Erectile Dysfunction in Patients With Non Ocular Behçet's Disease

NCT04386824 | Completed

• 1 other identifier: Descriptive
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Behçet Disease; Behcet Syndrome; Erectile Dysfunction

Keywords

Behçet's disease; erectile dysfunction

Outcome Measures

Primary Outcomes (2)

• International Index of Erectile Function-15

  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.

  1 week

• Optical coherence tomography angiography

  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.

  1 week

Study Arms (1)

Behçet's disease

Male patients who arediagnosed as Behçet's disease according to International Study Group Classification Criteria

Other: Erectil dysfunction

Interventions

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

Also known as: Ophthalmological Examination

Behçet's disease

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: male with Behçet's patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Behçet's disease (BD) is a chronic, multi-systemic vasculitis characterized by remissions and exacerbations, where etiology hasn't been fully elucidated \[1\]. It was first described as oral aphthae, genital ulcerations, and iridocyclitis with hypopyon by Hulusi Behçet in 1937 \[2\]. Although its etiology hasn't been fully understood, it is widely accepted that the disease is caused by excessive inflammatory response triggered by environmental factors in individuals with genetic susceptibility

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Antalya Tarining and Research Hospital Ethics Commitee

Antalya, Muratpasa, 07070, Turkey (Türkiye)

Location

Related Publications (1)

• Direskeneli H. Autoimmunity vs autoinflammation in Behcet's disease: do we oversimplify a complex disorder? Rheumatology (Oxford). 2006 Dec;45(12):1461-5. doi: 10.1093/rheumatology/kel329. Epub 2006 Sep 23. No abstract available.

  PMID: 16998234 RESULT

MeSH Terms

Conditions

Behcet Syndrome; Erectile Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

• Ayse Ayan, Dr.

  Antalya Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof, Dr

Study Record Dates

• First Submitted: May 2, 2020
• First Posted: May 13, 2020
• Study Start: June 15, 2019
• Primary Completion: December 10, 2019
• Study Completion: December 15, 2019
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)