The aim of this study was to evaluate the safety and efficacy of the artificial urinary sphincter ZSI 375 device in male patients with stress urinary incontinence (SUI) at 10 centres.
This was a retrospective, nonrandomised, multicentre study. From January 2012 to December 2014, and follow-up to February 2016, men with SUI were treated with the ZSI 375 device. The primary outcome was continence. The secondary outcome was complications rate.
A total of 147 patients with moderate-to-severe stress incontinence and mean age of 70.67 (26-85) years underwent implantation of the ZSI 375 device at 10 centres.The most common indication for placement was incontinence after radical prostatectomy (121 patients: 82.31%). The ZSI 375 device was considered successful in 86.40% of cases after 12 months follow-up, 83.52% after 24 months follow-up and 78.26% after 36 months follow-up. The infection rate was 6.12%, urethral erosion was 12.92% and mechanical failure was limited to 3.40% leading to ZSI 375 improvement.
This study confirmed safety and efficacy of ZSI 375 device to treat moderate-to-severe SUI in men.
Urologia. 2017 May 29 [Epub ahead of print]
Ireneusz Ostrowski, Mariusz Blewniewski, Frank Neugart, Burkhard von Heyden, Oscar Selvaggio, Francesco Iori, Steeve Foley, Manuel Fernández Arjona, Alejandro Carvajal Obando, Tobias Pottek
Department of Urology, Specialistic Hospital, Pulawy - Poland., Department of Urology, District Specialistic Hospital, Lodz - Poland., Urology Practice, Baden-Baden - Germany., Urology Practice, Gaildorf - Germany., Department of Urology, Ospedali Riuniti, Foggia - Italy., Department of Urology "U. Bracci", University Hospital Polyclinic Umberto I, Rome - Italy., Department of Urology, The Royal Berkshire NHS Foundation Trust, Reading - UK., Department of Urology, Henares University Hospital, Community of Madrid - Spain., San Vicente University Hospital Foundation, Medellín, Antioquia - Colombia., Department of Reconstructive Urology, Vivantes Urban Hospital, Berlin - Germany.