Effects of Tadalafil on LMR and MHR in Patients With ED

Study Overview
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Brief Summary
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The aim of the study was to investigate whether daily 5 mg tadalafil over eight weeks affects to Lymphocyte/Monocyte ratio (LMR) and Monocyte/High-Density Lipoprotein ratio (MHR) in patients with erectile dysfunction (ED). Thirty-one patients with organic ED and 31 healthy controls between July 2017 and November 2018 were included in this retrospective study. To avoid bias, the patients were randomly selected and the controls were also incorporated consecutively. The presence of ED was determined according to the International Erectile Function Index-5 (IIEF-5). The patients and the controls were evaluated in terms of IIEF-5, complete blood count, serum biochemistry, LMR, and MHR.

Detailed Description
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The medical records of the heterosexual men treated with the diagnosis of organic ED in the Urology department of a private hospital between July 2017 and October 2018 were evaluated retrospectively. The number of samples to be included in the study was determined by the help of the computer-assisted power analysis. Random sampling was performed from all cohorts of patients with ED. Thirty-one male patients between the ages of 39-65 with organic erectile dysfunction more than one year and treated with OAD 5 mg dose of tadalafil for eight weeks were selected as the treatment group (group T)The patients in group T have been assessed both before (T1) and after (T2) the treatment. Between the ages of 39-65, thirty-one healthy men who were admitted to the internal medicine outpatient clinic for their annual follow-up were selected consecutively and the control group (group C) was formed. All subjects in the control group were sexually active men with regular monogamous heterosexual relationships during the last one year. .

Official Title
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Evaluation of the Effects of a Daily Dose of 5 mg of Tadalafil on Lymphocyte to Monocyte Ratio and Monocyte to High-Density Lipoprotein Ratio in Patients With Erectile Dysfunction

Conditions
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Erectile Dysfunction, Inflammation

Intervention / Treatment
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* Drug: Tadalafil 5mg tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 39-65 years old men with ED 39-65 years old, haelthy men Patients that have received 5 mg tadalafil/day for 8 weeks Patients with informed consent forms Patients with no missing variables Exclusion Criteria: Patients with systemic autoimmune and inflammatory disease, congestive heart failure, chronic renal failure, and chronic hepatobiliary disease, chronic lung disease, and thyroid dysfunction, patients with acute infection, patients with neurological deficits, metabolic syndrome and malignancy Patients with a history of prostate, penile or pelvic surgery or radiotherapy,, patients receiving anticoagulant, beta-blocker, antidepressants and antipsychotics, hormonal therapy, patients with alcohol and smoking

Ages Eligible for Study
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Minimum Age: 39 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group T<br>31 Patients with ED who receiving 5 mg/day of Tadalafil for 8 weeks. | Drug: Tadalafil 5mg tablet<br>* Once-a-day 5 mg dose of tadalafil for 8 weeks<br>* Other names: phosphodiesterase type 5 (PDE5) inhibitor;|
| Group C<br>Thirty-one healthy men who were admitted to the internal medicine outpatient clinic for their annual follow-up | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymphocyte to Monocyte Ratio | ratio of values in complete blood count | up to 8 weeks | 
| monocyte to HDL ratio | an inflamamtoy marker | up to 8 weeks | 
| The International Index of Erectile Function (IIEF-5) Questionnaire | IIEF-5 scoring: The IIEF-5 score is the sum of the ordinal responses to the 5 items. 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunctio | up to 8 weeks | 
| monocyte count | complete blood count | up to 8 weeks | 
| lymphocyte count | complete blood count | up to 8 weeks | 
| HDL cholesterol | serum lipid profile | up to 8 weeks | 
| Testosteron | hormonal evaluation | up to 8 weeks | 
| fasting glucose | serum glucose level | at the 1st day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile Dysfunction, lymphocyte to monocyte ratio, monocyte to HDL ratio