Male stress urinary incontinence (SUI) represents a complication after radical prostatectomy or benign prostatic obstruction surgery. The artificial urinary sphincter is considered the standard treatment but interest on minimally invasive devices, such as adjustable balloons, has recently increased. Aim of this study is to evaluate the efficacy and safety of the ProACT system.

In this multicentric retrospective study, we reported the data from nine centers. Patients with SUI who underwent a ProACT device implantation for postoperative SUI and had a minimum follow-up of 24 months were included. Efficacy was evaluated at the maximum available follow-up and was assessed utilizing a 24-hour pad test. Patients were considered: “Dry” if presenting a urine leak weight lower than 8 g at the 24-hour pad test; “Improved” if presenting a reduction of urine leak higher than 50% (but >8 g/24 hours); “Failure” if presenting a reduction in urine leak lower than 50%. The evaluation included a record of intraoperative and long-term complications.

Safety and efficacy results are reported on 240 patients. 29.6% of patients were dry at 24 months, 37.5% were improved and 32.9% of patients were considered failures. The baseline mean pad weight of 367 g was reduced to 123 g at 24 months. Five-year follow-up on 152 patients showed similar efficacy. The complication rate was 22.5%, with the top complication being long-term balloon failure.

ProACT implantation represents a safe and efficacious treatment for male postoperative SUI at both medium and long-term follow up. 67.1% of patients were dry or improved at 24 months. The majority of complications are low grade.

Neurourology and urodynamics. 2019 Jul 14 [Epub ahead of print]

Enrico Finazzi Agrò, Andrea Gregori, Daniele Bianchi, Roberto Carone, Alessandro Giammò, Enrico Ammirati, Vanni Giovannelli, Ai Ling Romanò, Pasquale Martino, Alberto Saracino, Alessandro Volpe, Michele Favro, Giorgio Canepa, Virginia Varca, Anna Pinto, Giuseppe Farullo

Department of Surgical Sciences, University Tor Vergata, Roma, Italy., Department of Urology, ASST Rhodense, G. Salvini Hospital, Garbagnate Milanese, Milan, Italy., Department of Neuro-Urology, CTO – Spinal Unit, Città della Salute e della Scienza di Torino, Turin, Italy., Department of Urology, Usl Toscana Sud Est, San Donato Hospital, Arezzo, Italy., Urology Division, ASST Fatebenefratelli-Sacco, Milan, Italy., Department of Urology, University of Bari, Bari, Italy., Division of Urology, Maggiore della Carità Hospital, University of Eastern Piedmont, Novara, Italy., Division of Urology, E.O. Ospedali Galliera, Genoa, Italy., School of Specialization in Urology, University Tor Vergata, Roma, Italy.