Erectile Dysfunction in Patients With Non Ocular Behçet's Disease

It was aimed to demonstrate whether erectile dysfunction is affected by BH pathogenesis and whether there is a relationship between erectile dysfunction and BD pathogenesis by assessing both sexual function and retinal micro-vascular blood flow in BH which may involve vessels from all calibrations and nature.

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Key information

Conditions

Behçet Disease Behcet Syndrome Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Erectile Dysfunction Eye Diseases Genetic Diseases, Inborn Genital Diseases Genital Diseases, Male Hereditary Autoinflammatory Diseases Male Urogenital Diseases Mental Disorders Mouth Diseases Panuveitis Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Skin Diseases Skin Diseases, Genetic Skin Diseases, Vascular Skin and Connective Tissue Diseases Stomatognathic Diseases Urogenital Diseases Uveal Diseases Uveitis Uveitis, Anterior Vascular Diseases Vasculitis

Age range

18 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Antalya Tarining and Research Hospital Ethics Commitee

Antalya, Muratpasa, 07070, Turkey (Türkiye)

About this study

Patients with factors and results that could cause sexual dysfunction will be excluded from the study.An International Index of ErectileFunction (IIEF) questionnaire will be applied to a total of 35 patients under 45 years old who met the inclusion criteria. IIEF's erectile function,sexual desire,sexual satisfaction,orgasmic function and general satisfaction sub parameters and Optical Coherence Eye Tomography (OCTA) data will compared.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Definitive diagnosis of Behçet Disease
No comorbid disease known to be associated with erectile dysfunction, including hypertension and diabetes mellitus
Not overweight or obese (BMI≤25 kg/m2)
Non-smokers
No alcohol and/or substance abuse
No known psychiatric disorder

Exclusion criteria

prostatic disorder
medication that may influence on erectile function (antihistamines, ß-blockers, etc.)
sacroiliac joint or chronic articular involvement
family history of glaucoma

Treatment and study plan

Erectil dysfunction

Other

A complete ophthalmological examination including best-corrected visual acuity using the decimal system (BCVA), measurement of intraocular pressure (IOP) and axial length (AL), slit-lamp examination and dilated fundus examination

Other names: Ophthalmological Examination

Primary outcomes

International Index of Erectile Function-15

Time frame: 1 week

This scale assessing the quality of erectile function within the previous 4 weeks was developed by Rosen et al. in 1997. The Turkish validity study was performed by Turunç et al. [30]. The IIEF-15 assesses male sexual function in 5 domains: erectile function (1-30 points), orgasmic function (0-10 points), sexual desire (2-10 points), sexual satisfaction from intercourse (0-15 points) and overall satisfaction (2-10 points). In contrast to other functions, the severity of erectile dysfunction can be rated with an overall score ranging from 6 to 30 points. Erectile function was graded as follows: 0-10 points as severe erectile dysfunction (ED); 11-16 points as moderate ED; 17-21 points as mild-moderate ED; 22-25 points as mild ED; 26-30 points as no erectile dysfunction.
Optical coherence tomography angiography

Time frame: 1 week

It is a functional method that detects the movement contrast in the bloodstream and displays the capillary nets of the retina and choroid and the outer retina without using paint.It is a non-invasive method that provides static volumetric angiography information.From the quantitative measurement results presented by calculating automatically by the software used by the device, the area of the foveal avascular zone (PHASE), the value of the asymmetric index (AI), the superficial and Vascular density (VD) percentages and retinal thickness values in deep capillary plexuses were included in the study.OCTA findings are classified in stages 1-5. OCTA findings worsen as the stage number increases. While stage 1 shows normal superficial capillary plexus; In stage 5, decreased vascular density in the outer retina and significant thinning in the retina are observed.

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

Comparison of Erectile Dysfunction and Optical Coherence Tomography Angiography Findings in Patients With Non Ocular Behçet's Disease

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: May 13, 2020
Registry last updated: May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed