Overactive BladderNCT06511141
Sacral Neuromodulation for Male Overactive Bladder (MOAB)
A study testing Axonics SNM System in people with Overactive Bladder and Urinary Urgency Incontinence, run by Axonics, Inc. at 23 sites in United States.
Trial summary
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Overactive Bladder, Urinary Urgency Incontinence, Benign Prostatic Hyperplasia
- What is being tested?
- Axonics SNM System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 23 sitesUnited States
- Study dates
- 22 Oct 2024to Dec 2028
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged ≥ 18 years at the time of enrollment
- Able to complete bladder diaries and patient questionnaires
- Primary diagnosis of OAB (urinary urgency incontinence (UUI) or urinary frequency (UF)).
- 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 patient that is not a suitable candidate per investigator discretion
- Recent prostate therapy or procedure within the last 6 months at the time of enrollment
- Any neurological condition that could interfere with normal bladder function, including stroke, epilepsy, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)
- Previously implanted with a sacral neuromodulation device, including inactive SNM devices
- Any prior treatment with an Implantable Tibial Nerve Stimulation (ITNS)
- Positive response to Percutaneous Tibial Nerve Stimulation (PTNS) within the last 3 months at the time of enrollment
Show all 10Show fewer
- Underwent an external trial with any sacral neuromodulation device and was deemed a non-responder by a physician
- Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study objectives at the discretion of the participating physician.
- Uncontrolled diabetes
- Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
United States23 sites, 21 recruiting
- Recruiting
Anne Arundel Urology
Annapolis, Maryland, 21401
Megan Lormore
Mara Holton, MD
- Recruiting
Urology Partners of North Texas (UPNT)
Arlington, Texas, 76017
Grace Yoon
Michelle Le
- Recruiting
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
Cheryl Zinar
Kelly Liberatore
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35205
Alisha Hitt
Adam Baumgarten, MD
- Recruiting
University Hospitals Cleveland
Cleveland, Ohio, 44106
Twishasri Dasgupta
Aram Loeb, MD
- Recruiting
Wayne State University
Detroit, Michigan, 48201
Matthew Kronick
Aron Liaw, MD
- Completed
Urology Associates
Fairhope, Alabama, 36532
- Completed
Texas Oncology
Houston, Texas, 77070
- Recruiting
University of Miami
Miami, Florida, 33136
Maria N Odrosgoitia
Elena Cortizas
- Recruiting
USNC
Mountain View, California, 94040
Annette West
Edward Karpman, MD
- Recruiting
Tri Valley Urology
Murrieta, California, 92562
Kristi Dalton
Anita Deeds
- Recruiting
Louisiana State University
New Orleans, Louisiana, 70112
Jaya Mishra, PhD
Ryan Krlin, MD
- Recruiting
Integrated Medical Professionals
New York, New York, 10016
Michael Yang
Luis Leanez
- Recruiting
Lowcountry Urology Clinics
North Charleston, South Carolina, 29406
Josi Cortese
Justin Ellett, MD
- Recruiting
AdventHealth
Orlando, Florida, 32825
Genevieve Rexford
Daniel S. Hoffman, MD
- Recruiting
Advanced Urology Institute
Oxford, Florida, 34481
Josi Cortese
Caitlyn Gall
- Recruiting
Associated Urologists of North Carolina (AUNC)
Raleigh, North Carolina, 27612
Kiplyne Moffett, RN
Mark Jalkut, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Carter Day
Miranda Smith
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Natalie Rios
Jennette Sison
- Recruiting
Mayo Clinic
Scottsdale, Arizona, 85259
Sirena Castillo
Christopher Wolter, MD
- Recruiting
WK Clinical Research
Shreveport, Louisiana, 71103
Patricia Johnson
Sherry Stephens
- Recruiting
Utica Park Urology
Tulsa, Oklahoma, 74104
Alex Heinze, PA-C
Melanie Ketchandji, MD
- Recruiting
Potomac Urology
Woodbridge, Virginia, 22191
Annelise Marsh
Alok Desai, MD
About this study
Official title: Sacral Neuromodulation for Male Overactive Bladder
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
Read the detailed description
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients who have a prior history of radical prostatectomy or radiation for prostate cancer or who have a history of cytoreductive surgical intervention for benign prostatic hyperplasia (BPH).
