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

E

European Association of Urology Research Foundation

Status

Active, not recruiting

Conditions

Erectile Dysfunction

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03849586
EAU-RF 2018-01

Details and patient eligibility

About

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

Full 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).

Enrollment

1,076 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

30

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Central trial contact

Wim Witjes, MD, PhD; Christien Caris, MSc

Data sourced from clinicaltrials.gov

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