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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04157283
• Other study ID #: Mansoura University Hospital 3
• Status: Recruiting
• Start date: November 5, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: November 2019
• Source: Mansoura University Hospital
• Contact: Esmael M Ahmed, MD
• Phone: 00201000372787
• Email: deltaneuro[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 1, 2020
• Est. primary completion date: May 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis
• Sexual Dysfunction

Intervention

Diagnostic Test:
• MRI brain, visual evoked potential, Cerebrospinal Fluid, Sexual dysfunction measure, Depressive symptoms assessment and Multiple Sclerosis Quality of Life-54(MSQOL-54)
Neurophysiological Evaluation: Visual Evoked Potential (VEP). Imaging Evaluation: Conventional MRI. Cerebrospinal Fluid (CSF): 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). Depressive symptoms assessment through The BDI (The Beck Depression Inventory) which is the most common instrument measuring the severity of depression. Fatigue symptoms were evaluated through fatigue subscale of Multiple Sclerosis Quality of Life-54(MSQOL-54).

Locations

Country	Name	City	State
Egypt	Mansoura University Hospital	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

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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Fangerau T, Schimrigk S, Haupts M, Kaeder M, Ahle G, Brune N, Klinkenberg K, Kotterba S, Möhring M, Sindern E; Multiple Sclerosis Study Group. Diagnosis of multiple sclerosis: comparison of the Poser criteria and the new McDonald criteria. Acta Neurol Sca — View Citation

Fraser C, Mahoney J, McGurl J. Correlates of sexual dysfunction in men and women with multiple sclerosis. J Neurosci Nurs. 2008 Oct;40(5):312-7. — View Citation

Freedman MS, Thompson EJ, Deisenhammer F, Giovannoni G, Grimsley G, Keir G, Ohman S, Racke MK, Sharief M, Sindic CJ, Sellebjerg F, Tourtellotte WW. Recommended standard of cerebrospinal fluid analysis in the diagnosis of multiple sclerosis: a consensus st — View Citation

Kesselring J, Beer S. Symptomatic therapy and neurorehabilitation in multiple sclerosis. Lancet Neurol. 2005 Oct;4(10):643-52. Review. — View Citation

Lew-Starowicz M, Gianotten WL. Sexual dysfunction in patients with multiple sclerosis. Handb Clin Neurol. 2015;130:357-70. doi: 10.1016/B978-0-444-63247-0.00020-1. Review. — View Citation

Marrie RA. Environmental risk factors in multiple sclerosis aetiology. Lancet Neurol. 2004 Dec;3(12):709-18. Review. — View Citation

Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple — View Citation

Zivadinov R, Zorzon M, Bosco A, Bragadin LM, Moretti R, Bonfigli L, Iona LG, Cazzato G. Sexual dysfunction in multiple sclerosis: II. Correlation analysis. Mult Scler. 1999 Dec;5(6):428-31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Sexual Quality of Life-Male (SQOL-M)	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.	24-48 hours
Primary	The Sexual Quality of Life-Female (SQOL-F)	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.	24-48 hours
Primary	The international index of erectile function (IIEF)	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.	24-48 hours
Secondary	Beck's Depression Inventory	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	24-48 hours
Secondary	Fatigue symptoms	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.	24-48 hours