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临床试验/NCT05679999
NCT05679999已完成不适用

Carotid Artery Intima Media Thickness Can Predict the Response to Phosphodiesterase 5 Inhibitors in the Patients With Moderate Erectile Dysfunction

Bursa City Hospital1 个研究点 分布在 1 个国家目标入组 181 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
181
试验地点
1
主要终点
Coexistence of erectile dysfunction and increased CIMT

研究概览

简要总结

The aim of the present study was to examine the relationship between degrees of erectile dysfunction and carotid artery intima media thickness (CIMT) and its effect on the medical treatment of this disease. Considering that there are vascular pathologies in the etiology, it is important to reveal vascular disorders with CIMT, which is a non-invasive, easily applicable method, and to use it in the grading and treatment of erectile dysfunction.

详细描述

Background. It is known that vasculogenic disorders play a leading role in the pathophysiology of erectile dysfunction. Cardiovascular risk factors that cause vascular pathologies are also the main actors among the causes of erectile dysfunction. The thickness of the carotid artery intima-media (CIMT) is useful for demonstrate cardiovascular disorders. For this reason, the relationship between CIMT and erectile dysfunction and its use in predicting the response to phosphodiesterase 5 inhibitors (PDE5-I) are encountered in the literature. In this study, the investigators also evaluated the predictive value of CIMT in subgroups of patients according to the severity of erectile dysfunction. Methods. A total of 181 subjects were divided into two groups as patient group (n:150) and control group (n:31). The patients were also divided into subgroups as severe, moderate, mild-moderate, mild erectile dysfunction. Blood tests, carotid ultrasonography and The International Erectile Function Index-5 form (IIEF-5) were applied to all subjects. Tadalafil was administered to each patient. The patients were re-evaluated using the IIEF-5 questionnaire after 2 months of treatment period. According to response to medication, patients were also divided into subgroups as responders and non-responders. Results. Fasting blood glucose, BMI, IIEF score and CIMT were significantly higher in the patient group compared to the control group. The thickness of the carotid artery intima-media thickness was significantly correlated with IIEF-5 score. When the total patient group is evaluated, CIMT value of the responders was significantly lower compared to the non-responders. Carotid artery intima-media was significantly higher in nonresponders of patients with moderate/mild-moderate erectile dysfunction compared to responders, while there were no significant difference in CIMT between responders and non-responders of patients with severe/mild erectile dysfunction. Discussion. In patients with moderate/mild-moderate erectile dysfunction, increased CIMT is associated with an nonresponse to PDE5-I.

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
40 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients over 40 years of age and under 70 years

排除标准

  • Patients under 40 years of age and over 70 years old
  • Patients whose consent can not be obtained
  • Those with endocrine disease except type II diabetes mellitus
  • Concomitant malignancy
  • Psychiatric problems
  • Previous penile or pelvic surgery/trauma
  • Penile curvature / Peyronie's disease
  • Patients receiving treatment for erectile dysfunction
  • Chronic liver failure
  • Chronic kidney failure
  • Neurological disease
  • Patients with low testosteron level (≤300 ng/dL)

结局指标

主要结局

Coexistence of erectile dysfunction and increased CIMT

时间窗: 2 years

Association erectile dysfunction with CIMT measurement

次要结局

未报告次要终点

研究者

发起方
Bursa City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sedat Önen

Head of Urology Department

Bursa City Hospital

研究点 (1)

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