To evaluate the feasibility, safety, and efficacy during the first year of use of the UroActive® device in males with stress urinary incontinence (SUI).
This prospective, multicenter, single-arm, first-in-human study enrolled six male patients with bothersome SUI unresponsive to conservative or surgical treatments.
After UroActive® implantation, follow up was planned for 5 years (post-activation). Study endpoints included successful device activation, revision, and explantation rates. Other endpoints assessed 24 h pad-weight test reduction, pad usage, uroflowmetry, post-void residual urine, patient-reported outcomes (ICIQ-UI SF, EQ-5D, I-QOL, USP). Adverse events were collected throughout the study.
All six patients underwent successful implantation and device activation (100%). No explants or revisions were required during the 365 days post-activation. At 365 days post-activation, the pad weight was reduced by ≥50% in all patients and reduced by ≥75% in five (83.3%). Median pad use decreased from 3.7 to 1.0 pads/day. Uroflowmetry remained within acceptable ranges, and post-void 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.
In men with SUI, the UroActive® device demonstrates promising feasibility, safety, and functional outcomes during the 365 days post-activation. 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.
The Journal of urology. 2026 Jan 21 [Epub ahead of print]
Pierre Mozer, Aurelien Beaugerie, Marie-Aimée Perrouin-Verbe, Anne Denormandie, Juliette Cotte, Caroline Plassais, Stéphanie Tran, Dan Elliott, Emmanuel Chartier-Kastler
Sorbonne Université, Hôpital Universitaire Pitié Salpêtrière, Service d'urologie, AP-HP, 75013, Paris, France., Urology Department Centre Hospitalier Universitaire de Nantes, Nantes Université Nantes France., Department of Urology, Mayo Clinic, Rochester, Minnesota, USA.
PubMed http://www.ncbi.nlm.nih.gov/pubmed/41564274