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Recruiting NCT06511141

Sacral Neuromodulation for Male Overactive Bladder (MOAB)

No phase Interventional Overactive Bladder Urinary Urgency Incontinence Benign Prostatic Hyperplasia Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Axonics SNM System.
Who it may be relevant to
Registry conditions: Overactive Bladder, Urinary Urgency Incontinence, Benign Prostatic Hyperplasia, Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Sacral Neuromodulation for Male Overactive Bladder

Overview

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).

Interventions

  • Device Axonics SNM System
    To assess clinical outcomes of the Axonics SNM System in the male OAB population.

Primary outcome measures

  • Adverse event reporting (Safety) [Time frame: 6 months, 1 year]
  • Performance/Effectiveness - Reduction in UUI or UF episodes [Time frame: 6 months, 1 year]
Secondary outcome measures (1)
  • Performance/Effectiveness - Improvement in Quality of Life scoring [Time frame: 6 months, 1 year]

Eligibility criteria

Inclusion criteria

  • Participants aged ≥ 18 years at the time of enrollment
  • Able to complete bladder diaries and patient questionnaires
  • Primary diagnosis of OAB (urinary urgency incontinence (UUI) or urinary frequency (UF)).
  • 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

  • Any patient that is not a suitable candidate per investigator discretion
  • Recent prostate therapy or procedure within the last 6 months at the time of enrollment
  • 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)
  • Previously implanted with a sacral neuromodulation device, including inactive SNM devices
  • Any prior treatment with an Implantable Tibial Nerve Stimulation (ITNS)
  • Positive response to Percutaneous Tibial Nerve Stimulation (PTNS) within the last 3 months at the time of enrollment
  • Underwent an external trial with any sacral neuromodulation device and was deemed a non-responder by a physician
  • 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.
  • Uncontrolled diabetes
  • Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 21 centers
  • University of Alabama at Birmingham — Birmingham
  • Urology Associates — Fairhope
  • Mayo Clinic — Scottsdale
  • El Camino Health — Mountain View
  • Tri Valley Urology — Murrieta
  • University of Miami — Miami
  • Advanced Urology Institute — Oxford
  • Louisiana State University — New Orleans
  • … and 13 more centers

Identifiers

NCT: NCT06511141 · 105-0141

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