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. 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

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

More Details

Status
Recruiting
Sponsor
Axonics, Inc.

Study Contact

Gita Ghadimi, OD
949-396-6322
Gita.Ghadimi@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).