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CompletedNCT07878260Updated Oct 19, 2026

Erectile and Ejaculatory Function Following Coronary Revascularization

An observational study in Erectile Dysfunction, Coronary Artery Disease and Ejaculation Disorders, sponsored by Saglik Bilimleri Universitesi. Completed at 2 sites in Turkey (Türkiye). Open to male participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Saglik Bilimleri Universitesi · Observational

Updated Oct 19, 2026Eligibility revisedNewly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
135
Ages
18 Years to 80 Years
Sex
Male
01

Study 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.

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.

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.

02

Conditions studied

  • Erectile Dysfunction
  • Coronary Artery Disease
  • Ejaculation Disorders

Keywords

  • Coronary Revascularization
  • Percutaneous Coronary Intervention
  • Coronary Artery Bypass Grafting
  • Sexual Health Inventory for Men
  • Male Sexual Function
03

In context

Erectile Dysfunction

698 studies on the registry are indexed under Erectile Dysfunction; 116 are open to participants now.

This study's enrollment of 135 is close to the median of 135 across 120 observational studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Saglik Bilimleri Universitesi is the lead sponsor of 447 studies on the registry; 138 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Patients receiving dialysis.
  • History of liver cirrhosis.
  • Left ventricular ejection fraction below 40%.
  • Coronary revascularization (PCI or CABG) within the preceding month.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
135 participants (actual)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At enrollment (single assessment)

Secondary outcomes

  1. 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.

    Time frame: At enrollment (single assessment)

  2. 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.

    Time frame: At enrollment (single assessment)

07

Study locations

2 sites
  • Yenikent State Hospital
    Sakarya, Adapazarı 54100, Turkey (Türkiye)
  • Kulu State Hospital
    Konya, Kulu 42770, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2026 to primary completion in Oct 2026, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2026
First posted
Oct 16, 2026
StartActual
Jul 1, 2026
Primary completionActual
Oct 1, 2026
CompletionActual
Oct 1, 2026
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Also revised
eligibility
Registered
First appeared on the registry
Oct 16, 2026
Show all 2 updates
  1. Oct 19, 2026
    Eligibility Criteria revised
  2. Oct 16, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07878260
Responsible party
ÇAĞRI ÖKTEM (Urology Specialist, Ministry of Health, Turkey) — Principal investigator
First posted
Oct 16, 2026
Start date
Jul 1, 2026
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026
Last update
Oct 19, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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