A trial is enrolling men with stress urinary incontinence to test a new implant, after regulators in the US and France cleared the study.
Stress urinary incontinence, or SUI, causes involuntary urinary leakage and affects an estimated 40m Americans and 90m Europeans. It can significantly affect quality of life and often leads to depression, low self-esteem and social stigma.
The UroActive implant is placed around the urethral duct and is controlled according to the patient’s activity, without the need for complex manipulation, with the aim of offering ease of use and a better quality of life than current options.
Melissa Kaufman, professor of urologic surgery and chief of reconstructive urology and pelvic health at Vanderbilt Health, said: “We have seen firsthand the shortcomings of current SUI treatment options for our male and female patients.
“That’s why we’re so excited to be leading the SOPHIA2 trial, as it’s showing promise to provide significant improvements in addressing these issues.”
Kaufman is leading the trial in the US along with Andrew Peterson, professor of urology at Duke University School of Medicine.
The SOPHIA2 trial will enrol about 140 male patients with SUI across clinical trial sites in the US and France.
To be eligible, patients must be at least 22 years old, have a primary diagnosis of SUI for at least six months and have been deemed an appropriate candidate for surgery.
The primary end point is the responder rate at 26 weeks following device activation. The secondary end point is the proportion of patients who experience a change in overall impression of improvement from baseline to 26 weeks.
Data from the first-in-human SOPHIA study of the UroActive implant in men was presented at the American Urological Association 2024 annual meeting in San Antonio, showing positive outcomes on all primary and secondary end points.
According to the investigators, the devices were successfully implanted and activated in all six patients, and there were no explants or revisions required.
There was one severe adverse event, consisting of a haematoma after surgery with slow urinary stream, which self-resolved.
The UroActive device is also under investigation in women with SUI and has demonstrated comparable results in the clinical feasibility study.
