The Effect of Pelvic Floor Muscle Training for the Management of Incontinence in Older Women: a Single Blind Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Quantity of urine lost over a 7-day period measured by self-report.
研究概览
简要总结
To determine the effect of pelvic floor muscle training in women aged 70 years and over, who have proven stress urinary incontinence. The hypotheses to be tested are:
- That pelvic floor muscle training is effective in relief of symptoms of stress urinary incontinence as measured by a greater reduction in the number of episodes of incontinence, quantity of urine lost and improvement of quality of life.
- That women who undertake pelvic floor muscle training will show greater improvement of pelvic floor muscle function than women who have behavioural (bladder) training, as measured by real time transabdominal ultrasound.
详细描述
Urinary incontinence is associated with significant personal stress, shame and social stigma and affects around one-third of women over 60 years of age. It restricts the amount of physical activity and can lead to social isolation and poor health. Pelvic floor muscle re-education by physiotherapists is the most commonly recommended method of conservative management. Although a recent Cochrane review concluded that it was an effective treatment for women with stress and mixed incontinence, there is still no strong evidence for the effectiveness of this intervention in elderly women. It has also been suggested that bladder training alone is equally effective in patients with stress urinary incontinence, urge and mixed incontinence. This is contrary to current clinical experience. It is therefore important to distinguish the relative effectiveness of these interventions used in isolation in order to ensure that urinary incontinence is managed in the most effective and efficient way.
Comparisons: pelvic floor muscle training group and bladder training.
Assessments will be conducted at baseline, 1 month, 3 months and 5 months during the intervention period. Both groups will then continue with their home program for a further 7 months until their final assessment (Assessment 5).
Outcome measures will include: volume of urine lost during a stress test, completion of accident diaries, Degree of 'bother', quality of life using the Kings Health Questionnaire, and assessment of pelvic floor function using real time transabdominal diagnostic ultrasound.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Community-dwelling women aged over 65 years
- •urodynamically proven stress incontinence
- •Medically stable
排除标准
- •Already receiving physiotherapy intervention
- •Neurogenic incontinence
- •Cannot comply with training program
结局指标
主要结局
Quantity of urine lost over a 7-day period measured by self-report.
时间窗: 1, 3, 5 (end of intervention) and 12 months
Self report of urine leakage
Urine lost on stress test measured by pad weigh test.
时间窗: 1, 3, 5 (end of intervention) and 12 months
Pad weight following stress test
次要结局
- King's Health Questionnaire.(1, 3, 5 (end of intervention) and 12 months)
- Degree of bother(1, 3, 5 (end of intervention) and 12 months)
- Severity of stress incontinence(1, 3, 5 (end of intervention) and 12 months)
- Displacement of pelvic floor during muscle contraction(1, 3, 5 (end of intervention) and 12 months)
研究者
Mary Galea
Professor
University of Melbourne