PHOENIX: Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction
Study Details
Study Description
Brief Summary
Prospective collection of pre-defined parameters on the surgical treatment of male erectile dysfunction using Penile Prosthesis Implants (PPIs).
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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 Design
Outcome Measures
Primary Outcome Measures
- Patient Satisfaction score [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).
Secondary Outcome Measures
- Partner Satisfaction score [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).
- Patient satisfaction rate [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
- Partner satisfaction rate [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
- Overall time being satisfied with treatment since implantation [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
- International Index of Erectile Function - 5 (IIEF short form/SHIM) questionnaire [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.
- Sexual Encounter Profile (SEP) questions 2 and 3 [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.
- EQ-5D-5L quality of life questionnaire [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.
- Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire [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.
- Complications [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.
- Immediate Postoperative complications [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.
- Time of first activation, first cycling, first use, first intercourse, first orgasm, if applicable [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.
- Time being revision-free [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
- Revision-free rate [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male patient undergoing a surgical penile prosthesis implant for treatment of erectile dysfunction.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jessa Hospital | Hasselt | Belgium | ||
| 2 | UZ Leuven | Leuven | Belgium | ||
| 3 | University Hospital Schleswig Holstein | Kiel | Germany | ||
| 4 | San Raffaele Hospital | Milan | Italy | ||
| 5 | Hospital Germans Trias i Pujol | Barcelona | Spain | ||
| 6 | Hospital Universitario 12 Octubre | Madrid | Spain | ||
| 7 | Hospital Universitario La Paz | Madrid | Spain | ||
| 8 | Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Spain |
Sponsors and Collaborators
- European Association of Urology Research Foundation
- Boston Scientific Corporation
- Coloplast A/S
Investigators
- Principal Investigator: Koen van Renterghem, MD, PhD, Jessa Hospital, Hasselt, Belgium
- Principal Investigator: Federico Deho, MD, San Raffaele Hospital, Milan, Italy
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- EAU-RF 2018-01