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INSIST-ED: Italian Society of Andrology registry on penile prosthesis surgery. First data analysis

Edoardo Pescatori, Giovanni Alei, Gabriele Antonini, Antonio Avolio, Carlo Bettocchi, Marco Bitelli, Francesco Boezio, Tommaso Cai, Enrico Caraceni, Maurizio Carrino, Fulvio Colombo, Enrico Conti, Antonio Corvasce, Federico Dehò, Stefano Fiordelise, Nicola Ghidini, Emilio Italiano, Giuseppe La Pera, Giovanni Liguori, Carlo Maretti, Nicola Mondaini, Alessandro Natali, Carlo Negro, Alessandro Palmieri, Fabrizio Palumbo, Matteo Paradiso, Massimo Polito, Diego Pozza, Mauro Silvani, Aldo Tamai, Massimiliano Timpano, Lilia Utizi, Francesco Varvello, Patrizio Vicini, Antonio Vitarelli, Giorgio Franco
  • Giovanni Alei
    Policlinico Umberto I, Roma, Italy
  • Gabriele Antonini
    Policlinico Umberto I, Roma, Italy
  • Antonio Avolio
    Ospedale Mazzoni, Ascoli Piceno, Italy
  • Carlo Bettocchi
    Policlinico Bari, Bari, Italy
  • Marco Bitelli
    Ospedale S. Sebastiano Martire, Frascati, Italy
  • Francesco Boezio
    Ospedale Tatarella, Cerignola, Italy
  • Tommaso Cai
    Ospedale Santa Chiara, Trento, Italy
  • Enrico Caraceni
    Area Vasta 3, Civitanova Marche, Italy
  • Maurizio Carrino
    Ospedale Cardarelli, Napoli, Italy
  • Fulvio Colombo
    Policlinico S.Orsola-Malpighi, Bologna, Italy
  • Enrico Conti
    Ospedale San Bartolomeo, Sarzana, Italy
  • Antonio Corvasce
    Ospedale Bonomo, Andria, Italy
  • Federico Dehò
    Ospedale San Raffaele, Milano, Italy
  • Stefano Fiordelise
    AUSL Piacenza, Italy
  • Nicola Ghidini
    Hesperia Hospital, Modena, Italy
  • Emilio Italiano
    Ospedali Riuniti, Palermo, Italy
  • Giuseppe La Pera
    San Camillo Forlanini, Roma, Italy
  • Giovanni Liguori
    Ospedali Riuniti, Trieste, Italy
  • Carlo Maretti
    CIRM, Piacenza, Italy
  • Nicola Mondaini
    Ospedale S.M. Annunziata, Firenze, Italy
  • Alessandro Natali
    AUOC, Firenze, Italy
  • Carlo Negro
    Ospedale Cardinal Massaia, Asti, Italy
  • Alessandro Palmieri
    Università Federico II, Napoli, Italy
  • Fabrizio Palumbo
    Policlinico Bari, Bari, Italy
  • Matteo Paradiso
    Ospedale Cardinal Massaia, Asti, Italy
  • Massimo Polito
    Ospedali Riuniti, Ancona, Italy
  • Diego Pozza
    Wojtyla Hospital, Roma, Italy
  • Mauro Silvani
    Ospedale Infermi, Biella, Italy
  • Aldo Tamai
    Casa di Cura Eretenia, Vicenza, Italy
  • Massimiliano Timpano
    Ospedale Molinette, Torino, Italy
  • Lilia Utizi
    Area Vasta 3, Civitanova Marche, Italy
  • Francesco Varvello
    Ospedale San Lazzaro, Alba, Italy
  • Patrizio Vicini
    Rome American Hospital, Roma, Italy
  • Antonio Vitarelli
    Policlinico Bari, Bari, Italy
  • Giorgio Franco
    Policlinico Umberto I, Roma, Italy

Abstract

Objectives: The Italian Society of Andrology, i.e. “Società Italiana di Andrologia” (S.I.A.), launched on December 2014 a prospective, multicenter, monitored and internal review board approved Registry for penile implants, the “INSIST-ED” (Italian Nationwide Systematic Inventarisation of Surgical Treatment for ED) Registry. Purpose of this first report is to present a baseline data analysis of the characteristics of penile implant surgery in Italy. Material and methods: The INSIST-ED Registry is open to all surgeons implanting penile prostheses (all brands, all models) in Italy, providing anonymous patient, device, surgical procedure, outcome, follow-up data, for both first and revision surgeries. A Registry project Board overviews all the steps of the project, and a Registry Monitor interacts with the Registry implanting surgeons. Results: As by April 8, 2016, 31 implanting surgeons actively joined the Registry, entering 367 surgical procedures in its database, that comprise: 310 first implants, 43 prosthesis substitutions, 14 device explants without substitution. Implanted devices account for: 288 three-component devices (81,3%), 20 two-component devices (5,4%), 45 non-hydraulic devices (12,3%). Leading primary ED etiologies in first implant surgeries resulted: former radical pelvic surgery in 111 cases (35,8%), Peyronie’s disease in 66 cases (21,3%), diabetes in 39 cases (12,6%). Two intraoperative complications have been recorded. Main reasons for 57 revision surgeries were: device failure (52,6%), erosion (19,3%), infection (12,3%), patient dissatisfaction (10,5%). Surgical settings for patients undergoing a first penile implant were: public hospitals in 251 cases (81%), private environments in 59 cases (19%). Conclusions: The INSIST-ED Registry represents the first European experience of penile prosthesis Registry. This baseline data analysis shows that: three-pieces inflatable prosthesis is the most implanted device, leading etiology of erectile dysfunction (ED) in patient receiving a prosthesis is former radical pelvic surgery, primary reason for revision surgery is device failure, primary settings for first penile implant surgery are public hospitals. Evaluation of penile implant impact on recipients quality of life is presently ongoing.

Keywords

Penis; Penile prosthesis; Surgery; Surgical procedures; Implant; Registry; Quality of life; Impotence; Erectile dysfunction

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Submitted: 2016-05-02 11:47:29
Published: 2016-07-04 15:13:24
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Copyright (c) 2016 Edoardo Pescatori, Giovanni Alei, Gabriele Antonini, Antonio Avolio, Carlo Bettocchi, Marco Bitelli, Francesco Boezio, Tommaso Cai, Enrico Caraceni, Maurizio Carrino, Fulvio Colombo, Enrico Conti, Antonio Corvasce, Federico Dehò, Stefano Fiordelise, Nicola Ghidini, Emilio Italiano, Giuseppe La Pera, Giovanni Liguori, Carlo Maretti, Nicola Mondaini, Alessandro Natali, Carlo Negro, Alessandro Palmieri, Fabrizio Palumbo, Matteo Paradiso, Massimo Polito, Diego Pozza, Mauro Silvani, Aldo Tamai, Massimiliano Timpano, Lilia Utizi, Francesco Varvello, Patrizio Vicini, Antonio Vitarelli, Giorgio Franco

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