Clinical trial NCT03849586: Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction
Official title: Prospective Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Erectile Dysfunction
Keywords: penile prosthesis implant
Lead sponsor: European Association of Urology Research Foundation
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
name: Coloplast A/S
First posted: 2019-02-21
Enrollment: 1076
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male patients undergoing a surgical Penile Prosthesis Implant for treatment of erectile dysfunction.

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

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Satisfaction score
timeFrame: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Secondary outcomes:
measure: Partner Satisfaction score
timeFrame: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
measure: Patient satisfaction rate
timeFrame: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
measure: Partner satisfaction rate
timeFrame: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
measure: Overall time being satisfied with treatment since implantation
timeFrame: up to 10 years post surgery
measure: International Index of Erectile Function - 5 (IIEF short form/SHIM) questionnaire
timeFrame: at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery
measure: Sexual Encounter Profile (SEP) questions 2 and 3
timeFrame: at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery
measure: EQ-5D-5L quality of life questionnaire
timeFrame: at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery
measure: Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire
timeFrame: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
measure: Complications
timeFrame: during surgery and up to 10 years after surgery
measure: Immediate Postoperative complications
timeFrame: until 2 weeks after surgery
measure: Time of first activation, first cycling, first use, first intercourse, first orgasm, if applicable
timeFrame: up to 10 years post surgery
measure: Time being revision-free
timeFrame: up to 10 years post surgery
measure: Revision-free rate
timeFrame: at 1, 2, 4, 6, 8 and 10 years of Registry follow-up
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Hasselt
country: Belgium
facility: Jessa Hospital
city: Leuven
country: Belgium
facility: UZ Leuven
city: Lyon
country: France
facility: CHU Lyon Sud
city: Essen
country: Germany
facility: University Hospital Essen (AöR)
city: Lübeck
country: Germany
facility: University Hospital Schleswig Holstein
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
city: Foggia
country: Italy
facility: Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Foggia
city: Milan
country: Italy
facility: San Raffaele Hospital
city: Parma
country: Italy
facility: Casa di Cura Città di Parma
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitario Lisboa Norte
city: Barcelona
country: Spain
facility: Fundació Puigvert
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Boadilla del Monte
country: Spain
facility: Hospital Universitario HM Montepríncipe
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario 12 Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario La Zarzuela
city: Madrid
country: Spain
facility: Lyx Institute of Urology
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Móstoles
country: Spain
facility: Hospital Universitario Rey Juan Carlos
city: Palma De Mallorca
country: Spain
facility: Instituto Médico Rosselló
city: Santander
country: Spain
facility: Marques de Valdecilla University Hospital
city: Malmö
country: Sweden
facility: Lund University, Skane Hospital,
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: London
country: United Kingdom
facility: St.George's University Hospital
city: London
country: United Kingdom
facility: UCLH
Study officials:
affiliation: Jessa Hospital, Hasselt, Belgium
name: Koen van Renterghem, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Raffaele Hospital, Milan, Italy
name: Federico Deho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.