Targeting the limited access to penile prostheses in Italy: the Italian Registry for penile implants and the divulgative Institutional website

Edoardo Pescatori1, Giorgio Franco2, Enrico Caraceni3, Fulvio Colombo4, Federico Dehò5
  • 1 Hesperia Hospital (Modena)
  • 2 Policlinico Umberto I (Roma)
  • 3 Area Vasta 3 (Civitanova Marche)
  • 4 Policlinico S.Orsola-Malpighi (Bologna)
  • 5 Istituto San Raffaele (Milano)


In Italy presently patients with severe ED have limited access to the penile prosthesis option. This appears to be the result of different factors: Health Authorities do not have reliable figures on penile implantology; lay public is not properly (if at all) informed of the availability of the “prosthesis option”; National Health Care System Surgeons have few units/year available, while in private practice there is an issue of high device pricing; device Companies are not allowed direct consumer advertising.
The need of a prospective Registry on penile implants has been advocated (1).
The Italian Society of Andrology (S.I.A.) has devised a strategy to address the issue of limited use of the penile prosthesis option by means of the creation of both: a prospective Italian Registry for penile implants, and a divulgative Institutional website:

Materials and Methods

The Italian Registry for penile implants, named “INSIST-ED REGISTRY” (Italian Nationwide Systematic Inventarisation of Surgical Treatment for ED) is a prospective Registry of penile prostheses (all brands, all models), available to all implanting Surgeons operating in Italy, regardless of specific societary affiliations. Surgeons accepting to take part to the Registry agree to provide all data required by the fields of the database of the Registry (patient, device, surgical procedure, outcomes, follow-up data) for both first and revision surgeries, clear of any patient personal data.
The purpose of the Registry is to provide solid data on the dimension of implantology in Italy and to ascertain the impact of penile implants on recipients quality of life at 1 year f.u. by means of the recently developed questionnaire QOLSPP (2).
The divulgative Institutional website is a Institutional website devoted to the lay public, where only the implanting Surgeons that adhere to the Registry will be present.
The purpose of this website is chiefly to foster access of ED patients to penile prosthesis treatment, through a Institutional (S.I.A.) website that would promote the prosthesis option for patients that qualify for it. This website provides the lay public with information that both: have the credibility given by the umbrella of a Scientific Society (all the materials present in the website must in fact be approved by an ad-hoc S.I.A. scientific committee, the Authors), and could not be otherwise advertised by Companies in Italy. Of note, only those Surgeons taking part to the Registry will be entitled to be present in the Institutional website.


The Registry took officially off by December 2014. At the end of February we have 21 implanting Surgeons that decided to take part to the Registry, and are continuously adding cases to the Registry. The major device Companies for penile implants decided to support the project through pursuing the adhesion to the Registry of device implanters, and providing feedbacks of implanting activities to the Registry monitor. So far the overall project has been well accepted by the surgical community devoted to penile implantology, and by most of the Companies in the field.
Our inclusive strategy appears promising in that most of Italian implanting Surgeons should join the Registry.


Analysis of Registry data might produce meaningful information at political, social, scientific and lay public levels; in particular such data might prove instrumental in negotiations with Health Authorities, aimed to get an appropriate reimbursement for this surgery. Data generated by the Registry could possibly promote the development of Centers of Excellence (3) for penile prosthesis surgery.
The website, besides promoting the prosthesis option for patients that qualify for it, should also motivate penile prosthesis implanting Surgeons to adhere to the Registry, as only those Surgeons taking part to the Registry will be entitled to be present in the Institutional website (to write contributions, to provide contact data and link to personal website, etc).


The “INSIST-ED Registry” represents the first experience of this kind at both national and international levels. The Registry is producing a positive feedback by both Implanters and device Companies. We expect that analysis of Registry data will produce robust data on both: the dimension of the penile implantology in Italy, and the impact of penile implants on the quality of life of the recipients. We concomitantly pursue to foster access of ED patients to penile implant treatment through our ad hoc Institutional website that is informing in a scientific and unbiased fashion the lay public on the penile prosthesis option.


1. Agrawal V, Ralph D.: An audit of implanted penile prostheses in the UK. BJU Int. 2006;98:393-5.
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? J Sex Med. 2014;11:1005-12.
3. Henry GD, Kansal NS, Callaway M, Grigsby T, Henderson J, Noble J, Palmer T, Cleves MA, Ludlow JK, Simmons CJ, Mook TM.: Centers of excellence concept and penile prostheses: an outcome analysis. J Urol. 2009;181:1264-8.