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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-19

Study Completion Date

2031-12-31

Brief Summary

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Prospective, multicenter, single-arm study

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Detailed Description

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Conditions

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Stress Urinary Incontinence (SUI)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UroActive AUS Implant

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

Group Type EXPERIMENTAL

Artificial Urinary Sphincter (AUS)

Intervention Type DEVICE

AUS implant

Interventions

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Artificial Urinary Sphincter (AUS)

AUS implant

Intervention Type DEVICE

Eligibility Criteria

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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

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

Minimum Eligible Age

22 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No