Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction (PHOENIX)

Prospective Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction

Prospective collection of pre-defined parameters on the surgical treatment of male erectile dysfunction using Penile Prosthesis Implants (PPIs).

Study Overview

Status

Recruiting

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

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Antwerp, Belgium
        • Active, not recruiting
        • University Hospital Antwerp
      • Brugge, Belgium
        • Recruiting
        • AZ Sint-Jan
        • Contact:
          • Pieter D'hulst
      • Gent, Belgium
        • Recruiting
        • AZ Maria Middelares
        • Contact:
          • Marjan Waterloos
      • Hasselt, Belgium
        • Recruiting
        • Jessa hospital
        • Contact:
          • Koenraad van Renterghem, MD, PhD
      • Leuven, Belgium
        • Recruiting
        • UZ Leuven
        • Contact:
          • Maarten Albersen
      • Lyon, France
        • Recruiting
        • CHU Lyon Sud
        • Contact:
          • Nico Morel-Journel
        • Contact:
          • Damien Carnicelli
      • Essen, Germany
        • Recruiting
        • University Hospital Essen (AöR)
        • Contact:
          • Jochen Heß
      • Kiel, Germany
        • Not yet recruiting
        • University Hospital Schleswig Holstein
        • Contact:
          • Daniar Osmonov, MD
      • Bologna, Italy
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna
        • Contact:
          • Fulvio Colombo
      • Foggia, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Foggia
        • Contact:
          • Carlo Bettocchi
      • Milan, Italy
        • Recruiting
        • San Raffaele Hospital
        • Contact:
          • Federico Deho, MD
        • Sub-Investigator:
          • Paolo Capogrosso, MD
      • Parma, Italy
        • Active, not recruiting
        • Casa di Cura Città di Parma
      • Lisboa, Portugal
        • Recruiting
        • Centro Hospitalar Universitario Lisboa Norte
        • Contact:
          • Pedro Oliveira
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic de Barcelona
        • Contact:
          • Jose Torremadé
      • Barcelona, Spain
        • Recruiting
        • Hospital Germans Trias i Pujol
        • Contact:
          • Anna Sanromà
      • Barcelona, Spain
        • Active, not recruiting
        • Fundacio Puigvert
      • Boadilla del Monte, Spain
        • Recruiting
        • Hospital Universitario HM Monteprincipe
        • Principal Investigator:
          • Javier Romero Otero
      • Madrid, Spain
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
          • Enrique Lledó Garcia
        • Contact:
          • Alfonso Lafuente
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
          • Esaú Fernández Pascual
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario La Zarzuela
        • Contact:
          • Ignacio Moncada
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario 12 Octubre
        • Contact:
          • Javier Romero-Otero
      • Madrid, Spain
        • Recruiting
        • Lyx Institute of Urology
        • Contact:
          • Juan Ignacio Martínez-Salamanca
      • Majadahonda, Spain
        • Recruiting
        • Hospital Universitario Puerta de Hierro Majadahonda
        • Contact:
          • Juan Ignacio Martínez-Salamanca
      • Móstoles, Spain
        • Recruiting
        • Hospital Universitario Rey Juan Carlos
        • Contact:
          • Alessandro Fiorillo
      • Santander, Spain
        • Recruiting
        • Marqués de Valdecilla University Hospital
        • Contact:
          • Felix Campos
      • Malmö, Sweden
        • Recruiting
        • Lund University, Skane Hospital,
        • Contact:
          • Anders Bjartell
      • London, United Kingdom
        • Recruiting
        • UCLH
        • Principal Investigator:
          • David Ralph
        • Sub-Investigator:
          • Don Lee
      • London, United Kingdom
        • Not yet recruiting
        • St.George's University Hospital
        • Contact:
          • Marta Skrodzka

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Male patients undergoing a surgical Penile Prosthesis Implant for treatment of erectile dysfunction.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

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
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).
at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Patient satisfaction rate
Time Frame: 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
at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Partner satisfaction rate
Time Frame: 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
at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Overall time being satisfied with treatment since implantation
Time Frame: 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
up to 10 years post surgery
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
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
Time Frame: 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.
at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery
EQ-5D-5L quality of life questionnaire
Time Frame: 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.
at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery
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
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
Time Frame: 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.
during surgery and up to 10 years after surgery
Immediate Postoperative complications
Time Frame: 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.
until 2 weeks after surgery
Time of first activation, first cycling, first use, first intercourse, first orgasm, if applicable
Time Frame: 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.
up to 10 years post surgery
Time being revision-free
Time Frame: 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
up to 10 years post surgery
Revision-free rate
Time Frame: 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.
at 1, 2, 4, 6, 8 and 10 years of Registry follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2021

Primary Completion (Estimated)

February 1, 2032

Study Completion (Estimated)

February 1, 2032

Study Registration Dates

First Submitted

February 18, 2019

First Submitted That Met QC Criteria

February 19, 2019

First Posted (Actual)

February 21, 2019

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Investigators may share anonymized individual data with residents/urologist interested to analyze and publish the results of the registry

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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