Erectile Dysfunction
Conditions
Keywords
Erectile Dysfunction, ED, Fundus Oculi, Retinal Vascularization, International Index of Erectile Function Questionnaire, IIEF, Dynamic Vessel Analyzer, DVA, Phosphodiesterase type 5 Inhibitor, PDE5Is
Brief summary
The purpose of this study is to evaluate the correlation between fundus oculi's vascularization in patients with erectile dysfunction and not, and, in the same patients, before and after using drugs for ED.
Detailed description
The purpose of this study is to evaluate the correlation between fundus oculi's vascularization in patients with erectile dysfunction and not, and, in the same patients, before and after using drugs for ED. In this monocentric, prospective, observational case-control study 40 eyes of 40 patients affected by erectile dysfunction and 20 healthy age-matched controls will be enrolled. Patients will undergo DVA examination at baseline and 6 months after PDE5I therapy. Healthy subjects will be examined with DVA at baseline only.
Interventions
DRUGPhosphodiesterase type 5 Inhibitor (PDE5I)
Sponsors
Ospedale San Raffaele
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects with erectile dysfunction diagnosis (organic and psychogenic); * Subjects with Erectile Dysfunction diagnosis defined by IIEF score ≤ 25 * Subjects with stable partner for at least 6 months and sexually active. * Subjects aged between 40 - 60 years; * Signature of informed consent for patients
Exclusion criteria
* Subjects with ED secondary diagnosis to hormonal alterations (i.e. hypogonadism, hypo / hyperthyroidism, hyperprolactinemia); * Subjects with a diagnosis of ED post-traumatic and iatrogenic, since after pelvic surgery; * Subjects suffering from any ocular pathology that involves use of contact lenses and / or glasses; * Subjects smoking; * Individuals with uncontrolled systemic diseases; * All persons who do not confirm at least one criterion for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Static and dynamic retinal vessels diameter | Baseline and after 6 month of therapy | Analysis of the presence and prevalence of retinal vascularization alterations using Dynamic Vessel Analyzer (DVA) in patients with Erectile Dysfunction and in subject healthy volunteers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Index of Erectile Function (IIEF) Questionnaire | After 6 month of therapy | Revaluation of the correlation between Erectile Dysfunction and Fundus Oculi vascularization after 6 month of therapy for ED. |
Countries
Italy
Contacts
Primary ContactGiuseppe Querques, MD, PhD
Backup ContactRoberta Scano
Outcome results
None listed