Clinical Trial

Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in Men

Study acronym: SOPHIA
Active, Not Recruiting
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Summary
Prospective multicenter study designed to test the feasibility of the UroMems Artificial Urinary Sphincter.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2022-09-15; most recent amendment 2026-03-26.
Status change: Recruiting → Active, Not Recruiting 2023-09-13
Trial Details
NCT Number NCT05547672
Lead Sponsor UroMems SAS
Conditions Urinary Incontinence,Stress
Enrollment 6 participants
Start Date 2022-08-31
Primary Completion 2023-11-30 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2026-04-01