Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction (PHOENIX)

Prospective Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction

Prospective collection of pre-defined parameters on the surgical treatment of male erectile dysfunction using Penile Prosthesis Implants (PPIs).

Study Overview

• Status: Active, not recruiting
• Conditions: Erectile Dysfunction

Detailed Description

This will be a prospective collection of pre-defined parameters on the surgical treatment of male erectile dysfunction using Penile Prosthesis Implants (PPIs). The data collection will be undertaken from multiple centres in Europe. The participation will be by open invitation from the European Association of Urology (EAU) Section of Genitourinary Reconstructive Surgeons (ESGURS) to all its members, along with other urologists undertaking these procedures.

There will be no restriction on the number of patients enrolled per centre as long as they are consecutive. The aim is to have a long term collection of the dataset from as many centres as possible. An initial assessment for the robustness of the data collection and first clinical evaluation of the data collected will be performed 1 and 2 years after recruitment of the first patient by a nominated steering committee. Thereafter, the evaluations will be performed every 2 years until the end of Registry (10 years after the first patient was enrolled).

• Study Type: Observational
• Enrollment (Actual): 1076

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • University Hospital Antwerp
  • Bruges, Belgium
    • AZ Sint-Jan
  • Ghent, Belgium
    • AZ Maria Middelares
  • Hasselt, Belgium
    • Jessa Hospital
  • Leuven, Belgium
    • UZ Leuven
• France
  • Lyon, France
    • CHU Lyon Sud
• Germany
  • Essen, Germany
    • University Hospital Essen (AöR)
  • Lübeck, Germany
    • University Hospital Schleswig Holstein
• Italy
  • Bologna, Italy
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • Foggia, Italy
    • Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Foggia
  • Parma, Italy
    • Casa di Cura Città di Parma
• Portugal
  • Lisbon, Portugal
    • Centro Hospitalar Universitario Lisboa Norte
• Spain
  • Barcelona, Spain
    • Hospital Clinic de Barcelona
  • Barcelona, Spain
    • Hospital Universitari de Bellvitge
  • Barcelona, Spain
    • Hospital Germans Trias i Pujol
  • Barcelona, Spain
    • Fundacio Puigvert
  • Boadilla del Monte, Spain
    • Hospital Universitario HM Monteprincipe
  • Madrid, Spain
    • Hospital General Universitario Gregorio Marañón
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Hospital Universitario La Zarzuela
  • Madrid, Spain
    • Hospital Universitario 12 Octubre
  • Madrid, Spain
    • Lyx Institute of Urology
  • Majadahonda, Spain
    • Hospital Universitario Puerta de Hierro Majadahonda
  • Móstoles, Spain
    • Hospital Universitario Rey Juan Carlos
  • Palma de Mallorca, Spain
    • Instituto Médico Rosselló
  • Santander, Spain
    • Marqués de Valdecilla University Hospital
• Sweden
  • Malmo, Sweden
    • Lund University, Skane Hospital,
  • Stockholm, Sweden
    • Karolinska University Hospital
• United Kingdom
  • London, United Kingdom
    • UCLH
  • London, United Kingdom
    • St.George's University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Male patients undergoing a surgical Penile Prosthesis Implant for treatment of erectile dysfunction.

Description

Inclusion Criteria:

• Male patient undergoing a surgical penile prosthesis implant for treatment of erectile dysfunction.
• Participant is willing and able to give informed consent for participation in the Registry and is able to complete the questionnaires.

Exclusion Criteria:

• Participating center is unable to contribute consecutive patients.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction score	Patient Satisfaction score is defined as the mean patient satisfaction score as indicated by the Modified Patient EDITS Questionnaire. All items on the Patient EDITS will be scored from zero (no satisfaction or dissatisfaction) to four (high satisfaction). The mean satisfaction score for each patient will be calculated. To place scores in an easily interpretable metric, each mean score will be multiplied by 25 so that EDITS scores could range from a low of 0 (extremely low treatment satisfaction) to a high of 100 extremely high treatment satisfaction).	at week 12, year 1, 2, 4, 6, 8 and 10 after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Partner Satisfaction score	Partner Satisfaction score is defined as the mean partner satisfaction score as indicated by the Modified Partner EDITS Questionnaire. All items on the Partner EDITS will be scored from zero (no satisfaction or dissatisfaction) to four (high satisfaction). The mean satisfaction score for the partner will be calculated. To place scores in an easily interpretable metric, each mean score will be multiplied by 25 so that EDITS scores could range from a low of 0 (extremely low treatment satisfaction) to a high of 100 extremely high treatment satisfaction).	at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Patient satisfaction rate	The number of patients with an EDITS score ≥ 50 compared to the total number of patients	at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Partner satisfaction rate	The number of partners with an EDITS score ≥ 50 compared to the total number of partners	at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Overall time being satisfied with treatment since implantation	The interval from the date of regaining a patient EDITS score of 50 or more until the time of EDITS score of less than 50	up to 10 years post surgery
International Index of Erectile Function - 5 (IIEF short form/SHIM) questionnaire	The IIEF-5 score is the sum of the ordinal responses to five items; thus, the score can range from 0 to 25. Erectile Dysfunction (ED) severity can be classified into the following five categories based on IIEF-5 scores; severe (0-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22- 25). Mean IIEF-5 scores will be calculated at the indicated time points and numbers / percentages of patients in the different ED severity categories. Also change in IIEF-5 score compared to baseline will be calculated.	at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Sexual Encounter Profile (SEP) questions 2 and 3	For SEP question 2 and 3, scores are percentage of yes responses relative to number of sexual attempts/encounters. Proportions of yes responses will be treated as continuous variables. Post-operative results will also be compared to baseline.	at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery
EQ-5D-5L quality of life questionnaire	Results of the EQ-5D-5L quality of life questionnaire will be analyzed as described in the EuroQol EQ-5D-5L user guide. Post-operative results will also be compared to baseline.	at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire	QoLSPP is a 16-item questionnaire, with 4 domains: the functional, relational, social and personal domain. Responses are structured according to a six-point Likert scale, in most cases ranging from "never" (0) to "always" (5), where higher values represent more positive responses. Individual item scores will be analyzed as well as domain scores.	at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Complications	Type of complications, associated symptoms and whether or not a revision was needed will be recorded.	during surgery and up to 10 years after surgery
Immediate Postoperative complications	Type of complications, associated symptoms and whether or not a revision was needed will be recorded and classified according to the Clavien Dindo grading system.	until 2 weeks after surgery
Time of first activation, first cycling, first use, first intercourse, first orgasm, if applicable	The date of first cycling (inflating and deflating the prosthesis several times), the date of first activation and first use for sexual activity, the date of first sexual intercourse and the date of first orgasm, if applicable, will be reported.	up to 10 years post surgery
Time being revision-free	The interval from the date of surgery to the date of revision whereby revision is defined as any urogenital surgical intervention that is related to the function, placement, or site reaction to the implanted device	up to 10 years post surgery
Revision-free rate	The number of patients who are revision-free compared to the total number of patients.	at 1, 2, 4, 6, 8 and 10 years of Registry follow-up

Collaborators and Investigators

• Sponsor: European Association of Urology Research Foundation
• Collaborators: Boston Scientific Corporation; Coloplast A/S
• Investigators: Principal Investigator: Koen van Renterghem, MD, PhD, Jessa Hospital, Hasselt, Belgium

Publications and helpful links

General Publications

• 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. 2023 Jun;35(4):329-331. doi: 10.1038/s41443-022-00547-7. Epub 2022 Feb 26. No abstract available.
• van Renterghem K, Jorissen C, Van Huele A. Penile length changes after penile implant surgery. J Sex Med. 2023 Nov 30;20(12):1364-1366. doi: 10.1093/jsxmed/qdad125. No abstract available.
• Van Renterghem K, De Bruyn H, Yebes A, Calopedos R, Deho F, Torremade J, D'Anna M, Bettocchi C, Gomez BG, Caris C, Witjes W, Moncada I, Ralph D; EAU Research Foundation PHOENIX Study Group. Early complications after penile prosthesis surgery: findings from the PHOENIX multicenter registry. Int J Impot Res. 2025 May 7. doi: 10.1038/s41443-025-01080-z. Online ahead of print.

Helpful Links

• EAU Research Foundation website

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2021
• Primary Completion (Estimated): February 1, 2032
• Study Completion (Estimated): February 1, 2032

Study Registration Dates

• First Submitted: February 18, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: penile prosthesis implant
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Erectile Dysfunction
• Other Study ID Numbers: EAU-RF 2018-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Investigators may share anonymized individual data with residents/urologist interested to analyze and publish the results of the registry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No