ESSM Projects
Section Editor:
Andrea Salonia, MD, Urologist
Dept. Urology Scientific Institute H. San Raffaele
Via Olgettina 60 20132 Milan, Italy
e-mail: saloniaandrea@yahoo.com
Ref.: ESSM Registry Project
ESSM REGISTRY: A NEW, WEB-BASED ELECTRONIC CHART FOR EUROPEAN PATIENTS WITH SEXUAL DYSFUNCTION
Dear ESSM Member,
as widely communicated during last annual congress in Vienna, ESSM has developed and launched a web-based Registry which allows to objectively collect data about male sexual disorders across Europe.
Scientific interest in the field of Sexual Medicine has been growing widely since new and interesting clinical and basic science advances have been made. Furthermore, thanks to the effective, well tolerated and safe pharmacological therapies available on the market, an increasing proportion of men affected by different forms of Sexual Dysfunction have been seeking medical help.
Since the prevalence of these medical conditions has been increasing, it has become evident how collecting clinical and demographic patients' data from multiple Centres across Europe may play a crucial role in clinical practice and in developing future knowledge. Indeed, this may really help in optimising both patients' diagnosis and treatment and correctly follow-up patients overtime, as well.
Therefore, with these specific aims, an international, multicentric web-based database has been developed, specifically designed to 1) describe current male population complaining of sexual disorders and to have more and more complete data to actually represent the European situation as far as sexual dysfunction is concerned; 2) define clinically broad-accepted flow-charts in terms of both diagnosis and treatment; and 3) prospectively develop studies and common pharmacological trials across Europe.
This database not only allows collecting clinical data of each patient consecutively visited, but it also allows physicians to collect both laboratory tests and further eventual 2nd line investigations used to diagnose the patient intervention.
This electronic patient chart consists of different sub-headings:
- Demographic and general clinical data
- Medical history (i.e. investigation regarding comorbidities such as diabetes, hypertension, coronary artery disease, peripheral vascular disease, dyslipidemia, neurological diseases, dysthyroidism, depression, renal and/or hepatic failure)
- Previous cardio-vascular surgery (i.e. coronary by-pass and angioplasty, aneurysmectomy)
- Previous surgery for external genitalia (circumcision, varicocelectomy, hydrocelectomy, plasty of frenulum)
- Previous major urological surgery (i.e. prostate, kidney and bladder surgery)
- Lifestyle risk factors and recreational habits (i.e. cigarette smoking, alcohol consumption, recreational drugs use, physical activity, bicycling etc.)
- Sexual history (namely, investigations about presence of penile abnormalities, previous oral and topical therapy for erectile dysfunction, side effects of each drug etc.)
- General questions about sexual life (questions about ejaculation, general satisfaction of sexual life, orgasmic complaints)
- General questions about partner's sexual life (i.e. presence of desire, arousal, orgasm or pain disorder)
- Physical examination (with special attention paid to external genitalia, scrotum, testes, epididymis, deferent, prostate, cremasteric and bulbocavernous reflexes)
- Lab tests performed - considered relevant during andrological approach (i.e. fast glycemia, lipid profile, androgens and thyroidal screening, prolactin, eventually total serum PSA)
- Imaging and functional evaluation (i.e. dynamic penile power color Doppler parameters, NPT test)
- Internationally validated questionnaires (such as scores for the International Index of Erectile Function, Beck's Inventory for depression, Center for Epidemiological Studies Depression Scale, International Prostatic Symptom Score, Partial Androgen Deficiency in the Aging Male).
After having had a preliminary testing period - during which the access to the web Registry was limited to a selected number of European tertiary referral centers, I am actually proud to announce that the ESSM web Registry is now open to all ESSM members who desire to join this ambitious and scientifically rigorous project.
Data will be thus collected in a large group of Centres across the ESSM-affiliated European countries and this system will allow for the first time to assess the diagnostic and therapeutic trends followed for different sexual dysfunctions throughout Europe and will generate an independent database on the impact of the currently available therapies.
Although the web Registry is essentially an audit of care, requiring no intervention or change in patient care, potential participant centres should seek advice from their local research ethics committee as to whether formal approval is required.
Important advise
Information stored in the web Registry database is protected by security features but no Internet-based system can be considered to be totally secure. Participant centres should bear this in mind when entering free text data in the Registry. Whilst it is essential to record subject date-of-birth within the Registry, subject initials are not.
The database will generate a unique identifier number for each subject entered once the demographics page is completed; this may be used for subject identification purposes, rather than initials and date-of-birth. Centres that wish to avoid using initials should enter XXX in the relevant section of the database and keep a confidential and secure log of subject details related to each unique identifier for use in their own centre only.
ALL ESSM MEMBERS ARE KINDLY INVITED TO ENTROLL THEIR CENTRE AND TAKE PART IN THIS CHALLENGING PROJECT.
If you are interested in enrolling your patients, please contact the ESSM secretariat at admin@essm.org
Hoping to meet you all pretty soon, I remain at your disposal for both any further information you may need and any suggestion.
Thank you for your kind and precious co-operation and my best regards,
Andrea Salonia
ESSM Registry Project Director