OBJECTIVES: Objective of present analysis is to develop a full Health Technology Assesment (HTA) of devices currently available in Italy for the treatment of male severe urinary incontinence(SUI) after radical prostatectomy.

METHODS: in order to develop a full HTA, a multidisciplinary group of researchers was established with the aim to apply the European network for Health Technology Assessment (EUnetHTA) core model for the clinical devices available for the treatment of SUI after radical prostatectomy. A Systematic literature review were performed in order to identify the main competitors for the treatment of SUI patients and estimates the main clinical and economic information available for these devices.

RESULTS: Currently, three main artificial urinary sphincter (AUS) are available for the treatment of SUI in Italy: VICTO®, ZSI375®, AMS800®. In terms of safety, literature highlighted potential implantation problems in patients with non-flexible bladders or in patients already treated with radiotherapy. Clinical studies showed a significant continence improvement in patients with an implanted AUS (73% -ZSI375®, 75–90% -AMS800®, no data available-VICTO®). Up to date, no economic evaluations of these devices were performed in Italy. However, international literature demonstrate that in a long-term prospective AUS could become a valid cost-effective, and in some cases even cost-saving, alternative from the National Health System and social perspectives.

CONCLUSIONS: To our knowledge, this HTA represents the first preliminary national-level analysis focused on a relevant health issue as SUI. This study aims to identify the clinical and managerial critical issues in the use of AUS for the treatment of SUI after radical prostatectomy. Despite the high costs of these devices, their impact on quality of life for the patients represents an important issue that healthcare authorities and decision makers have to consider in order to review both disease management and reimbursement tariffs.