Sacral Neuromodulation for Male Overactive Bladder (MOAB)

  • Recruiting
  • Treatment
  • Interventional
  • Device
  • Axonics, Inc.
  • 18 - 75 Years


Study Purpose

To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.

Intervention

Device : Axonics SNM System


Eligibility Requirements

info icon Participants aged ≥ 18 years at the time of enrollment

info icon Able to complete bladder diaries and patient questionnaires

info icon Primary diagnosis of Urinary Urgency Incontinence (UUI)

info icon 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

info icon Underwent prostatectomy for prostate cancer at least 6 months prior to enrollment

info icon Underwent radiation therapy for prostate cancer at least 6 months prior to enrollment

info icon Underwent cytoreductive surgical intervention for BPH at least 6 months prior to enrollment

info icon Minimum age: 18

info icon Any patient that is not a suitable candidate per investigator discretion

info icon Recent prostate therapy or procedure within the last 6 months at the time of enrollment

info icon 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)

info icon Previously implanted with a sacral neuromodulation device, including inactive SNM devices

info icon Any prior treatment with an Implantable Tibial Nerve Stimulation (ITNS)

info icon Percutaneous Tibial Nerve Stimulation (PTNS) within the last 3 months at the time of enrollment

info icon Underwent an external trial with any sacral neuromodulation device and was deemed a non-responder by a physician

info icon Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study objectives (e.g. Crohn's disease, moderate to severe fibromyalgia, chronic pain)

info icon Uncontrolled diabetes

info icon Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone

Recruiting status

Recruiting

Estimated enrollment

120

 
Study start date

Oct 01, 2024

Study end date

Mar 31, 2027

Last updated

Mar 23, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Device

Study phase

NA

Allocation

Na

 

Sponsor:

Axonics, Inc.

Collaborator:

N/A

Investigator:

Karen Noblett, MD

NCT06511141

Clinic Location Investigator Distance RECRUITING STATUS Contact