Assessment of Sexual Dysfunction Among COVID-19 Recovered Patients

December 6, 2021 updated by: Reham Abdalla Ibrahim, Assiut University

Covid-19 pandemic has affected hundreds of millions globally(https ://coronavirus.jhu.edu/map.html), and hundreds of thousands in Egypt(https://www.care.gov.eg/EgyptCare/Index.aspx).

However, the long-term consequences of the disease are still largely unknown. Data from 2002-2004 epidemics of SARS suggest that cardiovascular sequelae, such as microangiopathy, cardiomyopathy and impaired endothelial function, are to be expected also in COVID-19 patients.(Vittori et al, 2020) Hyperinflammation and immunosuppression are prominently featured in COVID-19, causing a cytokine storm leading to development of micro-thrombosisand disseminated intravascular coagulation (DIC). (Jose et al, 2020).

These findings can be extremely relevant for male and female sexual health: indeed, based on these premises, there is quite enough evidence to hypothesize that consequences of COVID-19 can extend to sexual and reproductive health. (Sansone et al, 2020)

A self-administered questionnaire will be disseminated using online electronic social network (Facebook, What's App) including:

Sociodemographic age& gender. Sexual dysfunction will be assessed using International Index of Erectile Function-5 (IIEF-5) for males, and Arabic Female Sexual Function Index (ArFSFI) for females will be applied.

Covid-19 related factors.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The pandemic of coronavirus disease (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) represents a first-time challenge for healthcare. Despite of social distancing and isolation measures, the number of affected patients is growing daily. (Isidori et al, 2020) As of November 14th , 2021, more than 253.2 million COVID-19 cases have been confirmed worldwide, with more than 5 million deaths& more than 229.3 million subjects have recovered from COVID-19 worldwide. (https ://coronaviru s.jhu.edu/map.html)

While in Egypt more than 343 thousand COVID-19 cases with more than 19 thousand deaths have been confirmed& more than 282 thousand recoveries. (https://www.care.gov.eg/EgyptCare/Index.aspx)

However, the long-term consequences of the disease are still largely unknown. Data from 2002-2004 epidemics of SARS suggest that cardiovascular sequelae, such as microangiopathy, cardiomyopathy and impaired endothelial function, are to be expected also in COVID-19 patients. (Vittori et al, 2020)

Hyperinflammation and immunosuppression are prominently featured in COVID-19, causing a cytokine storm leading to development of micro-thrombosisand disseminated intravascular coagulation (DIC). (Jose et al, 2020)

This cytokine storm is strongly associated with the development of interstitial pneumonia (IP), however, although lungs are the primarily targeted organs, the cardiovascular system is globally affected.(Sun X et al, 2020)

Evidence in this regard supports the notion that the exaggerated production of early response proinflammatory cytokines, increases the risk of vascular hyperpermeability,possibly progressing to multiple organ failure and,ultimately, death.(Sansone et al, 2020)

Additionally, both venous and arterial thromboembolic complications as deep venous thrombosis (DVT) and stroke, including endothelial inflammation, have been reported. (Lodigiani et al, 2020)

Indeed, a growing body of evidence seems to support the theory that the endothelium is targeted by the SARS-CoV-2; (Sardu et al, 2020) most importantly, the endothelium expresses the protein angiotensin-converting enzyme 2 (ACE2),through which the virus can access host cells. (Zhang et al, 2020)

Endothelial dysfunctions, therefore, a pivotal determinant of COVID-19symptoms. (Jung et al, 2020)

These findings can be extremely relevant for male and female sexual health: indeed, based on these premises, there is quite enough evidence to hypothesize that consequences of COVID-19 can extend to sexual and reproductive health. (Sansone et al, 2020)

There is very limited literature on the incidence of sexual dysfunctions, particularly in women.(McCabe et al, 2016)

Studies on the incidence of sexual dysfunction in women are scarce and there is a deficiency of data available on this topic. In a recent study from the United Kingdom, Burri and Spector found that 5.8% of women reported symptoms that constituted a diagnosis of Female Sexual Dysfunction(FSD) and15.5% reported lifelong FSD.

There are few epidemiologic surveys addressing the incidence,as opposed to prevalence, of sexual disorders in men and there are large differences among existing studies. These differences can be explained by variations in study design, populations studied, and definitions of sexual dysfunctions. Because of these variations, itis impossible to specify the incidence of sexual dysfunctions inmen. Most research has been conducted on Erectile Dysfunction(ED). The most important common theme of the studies is that the incidence of sexual dysfunctions increases with age. (McCabe et al, 2016)

A self-administered questionnaire will be disseminated using online electronic social network (Facebook, What's App) including:

  1. Sociodemographic age& gender.
  2. Sexual dysfunction will be assessed using International Index of Erectile Function-5 (IIEF-5) for males, and Arabic Female Sexual Function Index (ArFSFI) for females will be applied.

  3. Covid-19 related factors:

    1. Duration of infection
    2. Fever
    3. Duration since recovery (in months)
    4. Diagnosis done by (PCR, rapid test, other)
    5. Complications (respiratory, vascular, cardiac, other)
    6. Quarantine (ICU, hospital, home, other)
    7. Positive family of positive COVID-19
    8. Spouse's sexual function
    9. Anticoagulants and antiplatelets

Study Type

Observational

Enrollment (Anticipated)

384

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Was calculated using epi info statistical package version 7. Based on the following parameters for cross sectional study; assumed sexual dysfunction proportion 0.50, acceptable margin of error 0.05, design effect 1, 95% confidence level. The required sample size will be 384 subjects.

Description

Inclusion Criteria:

  • 1. Age:

    1. Men: 18-60 years

    2. Women: 18- 50 years

      2. Marital Status: Married

      Exclusion Criteria:

      Chronic Diseases:

      Patients with known history of any chronic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identification of the prevalence of sexual dysfunction among covid-19 survivors.
Time Frame: December 2022
December 2022

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate and compare the duration since recovery and sexual dysfunction. 3- To evaluate and compare the duration since recovery and sexual dysfunction. 3- To evaluate and compare the duration since recovery and sexual d
Time Frame: December 2022
December 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Sahar Ismaiel, Professor, Professor of Dermatology, Venereology and Andrology, Faculty of Medicine, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2022

Primary Completion (ANTICIPATED)

January 30, 2023

Study Completion (ANTICIPATED)

April 1, 2023

Study Registration Dates

First Submitted

December 6, 2021

First Submitted That Met QC Criteria

December 6, 2021

First Posted (ACTUAL)

December 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 8, 2021

Last Update Submitted That Met QC Criteria

December 6, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCSD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

anonymous questionnaire to evaluate the effect of COVID-19 recovered patients on their sexual function.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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