An observational study in Erectile Dysfunction, sponsored by European Association of Urology Research Foundation. Active, not recruiting at 30 sites in 8 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by European Association of Urology Research Foundation · Observational
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).
701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.
This study's enrollment of 1,076 is above the median of 130 across 125 observational studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →European Association of Urology Research Foundation is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Male patients undergoing a surgical Penile Prosthesis Implant for treatment of erectile dysfunction.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Plan to share: Undecided — Investigators may share anonymized individual data with residents/urologist interested to analyze and publish the results of the registry
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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European Association of Urology Research Foundation