Clinical Trial

PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB

Recruiting
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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.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2025-01-17; most recent amendment 2026-07-02.
Status change: Not Yet Recruiting → Recruiting 2025-09-02
Trial Details
NCT Number NCT06789406
Lead Sponsor Axonics, Inc.
Conditions Urinary Urge Incontinence (UUI), Urinary Frequency (UF), Overactive Bladder (OAB)
Enrollment 55 participants
Start Date 2025-09-18
Primary Completion 2027-01 (estimated)
Study Completion 2031-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-12