Sacral Neuromodulation for Male Overactive Bladder (MOAB)
1 other identifier
interventional
150
1 country
20
Brief Summary
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2024
CompletedFirst Posted
Study publicly available on registry
July 19, 2024
CompletedStudy Start
First participant enrolled
October 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
April 15, 2026
April 1, 2026
3.1 years
July 16, 2024
April 13, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Adverse event reporting (Safety)
Device related, procedure-related and all serious adverse events
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
6 months, 1 year
Secondary Outcomes (1)
Performance/Effectiveness - Improvement in Quality of Life scoring
6 months, 1 year
Study Arms (3)
Post-prostatectomy
OTHERHistory of radical prostatectomy for cancer treatment at least 6 months prior to enrollment
Radiation
OTHERHistory of radiation for cancer treatment at least 6 months prior to enrollment
Benign Prostatic Hyperplasia (BPH)
OTHERHistory of cytoreductive BPH surgery at least 6 months prior to enrollment
Interventions
To assess clinical outcomes of the Axonics SNM System in the male OAB population.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Axonics, Inc.lead
Study Sites (20)
University of Alabama at Birmingham
Birmingham, Alabama, 35205, United States
Urology Associates
Fairhope, Alabama, 36532, United States
Mayo Clinic
Scottsdale, Arizona, 85259, United States
El Camino Health
Mountain View, California, 94040, United States
Tri Valley Urology
Murrieta, California, 92562, United States
University of Miami
Miami, Florida, 33136, United States
Advanced Urology Institute
Oxford, Florida, 34481, United States
Louisiana State University
New Orleans, Louisiana, 70112, United States
WK Clinical Research
Shreveport, Louisiana, 71103, United States
Anne Arundel Urology
Annapolis, Maryland, 21401, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Integrated Medical Professionals
New York, New York, 10016, United States
Associated Urologists of North Carolina (AUNC)
Raleigh, North Carolina, 27612, United States
University Hospitals Cleveland
Cleveland, Ohio, 44106, United States
Utica Park Urology
Tulsa, Oklahoma, 74104, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
Lowcountry Urology Clinics
North Charleston, South Carolina, 29406, United States
Urology Partners of North Texas (UPNT)
Arlington, Texas, 76017, United States
Texas Oncology
Houston, Texas, 77070, United States
Potomac Urology
Woodbridge, Virginia, 22191, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gita Ghadimi, OD
Boston Scientific Corporation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2024
First Posted
July 19, 2024
Study Start
October 22, 2024
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share