ClinicalTrials.gg
RecruitingNCT06511141Updated Oct 13, 2026

Sacral Neuromodulation for Male Overactive Bladder (MOAB)

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

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study summary

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

Read the 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).

02

Conditions studied

  • Overactive Bladder
  • Urinary Urgency Incontinence
  • Benign Prostatic Hyperplasia
  • Prostate Cancer
  • Prostatectomy
  • Urinary Frequency
03

In context

Urinary Bladder, Overactive

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

Key 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 and agrees to comply with specified evaluations at clinical 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, 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
Terms in these criteria, in plain language(3)

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.

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Other
    Post-prostatectomy

    History of radical prostatectomy for cancer treatment at least 6 months prior to enrollment

    Device: Axonics SNM System

  • Other
    Radiation

    History of radiation for cancer treatment at least 6 months prior to enrollment

    Device: Axonics SNM System

  • Other
    Benign Prostatic Hyperplasia (BPH)

    History of cytoreductive BPH surgery at least 6 months prior to enrollment

    Device: Axonics SNM System

Interventions

  • DeviceAxonics SNM System

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

06

What researchers measure

Primary outcomes

  1. Adverse event reporting (Safety)

    Device related, procedure-related and all serious adverse events

    Time frame: 6 months, 1 year

  2. 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

Secondary outcomes

  1. 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

07

Study locations

21 of 23 sites recruiting
  • University of Alabama at Birmingham
    Birmingham, Alabama 35205, United States
    Recruiting
    • Alisha Hitt · Contact
    • Adam Baumgarten, MD · Principal investigator
  • Urology Associates
    Fairhope, Alabama 36532, United States
    Completed

    Not enrolling at this site — choose another above.

  • Mayo Clinic
    Scottsdale, Arizona 85259, United States
    Recruiting
    • Sirena Castillo · Contact
    • Christopher Wolter, MD · Principal investigator
  • USNC
    Mountain View, California 94040, United States
    Recruiting
    • Annette West · Contact
    • Edward Karpman, MD · Principal investigator
  • Tri Valley Urology
    Murrieta, California 92562, United States
    Recruiting
    • Kristi Dalton · Contact
    • Anita Deeds · Contact
    • Varun Talanki, MD · Principal investigator
  • University of California San Francisco
    San Francisco, California 94143, United States
    Recruiting
    • Natalie Rios · Contact
    • Jennette Sison · Contact
    • Michelle Van Kuiken, MD · Principal investigator
  • University of Miami
    Miami, Florida 33136, United States
    Recruiting
    • Maria N Odrosgoitia · Contact
    • Elena Cortizas · Contact
    • Raveen Syan, MD · Principal investigator
  • AdventHealth
    Orlando, Florida 32825, United States
    Recruiting
    • Genevieve Rexford · Contact
    • Daniel S. Hoffman, MD · Principal investigator
  • Advanced Urology Institute
    Oxford, Florida 34481, United States
    Recruiting
    • Josi Cortese · Contact
    • Caitlyn Gall · Contact
    • Harvey Taub, MD · Principal investigator
  • Louisiana State University
    New Orleans, Louisiana 70112, United States
    Recruiting
    • Jaya Mishra, PhD · Contact
    • Ryan Krlin, MD · Principal investigator
  • WK Clinical Research
    Shreveport, Louisiana 71103, United States
    Recruiting
    • Patricia Johnson · Contact
    • Sherry Stephens · Contact
    • Gerard Henry, MD · Principal investigator
  • Anne Arundel Urology
    Annapolis, Maryland 21401, United States
    Recruiting
    • Megan Lormore · Contact
    • Mara Holton, MD · Principal investigator
    • Kari Bailey, MD · Sub investigator
  • Wayne State University
    Detroit, Michigan 48201, United States
    Recruiting
    • Matthew Kronick · Contact
    • Aron Liaw, MD · Principal investigator
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
    Recruiting
    • Carter Day · Contact
    • Miranda Smith · Contact
    • Meghan Cooper, DO · Principal investigator
  • Integrated Medical Professionals
    New York, New York 10016, United States
    Recruiting
    • Michael Yang · Contact
    • Luis Leanez · Contact
    • Jed Kaminetsky, MD · Principal investigator
    • Thomas Rechtschaffen, MD · Sub investigator
  • Associated Urologists of North Carolina (AUNC)
    Raleigh, North Carolina 27612, United States
    Recruiting
    • Kiplyne Moffett, RN · Contact
    • Mark Jalkut, MD · Principal investigator
    • John Kaspar, MD · Sub investigator
  • University Hospitals Cleveland
    Cleveland, Ohio 44106, United States
    Recruiting
    • Twishasri Dasgupta · Contact
    • Aram Loeb, MD · Principal investigator
  • Utica Park Urology
    Tulsa, Oklahoma 74104, United States
    Recruiting
    • Alex Heinze, PA-C · Contact
    • Melanie Ketchandji, MD · Principal investigator
  • MidLantic Urology
    Bala-Cynwyd, Pennsylvania 19004, United States
    Recruiting
    • Cheryl Zinar · Contact
    • Kelly Liberatore · Contact
    • Laurence Belkoff, DO · Principal investigator
  • Lowcountry Urology Clinics
    North Charleston, South Carolina 29406, United States
    Recruiting
    • Josi Cortese · Contact
    • Justin Ellett, MD · Principal investigator
  • Urology Partners of North Texas (UPNT)
    Arlington, Texas 76017, United States
    Recruiting
    • Grace Yoon · Contact
    • Michelle Le · Contact
    • Geoffrey Nuss, MD · Principal investigator
  • Texas Oncology
    Houston, Texas 77070, United States
    Completed

    Not enrolling at this site — choose another above.

  • Potomac Urology
    Woodbridge, Virginia 22191, United States
    Recruiting
    • Annelise Marsh · Contact
    • Alok Desai, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Minor edits only
    + 1 other change: verification date

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 ↗

10

Registry details

Key details

Study ID
NCT06511141
Lead sponsor
Axonics, Inc.
Responsible party
Sponsor
First posted
Jul 19, 2024
Start date
Oct 22, 2024
Primary completion
Dec 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Oct 13, 2026

Study contacts

Catherine Cabiling
Contact
catherine.cabiling@bsci.com
714-225-0903
Erum Shaikh
Contact
Erum.Shaikh@bsci.com
657-626-4310
Gita Ghadimi, OD
study director · Boston Scientific Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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