Effects of COVID-19 on Cavernous Smooth Muscle

Not Applicable

Completed

• Conditions: Covid19; Erectile Dysfunction Due to Diseases Classified Elsewhere
• Interventions: Diagnostic Test: corpus cavernosum electromyography

• Registration Number: NCT04980508
• Lead Sponsor: Ankara Yildirim Beyazıt University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-02-20
• Primary Completion: 2021-04-30
• Study Completion: 2021-05-30
• Status Verified: 2021-07
• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-07-26
• Last Update Submitted: 2021-07-26
• Study First Posted: 2021-07-28
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 29

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients that had COVID-19 and were treated as outpatients	corpus cavernosum electromyography	Patients underwent diagnostic evaluation including IIEF-5 form, penile color Doppler ultrasonography, corpus cavernosum electromyography, and fasting serum levels of testosterone, luteinizing hormone, follicle stimulating hormone, and prolactin measured in the morning (07-11 am). The relaxation degrees of cavernosal smooth muscles were calculated from the corpus cavernosum electromyography results.
Patients who were hospitalized due to COVID-19	corpus cavernosum electromyography	Patients underwent diagnostic evaluation including IIEF-5 form, penile color Doppler ultrasonography, corpus cavernosum electromyography, and fasting serum levels of testosterone, luteinizing hormone, follicle stimulating hormone, and prolactin measured in the morning (07-11 am). The relaxation degrees of cavernosal smooth muscles were calculated from the corpus cavernosum electromyography results.
Patients who did not have COVID-19	corpus cavernosum electromyography	Patients underwent diagnostic evaluation including IIEF-5 form, penile color Doppler ultrasonography, corpus cavernosum electromyography, and fasting serum levels of testosterone, luteinizing hormone, follicle stimulating hormone, and prolactin measured in the morning (07-11 am). The relaxation degrees of cavernosal smooth muscles were calculated from the corpus cavernosum electromyography results.

Primary Outcome Measures

Name	Time	Method
Corpus cavernosum electromyography relaxation degree	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	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

Trial Locations

Locations (1)

Ankara Yildirim Beyazit University, Schhol of Medicine; 🇹🇷 Ankara, Turkey