Sacral Neuromodulation for Male Overactive Bladder (MOAB)

Launched by AXONICS, INC. · Jul 16, 2024

Keywords

ClinConnect Summary

This clinical trial, called Sacral Neuromodulation for Male Overactive Bladder (MOAB), is studying a device called the Axonics SNM System to help men who suffer from overactive bladder and urinary urgency incontinence. The goal is to see how well this device works for men who have had treatments for prostate conditions, like prostate cancer or benign prostatic hyperplasia, at least six months ago. The trial is currently looking for male participants between the ages of 18 and 93 who can keep track of their bladder habits and answer some questions about their condition.

To be part of this study, participants must have a primary diagnosis of urinary urgency incontinence and must be willing to follow the study procedures, which include attending follow-up visits for up to one year. However, certain health issues or recent treatments may prevent someone from joining, such as having had a prostate procedure in the last six months or having specific neurological conditions that could affect bladder function. Participants will have the opportunity to help researchers understand if this new treatment can improve their quality of life.

Gender

MALE

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Participants aged ≥ 18 years at the time of enrollment
• • 2. Able to complete bladder diaries and patient questionnaires
• • 3. Primary diagnosis of Urinary Urgency Incontinence (UUI)
• • 4. 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
• • 5. Underwent prostatectomy for prostate cancer at least 6 months prior to enrollment
• • 6. Underwent radiation therapy for prostate cancer at least 6 months prior to enrollment
• • 7. Underwent cytoreductive surgical intervention for BPH at least 6 months prior to enrollment
• Key Exclusion Criteria:
• • 1. Any patient that is not a suitable candidate per investigator discretion
• • 2. Recent prostate therapy or procedure within the last 6 months at the time of enrollment
• • 3. 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)
• • 4. Previously implanted with a sacral neuromodulation device, including inactive SNM devices
• • 5. Any prior treatment with an Implantable Tibial Nerve Stimulation (ITNS)
• • 6. Percutaneous Tibial Nerve Stimulation (PTNS) within the last 3 months at the time of enrollment
• • 7. Underwent an external trial with any sacral neuromodulation device and was deemed a non-responder by a physician
• • 8. 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)
• • 9. Uncontrolled diabetes
• • 10. Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone