Urologists at Vanderbilt Well being are enrolling men with stress urinary incontinence (SUI) in a medical trial named SOPHIA2 to assess the security and efficacy of the UroActive implant, following an investigational gadget exemption clearance from the U.S. Meals and Drug Administration and the French Nationwide Company for the Security of Medicines and Well being Merchandise.
SUI, or involuntary urinary leakage, impacts an estimated 40 million Individuals and 90 million Europeans. SUI considerably impacts high quality of life, as it may be debilitating, and infrequently leads to despair, low vanity and social stigma.
The implant is positioned across the urethral duct and is managed primarily based on the affected person’s exercise, with out the necessity for advanced manipulation, intending to present sufferers with ease of use and a greater high quality of life than present choices.
“We’ve got seen firsthand the shortcomings of present SUI therapy choices for our female and male sufferers,” mentioned research co-principal investigator Melissa Kaufman, MD, PhD, the Patricia and Rodes Hart Professor of Urologic Surgical procedure and chief of Reconstructive Urology and Pelvic Well being at Vanderbilt Well being. “That’s why we’re so excited to be main the SOPHIA2 trial, because it’s exhibiting promise to present important enhancements in addressing these points.”
Kaufman is main the trial in the U.S. together with Andrew Peterson, MD, professor of Urology at Duke College College of Medication.
The trial will enroll roughly 140 male sufferers with SUI throughout medical trial websites in the U.S. and France. To be eligible for enrollment, sufferers have to be at the very least 22 years previous, have a major analysis of SUI for at the very least 6 months, and have been deemed an acceptable candidate for surgical procedure.
The first finish level is the responder fee at 26 weeks following gadget activation. The research’s secondary finish level is the proportion of sufferers who expertise a change in total impression of enchancment from baseline to 26 weeks.
Information from the first-in-human SOPHIA research of the UroActive implant in men was offered on the American Urological Affiliation 2024 Annual Assembly in San Antonio, exhibiting constructive outcomes on all major and secondary finish factors.
In accordance to the investigators, the units have been efficiently implanted and activated in all six sufferers, and there have been no explants nor revisions required. There was one extreme adversarial occasion, consisting of a hematoma after surgical procedure with gradual urinary stream, which was self-resolved.
The UroActive gadget can also be underneath investigation in girls with SUI and has demonstrated comparable outcomes in the medical feasibility research.
