Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction

NCT ID: NCT03849586

Last Updated: 2025-08-08

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1076 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-19

Study Completion Date

2032-02-29

Brief Summary

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

Detailed Description

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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).

Conditions

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Erectile Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Coloplast A/S

INDUSTRY

Sponsor Role collaborator

European Association of Urology Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

AZ Sint-Jan

Bruges, , Belgium

Site Status

AZ Maria Middelares

Ghent, , Belgium

Site Status

Jessa Hospital

Hasselt, , Belgium

Site Status

UZ Leuven

Leuven, , Belgium

Site Status

CHU Lyon Sud

Lyon, , France

Site Status

University Hospital Essen (AöR)

Essen, , Germany

Site Status

University Hospital Schleswig Holstein

Lübeck, , Germany

Site Status

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Site Status

Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Foggia

Foggia, , Italy

Site Status

San Raffaele Hospital

Milan, , Italy

Site Status

Casa di Cura Città di Parma

Parma, , Italy

Site Status

Centro Hospitalar Universitario Lisboa Norte

Lisbon, , Portugal

Site Status

Fundació Puigvert

Barcelona, , Spain

Site Status

Hospital Clínic de Barcelona

Barcelona, , Spain

Site Status

Hospital Germans Trias i Pujol

Barcelona, , Spain

Site Status

Hospital Universitari de Bellvitge

Barcelona, , Spain

Site Status

Hospital Universitario HM Montepríncipe

Boadilla del Monte, , Spain

Site Status

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Site Status

Hospital Universitario 12 Octubre

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Hospital Universitario La Zarzuela

Madrid, , Spain

Site Status

Lyx Institute of Urology

Madrid, , Spain

Site Status

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, , Spain

Site Status

Hospital Universitario Rey Juan Carlos

Móstoles, , Spain

Site Status

Instituto Médico Rosselló

Palma de Mallorca, , Spain

Site Status

Marques de Valdecilla University Hospital

Santander, , Spain

Site Status

Lund University, Skane Hospital,

Malmo, , Sweden

Site Status

Karolinska University Hospital

Stockholm, , Sweden

Site Status

St.George's University Hospital

London, , United Kingdom

Site Status

UCLH

London, , United Kingdom

Site Status

Countries

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Belgium France Germany Italy Portugal Spain Sweden United Kingdom

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.

Reference Type BACKGROUND
PMID: 35220417 (View on PubMed)

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.

Reference Type RESULT
PMID: 38037429 (View on PubMed)

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.

Reference Type RESULT
PMID: 40335744 (View on PubMed)

Related Links

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https://uroweb.org/research/projects/

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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