Overactive Bladder study: Axonics SNM System
Official title Sacral Neuromodulation for Male Overactive Bladder (MOAB)
ClinicalTrials.gov ID: NCT06511141
What this study is testing
- What it's testing
- The study will look at how well the device works after it has been approved for use in men.
- Who it's for
- Men who have overactive bladder, urinary urgency, or related urinary problems.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join 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...
You likely can't join 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...
- 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
See the full eligibility criteria
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Scottsdale, Arizona, United States
- Mountain View, California, United States
- Murrieta, California, United States
- San Francisco, California, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Oxford, Florida, United States
- New Orleans, Louisiana, United States
- Shreveport, Louisiana, United States
- Annapolis, Maryland, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Raleigh, North Carolina, United States
- Cleveland, Ohio, United States
- Tulsa, Oklahoma, United States
- Bala-Cynwyd, Pennsylvania, United States
- North Charleston, South Carolina, United States
- Arlington, Texas, United States
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Scottsdale, Arizona, United States; Mountain View, California, United States; Murrieta, California, United States; San Francisco, California, United States; Miami, Florida, United States and 15 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.