140 Participants NeededMy employer runs this trial
Artificial Urinary Sphincter for Stress Incontinence
(SOPHIA2 Trial)
Recruiting at 20 trial locations
RJ
Overseen ByRoshini Jain
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: UroMems SAS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
What You Need to Know Before You Apply
What is the purpose of this trial?
Prospective, multicenter, single-arm study
Who Is on the Research Team?
RJ
Roshini Jain
Principal Investigator
UroMems SAS
Are You a Good Fit for This Trial?
Inclusion Criteria
I am a man who is 22 years old or older.
I have had stress urinary incontinence for at least 6 months and am healthy enough for surgery.
I can read and understand, and am willing to sign the consent form.
What Are the Treatments Tested in This Trial?
Interventions
- UrOActive® Artificial Urinary sPHincter (AUS)
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Group I: UroActive AUS ImplantExperimental Treatment1 Intervention
Enrolled subjects who meet study eligibility criteria will proceed to receive the UroActive Artificial Urinary Sphincter (AUS) device
Find a Clinic Near You
Who Is Running the Clinical Trial?
UroMems SAS
Lead Sponsor
Trials
2
Recruited
10+
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