Actively Recruiting
PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB
Led by Axonics, Inc. · Updated on 2026-05-12
55
Participants Needed
5
Research Sites
314 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.
CONDITIONS
Official Title
PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Have a primary diagnosis of overactive bladder including urinary urgency incontinence or urinary frequency
- Are not candidates for or have failed conservative treatments for overactive bladder
- Willing and able to provide written consent and comply with follow-up evaluations at clinical centers
You will not qualify if you...
- Have any significant medical condition likely to interfere with study procedures or device operation, such as neurological conditions like multiple sclerosis
- Have any psychiatric or personality disorder that may interfere with study procedures or compliance
- Previously underwent an external sacral neuromodulation trial and was a non-responder or had a sacral neuromodulation device implantation without therapeutic benefit
- Have a history of allergic reaction to titanium, zirconia, polyurethane, epoxy, or silicone
- Are a female who is breastfeeding
- Are a female with a positive urine pregnancy test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
2
University of Missouri
Columbia, Missouri, United States, 65211
Actively Recruiting
3
Bradford Royal Infirmary
Bradford, West Yorkshire, United Kingdom, BD96RJ
Actively Recruiting
4
Pinderfields Hospital
Wakefield, West Yorkshire, United Kingdom, WF1 4DG
Actively Recruiting
5
University College London Hospital
London, United Kingdom, W1G 8PH
Actively Recruiting
Research Team
A
Anna Selverian
CONTACT
E
Erum Shaikh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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