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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07274982
Enrollment
380
Registered
2025-12-10
Start date
2025-05-01
Completion date
2025-11-28
Last updated
2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Dysfunction, Erectile Dysfunctions, Inflammation

Keywords

Erectile Dysfunctions, EASIX, modified EASIX, IIEF-5, endothelial inflammation

Brief summary

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.

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.

Interventions

OTHERIIEF-5

IIEF-5: The erectile dysfunction status of patients will be analyzed with the International Index of Erectile Function-5.

OTHERmEASIX

Endothelial function will be evaluated with mEAX.

Sponsors

Ministry of Health, Turkey
CollaboratorOTHER_GOV
Ataturk University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Difference in Modified EASIX score between ED and non-ED groupsRetrospective 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026