New Urinary Implant Study Has Reached Enrollment
Researchers have finished enrolling patients to test an electronic device designed to help manage urinary incontinence.
Updated on Sept. 20, 2026 in Stroke
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Enrollment has concluded for a 140-patient clinical study evaluating the UroActive, an artificial urinary sphincter designed to help manage incontinence. The device is intended to provide a technological alternative for patients, including those who experience chronic urinary leakage after prostate surgery.
Why it matters
Up to 20% of men suffer from chronic urinary incontinence following prostate cancer surgery, often relying on devices that require manual manipulation. This new implant aims to improve quality of life by replacing those traditional methods with an electronic, remote-controlled system.
The UroActive system is currently being evaluated in a 140-patient clinical study across 14 U.S. sites, building on a small first-in-human trial in France. In that preliminary study of six patients, daily pad counts decreased from 3.7 to 1.0 after one year.
The players
UroActive
An artificial urinary sphincter system that uses electronic components and remote control to manage incontinence.
The details
The UroActive system consists of a metal implant, which houses a battery with a 10-year lifespan and an electronic chip, placed in the abdomen via surgery. Patients use an external remote control to activate and adjust the pressure of the device, which regulates urine flow based on their daily activity. The design is intended to remove the need for the manual manipulation typically required by older artificial urinary sphincter models.
Timeline
2026: Enrollment completed for the 140-patient UroActive clinical study.
2027: Initial results from the SOPHIA2 study are expected.
Health Landscape
The development of the UroActive device marks a technological shift away from the traditional, purely mechanical artificial urinary sphincters that have long been the standard of care. By incorporating electronic regulation, this research program seeks to improve patient compliance and daily symptom management.
If you experience chronic urinary incontinence, it is worth discussing the range of available surgical and non-surgical management options with your physician. While this device is currently in a clinical study, your doctor can help you understand which treatments are currently approved for your specific needs.
The takeaway
The move toward electronic, remote-controlled implants may eventually offer a more convenient alternative for managing post-surgical incontinence. For now, patients should monitor their symptoms and discuss the established benefits and risks of current urinary devices with a urologist.
What happens next
Initial results from the 140-patient SOPHIA2 study are expected in 2027.
Further reading
Learn more about the latest innovations and management strategies in our Stroke section.
Source note: This article includes information reported by MedPage Today.
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