Clinical trial NCT04386824: Erectile Dysfunction in Patients With Non Ocular Behçet's Disease
Official title: Comparison of Erectile Dysfunction and Optical Coherence Tomography Angiography Findings in Patients With Non Ocular Behçet's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Behçet Disease
Behcet Syndrome
Erectile Dysfunction
Keywords: Behçet's disease
erectile dysfunction
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-05-13
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: International Index of Erectile Function-15
timeFrame: 1 week
measure: Optical coherence tomography angiography
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Tarining and Research Hospital Ethics Commitee
state: Muratpasa
Study officials:
affiliation: Antalya Training and Research Hospital
name: Ayse Ayan, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.