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… Click to show full abstract
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 followup 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-theart 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, ... Erectile dysfunction is a very common disorder with ranges up to over 50% [5], however even in the younger population erectile dysfunction can be an unneglectable sexual disorder [6]. First-line treatment is normally spoken oral pharmacotherapy with one of the available PDE-5is (Phospho Di-Esterase type 5 inhibitors). In non-responders Intracavernous treatment can be offered, which was by the way an available treatment nearly two decades before the PDE-5is [7]. However, the PDE-5is revolutionized the treatment for this patient population and made erectile dysfunction a much more discussable pathology [8]. There can be many reasons why patients on these conservative treatments stop treatment and ask for a reliable and long-term solution: side effects, planning sexual contact, diminishing or disappearing effect, repulsion for penile injections, partner dislike of the treatment, etc [9]. In these patients, a penile prosthesis implant (PPI) can be a lasting solution for their problem in a high-quality fashion. Penile implants are a surgical solution with a high patient and partner satisfaction rate, they are efficient and highly reliable [10]. Nevertheless, it is disappointing to see that PPI are often not proposed to patients as a high-quality solution for their erectile dysfunction due to lack of knowledge not only in the general population but also in the medical community, even in the urologist professionals [11]. When we look at the available penile implant devices, the most common used and most popular device is the three-piece inflatable penile implant, consisting of a reservoir, a pump, and two cylinders [12]. This is a closed hydraulic system that allows the penis to be in a flaccid and erect state depending on circumstances, giving the fact that the penis can be handled upon the patients and partners wish, it is the device with the highest satisfaction rate [13]. The two-piece devices with two cylinders and a pump serving as reservoir is mainly used in gender reassignment procedures for transgender patients [14]. Finally, the malleable devices are non-hydraulic and can be bended upon patients and partners demand. The use of either device depends on geographical factors, as well as on financial factors and patient characteristics. Malleable implants are often the first choice in difficult patients with a lot of fibrosis as we can encounter in post priapism patients [15]. The design of the registry is a prospective one. The data will be collected from different centers from all over Europe. The aim is to
               
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