RecruitingNot ApplicableNCT06968741
A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)
Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter In the treAtment of Stress Urinary Incontinence in Men
Sponsor
UroMems SAS
Enrollment
140 participants
Start Date
May 19, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
Prospective, multicenter, single-arm study
Eligibility
Sex: MALEMin Age: 22 Years
Inclusion Criteria4
- Male subjects aged ≥ 22 years old
- Able to read, comprehend and willing to sign an informed consent form
- Primary diagnosis of stress urinary incontinence for at least 6 months, as assessed by the investigator
- Appropriate surgical candidate with no medical or mental condition that would interfere with study procedures or confound study outcomes as assessed by the investigator
Exclusion Criteria4
- Currently enrolled or plans to enroll in another investigational device or clinical drug trial or has completed an investigational study (for urinary incontinence) in the past 3 months prior to informed consent
- Poor candidate for surgical procedures and/or anesthesia, as determined by investigator
- Currently implanted with an Active Implantable Medical Device (AIMD)
- Symptoms or diagnosis of urge incontinence or mixed incontinence (MI) with a predominant urgency component, as assessed by the investigator
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Interventions
DEVICEArtificial Urinary Sphincter (AUS)
AUS implant
Locations(21)
View Full Details on ClinicalTrials.gov
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NCT06968741
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