Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction
- Conditions
- Erectile Dysfunction
- Registration Number
- NCT03849586
- Lead Sponsor
- European Association of Urology Research Foundation
- Brief 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 1076
- 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.
- Participating center is unable to contribute consecutive patients.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method Overall time being satisfied with treatment since implantation up to 10 years post surgery The interval from the date of regaining a patient EDITS score of 50 or more until the time of EDITS score of less than 50
Partner satisfaction rate at week 12, year 1, 2, 4, 6, 8 and 10 after surgery The number of partners with an EDITS score ≥ 50 compared to the total number of partners
Partner Satisfaction score at week 12, year 1, 2, 4, 6, 8 and 10 after surgery Partner Satisfaction score is defined as the mean partner satisfaction score as indicated by the Modified Partner EDITS Questionnaire. All items on the Partner EDITS will be scored from zero (no satisfaction or dissatisfaction) to four (high satisfaction). The mean satisfaction score for the partner 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).
Patient satisfaction rate at week 12, year 1, 2, 4, 6, 8 and 10 after surgery The number of patients with an EDITS score ≥ 50 compared to the total number of patients
International Index of Erectile Function - 5 (IIEF short form/SHIM) questionnaire at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery The IIEF-5 score is the sum of the ordinal responses to five items; thus, the score can range from 0 to 25. Erectile Dysfunction (ED) severity can be classified into the following five categories based on IIEF-5 scores; severe (0-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22- 25). Mean IIEF-5 scores will be calculated at the indicated time points and numbers / percentages of patients in the different ED severity categories. Also change in IIEF-5 score compared to baseline will be calculated.
Sexual Encounter Profile (SEP) questions 2 and 3 at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery For SEP question 2 and 3, scores are percentage of yes responses relative to number of sexual attempts/encounters. Proportions of yes responses will be treated as continuous variables. Post-operative results will also be compared to baseline.
EQ-5D-5L quality of life questionnaire at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery Results of the EQ-5D-5L quality of life questionnaire will be analyzed as described in the EuroQol EQ-5D-5L user guide. Post-operative results will also be compared to baseline.
Revision-free rate at 1, 2, 4, 6, 8 and 10 years of Registry follow-up The number of patients who are revision-free compared to the total number of patients.
Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire at week 12, year 1, 2, 4, 6, 8 and 10 after surgery QoLSPP is a 16-item questionnaire, with 4 domains: the functional, relational, social and personal domain. Responses are structured according to a six-point Likert scale, in most cases ranging from "never" (0) to "always" (5), where higher values represent more positive responses. Individual item scores will be analyzed as well as domain scores.
Complications during surgery and up to 10 years after surgery Type of complications, associated symptoms and whether or not a revision was needed will be recorded.
Immediate Postoperative complications until 2 weeks after surgery Type of complications, associated symptoms and whether or not a revision was needed will be recorded and classified according to the Clavien Dindo grading system.
Time of first activation, first cycling, first use, first intercourse, first orgasm, if applicable up to 10 years post surgery The date of first cycling (inflating and deflating the prosthesis several times), the date of first activation and first use for sexual activity, the date of first sexual intercourse and the date of first orgasm, if applicable, will be reported.
Time being revision-free up to 10 years post surgery The interval from the date of surgery to the date of revision whereby revision is defined as any urogenital surgical intervention that is related to the function, placement, or site reaction to the implanted device
Trial Locations
- Locations (31)
University Hospital Antwerp
🇧🇪Antwerp, Belgium
AZ Sint-Jan
🇧🇪Brugge, Belgium
AZ Maria Middelares
🇧🇪Gent, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Jessa Hospital
🇧🇪Hasselt, 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
San Raffaele Hospital
🇮🇹Milan, Italy
Casa di Cura Città di Parma
🇮🇹Parma, Italy
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Fundació Puigvert
🇪🇸Barcelona, Spain
Hospital Germans Trias i Pujol
🇪🇸Barcelona, Spain
Hospital Universitario 12 Octubre
🇪🇸Madrid, Spain
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
Hospital Universitario HM Montepríncipe
🇪🇸Boadilla del Monte, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Universitario La Zarzuela
🇪🇸Madrid, Spain
Lyx Institute of Urology
🇪🇸Madrid, Spain
Instituto Médico Rosselló
🇪🇸Palma De Mallorca, Spain
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Spain
St.George's University Hospital
🇬🇧London, United Kingdom
Hospital Universitario Rey Juan Carlos
🇪🇸Móstoles, Spain
Lund University, Skane Hospital,
🇸🇪Malmö, Sweden
Marques de Valdecilla University Hospital
🇪🇸Santander, Spain
Karolinska University Hospital
🇸🇪Stockholm, Sweden
UCLH
🇬🇧London, United Kingdom
Centro Hospitalar Universitario Lisboa Norte
🇵🇹Lisboa, Portugal