Erectile Dysfunction in Patients With Non Ocular Behçet's Disease

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04386824
• Other study ID #: Descriptive
• Status: Completed
• Start date: June 15, 2019
• Est. completion date: December 15, 2019

Study information

• Verified date: May 2020
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 15, 2019
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Behçet Disease
• Behcet Syndrome
• Erectile Dysfunction

Intervention

Other:
• Erectil dysfunction
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

Locations

Country	Name	City	State
Turkey	Antalya Tarining and Research Hospital Ethics Commitee	Antalya	Muratpasa

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. Epub 2006 Sep 23. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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