Clinical trial NCT06511141: Sacral Neuromodulation for Male Overactive Bladder (MOAB)
Official title: Sacral Neuromodulation for Male Overactive Bladder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overactive Bladder
Urinary Urgency Incontinence
Benign Prostatic Hyperplasia
Prostate Cancer
Prostatectomy
Lead sponsor: Axonics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-19
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

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

Primary outcomes:
measure: Adverse event reporting (Safety)
timeFrame: 6 months, 1 year
measure: Performance/Effectiveness - Improvement in Qualify of Life scoring
timeFrame: 6 months, 1 year
measure: Performance/Effectiveness - Reduction in UUI episodes
timeFrame: 6 months, 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Mountain View
country: United States
facility: El Camino Health
state: California
city: Murrieta
country: United States
facility: Tri Valley Urology
state: California
city: Shreveport
country: United States
facility: WK Clinical Research
state: Louisiana
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cleveland
country: United States
facility: University Hospitals Cleveland
state: Ohio
city: Arlington
country: United States
facility: Urology Partners of North Texas (UPNT)
state: Texas
city: Houston
country: United States
facility: Texas Oncology
state: Texas
city: Woodbridge
country: United States
facility: Potomac Urology
state: Virginia
Study officials:
affiliation: Axonics, Inc.
name: Karen Noblett, MD
role: STUDY_DIRECTOR
References: