Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04980508 |
Other study ID # |
AnkaraYBU-URO-SU-02 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 20, 2021 |
Est. completion date |
May 30, 2021 |
Study information
Verified date |
July 2021 |
Source |
Ankara Yildirim Beyazit University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.