Sacral Neuromodulation for Male Overactive Bladder (MOAB)

Not Applicable

Recruiting

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

• Registration Number: NCT06511141
• Lead Sponsor: Axonics, Inc.

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).

Study Timeline

• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-19
• Study Start: 2024-10-22
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-07
• Last Update Posted: 2025-08-11
• Primary Completion: 2027-10
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 150

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 OAB (urinary urgency incontinence (UUI) or urinary frequency (UF)).
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

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 at the Investigator's discretion.
9. Uncontrolled diabetes
10. Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adverse event reporting (Safety)	6 months, 1 year	Device related, procedure-related and all serious adverse events
Performance/Effectiveness - Reduction in UUI or UF episodes	6 months, 1 year	Demonstrate a ≥ 50% reduction in the number of UUI or UF episodes on a 3-day diary

Secondary Outcome Measures

Name	Time	Method
Performance/Effectiveness - Improvement in Quality of Life scoring	6 months, 1 year	International Consultation of Incontinence Questionnaire Overactive Bladder Quality of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement.

Trial Locations

Locations (12)

Louisiana State University; 🇺🇸 New Orleans, Louisiana, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Urology Associates; 🇺🇸 Fairhope, Alabama, United States

El Camino Health; 🇺🇸 Mountain View, California, United States

Tri Valley Urology; 🇺🇸 Murrieta, California, United States

University of Miami; 🇺🇸 Miami, Florida, United States

WK Clinical Research; 🇺🇸 Shreveport, Louisiana, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University Hospitals Cleveland; 🇺🇸 Cleveland, Ohio, United States

Urology Partners of North Texas (UPNT); 🇺🇸 Arlington, Texas, United States

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