Clinical Trials in Sweden / NCT03849586
Active, not recruiting
Observational
Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction
NCT03849586 · tracked via the Priya Life Science Sweden tracker
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
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 | Status |
|---|---|---|---|
| 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 |
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 Sweden