Prof. Dr. Cemil Taşçıoğlu City Hospital
Istanbul, Turkey (Türkiye)
Location status: Recruiting
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Zeynep Yıldız Kızkın
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NCT Number: NCT07236684
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.
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Request Info30 year–50 year
Female
Observational
Istanbul, Turkey (Türkiye)
Location status: Recruiting
Zeynep Yıldız Kızkın
CONTACT
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Artvin Coruh University
Other
Identification of Factors Related to Urinary Incontinence in Patients With Multiple Sclerosis and Electromyographic Assessment of Pelvic Floor Muscle Activity: A Cross-Sectional Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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