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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04157283
Enrollment
120
Registered
2019-11-08
Start date
2019-11-05
Completion date
2020-06-01
Last updated
2019-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Sexual Dysfunction

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).

Interventions

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).

Sponsors

Mansoura University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Sexual Quality of Life-Male (SQOL-M)24-48 hoursAssesses 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 Sexual Quality of Life-Female (SQOL-F)24-48 hoursAssesses 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 international index of erectile function (IIEF)24-48 hoursIt'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

MeasureTime frameDescription
Beck's Depression Inventory24-48 hoursThe 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 symptoms24-48 hoursModified 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.

Countries

Egypt

Contacts

Primary ContactEsmael M Ahmed, MD
deltaneuro@yahoo.com00201000372787

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026