Sexual Dysfunction in Patients With Relapsing Remitting Multiple Sclerosis and Associated Comorbidities
NCT ID: NCT04157283
Last Updated: 2019-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2019-11-05
2020-06-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Group 1
60 male patients
MRI 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).
Group 2
60 female patients
MRI 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).
Interventions
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MRI 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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
20 Years
45 Years
ALL
No
Sponsors
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Mansoura University Hospital
OTHER
Responsible Party
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Ahmed Esmael
Assistant Prof of Neurology
Principal Investigators
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Esmael M Ahmed, MD
Role: PRINCIPAL_INVESTIGATOR
Assistant Prof of Neurology
Locations
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Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.
2) Chan,K.,& Tsang, L. (2011). Promote healthy eating among adolescents:A Hong Kong study . Journal of Consumer Marketing, 28(5), 354-362.
Fangerau T, Schimrigk S, Haupts M, Kaeder M, Ahle G, Brune N, Klinkenberg K, Kotterba S, Mohring M, Sindern E; Multiple Sclerosis Study Group. Diagnosis of multiple sclerosis: comparison of the Poser criteria and the new McDonald criteria. Acta Neurol Scand. 2004 Jun;109(6):385-9. doi: 10.1111/j.1600-0404.2004.00246.x.
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. doi: 10.1097/01376517-200810000-00010.
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 statement. Arch Neurol. 2005 Jun;62(6):865-70. doi: 10.1001/archneur.62.6.865.
Kesselring J, Beer S. Symptomatic therapy and neurorehabilitation in multiple sclerosis. Lancet Neurol. 2005 Oct;4(10):643-52. doi: 10.1016/S1474-4422(05)70193-9.
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.
Marrie RA. Environmental risk factors in multiple sclerosis aetiology. Lancet Neurol. 2004 Dec;3(12):709-18. doi: 10.1016/S1474-4422(04)00933-0.
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 sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366.
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. doi: 10.1177/135245859900500i610.
Other Identifiers
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Mansoura University Hospital 3
Identifier Type: -
Identifier Source: org_study_id
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