- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07274982
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Defne
-
Hatay, Defne, Turkey (Türkiye), 31000
- Defne State Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZTKLAB03112025KUGOEK2520UROLGY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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