An interventional study of Axonics SNM System in Overactive Bladder, Urinary Urgency Incontinence and Benign Prostatic Hyperplasia, sponsored by Axonics, Inc.. Recruiting at 23 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Axonics, Inc. (part of Boston Scientific Corporation) · Not applicable, Interventional, and Treatment
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
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).
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's planned enrollment of 150 is above the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Axonics, Inc. is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
First submitted before Axonics, Inc. became part of Boston Scientific Corporation.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
History of radical prostatectomy for cancer treatment at least 6 months prior to enrollment
Device: Axonics SNM System
History of radiation for cancer treatment at least 6 months prior to enrollment
Device: Axonics SNM System
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.
Adverse event reporting (Safety)
Device related, procedure-related and all serious adverse events
Time frame: 6 months, 1 year
Performance/Effectiveness - Reduction in UUI or UF episodes
Demonstrate a ≥ 50% reduction in the number of UUI or UF episodes on a 3-day diary
Time frame: 6 months, 1 year
Performance/Effectiveness - Improvement in Quality of Life scoring
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.
Time frame: 6 months, 1 year
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Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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