Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,076

participants targeted

Target at P75+ for all trials

Timeline

70mo left

Started Nov 2021

Longer than P75 for all trials

Geographic Reach

8 countries

30 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10.2 years study duration

Study Progress44%

Nov 2021Feb 2032

First Submitted

Initial submission to the registry

February 18, 2019

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed

2.7 years until next milestone

Study Start

First participant enrolled

November 19, 2021

Completed

10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2032

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2032

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

10.2 years

First QC Date

February 18, 2019

Last Update Submit

January 29, 2026

Conditions

Erectile Dysfunction

Keywords

penile prosthesis implant

Outcome Measures

Primary Outcomes (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).
at week 12, year 1, 2, 4, 6, 8 and 10 after surgery

Secondary Outcomes (13)

Partner Satisfaction score
at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Patient satisfaction rate
at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Partner satisfaction rate
at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Overall time being satisfied with treatment since implantation
up to 10 years post surgery
International Index of Erectile Function - 5 (IIEF short form/SHIM) questionnaire
at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery
+8 more secondary outcomes

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

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

You may qualify if:

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.

You may not qualify if:

Participating center is unable to contribute consecutive patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

European Association of Urology Research Foundationlead
Boston Scientific Corporationcollaborator
Coloplast A/Scollaborator

Study Sites (30)

University Hospital Antwerp

Antwerp, Belgium

Location

AZ Sint-Jan

Bruges, Belgium

Location

AZ Maria Middelares

Ghent, Belgium

Location

Jessa Hospital

Hasselt, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

CHU Lyon Sud

Lyon, France

Location

University Hospital Essen (AöR)

Essen, Germany

Location

University Hospital Schleswig Holstein

Lübeck, Germany

Location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy

Location

Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Foggia

Foggia, Italy

Location

Casa di Cura Città di Parma

Parma, Italy

Location

Centro Hospitalar Universitario Lisboa Norte

Lisbon, Portugal

Location

Fundació Puigvert

Barcelona, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Hospital Germans Trias i Pujol

Barcelona, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, Spain

Location

Hospital Universitario HM Montepríncipe

Boadilla del Monte, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Location

Hospital Universitario 12 Octubre

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario La Zarzuela

Madrid, Spain

Location

Lyx Institute of Urology

Madrid, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain

Location

Hospital Universitario Rey Juan Carlos

Móstoles, Spain

Location

Instituto Médico Rosselló

Palma de Mallorca, Spain

Location

Marques de Valdecilla University Hospital

Santander, Spain

Location

Lund University, Skane Hospital,

Malmo, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

St.George's University Hospital

London, United Kingdom

Location

UCLH

London, United Kingdom

Location

Related Publications (3)

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.
PMID: 35220417BACKGROUND
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.
PMID: 38037429RESULT
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.
PMID: 40335744RESULT

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

Koen van Renterghem, MD, PhD
Jessa Hospital, Hasselt, Belgium
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Duration: 10 Years
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 18, 2019

First Posted

February 21, 2019

Study Start

November 19, 2021

Primary Completion (Estimated)

February 1, 2032

Study Completion (Estimated)

February 1, 2032

Last Updated

February 2, 2026

Record last verified: 2026-01

Locations

ES(14)DE(2)BE(5)FR(1)SE(2)GB(2)PT(1)IT(3)

Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (30)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (30)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations