An interventional study of Axonics SNM System INS Model 5101 (R20) in Urinary Urge Incontinence (UUI), Urinary Frequency (UF) and Overactive Bladder (OAB), sponsored by Axonics, Inc.. Recruiting at 6 sites in 2 countries. Open to 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
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.
This post-market clinical follow-up (PMCF) is conducted to assess the continued safety, device performance, and clinical benefit of the rechargeable Axonics SNM System INS Model 5101 also referred to as R20.
242 studies on the registry are indexed under Urinary Incontinence, Urge; 39 are open to participants now.
This study's planned enrollment of 55 is below the median of 86 across 190 interventional studies indexed under Urinary Incontinence, Urge.
Browse Urinary Incontinence, Urge studies →Axonics, Inc. is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
First submitted after Axonics, Inc. became part of Boston Scientific Corporation.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Participants with the Axonics SNM System Model 5101 and followed up regarding their overactive bladder symptoms.
Device: 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.
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 months
Adverse event reporting (Safety)
Device related, procedure-related and all serious adverse events
Time frame: 3 months
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 months
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 months
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Jan 2027, 16 months after the start.
Of 77 interventional studies with no phase under Urinary Incontinence, Urge, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 16 months is below that.
How these figures are worked out, and which studies are left out of them.
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 ↗
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