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临床试验/NCT04980508
NCT04980508已完成不适用

COVID-19 Can Cause Cavernous Smooth Muscle Damage: Investigation of the Effects of COVID-19 on Cavernous Smooth Muscle by Corpus Cavernosum Electromyography

Ankara Yildirim Beyazıt University2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2021年2月20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
29
试验地点
2
主要终点
Corpus cavernosum electromyography relaxation degree

研究概览

简要总结

The aim of the study is to illuminate the role of COVID-19 in the pathophysiology of erectile dysfunction (ED). Nine patients that had COVID-19 and were treated as outpatients were classified as group 1, 10 patients who were hospitalized due to COVID-19 were classified as group 2, and 10 patients who did not have COVID-19 and applied to the urology outpatient clinic with ED complaints and had similar clinical characteristics were classified as the control group (group 3). Patients underwent diagnostic evaluation including International Index of Erectile Function-5 form, penile color Doppler ultrasonography, corpus cavernosum electromyography, and fasting serum levels of reproductive hormones (07-11 am). According to the results of our study, cavernous smooth muscle damage occurs in patients with COVID-19 and it has an important role in the pathophysiology of erectile dysfunction.

详细描述

COVID-19, which is caused by a novel coronavirus Sars-Cov-2, has been affecting people all over the world for more than a year and has resulted in many deaths. It can affect almost every part of the body and cause diseases including anosmia, hypogonadism, myopathy, neuropathy, and vasculitis. Studies have reported that it may cause erectile dysfunction (ED), however, its role in the pathophysiology of ED has not yet been fully elucidated.

Patients aged 20-50 years who applied to the urology outpatient clinic due to ED were included in the study. Nine patients that had COVID-19 and were treated as outpatients were classified as group 1, 10 patients who were hospitalized due to COVID-19 were classified as group 2, and 10 patients who did not have COVID-19 and applied to the urology outpatient clinic with ED complaints and had similar clinical characteristics were classified as the control group (group 3). Patients underwent diagnostic evaluation including International Index of Erectile Function (IIEF)-5 form, penile color Doppler ultrasonography (CDUS), corpus cavernosum electromyography (cc-EMG), and fasting serum levels of reproductive hormones (07-11 am).

According to penile CDUS results, distribution of vasculogenic pathologies in groups was as follows: 33% in group 1, 40% in group 2, and 40% in group 3. According to cc-EMG results, the pre-vasoactive drug (VAD) amplitudes of the patients in group 2 were significantly lower than those in group 3 (p: 0.005). Moreover, the pre-VAD amplitudes of the patients in group 1 were also significantly lower than those in group 3 (p: 0.042). In addition, while the RD values of the patients in group 2 were significantly lower than those in group 3, no significant difference was observed between other groups. There was no significant difference between the groups in terms of hormonal profile.

Cavernosal smooth muscle damage that occurs due to COVID-19-related endothelial dysfunction may disrupt the nutrition of cavernosal tissues. The deterioration of the nutrition of the cavernosal tissues may be one of the important reasons for the post-COVID-19 ED. The results of our study need to be confirmed with larger studies in which electromyographic as well as histopathological examinations are performed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients aged 20-50 years
  • Applied to the urology outpatient clinic with the complaint of erectile dysfunction
  • International Index of Erectile Function-5 score of <17

排除标准

  • Patients with concomitant neurological disease
  • Diabetes, coronary artery disease, kidney failure, hyperlipidemia, hypertension
  • Smoking and alcohol addiction
  • Hormonal drug use
  • History of pelvic trauma and history of penile, testicular, pelvic or perineal surgery
  • Diagnosis of malignancy
  • Patients that used opioids within the last 3 months

结局指标

主要结局

Corpus cavernosum electromyography relaxation degree

时间窗: 1 hour

Relaxation degree (RD) was defined as the percent decrease in the amplitudes of electrical activity of the corpus cavernosum(EACC). It can be formulated as RD = pre-injectional EACC (amp) - post-injectional EACC (amp) × 100/pre-injectional EACC (amp)

Corpus cavernosum electromyography amplitudes and frequency

时间窗: 1 hour

Measurements of the electrical activity of the corpus cavernosum were done for 10 minutes using coaxial needle electrodes during the flaccid state and after intracavernous papaverine (60 mg) injection

次要结局

未报告次要终点

研究者

发起方
Ankara Yildirim Beyazıt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

selman unal

Principal Investigator

Ankara Yildirim Beyazıt University

研究点 (2)

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