Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction

Erectile Dysfunction Clinical Trial

— PHOENIX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03849586
• Other study ID #: EAU-RF 2018-01
• Status: Recruiting
• Start date: November 19, 2021
• Est. completion date: February 2032

Study information

• Verified date: May 2024
• Source: European Association of Urology Research Foundation
• Contact: Christien Caris, MSc
• Phone: +31263890677
• Email: c.caris[@]uroweb.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: February 2032
• Est. primary completion date: February 2032
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Antwerp
Belgium	AZ Sint-Jan	Brugge
Belgium	AZ Maria Middelares	Gent
Belgium	Jessa Hospital	Hasselt
Belgium	UZ Leuven	Leuven
France	CHU Lyon Sud	Lyon
Germany	University Hospital Essen (AöR)	Essen
Germany	University Hospital Schleswig Holstein	Lübeck
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna	Bologna
Italy	Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Foggia	Foggia
Italy	San Raffaele Hospital	Milan
Italy	Casa di Cura Città di Parma	Parma
Portugal	Centro Hospitalar Universitario Lisboa Norte	Lisboa
Spain	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
Sweden	Lund University, Skane Hospital,	Malmö
Sweden	Karolinska University Hospital	Stockholm
United Kingdom	St.George's University Hospital	London
United Kingdom	UCLH	London

Sponsors (3)

Lead Sponsor	Collaborator
European Association of Urology Research Foundation	Boston Scientific Corporation, Coloplast A/S

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Portugal,  Spain,  Sweden,  United Kingdom, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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).	at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   EAU Research Foundation website