Sacral Neuromodulation for Male Overactive Bladder (MOAB)

Purpose

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

Conditions

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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

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. Positive response to 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 discretion of the participating physician. 9. Uncontrolled diabetes 10. Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Post-prostatectomy 		History of radical prostatectomy for cancer treatment at least 6 months prior to enrollment
  • Device: Axonics SNM System
    To assess clinical outcomes of the Axonics SNM System in the male OAB population.
Other
Radiation 		History of radiation for cancer treatment at least 6 months prior to enrollment
  • Device: Axonics SNM System
    To assess clinical outcomes of the Axonics SNM System in the male OAB population.
Other
Benign Prostatic Hyperplasia (BPH) 		History of cytoreductive BPH surgery at least 6 months prior to enrollment
  • Device: Axonics SNM System
    To assess clinical outcomes of the Axonics SNM System in the male OAB population.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35205
Contact:
Alisha Hitt

Mayo Clinic
Scottsdale, Arizona 85259
Contact:
Sirena Castillo

El Camino Health
Mountain View, California 94040
Contact:
Annette West

Tri Valley Urology
Murrieta, California 92562
Contact:
Vivian Cabral Perez

University of Miami
Miami, Florida 33136
Contact:
Maria N Odrosgoitia

Advanced Urology Institute
Oxford, Florida 34481
Contact:
Josi Cortese

Louisiana State University
New Orleans, Louisiana 70112
Contact:
Jaya Mishra, PhD

WK Clinical Research
Shreveport, Louisiana 71103
Contact:
Sherry Stephens

Anne Arundel Urology
Annapolis, Maryland 21401
Contact:
Megan Lormore

Wayne State University
Detroit, Michigan 48201
Contact:
Matthew Kronick

Mayo Clinic
Rochester, Minnesota 55905
Contact:
Carter Day

Integrated Medical Professionals
New York, New York 10016
Contact:
Michael Yang

Associated Urologists of North Carolina (AUNC)
Raleigh, North Carolina 27612
Contact:
Kiplyne Moffett, RN

University Hospitals Cleveland
Cleveland, Ohio 44106
Contact:
Imani Lucas

Utica Park Urology
Tulsa, Oklahoma 74104
Contact:
Alex Heinze, PA-C

MidLantic Urology
Bala-Cynwyd, Pennsylvania 19004
Contact:
Cheryl Zinar

Lowcountry Urology Clinics
North Charleston, South Carolina 29406
Contact:
Shanteese La Mons

Urology Partners of North Texas (UPNT)
Arlington, Texas 76017
Contact:
Michelle Le

Potomac Urology
Woodbridge, Virginia 22191
Contact:
Annelise Marsh

More Details

Status
Recruiting
Sponsor
Axonics, Inc.

Study Contact

Catherine Cabiling
714-225-0903
catherine.cabiling@bsci.com

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).