Behçet DiseaseNCT04386824
Erectile Dysfunction in Patients With Non Ocular Behçet's Disease
An observational study of Behçet Disease and Behcet Syndrome, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Behçet Disease, Behcet Syndrome, Erectile Dysfunction
- What is being tested?
- Erectil dysfunction
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2019to 15 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- prostatic disorder
- medication that may influence on erectile function (antihistamines, ß-blockers, etc.)
- sacroiliac joint or chronic articular involvement
- family history of glaucoma
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Tarining and Research Hospital Ethics Commitee
Antalya, Muratpasa, 07070
About this study
Official title: Comparison of Erectile Dysfunction and Optical Coherence Tomography Angiography Findings in Patients With Non Ocular Behçet's Disease
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.
Read the 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.
- Conditions
- Behçet Disease, Behcet Syndrome, Erectile Dysfunction
- Being tested
- Erectil dysfunction
- Keywords
- Behçet's disease, erectile dysfunction
- Medical subject headings
- Behcet Syndrome, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erectil dysfunctionOther
Also called Ophthalmological Examination
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
| Study group | Role | What they receive |
|---|---|---|
| Behçet's disease | Male patients who arediagnosed as Behçet's disease according to International Study Group Classification Criteria Receives: Other: Erectil dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start15 Jun 2019
- Primary completion10 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behçet DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayse Ayan, Antalya Training and Research Hospital
- Investigators
- Ayse Ayan, Dr., Principal investigator, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386824
- Sponsor's protocol ID
- Descriptive
- Status last verified
- May 2020
- First submitted
- 2 May 2020
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan will be shared with Statistical Package for the Social Sciences version 20.
Publications
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.
PubMed 16998234
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Erectile Dysfunction and Optical Coherence Tomography Angiography Findings in Patients With Non Ocular Behçet's Disease
- ClinicalTrials.gov ID
- NCT04386824
- Acronym / sponsor ID
- Descriptive
- Conditions
- Behçet Disease, Behcet Syndrome, Erectile Dysfunction
- Keywords
- Behçet's disease, erectile dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behçet's disease | – | Other: Erectil dysfunctionMale patients who arediagnosed as Behçet's disease according to International Study Group Classification Criteria |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- prostatic disorder
- medication that may influence on erectile function (antihistamines, ß-blockers, etc.)
- sacroiliac joint or chronic articular involvement
- family history of glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erectil dysfunctionAlso: Ophthalmological ExaminationA 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 | Other | Behçet's disease |
Primary outcome
International Index of Erectile Function-15
Time frame: 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.
Optical coherence tomography angiography
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Results publication: PubMed 16998234Direskeneli 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.
- Individual participant dataSharing planned: No. Plan will be shared with Statistical Package for the Social Sciences version 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayse Ayan, Dr. principal investigator
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behçet Disease and Behcet Syndrome, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Index of Erectile Function-15 (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04386824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.