Erectile Dysfunction Due to Arterial DiseaseNCT05679999
Carotid Artery Intima Media Thickness Can Predict the Response to Phosphodiesterase 5 Inhibitors in the Patients With Moderate Erectile Dysfunction
An observational study of Erectile Dysfunction Due to Arterial Disease, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction Due to Arterial Disease
- What is being tested?
- CIMT (Carotid artery intima media thickness measurement)
- How many people
- 181 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 31 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 40 to 70 years
- Men only
- Adult, Older adult
Study population: Patients over 40 years of age and under 70 years old with erectile dysfunction
Who may be able to join
- 1. Patients over 40 years of age and under 70 years
Who cannot join
- Patients under 40 years of age and over 70 years old
- Patients whose consent can not be obtained
- Those with endocrine disease except type II diabetes mellitus
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa
About this study
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.
Read the 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.
- Being tested
- CIMT (Carotid artery intima media thickness measurement)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIMT (Carotid artery intima media thickness measurement)Diagnostic test
Carotid artery intima media thickness measurement with ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Control group | 31 male volunteers who did not have erectile dysfunction Receives: Diagnostic Test: CIMT (Carotid artery intima media thickness measurement) | |
| Patient group | 150 patients with erectile dysfunction Receives: Diagnostic Test: CIMT (Carotid artery intima media thickness measurement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coexistence of erectile dysfunction and increased CIMT
Association erectile dysfunction with CIMT measurement
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction Due to Arterial 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
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sedat Önen, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679999
- Sponsor's protocol ID
- 2014/23-01
- Status last verified
- Jan 2023
- First submitted
- 26 Dec 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Artery Intima Media Thickness Can Predict the Response to Phosphodiesterase 5 Inhibitors in the Patients With Moderate Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT05679999
- Acronym / sponsor ID
- 2014/23-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Jan 2023 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: CIMT (Carotid artery intima media thickness measurement)31 male volunteers who did not have erectile dysfunction |
| Patient group | – | Diagnostic Test: CIMT (Carotid artery intima media thickness measurement)150 patients with erectile dysfunction |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Patients over 40 years of age and under 70 years old with erectile dysfunction
Key inclusion criteria (1 listed)
- 1. Patients over 40 years of age and under 70 years
Key exclusion criteria (5 listed)
- Patients under 40 years of age and over 70 years old
- Patients whose consent can not be obtained
- Those with endocrine disease except type II diabetes mellitus
- 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)
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 |
|---|---|---|
| CIMT (Carotid artery intima media thickness measurement)Carotid artery intima media thickness measurement with ultrasound | Diagnostic test | Control group, Patient group |
Primary outcome
Coexistence of erectile dysfunction and increased CIMT
Time frame: 2 years
Association erectile dysfunction with CIMT measurement
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 12 Jan 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Erectile Dysfunction Due to Arterial Disease
Recruiting
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction
RecruitingObservational study
EVERiST: Impact of Image Detected Accessory Pudendal Artery on Erection Recovery After Nerve Sparing Prostatectomy
Radical Prostatectomy, Erectile Dysfunction Following Radical Prostatectomy
RecruitingPhase 2
TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men
Erectile Dysfunction Due to Arterial Disease, Atheroscleroses
Not yet recruitingPhase 2
Clinical Trial Investigating the Effect of Exosomes as a Complementary Treatment in Severe to Moderate Erectile Dysfunction
Erectile Dysfunction, Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
Active, not recruiting
Low Intensity Shockwave Therapy for Erectile Dysfunction
Erectile Dysfunction, Erectile Dysfunction Following Radical Prostatectomy
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Erectile Dysfunction Due to Arterial Disease, run by Bursa City 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 1 inclusion and 5 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 12 Jan 2023. 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?
Coexistence of erectile dysfunction and increased CIMT (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2023.