The Effect of Pelvic Floor Muscle Training on Lower Urinary Tract Symptoms (LUTS) in Men With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- DAN-PSS-1 questionnaire
研究概览
简要总结
The aim of this study is to evaluate the effect of pelvic floor muscle training (PFMT) on Lower Urinary Tract Symptoms (LUTS) in men after stroke.
120 men with LUTS or increased LUTS after stroke is included and randomized into a treatment group or a control group. The subjects in the treatment group follows a 12 week standard PFMT program, while the control group is not given specific treatment of their LUTS but like the treatment group follows the standard rehabilitation program for stroke patient. Outcome are measured by
- 5 questionnaires
- Voiding diary
- 24-hour pad test
- pelvic floor muscle assessment test
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men, diagnosed with stroke clinical defined according World Health Organisation (WHO 1989) and confirmed by CT and MRI scan
- •Onset of last stroke ≥ 1 month
- •Normal cognitive function (minimal mental examination score > 25 ) (Folstein, Folstein et al. 1976).
- •LUTS according to ICS definition (Abrams, Cardozo et al. 2002), with start or aggravation in close relation to the stroke
- •Independent walking abilities indoor > 100 m with/without aids
- •Independence in toilet visits
- •Age > 18 years
排除标准
- •Prior history of LUTS surgery, pelvic surgery or trauma
- •More than 2 hospital diagnosed stroke
- •Other severe neurological diseases including dementia
- •Severe dysphasia
- •Severe psychiatric disease
- •Prostate cancer
- •Do not speak Danish or English
研究组 & 干预措施
Treatment
Treated with Pelvic Floor Muscle Training in 12 weeks
干预措施: Pelvic Floor Muscle training (Other)
Control
Receives standard rehabilitation after stroke
结局指标
主要结局
DAN-PSS-1 questionnaire
时间窗: 2010-2012
次要结局
- Pelvic Floor Muscle Assessment test(2010-2012)
研究者
Sigrid Tibaek
pt, Dr Med Sci
Glostrup University Hospital, Copenhagen