Urinary Urge Incontinence (UUI)NCT06186765
F15 Recharge Free Axonics SNM System Clinical Study
A study testing Axonics SNM System (Model 4101) in people with Urinary Urge Incontinence (UUI) and Urinary Frequency (UF), run by Axonics, Inc. at 16 sites in 3 countries.
Trial summary
Multicenter, prospective, non randomized, single arm evaluation of patients with overactive bladder (OAB) and/or fecal incontinence (FI) employing the Axonics recharge free SNM System. 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 SNM System (Model 4101)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 8 Dec 2023to Dec 2027
- 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
- Primary indication of overactive bladder (OAB) (urinary urgency incontinence (UUI)/ urinary frequency (UF)) or fecal incontinence (FI) who are not candidates for, or who have failed conservative treatment
- Willing and capable to provide written informed consent and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year.
Who cannot join
- Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (exclusion of neurological conditions such as multiple sclerosis)
- Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements
- Previously underwent an external sacral neuromodulation (SNM) trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder)
- History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
- A female who is breastfeeding
- A female with a positive urine pregnancy test
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
United States11 sites
Florida Gulf Clinical Research
Bradenton, Florida, 34205
Minnesota Urology
Coon Rapids, Minnesota, 55433
Houston Colon
Houston, Texas, 77030
East Coast Institute of Research
Jacksonville, Florida, 32216
Atrium Health
Macon, Georgia, 31201
Southern Shores Urogynecology
Myrtle Beach, South Carolina, 29572
Florida Bladder Institute
Naples, Florida, 34109
Columbia University Medical Center
New York, New York, 10032
Adult Pediatric Urology & Urogynecology
Omaha, Nebraska, 68114
The Oregon Clinic
Portland, Oregon, 97225
Hartford Healthcare
Waterford, Connecticut, 06385
United Kingdom4 sites
Queen Elizabeth Hospital
Birmingham, B15 2TH
Bristol Urological Institute
Bristol, BS105NB
University College London Hospital
London, W1G 8PH
Northern General Hospital
Sheffield, S5 7AU
About this study
Official title: Prospective, Non-randomized, Multicenter Clinical Evaluation of the Recharge Free Axonics SNM System (Model 4101)
Multicenter, prospective, non randomized, single arm evaluation of patients with overactive bladder (OAB) and/or fecal incontinence (FI) employing the Axonics recharge free SNM System.
Read the detailed description
A clinical evaluation to comply with new European Medical Device Regulations (EU MDR) guidelines. Multicenter, prospective, non-randomized, single arm study for OAB and/or FI to assess the safety and performance of the Food and Drug Administration (FDA) approved Axonics recharge free sacral neuromodulation (SNM) System, INS Model 4101. The product is currently marketed under the name F15.
- Being tested
- Axonics SNM System (Model 4101)
- Medical subject headings
- Urinary Incontinence, Urge, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axonics SNM System (Model 4101)Device
Safety and performance/effectiveness assessment of the recharge free Axonics SNM System (Model 4101 in participants with overactive bladder (OAB) or fecal incontinence (FI).
| Study group | Role | What they receive |
|---|---|---|
| Single Arm - Treatment Groups separated into OAB and FI | Other | Treatment Arm separated into 2 cohorts:
1. Overactive Bladder (OAB)
2. Fecal incontinence (FI) Receives: Device: Axonics SNM System (Model 4101) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance/Effectiveness - Improvement in Quality of Life scoring (OAB)
International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement.
Measured: 3 months
Performance/Effectiveness - Improvement in Fecal Incontinence Survey
Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): includes 5 items (solid, liquid, gas, wears pad and lifestyle alteration) and 5 frequencies (never = 0, rarely = 1, sometimes = 2, usually = 3, always = 4). Scores range from 0 for full continence to 20 for complete incontinence. A higher score is indicative of the severity of fecal incontinence.
Measured: 3 months
Adverse event reporting (Safety)
Device-related, procedure-related and all serious adverse events
Measured: 3 months
Secondary outcomes (4)
Performance/Effectiveness - Improvement in Quality of Life scoring (OAB)
International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement.
Measured: 1 year
Performance/Effectiveness - Improvement in Fecal Incontinence Survey
Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): includes 5 items (solid, liquid, gas, wears pad and lifestyle alteration) and 5 frequencies (never = 0, rarely = 1, sometimes = 2, usually = 3, always = 4). Scores range from 0 for full continence to 20 for complete incontinence. A higher score is indicative of the severity of fecal incontinence.
