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Neuromodulation

Sacral Neuromodulation for Overactive Bladder

N/A
Recruiting
Research Sponsored by Axonics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Key
1. Participants aged ≥ 18 years at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 1 year
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to study how well the Axonics SNM System works in treating overactive bladder in men after it has been approved for use."

Who is the study for?
This trial is for men over 18 with an overactive bladder due to conditions like prostate cancer, benign prostatic hyperplasia, or after treatments like prostatectomy. Participants must have urinary urgency incontinence and be willing to attend follow-up assessments for a year.
What is being tested?
The Axonics SNM System, a device designed to treat overactive bladder symptoms in men, is being tested. The study will monitor the effectiveness of this system post-market in real-world clinical settings.
What are the potential side effects?
While specific side effects are not listed here, similar neuromodulation devices can cause discomfort at the implant site, movement of the device within the body, technical problems with the device itself or potential changes in urinary patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
Select...
My main diagnosis is Urinary Urgency Incontinence.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse event reporting (Safety)
Performance/Effectiveness - Improvement in Qualify of Life scoring
Performance/Effectiveness - Reduction in UUI episodes

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Clinical outcomes with use of Axonics SNM system for the male OAB population.

Find a Location

Who is running the clinical trial?

Axonics, Inc.Lead Sponsor
5 Previous Clinical Trials
642 Total Patients Enrolled
Karen Noblett, MDStudy DirectorAxonics, Inc.
10 Previous Clinical Trials
1,012 Total Patients Enrolled
~80 spots leftby Dec 2026
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