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

NCT04157283 | Unknown

• 1 other identifier: Mansoura University Hospital 3
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This work aims to:

1. 1.Investigate and correlate Sexual Dysfunction in relapsing-remitting Multiple Sclerosis patients with specific focus on
2. 2.Specific neurologic deficit.
3. 3.Depressive symptoms.
4. 4.Comorbid factors.
5. 5.Fatigue symptoms.
6. 6.To investigate the impact of Sexual dysfunction on Sexual Quality of Life (SQoL).
7. 7.To search for possible gender difference.

Conditions

Multiple Sclerosis; Sexual Dysfunction

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Beck's Depression Inventory

  24-48 hours

• Fatigue symptoms

  24-48 hours

Study Arms (2)

Group 1

60 male patients

Diagnostic Test: MRI brain, visual evoked potential, Cerebrospinal Fluid, Sexual dysfunction measure, Depressive symptoms assessment and Multiple Sclerosis Quality of Life-54(MSQOL-54)

Group 2

60 female patients

Diagnostic Test: MRI brain, visual evoked potential, Cerebrospinal Fluid, Sexual dysfunction measure, Depressive symptoms assessment and Multiple Sclerosis Quality of Life-54(MSQOL-54)

Interventions

MRI brain, visual evoked potential, Cerebrospinal Fluid, Sexual dysfunction measure, Depressive symptoms assessment and Multiple Sclerosis Quality of Life-54(MSQOL-54) DIAGNOSTIC_TEST

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 1; Group 2

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

120 MS adolescent patients meeting the McDonald's criteria; 60 male cases and 60 female cases

You may qualify if:

• MS adolescent patients meeting the McDonald's criteria; 60 male cases and 60 female cases recruited from Mansoura University Hospitals

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University Hospital: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

Related Publications (10)

• Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.

  PMID: 18970977 RESULT

• 2) Chan,K.,& Tsang, L. (2011). Promote healthy eating among adolescents:A Hong Kong study . Journal of Consumer Marketing, 28(5), 354-362.

  RESULT

• 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.

  PMID: 15147460 RESULT

• 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.

  PMID: 18856253 RESULT

• 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.

  PMID: 15956157 RESULT

• 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.

  PMID: 16168933 RESULT

• 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.

  PMID: 26003254 RESULT

• 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.

  PMID: 15556803 RESULT

• 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.

  PMID: 21387374 RESULT

• 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.

  PMID: 10618700 RESULT

MeSH Terms

Conditions

Multiple Sclerosis; Sexual Dysfunction, Physiological

Interventions

Evoked Potentials, Visual

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ocular Physiological Phenomena

Study Officials

• Esmael M Ahmed, MD

  Assistant Prof of Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esmael M Ahmed, MD

CONTACT

00201000372787; deltaneuro@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof of Neurology

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 8, 2019
• Study Start: November 5, 2019
• Primary Completion: May 5, 2020
• Study Completion: June 1, 2020
• Last Updated: November 8, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)