Clinical Trials Directory

Trials / Unknown

UnknownNCT04157283

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

Status
Unknown
Phase
Study type
Observational
Enrollment
120 (estimated)
Sponsor
Mansoura University Hospital · Academic / Other
Sex
All
Age
20 Years – 45 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTMRI 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).

Timeline

Start date
2019-11-05
Primary completion
2020-05-05
Completion
2020-06-01
First posted
2019-11-08
Last updated
2019-11-08

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04157283. Inclusion in this directory is not an endorsement.