Identification of Factors Related to Urinary Incontinence in Patients With Multiple Sclerosis and Electromyographic Assessment of Pelvic Floor Muscle Activity: A Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Expanded disability status scale (EDSS)
研究概览
简要总结
The study aimed to explore the link between urinary incontinence (UI) severity in patients with multiple sclerosis (PwMS), electromyography (EMG) findings, and other relevant factors.
详细描述
The study will consist of a cross-sectional observational analysis involving a cohort of 47 PwMS. The assessment will be employed various instruments, including the Expanded Disability Status Scale (EDSS), Neurogenic Bladder Symptom Score (NBSS), International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), Incontinence Impact Questionnaire (IIQ-7), International Physical Activity Questionnaire (IPAQ), Fatigue Severity Scale (FSS), EMG.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 30 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •having an MS diagnosis according to the 2017 revised McDonald criteria,
- •experiencing symptoms of UI as defined by the International Continence Society (ICS),
- •having an EDSS score below 6.5,
- •PwMS with no communication issues.
排除标准
- •PwMS who did not give consent to participate,
- •those with medication changes in the past 6 months,
- •pregnant PwMS,
- •recent vaginal or caesarean deliveries within 6 months,
- •pelvic organ prolapse,
- •urinary tract infection,
- •recent attack history in the past month.
结局指标
主要结局
Expanded disability status scale (EDSS)
时间窗: Single assessment at enrollment
The Expanded disability status scale (EDSS) will be assessed disability and progression in PwMS, with scores from 0 (normal neurological exam) to 10 (death from MS). Higher scores indicate greater disability.
Neurogenic Bladder Symptom Score (NBSS)
时间窗: Single assessment at enrollment
Storage, voiding, and complication symptoms of neurogenic bladder will be assessed with the Neurogenic Bladder Symptom Score (NBSS), a 24-item questionnaire covering incontinence, storage and voiding, and outcomes.
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
时间窗: Single assessment at enrollment
The frequency and amount of leakage will be assessed using a six-item scale, and urinary incontinence will be categorised into four groups: mild (1-5), moderate (6-12), severe (13-18) and very severe.
Incontinence Impact Questionnaire (IIQ-7)
时间窗: Single assessment at enrollment
Urinary symptoms' impact on daily activities was assessed with the Incontinence Impact Questionnaire (IIQ-7). The 7-item Likert scale has a score range of 0-21, with higher scores reflecting an increased negative impact of incontinence on social functioning, quality of life, and physical activity.
Pelvic Floor Muscle Activity
时间窗: Single assessment at enrollment
An electromyography (EMG) device with surface electrodes will be used to assess pelvic floor muscle (PFM) activity. Patients received training beforehand, and measurements were taken noninvasively with two electrodes around the perineum and vagina and one on the inner thigh in women.
International Physical Activity Questionnaire (IPAQ)
时间窗: Single assessment at enrollment
The International Physical Activity Questionnaire (IPAQ) assesses the frequency and duration of vigorous, moderate, and walking-like activities over a week. The values are multiplied by factors of 8, 4, and 3.3 Metabolic Equivalent of Tasks, respectively, to help measure overall physical activity. The minimum score for the IPAQ is 0, while there is no theoretically determined maximum score. Higher scores are associated with the individual engaging in a higher level of physical activity.
Fatigue severity scale (FSS)
时间窗: Single assessment at enrollment
Fatigue severity scale (FSS) assesses fatigue severity in MS with nine items rated on a 7-point Likert scale. The mean score, adapted to Turkish society, indicates pathological fatigue if it is 4 or higher.
次要结局
未报告次要终点
研究者
Zeynep Yıldız Kızkın
Lecturer
Artvin Coruh University
