Clinical trial NCT04980508: Effects of COVID-19 on Cavernous Smooth Muscle
Official title: COVID-19 Can Cause Cavernous Smooth Muscle Damage: Investigation of the Effects of COVID-19 on Cavernous Smooth Muscle by Corpus Cavernosum Electromyography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction Due to Diseases Classified Elsewhere
Covid19
Keywords: Erectile Dysfunction
COVID-19
Electromyography
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 29
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Corpus cavernosum electromyography, penile color Doppler ultrasonography and hormonal examinations were compared between the groups of patients with erectile dysfunction who did not have COVID-19, who were diagnosed with COVID-19 and were treated as outpatients or inpatients.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Corpus cavernosum electromyography amplitudes and frequency
timeFrame: 1 hour
measure: Corpus cavernosum electromyography relaxation degree
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yildirim Beyazit University, Schhol of Medicine
Study officials:
affiliation: Ankara Yildirim Beyazit University School of Medicine
name: Onder Kayigil, Professor
role: STUDY_CHAIR
References: