Carotid Artery Intima Media Thickness Can Predict the Response to Phosphodiesterase 5 Inhibitors in the Patients With Moderate Erectile Dysfunction

January 11, 2023 updated by: Sedat Önen, Bursa City Hospital
The aim of the present study was to examine the relationship between degrees of erectile dysfunction and carotid artery intima media thickness (CIMT) and its effect on the medical treatment of this disease. Considering that there are vascular pathologies in the etiology, it is important to reveal vascular disorders with CIMT, which is a non-invasive, easily applicable method, and to use it in the grading and treatment of erectile dysfunction.

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

Background. It is known that vasculogenic disorders play a leading role in the pathophysiology of erectile dysfunction. Cardiovascular risk factors that cause vascular pathologies are also the main actors among the causes of erectile dysfunction. The thickness of the carotid artery intima-media (CIMT) is useful for demonstrate cardiovascular disorders. For this reason, the relationship between CIMT and erectile dysfunction and its use in predicting the response to phosphodiesterase 5 inhibitors (PDE5-I) are encountered in the literature. In this study, the investigators also evaluated the predictive value of CIMT in subgroups of patients according to the severity of erectile dysfunction. Methods. A total of 181 subjects were divided into two groups as patient group (n:150) and control group (n:31). The patients were also divided into subgroups as severe, moderate, mild-moderate, mild erectile dysfunction. Blood tests, carotid ultrasonography and The International Erectile Function Index-5 form (IIEF-5) were applied to all subjects. Tadalafil was administered to each patient. The patients were re-evaluated using the IIEF-5 questionnaire after 2 months of treatment period. According to response to medication, patients were also divided into subgroups as responders and non-responders. Results. Fasting blood glucose, BMI, IIEF score and CIMT were significantly higher in the patient group compared to the control group. The thickness of the carotid artery intima-media thickness was significantly correlated with IIEF-5 score. When the total patient group is evaluated, CIMT value of the responders was significantly lower compared to the non-responders. Carotid artery intima-media was significantly higher in nonresponders of patients with moderate/mild-moderate erectile dysfunction compared to responders, while there were no significant difference in CIMT between responders and non-responders of patients with severe/mild erectile dysfunction. Discussion. In patients with moderate/mild-moderate erectile dysfunction, increased CIMT is associated with an nonresponse to PDE5-I.

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.
181

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
      • Bursa, Turkey
        • Bursa Yuksek Ihtisas Training and Research Hospital

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

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients over 40 years of age and under 70 years old with erectile dysfunction

Description

Inclusion Criteria:

1. Patients over 40 years of age and under 70 years

Exclusion Criteria:

  1. Patients under 40 years of age and over 70 years old
  2. Patients whose consent can not be obtained
  3. Those with endocrine disease except type II diabetes mellitus
  4. Concomitant malignancy

6. Psychiatric problems 7. Previous penile or pelvic surgery/trauma 8. Penile curvature / Peyronie's disease 9. Patients receiving treatment for erectile dysfunction 10. Chronic liver failure 11. Chronic kidney failure 12. Neurological disease 13. Patients with low testosteron level (≤300 ng/dL)

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.
Control group
31 male volunteers who did not have erectile dysfunction
Diagnostic test: CIMT (Carotid artery intima media thickness measurement)
Carotid artery intima media thickness measurement with ultrasound
Patient group
150 patients with erectile dysfunction
Diagnostic test: CIMT (Carotid artery intima media thickness measurement)
Carotid artery intima media thickness measurement with ultrasound

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
Coexistence of erectile dysfunction and increased CIMT
Time Frame: 2 years
Association erectile dysfunction with CIMT measurement
2 years

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.
Bursa City Hospital

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.
January 1, 2018

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 31, 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 31, 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).
December 26, 2022

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.
December 26, 2022

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.
January 11, 2023

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.
January 12, 2023

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.
January 11, 2023

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.
January 1, 2023

More Information

Terms related to this study

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.
  • 2014/23-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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