Assessment of the Effectiveness of Guided by a Physiotherapist Versus Non-guided Pelvic Floor Exercises for Urinary Incontinence (UI) in Patients With Relapsing-Remitting (RR) Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Decrease in the number of urinary leakages from baseline
研究概览
简要总结
The aim of the study is to evaluate the effectiveness of guided versus non guided pelvic floor exercises for urinary incontinence in patients with Relapsing-Remitting Multiple Sclerosis
详细描述
Subjects of the study should conduct a specific training in pelvic floor exercises. They were randomly assigned into 2 groups: Group A only received written instructions for exercises to be performed at home; Group B received written instructions and, in addition, exercises were performed in a 30 minutes weekly session with a physiotherapist guiding them
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Relapsing-Remitting Multiple Sclerosis
- •Diagnosed with Urinary Incontinence
- •Minimental Sate Examination (MMSE) scale: More than 24
- •Expanded Disability Status Scale (EDSS) scale: Bladder function 0-4; EDSS 0-6,5
- •Willing to participate in the study
- •Having Signed an informed consent
排除标准
- •Diagnosed with another neurological disease
- •Diagnosed with kidney diseases
- •Having a Relapse of the disease in the last 6 months
- •In Women: Pregnancy os postpartum < 6 months
- •Having gone through surgery for urinary incontinence or prolapses or prostate diseases
- •Having gone through other treatment for pelvic floor
- •MMSE scale: Under 24
- •EDSS scale: Bladder function 5-6 or not knowing; EDSS 7-10
- •ICIQ-SF scale: Severity 19-21
- •Not willing to participate or sign the informed consent form or not able to understand the study
研究组 & 干预措施
Guided Pelvic floor exercises
Pelvic floor exercises guided by a physiotherapist
干预措施: Pelvic floor exercises guided by a physiotherapist (Procedure)
Non-guided pelvic floor exercises
Pelvic floor exercises not guided
干预措施: Non guided pelvic floor exercises (Procedure)
结局指标
主要结局
Decrease in the number of urinary leakages from baseline
时间窗: 12 weeks
Difference in the mean number of leakages (Registered for 3 days with a bladder diary)
次要结局
- Decrease in the number of urinary leakages from baseline(4 and 8 weeks)
- Change in quality of life from baseline(4,8 and 12 weeks)
- Adherence(12 weeks)
- Lower urinary tract symptoms from baseline(4,8 and 12 weeks)
- Decrease of urinary incontinence severity from baseline(4,8 and 12 weeks)