Sexual Dysfunction in Patients With Relapsing Remitting Multiple Sclerosis and Associated Comorbidities

November 6, 2019 updated by: Ahmed Esmael, Mansoura University Hospital

This work aims to:

  1. Investigate and correlate Sexual Dysfunction in relapsing-remitting Multiple Sclerosis patients with specific focus on

    1. Specific neurologic deficit.
    2. Depressive symptoms.
    3. Comorbid factors.
    4. Fatigue symptoms.
  2. To investigate the impact of Sexual dysfunction on Sexual Quality of Life (SQoL).
  3. To search for possible gender difference.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The present study is a cross sectional study on 120 MS adolescent patients meeting the McDonald's criteria; 60 male cases and 60 female cases recruited from Mansoura University Hospitals, Egypt.

All patients were subjected to the following:

  1. Clinical Evaluation:

    1. Thorough neurological examination.
    2. Cognitive functions by Minimental State Examination (MMSE).

    e. Expanded Disability Severity Scale (EDSS).

  2. Neurophysiological Evaluation:

    a. Visual Evoked Potential (VEP).

  3. Imaging Evaluation:

    a. Conventional MRI.

  4. Cerebrospinal Fluid (CSF):
  5. Sexual dysfunction measure: through the international index of erectile function (IIEF), female sexual function questionnaire (SFQ) and the sexual Quality of life male and female version (SQoL) (American Psychiatric Association, 1994).
  6. Depressive symptoms assessment through The BDI (The Beck Depression Inventory) which is the most common instrument measuring the severity of depression.
  7. Fatigue symptoms were evaluated through fatigue subscale of Multiple Sclerosis Quality of Life-54(MSQOL-54).

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

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

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35516
        • Recruiting
        • Mansoura University Hospital
        • Principal Investigator:
          • Esmael M Ahmed, MD

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

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

120 MS adolescent patients meeting the McDonald's criteria; 60 male cases and 60 female cases

Description

Inclusion Criteria:

  • 120 MS adolescent patients meeting the McDonald's criteria; 60 male cases and 60 female cases recruited from Mansoura University Hospitals

Exclusion Criteria:

The exclusion criteria:

  • Active relapse or relapse during 30 day prior to survey due to significant changes in all life activities during this period including sexuality.
  • EDSS score equal or higher than 6.5.
  • Current pregnancy in female patients.
  • Form of the disease other than RRMS.
  • Patients with any sort of cognitive impairment preventing them from understanding Questionnaire.
  • Poorly controlled concomitant diseases were excluded.
  • Patients with past history of any sexual problems prior to the first MS attack.
  • UN married Patients.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
60 male patients
Diagnostic test: MRI brain, visual evoked potential, Cerebrospinal Fluid, Sexual dysfunction measure, Depressive symptoms assessment and Multiple Sclerosis Quality of Life-54(MSQOL-54)

  1. Neurophysiological Evaluation:

    Visual Evoked Potential (VEP).

  2. Imaging Evaluation:

    Conventional MRI.

  3. Cerebrospinal Fluid (CSF):
  4. Sexual dysfunction measure: through the international index of erectile function (IIEF), female sexual function questionnaire (SFQ) and the sexual Quality of life male and female version (SQoL) (American Psychiatric Association, 1994).
  5. Depressive symptoms assessment through The BDI (The Beck Depression Inventory) which is the most common instrument measuring the severity of depression.
  6. Fatigue symptoms were evaluated through fatigue subscale of Multiple Sclerosis Quality of Life-54(MSQOL-54).
Group 2
60 female patients
Diagnostic test: MRI brain, visual evoked potential, Cerebrospinal Fluid, Sexual dysfunction measure, Depressive symptoms assessment and Multiple Sclerosis Quality of Life-54(MSQOL-54)

  1. Neurophysiological Evaluation:

    Visual Evoked Potential (VEP).

  2. Imaging Evaluation:

    Conventional MRI.

  3. Cerebrospinal Fluid (CSF):
  4. Sexual dysfunction measure: through the international index of erectile function (IIEF), female sexual function questionnaire (SFQ) and the sexual Quality of life male and female version (SQoL) (American Psychiatric Association, 1994).
  5. Depressive symptoms assessment through The BDI (The Beck Depression Inventory) which is the most common instrument measuring the severity of depression.
  6. Fatigue symptoms were evaluated through fatigue subscale of Multiple Sclerosis Quality of Life-54(MSQOL-54).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Sexual Quality of Life-Male (SQOL-M)
Time Frame: 24-48 hours
Assesses the relationship between male sexual dysfunction and quality of life. It contains 11 items, each items are scored from 1 to 6 points (worst to best)-completely Agree = 1 to Completely Disagree = 6. The total score can range from 11 to 66 points.
24-48 hours
The Sexual Quality of Life-Female (SQOL-F)
Time Frame: 24-48 hours
Assesses the relationship between female sexual dysfunction and quality of life. It consists of 18 items, rated using a six-point scale (completely agree to completely disagree). The total score can range from 18 to 108 points. Higher scores indicate better female sexual quality of life.
24-48 hours
The international index of erectile function (IIEF)
Time Frame: 24-48 hours
It's formed of 15 questions about main domains of male sexual function and each one had a score of 0-5 but used in Arabic translation.
24-48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck's Depression Inventory
Time Frame: 24-48 hours

The highest possible total for the whole test would be sixty-three. The lowest possible score for each question is zero, the lowest possible score for the test would be zero. This would mean you circles zero on each question. You can evaluate your depression according to the score below:

1-10 score considered normal. 11-16 score considered Mild depression. 17-20 score considered borderline clinical depression. 21-30 score considered moderate depression. 31-40score considered severe depression. Over 40 score considered extreme depression
24-48 hours
Fatigue symptoms
Time Frame: 24-48 hours

Modified Fatigue Impact Scale (MFIS):

Items on the MFIS can be aggregated into three subscales (physical, cognitive, and psychosocial), as well as into a total MFIS score. All items are scaled so that higher scores indicate a greater impact of fatigue on a person's activities. The total MFIS score can range from 0 to 84. It is computed by adding scores on the physical, cognitive, and psychosocial subscales but used in Arabic translation.
24-48 hours

Collaborators and Investigators

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

Sponsor

Mansoura University Hospital

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 (ACTUAL)

November 5, 2019

Primary Completion (ANTICIPATED)

May 5, 2020

Study Completion (ANTICIPATED)

June 1, 2020

Study Registration Dates

First Submitted

November 5, 2019

First Submitted That Met QC Criteria

November 6, 2019

First Posted (ACTUAL)

November 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2019

Last Update Submitted That Met QC Criteria

November 6, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mansoura University Hospital 3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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