The Predictive Value of Modified EASIX Score for Determining Erectile Dysfunction Severity

December 9, 2025 updated by: okkes zortuk, Ataturk University

The Importance of Modified EASIX Score in Determining Severity of Erectile Dysfunction - A Single-Center Retrospective Case-Control Study

This retrospective single-center case-control study evaluates whether the Modified EASIX score (LDH × CRP / Platelets), calculated from routine blood tests, predicts severity of erectile dysfunction (ED) as measured by the IIEF-5 questionnaire. Medical records from January 1, 2024 to September 30, 2025 will be reviewed. Patients will be classified by IIEF-5 (≤21 = ED; ≥22 = no ED) and Modified EASIX distributions and predictive performance (ROC/AUC) will be compared between groups. No additional interventions will be performed.

Study Overview

Detailed Description

This retrospective observational study will include adult male patients aged 18-65 attending the urology outpatient clinic. Demographic data, comorbidities, IIEF-5 scores and routine laboratory results (LDH, CRP, platelet count and other routine biochemistry/hematology) obtained during routine follow-up will be extracted from medical records covering January 2024-September 2025. The Modified EASIX score will be computed as: LDH × CRP / Platelets. Patients will be grouped according to IIEF-5: ED group (IIEF-5 ≤21) and non-ED group (IIEF-5 ≥22). Primary analyses include group comparisons of Modified EASIX, correlation analyses with IIEF-5, logistic regression for association and ROC analysis to evaluate discriminatory performance and optimal cut-offs. Analyses will use IBM SPSS 27 and GraphPad Prism 9. No changes to patient management were made for study purposes; no additional sampling or interventions were performed.

Study Type

Observational

Enrollment (Actual)

380

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

    • Defne
      • Hatay, Defne, Turkey (Türkiye), 31000
        • Defne State 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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult male patients aged 18-65 who attended the urology outpatient clinic and had documented IIEF-5 scores and routine laboratory results (LDH, CRP, platelet count) between January 2024 and September 2025. The study includes both patients with erectile dysfunction (IIEF-5 ≤ 21) and those without erectile dysfunction (IIEF-5 ≥ 22), using retrospectively collected medical records from a single center (Defne State Hospital).

Description

Inclusion Criteria:

Male patients aged 18-65. Followed at the urology outpatient clinic with a documented IIEF-5 questionnaire.

Available routine laboratory data including LDH, CRP and platelet count within the study period (Jan 1, 2024 - Sep 30, 2025).

Exclusion Criteria:

Use of penile prosthesis. Patients without an organic ED diagnosis when relevant (per protocol: "Patients without an organic ED diagnosis will be excluded from the study").

Missing essential data for Modified EASIX calculation or IIEF-5.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Erectile Dysfunction Group
IIEF-5: The erectile dysfunction status of patients will be analyzed with the International Index of Erectile Function-5.
Endothelial function will be evaluated with mEAX.
Non-Erectile Dysfunction Group
IIEF-5: The erectile dysfunction status of patients will be analyzed with the International Index of Erectile Function-5.
Endothelial function will be evaluated with mEAX.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Modified EASIX score between ED and non-ED groups
Time Frame: Retrospective records from Jan 1, 2024 to Sep 30, 2025.
Mean Modified EASIX (LDH × CRP / Platelets) in each group. Group comparison (t-test) and effect size.
Retrospective records from Jan 1, 2024 to Sep 30, 2025.
Difference in Modified EASIX score between ED and non-ED groups
Time Frame: Time Frame: Retrospective records from Jan 1, 2024 to Sep 30, 2025.
Median Modified EASIX (LDH × CRP / Platelets) in each group. Group comparison (Mann-Whitney U) and effect size.
Time Frame: Retrospective records from Jan 1, 2024 to Sep 30, 2025.

Collaborators and Investigators

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

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.

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)

May 1, 2025

Primary Completion (Actual)

November 15, 2025

Study Completion (Actual)

November 28, 2025

Study Registration Dates

First Submitted

November 28, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Actual)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be publicly shared because the study is based on retrospective medical records containing sensitive personal health information. Due to privacy concerns and institutional data-protection regulations, de-identified datasets cannot be released outside the research team.

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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