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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- lymphocyte count
研究概览
简要总结
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.
详细描述
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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研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 39 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group T
31 Patients with ED who receiving 5 mg/day of Tadalafil for 8 weeks.
干预措施: Tadalafil 5mg tablet (Drug)
结局指标
主要结局
lymphocyte count
时间窗: up to 8 weeks
complete blood count
HDL cholesterol
时间窗: up to 8 weeks
serum lipid profile
monocyte to HDL ratio
时间窗: up to 8 weeks
an inflamamtoy marker
monocyte count
时间窗: up to 8 weeks
complete blood count
Testosteron
时间窗: up to 8 weeks
hormonal evaluation
fasting glucose
时间窗: at the 1st day
serum glucose level
Lymphocyte to Monocyte Ratio
时间窗: up to 8 weeks
ratio of values in complete blood count
The International Index of Erectile Function (IIEF-5) Questionnaire
时间窗: 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
次要结局
未报告次要终点
研究者
Mehmet Necmettin Mercimek
Principal Investigator
Samsun Liv Hospital