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Clinical indications for penile prosthesis implantation: data from the national prospective registry of penile prosthesis implantation “INSIST-ED”

Capogrosso, P1; Pescatori, E1; Cazzaniga, W1; Caraceni, E1; Colombo, F1; Negro, C1; Ciampalini, S1; Dachille, G1; Bettocchi, C1; Antonini, G1; Capone, M1; Polito, M1; Salonia, A1; Palmieri, A1Dehò, F1

1: Societa' Italiana di Andrologia, Rome, Italy

Objective: The European Urological Association (EAU) guidelines suggest penile prosthesis implantation (PPI) only as a third line therapy for the treatment of erectile dysfunction (ED). We looked at the current indications for PPI in clinical practice using data from a prospective national registry.

Materials and Methods: Data from a national multi-institutional database of PPI including patients treated in 2014-2017 in Italy (INSIST-ED) were analysed. Data have been prospectively recorded by 45 surgeons on a dedicated website ( and revised by a single datamanager. According to EAU guidelines, the indication for PPI was considered appropriate when patients have been offered both a first line (e.g. PDE5is and/or vacuum therapy) and a second line (e.g. intracavernous injection) treatment approach before surgical treatment. Patients with penile curvature and ED were considered as properly submitted to PPI when they were previously offered at least with PDE5is. Logistic regression analyses tested the association between clinical characteristics, surgeon experience and ED etiology with the likelihood of a proper indication for PPI.

Results: Complete data were available for 579 patients; median (IQR) age was 61 (56-67) years. ED etiology was vasculogenic in 39% (226) and post-pelvic surgery in 40% (231) of cases, respectively. Overall, only 20 (3.5%) patients did not have a proper indication for PPI according to EAU guidelines. Of them, 14 (70%) and 6 (30%) were either nonresponders to or refused a first-line ED therapy and were not offered with a second line therapy prior to surgery. Moreover, most patients with a proper PPI indication were treated in a public center [442 (79%) vs. 117 (21%)]. Both nonresponders to a previous ED therapy (OR: 3.3; 95%CI: 1.2-9.1, p=0.01) and patients treated in a private center (OR: 2.51; 95%CI>1.01-6.3, p=0.04) were more likely to undergo PPI surgery without a proper indication according to current EAU guidelines. No significant association was found between ED etiology, surgeon’s experience and patients’ age and the likelihood of a proper indication for PPI.

Conclusions: Current findings from a national registry showed that EAU guidelines are properly followed in terms of indications for PPI surgery in patients with ED. Patients treated in a private hospital setting and those nonresponders to a previous first-line treatment were more likely to be counseled for PPI before being offered a second-line therapy.


Work supported by industry: no.

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