Erectile Dysfunction in Patients With Non Ocular Behçet's Disease

Completed

• Conditions: Behçet Disease; Behcet Syndrome; Erectile Dysfunction
• Interventions: Other: Erectil dysfunction

• Registration Number: NCT04386824
• Lead Sponsor: Antalya Training and Research Hospital

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-06-15
• Primary Completion: 2019-12-10
• Study Completion: 2019-12-15
• Status Verified: 2020-05
• Study First Submitted: 2020-05-02
• Study First Submitted QC: 2020-05-12
• Last Update Submitted: 2020-05-12
• Study First Posted: 2020-05-13
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Optical coherence tomography angiography	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.
International Index of Erectile Function-15	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.

Trial Locations

Locations (1)

Antalya Tarining and Research Hospital Ethics Commitee; 🇹🇷 Antalya, Muratpasa, Turkey