Penile Prostheses Registries

Before these two studies the published data on penile implant surgery consisted mostly of single-surgeon small series and retrospective experiences, rather than prospective, large, multicenter data collection [3-7]. Accordingly, it has been advocated the creation of prospective databases i.e. clinical data registries also to monitor more accurately the results of surgery, and to have solid grounds to formulate sound specific guidelines [8].


Commentary
Data of the first two existing registries on penile prostheses -PROPPER in U.S.A. and INSIST-ED in Italy-have been recently published [1,2]. This represents an absolute novelty in the scientific literature. Although the two registries have several structural differences that mandate caution in making comparisons between the respective outcomes, some key outcome data are similar.
Before these two studies the published data on penile implant surgery consisted mostly of single-surgeon small series and retrospective experiences, rather than prospective, large, multicenter data collection [3][4][5][6][7]. Accordingly, it has been advocated the creation of prospective databases i.e. clinical data registries also to monitor more accurately the results of surgery, and to have solid grounds to formulate sound specific guidelines [8].
According to the American Medical Association "a clinical data registry records information about the health status of patients and the health care they receive over varying periods of time. Clinical data registries typically focus on patients who share a common reason for needing health care. They allow health care professionals and others to see what treatments are available, and how patients with different characteristics respond to various treatments. This information can be used to inform patients and their health care professionals as they decide the best course of treatment and to improve care for patients in the future. Information from registries may also be used to compare the performance of healthcare providers with regard to their outcomes and resource use" [9]. This definition captures most of the reasons why I feel that registries for penile implants are strongly needed; I will go through the key points of the definition.
"Health status of the patients … reasons for needing health care": it is important to understand who are the people that presently benefit the most of penile prostheses. Both registries show that the leading primary cause of severe ED in men receiving a first penile implant is former radical pelvic surgery: radical prostatectomy accounting for 28% of all surgeries in the PROPPER study, and radical pelvic surgery accounting for 35.8% of new procedures in the INSIST-ED registry. Diabetes emerges also as a relevant cause in both registries. This clearly shows that penile implant surgery is not a sort of "lifestyle" surgery but a strategic tool to restore a key male function erections in men that developed ED as a consequence of significant medical conditions, as for instance cancer treatment. "This information can be used to inform patients and their health care professionals as they decide the best course of treatment and to improve care for patients in the future". I definitely agree with this statement. Up to now published data on penile implant patients consisted mostly of small series of single-surgeon, retrospective experiences rather than a prospective, large, multicenter evaluation.
Registries have now the potential to provide information through significant numbers of what works better in terms of preoperative care, intraoperative strategies, postoperative management, for the best patient outcomes. Such information will be of help for all the surgeons devoted to penile implant surgery.
"Information from registries may also be used to compare the performance of healthcare providers with regard to their outcomes and resource use". When it comes to interact with healthcare providers, often penile prosthetic surgery is not perceived as a strategic and often the only treatment to restore a key function for men, as erection is. It is expected that registries data-in particular the finding that pelvic cancer treatment is the leading ED cause for penile prosthesis surgery and quality of life data, may positively impact on resources allocation to this area by public Health Authorities.
In conclusion, I do hope that the first experiences of penile prosthesis surgery registries, INSIST-ED in Italy and PROPPER in U.S.A., will be soon followed by other Countries, so to generate a great amount of prospective, multicenter, multinational, comparable data for the benefit of our patients, i.e. better Public Health policies, and possibly also of surgeons, i.e. definition of the best operative standards.