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

• Conditions: Multiple Sclerosis; Sexual Dysfunction
• Interventions: Diagnostic Test: MRI brain, visual evoked potential, Cerebrospinal Fluid, Sexual dysfunction measure, Depressive symptoms assessment and Multiple Sclerosis Quality of Life-54(MSQOL-54)

• Registration Number: NCT04157283
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2019-11
• Study Start: 2019-11-05
• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2019-11-06
• Last Update Submitted: 2019-11-06
• Study First Posted: 2019-11-08
• Last Update Posted: 2019-11-08
• Primary Completion: 2020-05-05
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	MRI brain, visual evoked potential, Cerebrospinal Fluid, Sexual dysfunction measure, Depressive symptoms assessment and Multiple Sclerosis Quality of Life-54(MSQOL-54)	60 male patients
Group 2	MRI brain, visual evoked potential, Cerebrospinal Fluid, Sexual dysfunction measure, Depressive symptoms assessment and Multiple Sclerosis Quality of Life-54(MSQOL-54)	60 female patients

Primary Outcome Measures

Name	Time	Method
The Sexual Quality of Life-Female (SQOL-F)	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.
The Sexual Quality of Life-Male (SQOL-M)	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.
The international index of erectile function (IIEF)	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

Name	Time	Method
Beck's Depression Inventory	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
Fatigue symptoms	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.

Trial Locations

Locations (1)

Mansoura University Hospital; 🇪🇬 Mansoura, Dakahlia, Egypt