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

NCT ID: NCT07274982

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

380 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-11-28

Brief Summary

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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

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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.

Conditions

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Erectile Dysfunctions Endothelial Dysfunction Inflammation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Erectile Dysfunction Group

Erectile Dysfunction Group

IIEF-5

Intervention Type OTHER

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

mEASIX

Intervention Type OTHER

Endothelial function will be evaluated with mEAX.

Non-Erectile Dysfunction Group

Non-Erectile Dysfunction Group

IIEF-5

Intervention Type OTHER

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

mEASIX

Intervention Type OTHER

Endothelial function will be evaluated with mEAX.

Interventions

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IIEF-5

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

Intervention Type OTHER

mEASIX

Endothelial function will be evaluated with mEAX.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Turkey

OTHER_GOV

Sponsor Role collaborator

Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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okkes zortuk

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Defne State Hospital

Hatay, Defne, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 35887519 (View on PubMed)

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.

Reference Type RESULT
PMID: 34432870 (View on PubMed)

Other Identifiers

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ZTKLAB03112025KUGOEK2520UROLGY

Identifier Type: -

Identifier Source: org_study_id

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