First-In-Human Assessment of the UroActive Electronic Artificial Urinary Sphincter for Treating Male Patients with Stress Urinary Incontinence

PURPOSE: To evaluate the feasibility, safety, and efficacy during the first year of use of the UroActive device in male patients with stress urinary incontinence. MATERIALS AND METHODS: This prospective, multicenter, single-arm, first-in-human study enrolled 6 male patients with bothersome stress urinary incontinence unresponsive to conservative or surgical treatments. After UroActive implantation, follow-up was planned for 5 years (postactivation). Study end points included successful device activation, revision, and explantation rates. Other end points assessed 24 hours pad-weight test reduction, pad usage, uroflowmetry, postvoid residual urine, and patient-reported outcomes (International Consultation Incontinence Questionnaires UI Short Form, EQ-5D, I-QOL, Urinary Symptom Profile). Adverse events were collected throughout the study. RESULTS: All 6 patients underwent successful implantation and device activation (100%). No explants or revisions were required during the 365 days postactivation. At 365 days postactivation, the pad weight was reduced by ≥ 50% in all patients and reduced by ≥ 75% in 5 (83.3%). The median pad use decreased from 3.7 to 1.0 pad per day. Uroflowmetry remained within acceptable ranges, and postvoid residual urine was minimal. Quality of life scores significantly improved across all instruments. Nine device deficiencies were reported, all involving the patient remote control. No unanticipated serious adverse events occurred. CONCLUSIONS: In men with stress urinary incontinence, the UroActive device demonstrates promising feasibility, safety, and functional outcomes during the 365 days postactivation. Patients experienced substantial symptom improvement and high satisfaction, with no surgical revisions. Larger studies with extended follow-up are needed to confirm these findings and assess long-term device performance.