UUI), Urinary Frequency (UF), Fecal Incontinence (FI), Overactive Bladder (OAB)
- Being tested
- Axonics External Trial System (ETS)
- Keywords
- Peripheral nerve evaluation, External trial system, Pilot study
- Medical subject headings
- Urinary Incontinence, Urge, Fecal Incontinence, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axonics External Trial System (ETS)Device
Also called Basic or Advanced Trial
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 group | Role | What they receive |
|---|---|---|
| Patients diagnosed with OAB and/or FI who are candidates for Axonics SNM (PNE) procedure | Experimental | External trial system used evaluated whether patients with OAB or FI will be responsive to sacral neuromodulation. Receives: Device: Axonics External Trial System (ETS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 5-7
Adverse Events reporting (Safety)
Device- or procedure-related adverse events as determined by the independent physician adjudicated (IPA).
Measured: Day 0-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start30 Apr 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Urge Incontinence (UUI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ailsa Wilson Edwards, MD, Principal investigator, Calvary North Adelaide Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335484
- Sponsor's protocol ID
- 105-0179
- Status last verified
- Oct 2026
- First submitted
- 6 Jan 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Axonics External Trial System (ETS-02)
- ClinicalTrials.gov ID
- NCT07335484
- Acronym / sponsor ID
- 105-0179
- Conditions
- Urinary Urge Incontinence (UUI), Urinary Frequency (UF), Fecal Incontinence (FI), Overactive Bladder (OAB)
- Keywords
- Peripheral nerve evaluation, External trial system, Pilot study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Axonics, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with OAB and/or FI who are candidates for Axonics SNM (PNE) procedure | Experimental | Device: Axonics External Trial System (ETS)External trial system used evaluated whether patients with OAB or FI will be responsive to sacral neuromodulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axonics External Trial System (ETS)Also: Basic or Advanced TrialA 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. | Device | Patients diagnosed with OAB and/or FI who are candidates for Axonics SNM (PNE) procedure |
Primary outcome
Overall Feasibility
Time frame: 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)
Time frame: Day 0-7
Device- or procedure-related adverse events as determined by the independent physician adjudicated (IPA).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Urinary Urge Incontinence (UUI)
Active, not recruiting
F15 Recharge Free Axonics SNM System Clinical Study
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
Recruiting
PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
Recruiting
Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System
Urinary Urge Incontinence
Recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ailsa Wilson Edwards, MD principal investigator
Calvary North Adelaide Hospital
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axonics External Trial System (ETS) in people with Urinary Urge Incontinence (UUI) and Urinary Frequency (UF), run by Axonics, Inc. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erum Shaikh (657.626.4310, Erum.Shaikh@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Feasibility (time frame: Day 5-7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.