Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction
NCT ID: NCT03849586
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1076 participants
OBSERVATIONAL
2021-11-19
2032-02-29
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Participant is willing and able to give informed consent for participation in the Registry and is able to complete the questionnaires.
Exclusion Criteria
18 Years
MALE
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Coloplast A/S
INDUSTRY
European Association of Urology Research Foundation
OTHER
Responsible Party
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Principal Investigators
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Koen van Renterghem, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Jessa Hospital, Hasselt, Belgium
Federico Deho, MD
Role: PRINCIPAL_INVESTIGATOR
San Raffaele Hospital, Milan, Italy
Locations
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University Hospital Antwerp
Antwerp, , Belgium
AZ Sint-Jan
Bruges, , Belgium
AZ Maria Middelares
Ghent, , Belgium
Jessa Hospital
Hasselt, , Belgium
UZ Leuven
Leuven, , Belgium
CHU Lyon Sud
Lyon, , France
University Hospital Essen (AöR)
Essen, , Germany
University Hospital Schleswig Holstein
Lübeck, , Germany
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, , Italy
Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Foggia
Foggia, , Italy
San Raffaele Hospital
Milan, , Italy
Casa di Cura Città di Parma
Parma, , Italy
Centro Hospitalar Universitario Lisboa Norte
Lisbon, , Portugal
Fundació Puigvert
Barcelona, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital Germans Trias i Pujol
Barcelona, , Spain
Hospital Universitari de Bellvitge
Barcelona, , Spain
Hospital Universitario HM Montepríncipe
Boadilla del Monte, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario 12 Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario La Zarzuela
Madrid, , Spain
Lyx Institute of Urology
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, , Spain
Hospital Universitario Rey Juan Carlos
Móstoles, , Spain
Instituto Médico Rosselló
Palma de Mallorca, , Spain
Marques de Valdecilla University Hospital
Santander, , Spain
Lund University, Skane Hospital,
Malmo, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
St.George's University Hospital
London, , United Kingdom
UCLH
London, , United Kingdom
Countries
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References
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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.
Related Links
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EAU Research Foundation website
Other Identifiers
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EAU-RF 2018-01
Identifier Type: -
Identifier Source: org_study_id
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