AzTrials
AzTrials

Erectile DysfunctionPHOENIXNCT03849586

Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction

An observational study of Erectile Dysfunction, run by European Association of Urology Research Foundation at 30 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Erectile Dysfunction
How many people
1,076 participants
Where
30 sitesin 8 countries
Study dates
19 Nov 2021to Feb 2032
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • Participating center is unable to contribute consecutive patients.

Trial locations and contacts

30 sites in 8 countries.

30 sites in 8 countries

Spain14 sites

  • Fundació Puigvert

    Barcelona

  • Hospital Clínic de Barcelona

    Barcelona

  • Hospital Germans Trias i Pujol

    Barcelona

  • Hospital Universitari de Bellvitge

    Barcelona

  • Hospital Universitario HM Montepríncipe

    Boadilla del Monte

  • Hospital General Universitario Gregorio Marañon

    Madrid

  • Hospital Universitario 12 Octubre

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario La Zarzuela

    Madrid

  • Lyx Institute of Urology

    Madrid

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda

  • Hospital Universitario Rey Juan Carlos

    Móstoles

  • Instituto Médico Rosselló

    Palma de Mallorca

  • Marques de Valdecilla University Hospital

    Santander

Other trials in Spain

Belgium5 sites

  • University Hospital Antwerp

    Antwerp

  • AZ Sint-Jan

    Bruges

  • AZ Maria Middelares

    Ghent

  • Jessa Hospital

    Hasselt

  • UZ Leuven

    Leuven

Other trials in Belgium

Italy3 sites

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna

  • Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Foggia

    Foggia

  • Casa di Cura Città di Parma

    Parma

Other trials in Italy

Germany2 sites

  • University Hospital Essen (AöR)

    Essen

  • University Hospital Schleswig Holstein

    Lübeck

Other trials in Germany

Sweden2 sites

  • Lund University, Skane Hospital,

    Malmö

  • Karolinska University Hospital

    Stockholm

Other trials in Sweden

United Kingdom2 sites

  • St.George's University Hospital

    London

  • UCLH

    London

Other trials in United Kingdom

France1 site

  • CHU Lyon Sud

    Lyon

Other trials in France

Portugal1 site

  • Centro Hospitalar Universitario Lisboa Norte

    Lisbon

Other trials in Portugal

About this study

Official title: 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).

Read the 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).

Keywords
penile prosthesis implant
Medical subject headings
Erectile Dysfunction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery

Secondary outcomes (13)

  1. 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).

    Measured: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery

  2. Patient satisfaction rate

    The number of patients with an EDITS score ≥ 50 compared to the total number of patients

    Measured: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery

  3. Partner satisfaction rate

    The number of partners with an EDITS score ≥ 50 compared to the total number of partners

    Measured: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery

  4. 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

    Measured: up to 10 years post surgery

  5. 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.

    Measured: at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery

  6. 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.

    Measured: at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery

  7. 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.

    Measured: at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery

  8. 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.

    Measured: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery

  9. Complications

    Type of complications, associated symptoms and whether or not a revision was needed will be recorded.

    Measured: during surgery and up to 10 years after surgery

  10. 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.

    Measured: until 2 weeks after surgery

  11. 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.

    Measured: up to 10 years post surgery

  12. 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

    Measured: up to 10 years post surgery

  13. Revision-free rate

    The number of patients who are revision-free compared to the total number of patients.

    Measured: at 1, 2, 4, 6, 8 and 10 years of Registry follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2019
  2. Study start19 Nov 2021
  3. Primary completionFeb 2032 (estimated)
  4. Study completionFeb 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,076 participants (actual)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03849586
Sponsor's protocol ID
EAU-RF 2018-01
Acronym
PHOENIX
Status last verified
Jun 2026
First submitted
18 Feb 2019
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Investigators may share anonymized individual data with residents/urologist interested to analyze and publish the results of the registry

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.

    PubMed 35220417

  • Caris C, Timmerman H, Witjes W, van Renterghem K, Deho F, Pescatori E, Utizi L, Caraceni E. The quality of life and sexuality with penile prosthesis questionnaire. A translation and cross-cultural adaptation into multiple languages. J Sex Med. 2026 Mar 9;23(4):qdag069. doi: 10.1093/jsxmed/qdag069. No abstract available.

    PubMed 41838870

  • 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.

    PubMed 38037429

  • 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. 2026 Jan;38(1):30-36. doi: 10.1038/s41443-025-01080-z. Epub 2025 May 7.

    PubMed 40335744

  • Van Renterghem K, Yebes A, Lamers G, Torremade J, Bettocchi C, Garcia-Gomez B, Lee WG, Caris C, Witjes W, Moncada I, Ralph D; EAU Research Foundation PHOENIX Study Group. Predictors of penile prosthesis length: results from the PHOENIX registry. Int J Impot Res. 2026 Jun 1. doi: 10.1038/s41443-026-01294-9. Online ahead of print.

    PubMed 42225959

Questions about this trial

What is this clinical trial studying?

An observational study of Erectile Dysfunction, run by European Association of Urology Research Foundation at 30 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Spain, Belgium, Italy, Germany, Sweden and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Satisfaction score (time frame: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03849586, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in