Prospective collection of pre-defined parameters on the surgical treatment of male erectile dysfunction using Penile Prosthesis Implants (PPIs).
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).
Study Type
OBSERVATIONAL
Enrollment
1,076
University Hospital Antwerp
Antwerp, Belgium
Patient Satisfaction score
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).
Time frame: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Partner Satisfaction score
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).
Time frame: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Patient satisfaction rate
The number of patients with an EDITS score ≥ 50 compared to the total number of patients
Time frame: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Partner satisfaction rate
The number of partners with an EDITS score ≥ 50 compared to the total number of partners
Time frame: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Overall time being satisfied with treatment since implantation
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 20 more locations
Time frame: up to 10 years post surgery
International Index of Erectile Function - 5 (IIEF short form/SHIM) questionnaire
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.
Time frame: at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Sexual Encounter Profile (SEP) questions 2 and 3
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.
Time frame: at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery
EQ-5D-5L quality of life questionnaire
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.
Time frame: at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire
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.
Time frame: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Complications
Type of complications, associated symptoms and whether or not a revision was needed will be recorded.
Time frame: during surgery and up to 10 years after surgery
Immediate Postoperative complications
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 frame: until 2 weeks after surgery
Time of first activation, first cycling, first use, first intercourse, first orgasm, if applicable
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 frame: up to 10 years post surgery
Time being revision-free
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
Time frame: up to 10 years post surgery
Revision-free rate
The number of patients who are revision-free compared to the total number of patients.
Time frame: at 1, 2, 4, 6, 8 and 10 years of Registry follow-up