Managing Urinary Incontinence in Elderly Village Women in Rural Bangladesh: a Cluster Randomized Trial of a Community Exercise-based Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 579
- 试验地点
- 2
- 主要终点
- Frequency of involuntary leakage of urine
研究概览
简要总结
An intervention consisting of group and home based exercise will be used over 6 months to assess whether this is helpful in managing urinary incontinence in elderly village women in Bangladesh. This intervention, supplemented by education about managing incontinence, will be used in half the villages in the trial. In the other half women will receive only the education component.
详细描述
This is a cluster randomized trial in which all women aged 60-75 years reporting symptoms of urinary incontinence are randomly assigned, by village of residence, to either exercise plus education of to education alone.
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
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 60-75 years reporting incontinence on a screening questionnaire (yes to questions 2,3or 4 on the 6 item Urinary Distress Index)
排除标准
- •They report a uterine prolapse which is (or becomes) known to be of 3rd degree or higher.
- •They are assessed by the village paramedic to be incapable of standing from sitting without help from someone else.
- •They are assessed by the village paramedic to be unable to walk without help at a normal pace for someone of her age.
- •They are assessed by the village paramedic as not having the intellectual capacity to understand questions and follow instructions.
结局指标
主要结局
Frequency of involuntary leakage of urine
时间窗: Baseline and 24 weeks
The frequency of involuntary leakage over 3 days will be measured at each time point
次要结局
- Quality of life as measured by a Bangla version of the Euroqol 5 dimension scale (EQ-5D)(Baseline and 24 weeks)
- Distress caused by urinary symptoms(Baseline and 24 weeks)
- Depression as measured on a Bangla version of the 10 item Center for Epidemiological Studies Depression Scale (CES-D 10)(Baseline, 12 weeks and 24 weeks)
- Frequency of micturition(Baseline and 24 weeks)
- Severity of urinary symptoms(Baseline, 12 weeks and 24 weeks)
研究者
Nicola Cherry
Professor
University of Alberta