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Trial Title:
Sacral Neuromodulation for Male Overactive Bladder (MOAB)
NCT ID:
NCT06511141
Condition:
Overactive Bladder
Urinary Urgency Incontinence
Benign Prostatic Hyperplasia
Prostate Cancer
Prostatectomy
Conditions: Official terms:
Urinary Bladder, Overactive
Prostatic Hyperplasia
Hyperplasia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Axonics SNM System
Description:
To assess clinical outcomes of the Axonics SNM System in the male OAB population.
Arm group label:
Single Arm
Summary:
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of
overactive bladder in male patients.
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).
Criteria for 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
Gender:
Male
Gender based:
Yes
Gender description:
Only male patients will be enrolled in this study.
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
WK Clinical Research
Address:
City:
Shreveport
Zip:
71103
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sherry Stephens
Investigator:
Last name:
Gerard Henry, MD
Email:
Principal Investigator
Start date:
October 1, 2024
Completion date:
March 2027
Lead sponsor:
Agency:
Axonics, Inc.
Agency class:
Industry
Source:
Axonics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06511141
