Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction

NCT03849586 · tracked via the Priya Life Science Spain tracker

Sponsor

European Association of Urology Research Foundation

Phase

Observational

Started

2021-11-19

Last updated

2026-06-16

Condition(s) studied

Erectile Dysfunction

Study summary

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

Eligibility

Sex

MALE

Min age

18 Years

Max age

—

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.

Primary outcome measure(s)

Patient Satisfaction score — at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
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).

Trial sites (30)

Facility	City	Region
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
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,	Malmö	Sweden
Karolinska University Hospital	Stockholm	Sweden
St.George's University Hospital	London	United Kingdom
UCLH	London	United Kingdom

More European Association of Urology Research Foundation trials in Spain

Optilume Registry for Treatment of Stricture of the Anterior Urethra Active, not recruiting

Prostate Cancer Awareness and Initiative for Screening in the European Union Enrolling by invitation

Prospective Registry for Patients Undergoing Surgery for Male Stress Urinary Incontinence Active, not recruiting

Other trials for the same condition

Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction Active, not recruiting

Autologous PRP and Focal Shock Waves for Erectile Dysfunction Active, not recruiting

Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction. Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03849586 on ClinicalTrials.gov ↗ ← All trials in Spain