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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
| Coloplast A/S | INDUSTRY |
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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).
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | at week 12, year 1, 2, 4, 6, 8 and 10 after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Male patients undergoing a surgical Penile Prosthesis Implant for treatment of erectile dysfunction.
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| Name | Affiliation | Role |
|---|---|---|
| Koen van Renterghem, MD, PhD | Jessa Hospital, Hasselt, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Antwerp | Antwerp | Belgium | ||||
| AZ Sint-Jan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35220417 | Background | van Renterghem K, Deho F. Perspective on the PHOENIX trial: prospective registry for patients undergoing penile prosthesis implantation for male erectile dysfunction in multiple European centers. Int J Impot Res. 2023 Jun;35(4):329-331. doi: 10.1038/s41443-022-00547-7. Epub 2022 Feb 26. No abstract available. | |
| 41838870 | Background |
| Label | URL |
|---|---|
| EAU Research Foundation website | View source |
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Investigators may share anonymized individual data with residents/urologist interested to analyze and publish the results of the registry
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| 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | up to 10 years post surgery |
| Revision-free rate | The number of patients who are revision-free compared to the total number of patients. | at 1, 2, 4, 6, 8 and 10 years of Registry follow-up |
| 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 |
| Caris C, Timmerman H, Witjes W, van Renterghem K, Deho F, Pescatori E, Utizi L, Caraceni E. The quality of life and sexuality with penile prosthesis questionnaire. A translation and cross-cultural adaptation into multiple languages. J Sex Med. 2026 Mar 9;23(4):qdag069. doi: 10.1093/jsxmed/qdag069. No abstract available. |
| 38037429 | Result | van Renterghem K, Jorissen C, Van Huele A. Penile length changes after penile implant surgery. J Sex Med. 2023 Nov 30;20(12):1364-1366. doi: 10.1093/jsxmed/qdad125. No abstract available. |
| 40335744 | Result | Van Renterghem K, De Bruyn H, Yebes A, Calopedos R, Deho F, Torremade J, D'Anna M, Bettocchi C, Gomez BG, Caris C, Witjes W, Moncada I, Ralph D; EAU Research Foundation PHOENIX Study Group. Early complications after penile prosthesis surgery: findings from the PHOENIX multicenter registry. Int J Impot Res. 2026 Jan;38(1):30-36. doi: 10.1038/s41443-025-01080-z. Epub 2025 May 7. |
| 42225959 | Result | Van Renterghem K, Yebes A, Lamers G, Torremade J, Bettocchi C, Garcia-Gomez B, Lee WG, Caris C, Witjes W, Moncada I, Ralph D; EAU Research Foundation PHOENIX Study Group. Predictors of penile prosthesis length: results from the PHOENIX registry. Int J Impot Res. 2026 Jun 1. doi: 10.1038/s41443-026-01294-9. Online ahead of print. |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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