- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03849586
Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction (PHOENIX)
Prospective Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction
Study Overview
Status
Conditions
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).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Christien Caris, MSc
- Phone Number: +31263890677
- Email: c.caris@uroweb.org
Study Contact Backup
- Name: Wim Witjes, MD, PhD
- Phone Number: +31263890677
- Email: w.witjes@uroweb.org
Study Locations
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Antwerp, Belgium
- Active, not recruiting
- University Hospital Antwerp
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Brugge, Belgium
- Recruiting
- AZ Sint-Jan
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Contact:
- Pieter D'hulst
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Gent, Belgium
- Recruiting
- AZ Maria Middelares
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Contact:
- Marjan Waterloos
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Hasselt, Belgium
- Recruiting
- Jessa hospital
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Contact:
- Koenraad van Renterghem, MD, PhD
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Leuven, Belgium
- Recruiting
- UZ Leuven
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Contact:
- Maarten Albersen
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Lyon, France
- Recruiting
- CHU Lyon Sud
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Contact:
- Nico Morel-Journel
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Contact:
- Damien Carnicelli
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Essen, Germany
- Recruiting
- University Hospital Essen (AöR)
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Contact:
- Jochen Heß
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Kiel, Germany
- Not yet recruiting
- University Hospital Schleswig Holstein
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Contact:
- Daniar Osmonov, MD
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Bologna, Italy
- Recruiting
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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Contact:
- Fulvio Colombo
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Foggia, Italy
- Recruiting
- Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Foggia
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Contact:
- Carlo Bettocchi
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Milan, Italy
- Recruiting
- San Raffaele Hospital
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Contact:
- Federico Deho, MD
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Sub-Investigator:
- Paolo Capogrosso, MD
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Parma, Italy
- Active, not recruiting
- Casa di Cura Città di Parma
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Lisboa, Portugal
- Recruiting
- Centro Hospitalar Universitario Lisboa Norte
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Contact:
- Pedro Oliveira
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Barcelona, Spain
- Recruiting
- Hospital Clinic de Barcelona
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Contact:
- Jose Torremadé
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Barcelona, Spain
- Recruiting
- Hospital Germans Trias i Pujol
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Contact:
- Anna Sanromà
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Barcelona, Spain
- Active, not recruiting
- Fundacio Puigvert
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Boadilla del Monte, Spain
- Recruiting
- Hospital Universitario HM Monteprincipe
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Principal Investigator:
- Javier Romero Otero
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Madrid, Spain
- Recruiting
- Hospital General Universitario Gregorio Marañon
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Contact:
- Enrique Lledó Garcia
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Contact:
- Alfonso Lafuente
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Madrid, Spain
- Recruiting
- Hospital Universitario La Paz
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Contact:
- Esaú Fernández Pascual
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Madrid, Spain
- Recruiting
- Hospital Universitario La Zarzuela
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Contact:
- Ignacio Moncada
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Madrid, Spain
- Recruiting
- Hospital Universitario 12 Octubre
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Contact:
- Javier Romero-Otero
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Madrid, Spain
- Recruiting
- Lyx Institute of Urology
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Contact:
- Juan Ignacio Martínez-Salamanca
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Majadahonda, Spain
- Recruiting
- Hospital Universitario Puerta de Hierro Majadahonda
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Contact:
- Juan Ignacio Martínez-Salamanca
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Móstoles, Spain
- Recruiting
- Hospital Universitario Rey Juan Carlos
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Contact:
- Alessandro Fiorillo
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Santander, Spain
- Recruiting
- Marqués de Valdecilla University Hospital
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Contact:
- Felix Campos
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Malmö, Sweden
- Recruiting
- Lund University, Skane Hospital,
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Contact:
- Anders Bjartell
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London, United Kingdom
- Recruiting
- UCLH
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Principal Investigator:
- David Ralph
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Sub-Investigator:
- Don Lee
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London, United Kingdom
- Not yet recruiting
- St.George's University Hospital
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Contact:
- Marta Skrodzka
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Satisfaction score
Time Frame: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
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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).
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at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Partner Satisfaction score
Time Frame: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
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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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at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
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Patient satisfaction rate
Time Frame: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
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The number of patients with an EDITS score ≥ 50 compared to the total number of patients
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at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
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Partner satisfaction rate
Time Frame: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
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The number of partners with an EDITS score ≥ 50 compared to the total number of partners
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at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
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Overall time being satisfied with treatment since implantation
Time Frame: up to 10 years post surgery
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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
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up to 10 years post surgery
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International Index of Erectile Function - 5 (IIEF short form/SHIM) questionnaire
Time Frame: at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery
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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.
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at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery
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Sexual Encounter Profile (SEP) questions 2 and 3
Time Frame: at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery
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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.
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at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery
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EQ-5D-5L quality of life questionnaire
Time Frame: at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery
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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.
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at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery
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Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire
Time Frame: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
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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.
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at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
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Complications
Time Frame: during surgery and up to 10 years after surgery
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Type of complications, associated symptoms and whether or not a revision was needed will be recorded.
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during surgery and up to 10 years after surgery
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Immediate Postoperative complications
Time Frame: until 2 weeks after surgery
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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.
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until 2 weeks after surgery
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Time of first activation, first cycling, first use, first intercourse, first orgasm, if applicable
Time Frame: up to 10 years post surgery
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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.
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up to 10 years post surgery
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Time being revision-free
Time Frame: up to 10 years post surgery
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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
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up to 10 years post surgery
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Revision-free rate
Time Frame: at 1, 2, 4, 6, 8 and 10 years of Registry follow-up
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The number of patients who are revision-free compared to the total number of patients.
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at 1, 2, 4, 6, 8 and 10 years of Registry follow-up
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Collaborators and Investigators
Investigators
- Principal Investigator: Koen van Renterghem, MD, PhD, Jessa Hospital, Hasselt, Belgium
- Principal Investigator: Federico Deho, MD, San Raffaele Hospital, Milan, Italy
Publications and helpful links
General Publications
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EAU-RF 2018-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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