The intention of this registry is to prospectively collect data from 1,000 patients with a penile prosthesis implant (PPI), as used in daily urological practice, regardless of the type of implant. All surgeons who implant penile prostheses are welcome to participate. This will enable us to report on patient and partner satisfaction, as well as assess the mechanical reliability of the different PPIs on the market.
The study goal is to demonstrate whether this therapeutic option is a good treatment in patients with erectile dysfunction (ED) who do not respond to other treatments (refractory ED). Furthermore, there is hope to identify clinical and surgical factors that correlate with patient outcome, surgical complications and mechanical reliability of the devices used in daily urological practice. Treatment recommendations and guidelines can then be further improved resulting in better care for this group of ED patients.
In the registry, treatment satisfaction, sexual function and quality of life will be assessed by means of specific patient questionnaires. After identification of all necessary questionnaires, it was found not all questionnaires were available in the required languages and a translation process was started. For some questionnaires single forward translation was used while for others, such as the Quality of Life and Sexuality with Penile Prosthesis questionnaire (QoLSPP) and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire, a recognised professional methodology was used, in line with the international ISPOR guidelines (the professional society for health economics and outcomes research), including forward and backward translation, as well as cognitive debriefing.
Cognitive debriefing is testing the translated questionnaires on a small group of relevant patients (e.g. patients who are treated with an implant or patients with ED) in order to test alternative wording and to check understandability, interpretation and cultural relevance of the translation. This testing was done by means of patient and partner interviews by urologists interested in participating in the registry. The value of each question in the QoLSPP questionnaire will be validated with the registry outcome measures at a later stage.
The interviewing process is taking longer than expected, because of COVID-19 among other things, and is ongoing in Germany, France, Sweden and the Netherlands. In Belgium (Dutch language), Italy, Spain, Portugal and United Kingdom, the interviews have been completed and questionnaires have been finalised. They have been implemented in the database. These countries, except for the UK where we await ethical committee approval, have started recruitment. Despite the challenges we faced - surgical lockdowns and restrictions in surgical capacity due to COVID-19 - recruitment is progressing reasonable well.
Since the questionnaires are an important part of this registry (the patient satisfaction score, measured by means of the EDITS questionnaire, is the main outcome parameter), it is of the utmost importance that questionnaires are completed by the participating patients (and partners). To make it easier for the patient to complete the outcome measures (PROMS), the Marvin data entry system enables creating a patient account so the patient can complete the questionnaires online at his convenience. We recommend using the possibility to create a patient account for as many patients as possible.
Clinical data pre, per and post-surgical implantation are being collected and entered into the database by urologists and their representatives.
All European centres who offer PPI to their patients with erectile dysfunction are welcome to join. High as well as low-volume centres can participate in order to get a good representation of daily clinical urological practice. In this registry we will collect pre-defined parameters related to this type of surgery. All registered devices that are used as implant in daily urological practice can and should be included. No extra visits are required to collect the data, patients are seen on a regular basis according to standard clinical practice. Patient inclusion should be consecutive. Quite some centres have already shown interest in setting up such a registry. They will start participating by contributing their patient data after receipt of the patient’s consent.
Should you be interested in participating in this registry, you can contact Mrs. Christien Caris below.
Principal investigators: Dr. Koen Van Renterghem, Hasselt (BE) Dr. Federico Deho, Milano (IT)
Funders: Boston Scientific Corporation Coloplast Corporation
Formal sponsor: EAU Research Foundation
This article first appeared in the March-May 2022 edition of European Urology Today.