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Perspective on the PHOENIX trial: prospective registry for patients undergoing penile prosthesis implantation for male erectile dysfunction in multiple European centers

International Journal of Impotence Research volume 35, pages 329–331 (2023)Cite this article

Subjects

The PHOENIX trial is a prospective multicentric survey on Penile Implant Surgery conducted by the European Association of Urology-Research Foundation (EAU-RF) (https://clinicaltrials.gov/ct2/show/NCT03849586). The goal is to collect data on daily practice regarding surgical treatment, short and long-term follow-up outcome of patients treated with available penile implant devices. The survey will look at efficacy, morbidity, complications, quality of life, patient and partner satisfaction. These data will be collected in a registry database run by EAU-RF. The main outcome is patient satisfaction at 12 weeks, year one and two post-operative, and for a total of 10 years every 2 years subsequently. Also the partner outcome will be evaluated with the same intervals. Moreover, a plethora of data will be collected on the indication for surgery, the comorbidity of patients, the baseline characteristics of patients, the surgical technique used, etc. Per-operative data collected are scrubbing techniques, antibiotic prophylaxis, surgical approach, operating time, use of drain, use of dressing after the operation, hospital stay, etc. Finally, the post-operative observations will be monitored: duration of antibiotic prophylaxis, post-operative pain, first activation, first orgasm, mechanical outcome, etc. It is striking to realize that especially in penile implant surgery there is a big lack of objective data and evidence-based guidelines. Most if not all of the literature available is surgeon-related subjective outcome, prospective and multicentric data are nearly unavailable. The PHOENIX trial will be unique in this sense that it will enable the penile implant surgeons to have evidence-based and state-of-the-art guidelines available not just relying on personal experiences describing what happened in a group of (selected) patients. To assess the satisfaction we use the EDITS scoring system. However also partner satisfaction will be registered since involvement of the partner is of utmost importance in this particular population, this is done with the modified partner EDITS score [1]. Other scores such as IIEF-5 [2], SEP 2 and 3 [3], EQ-5D-5L [4] are evaluated as well and compared with baseline over time. Post-operative events (hematoma, fever, pain, etc.) are observed as well. More surgery-specific complications are registered likewise, infection, erosion, mechanical failure, etc.

Concerning the functioning of the device many parameters are observed and registered: floppy glans, first activation, first cycling, first use, first intercourse, first orgasm, …

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Authors and Affiliations

  1. Dept. of Urology Jessa Hospital Hasselt Belgium, Hasselt University Belgium, University Hospitals Leuven Belgium, Leuven, Belgium

    Koenraad van Renterghem

  2. Università degli Studi dell’Insubria, Varese, Italy

    Federico Deho

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  1. Koenraad van Renterghem
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  2. Federico Deho
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Contributions

KR: concept, writing, editing article. FD: assisting in writing article.

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Correspondence to Koenraad van Renterghem.

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van Renterghem, K., Deho, F. Perspective on the PHOENIX trial: prospective registry for patients undergoing penile prosthesis implantation for male erectile dysfunction in multiple European centers. Int J Impot Res 35, 329–331 (2023). https://doi.org/10.1038/s41443-022-00547-7

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