- Conditions
- Overactive Bladder, Urinary Urgency Incontinence, Benign Prostatic Hyperplasia, Prostate Cancer, Prostatectomy, Urinary Frequency
- Being tested
- Axonics SNM System
- Medical subject headings
- Urinary Bladder, Overactive, Prostatic Hyperplasia, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axonics SNM SystemDevice
To assess clinical outcomes of the Axonics SNM System in the male OAB population.
| Study group | Role | What they receive |
|---|---|---|
| Post-prostatectomy | Other | History of radical prostatectomy for cancer treatment at least 6 months prior to enrollment Receives: Device: Axonics SNM System |
| Radiation | Other | History of radiation for cancer treatment at least 6 months prior to enrollment Receives: Device: Axonics SNM System |
| Benign Prostatic Hyperplasia (BPH) | Other | History of cytoreductive BPH surgery at least 6 months prior to enrollment Receives: Device: Axonics SNM System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event reporting (Safety)
Device related, procedure-related and all serious adverse events
Measured: 6 months, 1 year
Performance/Effectiveness - Reduction in UUI or UF episodes
Demonstrate a ≥ 50% reduction in the number of UUI or UF episodes on a 3-day diary
Measured: 6 months, 1 year
Secondary outcomes (1)
Performance/Effectiveness - Improvement in Quality of Life scoring
International Consultation of 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: 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start22 Oct 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gita Ghadimi, OD, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511141
- Sponsor's protocol ID
- 105-0141
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2024
- 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
- Sacral Neuromodulation for Male Overactive Bladder
- ClinicalTrials.gov ID
- NCT06511141
- Acronym / sponsor ID
- 105-0141
- Conditions
- Overactive Bladder, Urinary Urgency Incontinence, Benign Prostatic Hyperplasia, Prostate Cancer, Prostatectomy, Urinary Frequency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Axonics, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Jul 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.
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
Detailed description
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients who have a prior history of radical prostatectomy or radiation for prostate cancer or who have a history of cytoreductive surgical intervention for benign prostatic hyperplasia (BPH).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Post-prostatectomy | Other | Device: Axonics SNM SystemHistory of radical prostatectomy for cancer treatment at least 6 months prior to enrollment |
| Radiation | Other | Device: Axonics SNM SystemHistory of radiation for cancer treatment at least 6 months prior to enrollment |
| Benign Prostatic Hyperplasia (BPH) | Other | Device: Axonics SNM SystemHistory of cytoreductive BPH surgery at least 6 months prior to enrollment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants aged ≥ 18 years at the time of enrollment
- Able to complete bladder diaries and patient questionnaires
- Primary diagnosis of OAB (urinary urgency incontinence (UUI) or urinary frequency (UF)).
- 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 (10 listed)
- Any patient that is not a suitable candidate per investigator discretion
- Recent prostate therapy or procedure within the last 6 months at the time of enrollment
- Any neurological condition that could interfere with normal bladder function, including stroke, epilepsy, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)
- Previously implanted with a sacral neuromodulation device, including inactive SNM devices
- Any prior treatment with an Implantable Tibial Nerve Stimulation (ITNS)
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 SystemTo assess clinical outcomes of the Axonics SNM System in the male OAB population. | Device | Benign Prostatic Hyperplasia (BPH), Post-prostatectomy, Radiation |
Primary outcome
Adverse event reporting (Safety)
Time frame: 6 months, 1 year
Device related, procedure-related and all serious adverse events
Performance/Effectiveness - Reduction in UUI or UF episodes
Time frame: 6 months, 1 year
Demonstrate a ≥ 50% reduction in the number of UUI or UF episodes on a 3-day diary
1 secondary outcome
Performance/Effectiveness - Improvement in Quality of Life scoring
Time frame: 6 months, 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.
Gita Ghadimi, OD study director
Boston Scientific Corporation
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axonics SNM System in people with Overactive Bladder and Urinary Urgency Incontinence, run by Axonics, Inc. at 23 sites in United States.
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 4 inclusion and 10 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 23 sites in United States. 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 Catherine Cabiling (714-225-0903, catherine.cabiling@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event reporting (Safety) (time frame: 6 months, 1 year). 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.