NCT03849586

Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction

Prospective Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,076 (actual)
• Sponsor: European Association of Urology Research Foundation · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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).

Conditions

• Erectile Dysfunction

Timeline

• Start date: 2021-11-19
• Primary completion: 2032-02-01
• Completion: 2032-02-01
• First posted: 2019-02-21
• Last updated: 2026-02-02

Locations

30 sites across 8 countries: Belgium, France, Germany, Italy, Portugal, Spain, Sweden, United Kingdom