Clinical trial NCT04157283: Sexual Dysfunction in Patients With Relapsing Remitting Multiple Sclerosis and Associated Comorbidities
Official title: Sexual Dysfunction in Patients With Relapsing Remitting Multiple Sclerosis and Associated Comorbidities
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Sexual Dysfunction
Lead sponsor: Mansoura University Hospital
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 120 MS adolescent patients meeting the McDonald's criteria; 60 male cases and 60 female cases

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).

Eligibility 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.

Primary outcomes:
measure: The Sexual Quality of Life-Male (SQOL-M)
timeFrame: 24-48 hours
measure: The Sexual Quality of Life-Female (SQOL-F)
timeFrame: 24-48 hours
measure: The international index of erectile function (IIEF)
timeFrame: 24-48 hours
Secondary outcomes:
measure: Beck's Depression Inventory
timeFrame: 24-48 hours
measure: Fatigue symptoms
timeFrame: 24-48 hours
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
state: Dakahlia
Study officials:
affiliation: Assistant Prof of Neurology
name: Esmael M Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
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