==inizio objective==
The penile prosthesis option presently suffers a paradox: despite being for the patient with severe ED the solution that scores the highest in terms of satisfaction, the vast majority of patients that qualify for it do not have access to it. Several are the barriers to the penile prosthesis solution: patients are not informed / misinformed about this option, costs of penile implants are significant, no reliable figures on the dimensions of penile implant field are available. Two key interventions appear accordingly needed: to produce reliable data on the phenomenon “penile implant surgery” at National level, and to correctly inform the general population of the benefits and limits of the penile prosthesis option.
For these purposes a prospective Registry for penile implants and a Institutional informative website aimed to popularize the potentials of the penile prosthesis option to the lay public have been launched on December 2014 by the Italian Society of Andrology (S.I.A.) (1).
==fine objective==
==inizio methodsresults==
The “INSIST-ED REGISTRY” (Italian Nationwide Systematic Inventarisation of Surgical Treatment for ED) is a prospective Registry of penile prostheses (all brands, all models) open to all implanting surgeons operating in Italy. Registry surgeons agree to provide anonimous patient, device, surgical procedure, outcomes, follow-up data, for both first and revision surgeries. The impact of penile implants on recipients quality of life at 1 year f.u. is to be assessed by the QOLSPP questionnaire (2). S.I.A. concurrently created an Institutional website (www.androprotesi.it) aimed to provide lay public with sound information on the penile prosthesis option; only implanting surgeons adhering to the Registry and active on it are present in such website with a personal page.
==fine methodsresults==
==inizio results==
As February 2016, 44 implanting surgeons joined the Registry, and 326 surgical procedures have been entered in the Registry database. We report analysis of the first 300 consecutive cases entered in the Registry; they comprise: 252 (84%) new implants, 37 (12,3%) prosthesis substitutions, 10 (3,3%) device removal without substitution, 1 simple surgical revision. Geographic distribution: 121 (40,3%) procedures were performed in North Italy, 115 (38,3%) in Centre Italy, 64 (21%) in South Italy. Chief ED etiologies of the Registry cases were: 107 (35,6%) iatrogenic (radical pelvic surgery), 62 (20,6%) Peyronie’s cases, 31 (10,3%) diabetes. The overall 289 implanted devices are represented by: 235 (81,3) three-component devices, 18 (6,2) two-component devices, 36 (12,4%) non hydraulic devices. Surgical settings: 79% of all the performed procedures took place in public hospitals, the remaining 21% in private settings. Waiting time from indication to surgery for new implants: 12 months in public hospitals, 1,4 months in private settings.
==fine results==
==inizio discussions==
Penile prosthetic surgery has potentials to become both: more acknowledged by the ED population, and more accessible. This project moves in the direction to promote the realization of such potentials through the “INSIST-ED” Registry, and the Institutional informative website www.androprotesi.it. Our Registry is the first experience of this kind in Europe. In the rest of the world another Registry only is ongoing, in the U.S.A.: “PROPPER” (3), launched in 2011. It differs from our Registry in the following aspects: it is a Company-devised study that evaluates only the devices produced by that Company, and with the Company itself having direct access to data and planning their analysis. Conversely, in the “INSIST-ED” Registry the Scientific Society S.I.A. has devised the study (opened to devices of all Companies), owns the database, and plans data analysis.
We will soon start collecting data on the impact of penile prostheses on recipients quality of life through the only validated tool for this purpose: the QOLSPP (2).
==fine discussions==
==inizio conclusion==
The INSIST-ED Registry represents the first European experience of penile prosthesis Registry. The first data analysis at one year since its start is providing for the first time objective data on the landscape of penile implantology in Italy. We hope that such data will be instrumental also to negotiate with Health Authorities better policies for the penile implant surgery area (for instance, more favourable reimbursements and more devices available in public hospitals). We also expect that our project will induce a more appropriate request of access to the “penile prosthesis option” by the severe ED population, now correctly informed by the Institutional website www.androprotesi.it .
==fine conclusion==
==inizio references==
1. Pescatori E, Franco G:
Introducing the first Registry for penile implants: the INSIST-ED Registry (Italian Nationwide Systematic Inventarisation of Surgical Treatment for ED). J Sex Med 2015;12(suppl 3):216–240 HP-06-005
2. Caraceni E, Utizi L: A questionnaire for the evaluation of quality of life after penile prosthesis implant: quality of life and sexuality with penile prosthesis (QoLSPP): to what extent does the implant affect the patient’s life? JSM 2014; 11: 1005-12
3. Henry GD et al: The Who, How and What of Real-World Penile Implantation in 2015: The PROPPER Registry Baseline Data. J Urol. 2016;195(2):427-33
==fine references==