Urinary Incontinence, UrgeARTISAN-SNMNCT03327948
Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt
A study testing Axonics Sacral Neuromodulation System (SNM) System in people with Urinary Incontinence, Urge, run by Axonics, Inc. at 4 sites in 3 countries.
Trial summary
The ARTISAN-SNM study is designed to evaluate the safety and effectiveness of the Axonics Sacral Neuromodulation System as an aid in the treatment of the symptoms of urinary urgency incontinence (UUI) in patients who have failed or could not tolerate more conservative treatments. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Urinary Incontinence, Urge
- What is being tested?
- Axonics Sacral Neuromodulation System (SNM) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 21 Nov 2017to 29 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Primary Inclusion Criteria:
- Diagnosis of UUI demonstrated on a 72-hour voiding diary defined as a minimum of four (4) leaking episodes associated with urgency, at least 50% of all leaking episodes associated with urgency, and at least one leaking episode each 24-hour period.
- Greater than or equal to 6 months' history of UUI diagnosis
- For male subjects only: Peak flow rate > 15 cc/s as verified by uroflowmetry within 6 months prior to enrollment; Residual bladder volume < 150 cc tested within 6 months prior to enrollment
- 21 years of age and older
- Willing and capable of providing informed consent
- Capable of participating in all testing associated with this clinical investigation
Primary Exclusion Criteria:
- Stress incontinence or mixed incontinence.
- Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
- Interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines
- A female who is breastfeeding
- A female with a positive urine pregnancy test
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Cleveland Clinic
Cleveland, Ohio, 44106
UC Irvine Health
Irvine, California, 95134
About this study
Official title: Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt (ARTISAN-SNM)
The ARTISAN-SNM study is designed to evaluate the safety and effectiveness of the Axonics Sacral Neuromodulation System as an aid in the treatment of the symptoms of urinary urgency incontinence (UUI) in patients who have failed or could not tolerate more conservative treatments.
Read the detailed description
The ARTISAN-SNM Trial which was a single-arm, prospective study that included 29 centers and enrolled 129 participants. The primary aim of the study was to evaluate the safety and efficacy of the Axonics SNM System for the treatment of UUI symptoms. Primary outcome was improvement in UUI episodes on a 3-day bladder diary. Secondary outcomes included quality of life using the ICIQ-OABqol questionnaire, patient satisfaction, and bowel symptoms captured using the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FIS). Participants were followed out to 2 years and data was reported at 6 months, 1 year and 2 years
- Conditions
- Urinary Incontinence, Urge
- Being tested
- Axonics Sacral Neuromodulation System (SNM) System
- Keywords
- Sacral neuromodulation (SNM), SNM
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axonics Sacral Neuromodulation System (SNM) SystemDevice
Axonics Sacral Neuromodulation System (SNM) System
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Urinary Urgency Incontinence Receives: Device: Axonics Sacral Neuromodulation System (SNM) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Responders
Responders are defined as patients with greater than or equal to 50% reduction in symptoms
Measured: 2 years
Secondary outcomes (3)
ICIQ-OAB-qol
International Consultation on Incontinence Modular Questionnaire (ICIQ)- Overactive Bladder (OAB), Quality of Life (qol). Score range of 0-100, with greater values indicating better quality of life.
Measured: 2 years
Daily Number of Urgency Leaks
The daily number of urgency leaks is measured by a bladder diary
Measured: 2 years
Voids
Measured by a bladder diary
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start21 Nov 2017
- Primary completion18 Jan 2019
- Study completion29 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Incontinence, UrgeStudies 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
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Goldman, MD FACS, Principal investigator, The Cleveland ClinicFelicia Lane, MD, Principal investigator, UC Irvine Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327948
- Sponsor's protocol ID
- 105-0050
- Acronym
- ARTISAN-SNM
- Status last verified
- Oct 2025
- First submitted
- 27 Oct 2017
- Last updated
- 24 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt (ARTISAN-SNM)
- ClinicalTrials.gov ID
- NCT03327948
- Acronym / sponsor ID
- ARTISAN-SNM / 105-0050
- Conditions
- Urinary Incontinence, Urge
- Keywords
- Sacral neuromodulation (SNM), SNM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Axonics, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- 29 Jun 2020 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Posted 3 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ARTISAN-SNM study is designed to evaluate the safety and effectiveness of the Axonics Sacral Neuromodulation System as an aid in the treatment of the symptoms of urinary urgency incontinence (UUI) in patients who have failed or could not tolerate more conservative treatments.
Detailed description
The ARTISAN-SNM Trial which was a single-arm, prospective study that included 29 centers and enrolled 129 participants. The primary aim of the study was to evaluate the safety and efficacy of the Axonics SNM System for the treatment of UUI symptoms. Primary outcome was improvement in UUI episodes on a 3-day bladder diary. Secondary outcomes included quality of life using the ICIQ-OABqol questionnaire, patient satisfaction, and bowel symptoms captured using the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FIS). Participants were followed out to 2 years and data was reported at 6 months, 1 year and 2 years
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Axonics Sacral Neuromodulation System (SNM) SystemUrinary Urgency Incontinence |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 Sacral Neuromodulation System (SNM) SystemAxonics Sacral Neuromodulation System (SNM) System | Device | Treatment group |
Primary outcome
Proportion of Responders
Time frame: 2 years
Responders are defined as patients with greater than or equal to 50% reduction in symptoms
3 secondary outcomes
ICIQ-OAB-qol
Time frame: 2 years
Daily Number of Urgency Leaks
Time frame: 2 years
Voids
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Urinary Incontinence, Urge
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Recruiting
Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device
Urge Urinary Incontinence
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. This study is not recruiting at the moment.
Howard Goldman, MD FACS principal investigator
The Cleveland Clinic
Felicia Lane, MD principal investigator
UC Irvine Health
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axonics Sacral Neuromodulation System (SNM) System in people with Urinary Incontinence, Urge, run by Axonics, Inc. at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Netherlands, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 3 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Responders (time frame: 2 years). 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 24 Oct 2025.