Urologists at Vanderbilt Well being are enrolling males with stress urinary incontinence (SUI) in a medical trial named SOPHIA2 to assess the protection 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 People and 90 million Europeans. SUI considerably impacts high quality of life, as it may be debilitating, and infrequently leads to despair, low self-esteem 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 complicated manipulation, intending to present sufferers with ease of use and a greater high quality of life than present choices.
We’ve seen firsthand the shortcomings of present SUI remedy choices for our male and feminine sufferers. That is why we’re so excited to be main the SOPHIA2 trial, because it’s displaying promise to present important enhancements in addressing these points.”
Melissa Kaufman, MD, PhD, examine co-principal investigator, the Patricia and Rodes Hart Professor of Urologic Surgical procedure and chief of Reconstructive Urology and Pelvic Well being at Vanderbilt Well being
Kaufman is main the trial within the U.S. together with Andrew Peterson, MD, professor of Urology at Duke College Faculty of Drugs.
The trial will enroll roughly 140 male sufferers with SUI throughout medical trial websites within the U.S. and France. To be eligible for enrollment, sufferers should be at the least 22 years previous, have a major analysis of SUI for at the least 6 months, and have been deemed an applicable candidate for surgical procedure.
The first finish level is the responder charge at 26 weeks following gadget activation. The examine’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 examine of the UroActive implant in males was offered on the American Urological Affiliation 2024 Annual Assembly in San Antonio, displaying 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 hostile occasion, consisting of a hematoma after surgical procedure with sluggish urinary stream, which was self-resolved.
The UroActive gadget can be beneath investigation in girls with SUI and has demonstrated comparable ends in the medical feasibility examine.
