Clinical Trials in the USA / NCT06789406
Recruiting
Not applicable
PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB
NCT06789406 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Urinary Urge Incontinence (UUI)Urinary Frequency (UF)Overactive Bladder (OAB)
Investigational drug(s) / intervention(s)
Axonics SNM System INS Model 5101 (R20)
Axonics SNM System INS Model 5101 (R20): Participants treated with the rechargeable Axonics SNM System Model 5101 also referred to as R20. Commercial devices used in this study are within their intended use as described in each geography's approved instructions for use.
Study summary
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.
Eligibility
Inclusion Criteria:
1. 18 years or older
2. Primary indication of OAB (urinary urgency incontinence (UUI) / urinary frequency (UF) who are not candidates for, or who have failed conservative treatment
3. Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments
Exclusion Criteria:
1. Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (i.e., neurological conditions such as multiple sclerosis)
2. Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements
3. Previously underwent an external sacral neuromodulation SNM trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder)
4. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
5. A female who is breastfeeding
6. A female with a positive urine pregnancy test
Primary outcome measure(s)
- Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB) — 3 months
To demonstrate an improvement in Overactive Bladder Quality of Life using the International Consultation of Incontinence Questionnaire Overactive Bladder Qualify 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. - Adverse event reporting (Safety) — 3 months
Device related, procedure-related and all serious adverse events
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Chicago | Chicago | Illinois | Recruiting |
| University of Missouri | Columbia | Missouri | Recruiting |
| Bradford Royal Infirmary | Bradford | West Yorkshire | Recruiting |
| Pinderfields Hospital | Wakefield | West Yorkshire | Recruiting |
| St James's University Hospital | Leeds | United Kingdom | Recruiting |
| University College London Hospital | London | United Kingdom | Recruiting |
More Axonics, Inc. trials in the USA
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06789406 on ClinicalTrials.gov ↗ ← All trials in the USA