Sacral Neuromodulation for Male Overactive Bladder (MOAB)

Axonics

Status: Enrolling

Conditions: Prostatectomy; Benign Prostatic Hyperplasia; Urinary Urgency Incontinence; Prostate Cancer; Overactive Bladder

Treatments: Device: Axonics SNM System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06511141

105-0141

Details and patient eligibility

About

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

Full 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).

Enrollment: 150 estimated patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Single Arm

Other group

Description:

Clinical outcomes with use of Axonics SNM system for the male OAB population.

Treatment:

Device: Axonics SNM System