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临床试验/NCT07489794
NCT07489794招募中不适用

FACTORS ASSOCIATED WITH URINARY INCONTINENCE AND EVALUATION OF PELVIC FLOOR MUSCLE ACTIVITY IN PATIENTS WITH MULTIPLE SCLEROSIS: CROSS-SECTIONAL STUDY

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2026年3月9日最近更新:
适应症

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
Pelvic floor muscle activity with surface EMG

研究概览

简要总结

This study aims to investigate the relationship between urinary incontinence severity and surface electromyography (EMG) findings in women with multiple sclerosis. It will also examine the association of urinary incontinence with disability, quality of life, physical activity, and fatigue.

详细描述

This study investigates the relationship between urinary incontinence (UI) severity and pelvic floor muscle activity in women with multiple sclerosis (MS). UI is common in MS and negatively affects quality of life, physical activity, and social participation. The study also explores how UI severity is associated with disability, fatigue, and overall quality of life.

Participants' demographic and clinical information, including age, disease duration, MS type, and disability level (measured by the Expanded Disability Status Scale, EDSS), will be recorded. Standardized questionnaires will assess urinary symptoms, their impact on daily life, physical activity, and fatigue. Pelvic floor muscle activity will be evaluated using surface electromyography (EMG) with biofeedback, conducted by trained physiotherapists.

The study will be conducted at the Pelvic Floor Health Center and is planned as a cross-sectional study. All assessments, including questionnaires and EMG measurements, are expected to take approximately 45 minutes per participant. Findings from this study aim to improve understanding of UI in women with MS and guide future interventions.

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

入选标准

  • Diagnosis of multiple sclerosis (MS) according to the 2017 revised McDonald criteria.
  • Female patients aged 30-50 years (age range with higher prevalence of urinary incontinence in MS).
  • Experiencing urinary incontinence (UI) symptoms according to the International Continence Society (ICS) definition.
  • EDSS (Expanded Disability Status Scale) score below 6.
  • Patients with no communication difficulties. -

排除标准

  • MS patients who do not provide consent to participate in the study.
  • MS patients who have had a medication change within the last 6 months.
  • Pregnant MS patients.
  • History of vaginal or cesarean delivery within the last 6 months.
  • Pelvic organ prolapse.
  • Urinary tract infection

结局指标

主要结局

Pelvic floor muscle activity with surface EMG

时间窗: baseline

Evaluated using biofeedback-assisted surface EMG. Metrics recorded include mean EMG activity during contraction and rest phases, standard deviation of EMG activity, peak and minimum EMG values, contraction onset, and relaxation times

次要结局

  • International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)(baseline)
  • Incontinence Impact Questionnaire (IIQ-7)(baseline)
  • International Physical Activity Questionnaire (IPAQ)(baseline)
  • Fatigue Severity Scale (FSS)(baseline)

研究者

发起方
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
申办方类型
Other
责任方
Principal Investigator
主要研究者

Busra Aydin Erkilic

physiotherapist

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

研究点 (1)

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