Effects of Tadalafil on LMR and MHR in Patients With ED
- Registration Number
- NCT03918993
- Lead Sponsor
- Samsun Liv Hospital
- Brief Summary
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
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.
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Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 62
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group T Tadalafil 5mg tablet 31 Patients with ED who receiving 5 mg/day of Tadalafil for 8 weeks.
- Primary Outcome Measures
Name Time Method lymphocyte count up to 8 weeks complete blood count
HDL cholesterol up to 8 weeks serum lipid profile
monocyte to HDL ratio up to 8 weeks an inflamamtoy marker
monocyte count up to 8 weeks complete blood count
Testosteron up to 8 weeks hormonal evaluation
fasting glucose at the 1st day serum glucose level
Lymphocyte to Monocyte Ratio up to 8 weeks ratio of values in complete blood count
The International Index of Erectile Function (IIEF-5) Questionnaire up to 8 weeks 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Samsun Liv Hospital
🇹🇷Samsun, Turkey
Samsun Liv Hospital🇹🇷Samsun, Turkey