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Effects of COVID-19 on Cavernous Smooth Muscle

Primary Purpose

Erectile Dysfunction Due to Diseases Classified Elsewhere, Covid19

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
corpus cavernosum electromyography
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Erectile Dysfunction Due to Diseases Classified Elsewhere focused on measuring Erectile Dysfunction, COVID-19, Electromyography

Eligibility Criteria

20 Years - 50 Years (Adult)MaleDoes not accept 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

Sites / Locations

  • Ankara Yildirim Beyazit University, Schhol of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Patients that had COVID-19 and were treated as outpatients

Patients who were hospitalized due to COVID-19

Patients who did not have COVID-19

Arm 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.

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 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.

Outcomes

Primary Outcome Measures

Corpus cavernosum electromyography amplitudes and frequency
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
Corpus cavernosum electromyography relaxation degree
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)

Secondary Outcome Measures

Full Information

First Posted
July 26, 2021
Last Updated
July 26, 2021
Sponsor
Ankara Yildirim Beyazıt University
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1. Study Identification

Unique Protocol Identification Number
NCT04980508
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 20, 2021 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Yildirim Beyazıt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction Due to Diseases Classified Elsewhere, Covid19
Keywords
Erectile Dysfunction, COVID-19, Electromyography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients that had COVID-19 and were treated as outpatients
Arm Type
Active Comparator
Arm 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.
Arm Title
Patients who were hospitalized due to COVID-19
Arm Type
Active Comparator
Arm 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.
Arm Title
Patients who did not have COVID-19
Arm Type
Active Comparator
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
corpus cavernosum electromyography
Intervention Description
Cc-EMG was performed by using the cc-EMG module of Ellipse 4 device (Andromeda, Germany), which comprises of a 2-channel electromyography amplifier with a row sampling rate of 16 kHz, filtered sampling rate of 166.67 Hz and a band width of 0.5-30 Hz with the speed of the thermo-writer paper set at 5 mm/s. Measurements of the electrical activity of the corpus cavernosum (EACC) were done for 10 minutes using coaxial needle electrodes during the flaccid state and after intracavernous papaverine (60 mg) injection.
Primary Outcome Measure Information:
Title
Corpus cavernosum electromyography amplitudes and frequency
Description
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
Time Frame
1 hour
Title
Corpus cavernosum electromyography relaxation degree
Description
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)
Time Frame
1 hour

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Onder Kayigil, Professor
Organizational Affiliation
Ankara Yildirim Beyazit University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Ankara Yildirim Beyazit University, Schhol of Medicine
City
Ankara
ZIP/Postal Code
06800
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of COVID-19 on Cavernous Smooth Muscle

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