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

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ClinicalTrials.gov Identifier: NCT04157283
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Esmael, Mansoura University Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment
Multiple Sclerosis Sexual Dysfunction Diagnostic Test: MRI brain, visual evoked potential, Cerebrospinal Fluid, Sexual dysfunction measure, Depressive symptoms assessment and Multiple Sclerosis Quality of Life-54(MSQOL-54)

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).

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Sexual Dysfunction in Patients With Relapsing Remitting Multiple Sclerosis and Associated Comorbidities
Actual Study Start Date : November 5, 2019
Estimated Primary Completion Date : May 5, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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


  2. 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.




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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
120 MS adolescent patients meeting the McDonald's criteria; 60 male cases and 60 female cases
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04157283


Contacts
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Contact: Esmael M Ahmed, MD 00201000372787 deltaneuro@yahoo.com

Locations
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Egypt
Mansoura University Hospital Recruiting
Mansoura, Dakahlia, Egypt, 35516
Contact: Esmael M Ahmed, MD    00201000382898    deltaneuro@yahoo.com   
Principal Investigator: Esmael M Ahmed, MD         
Sponsors and Collaborators
Mansoura University Hospital
Investigators
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Principal Investigator: Esmael M Ahmed, MD Assistant Prof of Neurology

Publications of Results:
2) Chan,K.,& Tsang, L. (2011). Promote healthy eating among adolescents:A Hong Kong study . Journal of Consumer Marketing, 28(5), 354-362.

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Responsible Party: Ahmed Esmael, Assistant Prof of Neurology, Mansoura University Hospital
ClinicalTrials.gov Identifier: NCT04157283    
Other Study ID Numbers: Mansoura University Hospital 3
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases