A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS) (SOPHIA2)

UroMems

Status: Enrolling

Conditions: Stress Urinary Incontinence (SUI)

Treatments: Device: Artificial Urinary Sphincter (AUS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06968741

CIP CSO2307120900

Details and patient eligibility

About

Prospective, multicenter, single-arm study

Enrollment: 140 estimated patients

Sex: Male

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 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

Key Exclusion Criteria:

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

UroActive AUS Implant

Experimental group

Description:

Enrolled subjects who meet study eligibility criteria will proceed to receive the UroActive Artificial Urinary Sphincter (AUS) device

Treatment:

Device: Artificial Urinary Sphincter (AUS)