PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAxonics, Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
18 years or older
Primary indication of OAB (urinary urgency incontinence (UUI) / urinary frequency (UF) who are not candidates for, or who have failed conservative treatment
Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments
Disqualifiers
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)
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
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)
History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
Trial design
Design model
Single group
Treatments tested in this trial
Axonics SNM System INS Model 5101 (R20)
DeviceParticipants 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.
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: Overactive BladderOther 1 intervention
Trial outcomes
Primary outcomes
1
Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB)
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.
Time frame
3 months2
Adverse event reporting (Safety)
Device related, procedure-related and all serious adverse events
Time frame
3 monthsSecondary outcomes
1
Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB)
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.
Time frame
12 months2
Performance/Effectiveness - Improvement in Qualify of Life scoring (FI)
Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): scores range from 0 for full continence to 20 for complete incontinence. A higher score is indicative of the severity of fecal incontinence. Assessed if participant had a score of ≥6 at baseline.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov