Sexual Dysfunction in Patients With Relapsing Remitting Multiple Sclerosis and Associated Comorbidities
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The Sexual Quality of Life-Female (SQOL-F)
研究概览
简要总结
This work aims to:
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Investigate and correlate Sexual Dysfunction in relapsing-remitting Multiple Sclerosis patients with specific focus on
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Specific neurologic deficit.
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Depressive symptoms.
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Comorbid factors.
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Fatigue symptoms.
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To investigate the impact of Sexual dysfunction on Sexual Quality of Life (SQoL).
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To search for possible gender difference.
详细描述
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:
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Clinical Evaluation:
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Thorough neurological examination.
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Cognitive functions by Minimental State Examination (MMSE).
e. Expanded Disability Severity Scale (EDSS). 2. Neurophysiological Evaluation:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •120 MS adolescent patients meeting the McDonald's criteria; 60 male cases and 60 female cases recruited from Mansoura University Hospitals
排除标准
- •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.
- •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.
结局指标
主要结局
The Sexual Quality of Life-Female (SQOL-F)
时间窗: 24-48 hours
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.
The Sexual Quality of Life-Male (SQOL-M)
时间窗: 24-48 hours
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.
The international index of erectile function (IIEF)
时间窗: 24-48 hours
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.
次要结局
- Beck's Depression Inventory(24-48 hours)
- Fatigue symptoms(24-48 hours)
研究者
Ahmed Esmael
Assistant Prof of Neurology
Mansoura University Hospital