Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Perspective
  • Published:

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, …

This is a preview of subscription content, access via your institution

Access options

Buy this article

  • Purchase on SpringerLink
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

References

  1. Althof SE, Corty EW, Levine SB, Levine F, Burnett AL, Mc Vary V, et al. EDITS: development of questionnaires for evaluating satisfaction with treatments for erectile dysfunction. Urology. 1999;53:793–9.

    Article  CAS  PubMed  Google Scholar 

  2. Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997;49:822–30.

    Article  CAS  PubMed  Google Scholar 

  3. Hatzichristou D, Paraskevi S, Banner L, Althof SE, Lonnee-Hoffmanf RA, Dennerstein L, et al. Diagnosing sexual dysfunction in men and women: sexual history taking and the role of symptom scales and questionnaires. J Sex Med. 2016;13:1166–82.

    Article  PubMed  Google Scholar 

  4. Herdman M, Gudex C, Lloyd A, Janssen MF, Kind P, Parkin D, et al. Development and preliminary testing of the new version of EQ (EQ-5D-5L). Qual Life Res. 2011;20:1727–36.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  5. Eardley I. The incidence, prevalence and natural history of erectile dysfunction. Sex Med Rev. 2013;1:3–16.

    Article  PubMed  Google Scholar 

  6. Capogrosso P, Colicchia M, Ventimiglia E, Castagna G, Clementi MC, Suardi N, et al. One out of four with newly diagnosed erectile dysfunction is a young man-worrisome picture from the everyday practice. J Sex Med. 2013;10:1833–41.

    Article  PubMed  Google Scholar 

  7. Virag R, Virag H. Trial of intracavernous papaverine in the treatment of impotence. Therapeutic prospects J Mal Vasc. 1983;8:293–5.

    CAS  PubMed  Google Scholar 

  8. Hatzimouratidis K, Salonia A, Adaikan G, Buvat J, Carrier S, El-Meliegy A, et al. Pharmacotherapy for erectile dysfunction: recommendations from the fourth international consolation for sexual medicine. J Sex Med. 2016;13:130–71.

    Article  Google Scholar 

  9. Corona G, Rastrelli G, Burri A, Serra E, Gianfrilli D, Mannucci E, et al. First-generation phosphodiesterase type 5 inhibitors drop out: a comprehensive review and meta-analysis. Andrology. 2016;4:1002.

    Article  CAS  PubMed  Google Scholar 

  10. Trost LW, McCaslin R, Linder B, Hellstrom WJ. Long term outcomes of penile prostheses for the treatment of erectile dysfunction. Expert Rev Med Devices. 2013;10:353–66.

    Article  CAS  PubMed  Google Scholar 

  11. Akakpo W, Pineda MA, Burnett AL. Critical analysis of satisfaction assessment after penile prosthesis surgery. Sex Med Rev. 2017;5:244.

    Article  PubMed  Google Scholar 

  12. Vakalopoulos I, Kampantais S, Ioannidis S, Laskaridis L, Dimopoulos D, Toutziaris C, et al. High patient satisfaction after inflatable penile prosthesis implantation correlates with female partner satisfaction. J Sex Med. 2013;10:2774–81.

    Article  PubMed  Google Scholar 

  13. Bernal R, Henry G. Contempory patient satisfaction rates for three piece inflatable penile prostheses. Adv Urol. 2012;2012:707321.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Blecher G, Nim C, Ralph D. Prosthetic placement after phalloplasty. Urol Clin N Am. 2019;46:591–603.

    Article  Google Scholar 

  15. Eardley I. Malleable versus inflatable implant? Which one to choose. Eardley I J Sex Med. 2017;14:975–6.

    Article  PubMed  Google Scholar 

Download references

Author information

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

Authors
  1. Koenraad van Renterghem
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Federico Deho
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

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

Corresponding author

Correspondence to Koenraad van Renterghem.

Ethics declarations

Competing interests

The authors declare no competing interests.

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

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

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/s41443-022-00547-7

Search

Advanced search

Quick links