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
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
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- 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