Erectile Dysfunction Clinical Trial
Official title:
Comparison of Erectile Dysfunction and Optical Coherence Tomography Angiography Findings in Patients With Non Ocular Behçet's Disease
NCT number | NCT04386824 |
Other study ID # | Descriptive |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 15, 2019 |
Est. completion date | December 15, 2019 |
Verified date | May 2020 |
Source | Antalya Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Antalya Tarining and Research Hospital Ethics Commitee | Antalya | Muratpasa |
Lead Sponsor | Collaborator |
---|---|
Antalya Training and Research Hospital |
Turkey,
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
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 |
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