Clinical Trial

A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)

Name: A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS) — clinical trial record (NCT06968741)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: SOPHIA2

Recruiting

View on ClinicalTrials.gov →

Summary

Prospective, multicenter, single-arm study

Protocol Amendment History 3 amendments

This ClinicalTrials.gov record has been amended 3 times since 2025-05-05; most recent amendment 2026-03-26.

Status change: Not Yet Recruiting → Recruiting 2025-05-16

Trial Details

NCT Number	NCT06968741
Lead Sponsor	UroMems SAS
Conditions	Stress Urinary Incontinence (SUI)
Enrollment	140 participants
Start Date	2025-05-19
Primary Completion	2026-12 (estimated)
Study Completion	2031-12 (estimated)
Updated on ClinicalTrials.gov	2026-03-27