Erectile Dysfunction in Patients With Non Ocular Behçet's Disease

May 12, 2020 updated by: Ayse Ayan, Antalya Training and Research Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Muratpasa
      • Antalya, Muratpasa, Turkey, 07070
        • Antalya Tarining and Research Hospital Ethics Commitee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Behçet's disease
Male patients who arediagnosed as Behçet's disease according to International Study Group Classification Criteria
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
Other Names:
  • Ophthalmological Examination

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 week
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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Antalya Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ayse Ayan, Dr., Antalya Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Descriptive

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Plan will be shared with Statistical Package for the Social Sciences version 20.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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