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Effects of COVID-19 on Cavernous Smooth Muscle

A

Ankara Yildirim Beyazıt University

Status

Completed

Conditions

Covid19
Erectile Dysfunction Due to Diseases Classified Elsewhere

Treatments

Diagnostic Test: corpus cavernosum electromyography

Study type

Interventional

Funder types

Other

Identifiers

NCT04980508
AnkaraYBU-URO-SU-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

29 patients

Sex

Male

Ages

20 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

29 participants in 3 patient groups

Patients that had COVID-19 and were treated as outpatients
Active Comparator group
Description:
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.
Treatment:
Diagnostic Test: corpus cavernosum electromyography
Patients who were hospitalized due to COVID-19
Active Comparator group
Description:
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.
Treatment:
Diagnostic Test: corpus cavernosum electromyography
Patients who did not have COVID-19
Active Comparator group
Description:
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.
Treatment:
Diagnostic Test: corpus cavernosum electromyography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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