Urologists at Vanderbilt Health announced on Mar. 11 the start of patient enrollment for a clinical trial called SOPHIA2, which will test the safety and effectiveness of the UroActive implant for men with stress urinary incontinence (SUI). The study follows investigational device exemption clearance from both the U.S. Food and Drug Administration and the French National Agency for the Safety of Medicines and Health Products.
SUI, or involuntary leakage of urine, affects about 40 million people in the United States and 90 million in Europe. The condition can have a major impact on quality of life, often leading to depression, low self-esteem, and social stigma.
The UroActive implant is designed to be placed around the urethral duct and adjusts automatically based on patient activity. It does not require complex manipulation by patients, aiming to improve ease of use and overall quality of life compared to current treatment options.
The SOPHIA2 trial will enroll approximately 140 male patients with SUI at sites across the United States and France. Eligible participants must be at least 22 years old, have had a primary diagnosis of SUI for at least six months, and be considered suitable candidates for surgery. The main goal is to measure how many patients respond positively at 26 weeks after device activation. A secondary goal is to assess changes in patients' overall impression of improvement over that period.
Data from an earlier first-in-human SOPHIA study were presented at the American Urological Association's 2024 Annual Meeting in San Antonio. Investigators said all six men who received implants had successful procedures without any need for removal or revision. There was one severe adverse event—a hematoma after surgery causing slow urinary stream—which resolved on its own.
The UroActive device is also being studied as a treatment option for women with SUI, where it has shown similar results in feasibility studies.