Measured: 1 year
Performance/Effectiveness - Improvement in Quality of Life Survey (FI)
Fecal Incontinence Quality of Life (FIQoL): includes four different subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Subscale scores range from 1 to 5, with 1 indicating lower functional status of qualify of life.
Measured: 3 months, 6 months, 1 year
Adverse event reporting (Safety)
Device-related, procedure-related and all serious adverse events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start8 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (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
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Bertil Blok, MD, PhD, Principal investigator, Erasmus Medical CenterGita Ghadimi, OD, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186765
- Sponsor's protocol ID
- 105-0108
- Status last verified
- Oct 2026
- First submitted
- 13 Dec 2023
- 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, Non-randomized, Multicenter Clinical Evaluation of the Recharge Free Axonics SNM System (Model 4101)
- ClinicalTrials.gov ID
- NCT06186765
- Acronym / sponsor ID
- 105-0108
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Axonics, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Jan 2024 (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.
Multicenter, prospective, non randomized, single arm evaluation of patients with overactive bladder (OAB) and/or fecal incontinence (FI) employing the Axonics recharge free SNM System.
Detailed description
A clinical evaluation to comply with new European Medical Device Regulations (EU MDR) guidelines. Multicenter, prospective, non-randomized, single arm study for OAB and/or FI to assess the safety and performance of the Food and Drug Administration (FDA) approved Axonics recharge free sacral neuromodulation (SNM) System, INS Model 4101. The product is currently marketed under the name F15.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm - Treatment Groups separated into OAB and FI | Other | Device: Axonics SNM System (Model 4101)Treatment Arm separated into 2 cohorts: 1. Overactive Bladder (OAB) 2. Fecal incontinence (FI) |
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
- Primary indication of overactive bladder (OAB) (urinary urgency incontinence (UUI)/ urinary frequency (UF)) or fecal incontinence (FI) who are not candidates for, or who have failed conservative treatment
- Willing and capable to provide written informed consent and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year.
Key exclusion criteria (6 listed)
- Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (exclusion of neurological conditions such as multiple sclerosis)
- Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements
- Previously underwent an external sacral neuromodulation (SNM) trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder)
- History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
- A female who is breastfeeding
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 SNM System (Model 4101)Safety and performance/effectiveness assessment of the recharge free Axonics SNM System (Model 4101 in participants with overactive bladder (OAB) or fecal incontinence (FI). | Device | Single Arm - Treatment Groups separated into OAB and FI |
Primary outcome
Performance/Effectiveness - Improvement in Quality of Life scoring (OAB)
Time frame: 3 months
International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement.
Performance/Effectiveness - Improvement in Fecal Incontinence Survey
Time frame: 3 months
Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): includes 5 items (solid, liquid, gas, wears pad and lifestyle alteration) and 5 frequencies (never = 0, rarely = 1, sometimes = 2, usually = 3, always = 4). Scores range from 0 for full continence to 20 for complete incontinence. A higher score is indicative of the severity of fecal incontinence.
Adverse event reporting (Safety)
Time frame: 3 months
Device-related, procedure-related and all serious adverse events
4 secondary outcomes
Performance/Effectiveness - Improvement in Quality of Life scoring (OAB)
Time frame: 1 year
Performance/Effectiveness - Improvement in Fecal Incontinence Survey
Time frame: 1 year
Performance/Effectiveness - Improvement in Quality of Life Survey (FI)
Time frame: 3 months, 6 months, 1 year
Adverse event reporting (Safety)
Time frame: 1 year
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
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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.
Prof. Bertil Blok, MD, PhD principal investigator
Erasmus Medical Center
Gita Ghadimi, OD study director
Boston Scientific Corporation
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axonics SNM System (Model 4101) in people with Urinary Urge Incontinence (UUI) and Urinary Frequency (UF), run by Axonics, Inc. at 16 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?
The sponsor lists 3 inclusion and 6 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: under way, not looking for participants, 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 16 sites in United States, United Kingdom, Netherlands. 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?
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?
Performance/Effectiveness - Improvement in Quality of Life scoring (OAB) (time frame: 3 months). The study lists 3 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.