Erectile DysfunctionNCT07878260
Erectile and Ejaculatory Function Following Coronary Revascularization
An observational study of Erectile Dysfunction and Coronary Artery Disease, run by Saglik Bilimleri Universitesi at 2 sites in Turkey (Türkiye).
Trial summary
This observational, cross-sectional study aims to compare erectile and ejaculatory function between men with a history of coronary revascularization and men without known coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction, Coronary Artery Disease, Ejaculation Disorders
- How many people
- 135 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 1 Oct 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
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 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consisted of 135 adult male participants recruited from cardiology and urology outpatient clinics. Participants were categorized into two groups according to their cardiovascular history: 66 men with previous coronary revascularization (PCI or CABG) and 69 men without known coronary artery disease or coronary revascularization. Sexual function was evaluated using standardized self-administered questionnaires, including the SHIM, PEDT, and MSHQ-EjD.
Who may be able to join
- Adult male participants aged 18 years or older.
- Attendance at cardiology or urology outpatient clinics.
- Voluntary participation in the study.
- For the coronary revascularization group: a history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at least one month before questionnaire assessment.
- For the comparison group: no known history of coronary artery disease, PCI, or CABG.
Who cannot join
- Patients receiving dialysis.
- History of liver cirrhosis.
- Left ventricular ejection fraction below 40%.
- Coronary revascularization (PCI or CABG) within the preceding month.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kulu State Hospital
Konya, Kulu, 42770
Yenikent State Hospital
Sakarya, Adapazarı, 54100
About this study
Official title: Erectile and Ejaculatory Function in Men With and Without a History of Coronary Revascularization: A Cross-Sectional Comparative Study
This observational, cross-sectional study aims to compare erectile and ejaculatory function between men with a history of coronary revascularization and men without known coronary artery disease.
The study included 135 adult male participants, including 66 men who had previously undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) and 69 men without known coronary artery disease.
Read more
Erectile function was evaluated using the Sexual Health Inventory for Men (SHIM), premature ejaculation symptoms using the Premature Ejaculation Diagnostic Tool (PEDT), and ejaculatory function using the Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD). Self-reported ejaculation latency was also assessed.
The primary objective was to investigate the association between previous coronary revascularization and erectile function. Secondary objectives included comparing premature ejaculation symptoms, ejaculatory function, and ejaculation latency between the two groups.
Read the detailed description
This observational, cross-sectional, comparative study was conducted among adult male patients attending cardiology and urology outpatient clinics. The study investigated whether a history of coronary revascularization was associated with differences in erectile and ejaculatory function.
A total of 135 male participants were included. Participants were divided into two groups according to their cardiovascular history. The coronary revascularization group consisted of 66 men who had previously undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). The comparison group consisted of 69 men without a known history of coronary artery disease or coronary revascularization.
Participants in the revascularization group were evaluated at least one month after their most recent PCI or CABG procedure. Patients receiving dialysis, those with cirrhosis, those with a left ventricular ejection fraction below 40%, and those who had undergone coronary revascularization within the preceding month were excluded.
Erectile function was assessed using the five-item Sexual Health Inventory for Men (SHIM), with lower scores indicating poorer erectile function. Premature ejaculation symptoms were assessed using the Premature Ejaculation Diagnostic Tool (PEDT). Ejaculatory function and ejaculation-related distress were evaluated using the Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD). Self-reported ejaculation latency was recorded in minutes.
The primary outcome was the SHIM score. Secondary outcomes included PEDT scores, MSHQ-EjD scores, and self-reported ejaculation latency.
Between-group comparisons were performed using the Mann-Whitney U test and Fisher's exact test, as appropriate. Multivariable linear regression was performed to evaluate the association between coronary revascularization history and SHIM scores after adjustment for age, diabetes mellitus, hypertension, and smoking status. Body mass index was additionally included in a sensitivity analysis.
No experimental treatment or study-specific therapeutic intervention was administered. All assessments were performed as part of a single observational evaluation.
- Keywords
- Coronary Revascularization, Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting, Sexual Health Inventory for Men, Male Sexual Function
- Medical subject headings
- Erectile Dysfunction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Control Group (No Known Coronary Artery Disease) | Adult male participants without a known history of coronary artery disease, percutaneous coronary intervention, or coronary artery bypass grafting (n = 69). Sexual function was assessed using the SHIM, PEDT, and MSHQ-EjD questionnaires | |
| Group 2 - Coronary Revascularization Group (Previous Coronary Revascularization) | Adult male participants with a history of coronary artery disease who had undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at least one month before questionnaire assessment (n = 66). Sexual function was assessed using the SHIM, PEDT, and MSHQ-EjD questionnaires. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile Function Assessed by SHIM
Erectile function was assessed using the five-item Sexual Health Inventory for Men (SHIM). Total scores range from 5 to 25, with lower scores indicating poorer erectile function. A score of 21 or lower was considered positive for erectile dysfunction screening.
Measured: At enrollment (single assessment)
Secondary outcomes (2)
Premature Ejaculation Symptoms
Premature ejaculation symptoms were assessed using the five-item Premature Ejaculation Diagnostic Tool (PEDT). Total scores range from 0 to 20, with higher scores indicating a greater likelihood of premature ejaculation. Scores of 11 or higher were considered positive screening results.
Measured: At enrollment (single assessment)
Ejaculatory Function
Ejaculatory function was evaluated using the sum of the first three items of the Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD). Higher scores indicate better ejaculatory function.
Measured: At enrollment (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Jul 2026
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies 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
- Cross-sectional
- Enrolment
- 135 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ÇAĞRI ÖKTEM, Ministry of Health, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878260
- Sponsor's protocol ID
- CAD-SEXFUNC-2026
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided