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

NCT07274982 | Completed

• 1 other identifier: ZTKLAB03112025KUGOEK2520UROLGY
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunctions; Endothelial Dysfunction; Inflammation

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Difference in Modified EASIX score between ED and non-ED groups

  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

  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.

Study Arms (2)

Erectile Dysfunction Group

Erectile Dysfunction Group

Other: IIEF-5; Other: mEASIX

Non-Erectile Dysfunction Group

Non-Erectile Dysfunction Group

Other: IIEF-5; Other: mEASIX

Interventions

IIEF-5 OTHER

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

Erectile Dysfunction Group; Non-Erectile Dysfunction Group

mEASIX OTHER

Endothelial function will be evaluated with mEAX.

Erectile Dysfunction Group; Non-Erectile Dysfunction Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Only self-identified male participants aged 18-65 are eligible, as the study focuses on erectile dysfunction, a condition specific to individuals with male genital anatomy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead
• Ministry of Health, Turkey: collaborator

Study Sites (1)

Defne State Hospital

Hatay, Defne, 31000, Turkey (Türkiye)

Location

Related Publications (2)

• Zinczuk A, Rorat M, Simon K, Jurek T. EASIX, Modified EASIX and Simplified EASIX as an Early Predictor for Intensive Care Unit Admission and Mortality in Severe COVID-19 Patients. J Pers Med. 2022 Jun 21;12(7):1022. doi: 10.3390/jpm12071022.

  PMID: 35887519 RESULT

• Pennisi M, Sanchez-Escamilla M, Flynn JR, Shouval R, Alarcon Tomas A, Silverberg ML, Batlevi C, Brentjens RJ, Dahi PB, Devlin SM, Diamonte C, Giralt S, Halton EF, Jain T, Maloy M, Mead E, Palomba ML, Ruiz J, Santomasso B, Sauter CS, Scordo M, Shah GL, Park JH, Yanez San Segundo L, Perales MA. Modified EASIX predicts severe cytokine release syndrome and neurotoxicity after chimeric antigen receptor T cells. Blood Adv. 2021 Sep 14;5(17):3397-3406. doi: 10.1182/bloodadvances.2020003885.

  PMID: 34432870 RESULT

MeSH Terms

Conditions

Erectile Dysfunction; Inflammation

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 10, 2025
• Study Start: May 1, 2025
• Primary Completion: November 15, 2025
• Study Completion: November 28, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)