The Effectiveness of Circular Muscle Exercise (the Paula Method) as Compared to Pelvic Floor Muscle Training (PFMT), for Urinary Stress Incontinence (SUI) in Menopausal Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- change in the quantity of urinary leakage, measured by the one hour pad test
研究概览
简要总结
The Investigators decided to examine whether the Paula method is more effective than Pelvic Floor Muscle Training (PFMT) in terms of urinary leakage amount, as it measured by pad test in menopause women without an hormonal therapy. In addition to the pad test and two urinary incontinence questionnaires, we will use other assessment tools such as; quality of life and sexual function which have been found to correlate significantly with pad test results. These results may indicate that menopausal women with Stress Urinary Incontinence may be more successful controlling incontinence if they will practice the Paula method as compared to PFMT.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women after menopause (12 months with no period)
- •aged 40 or more
- •have a positive pad test leakage of 1-50 grams
- •no systemic or local hormonal therapy
- •literate in Hebrew and/or English
排除标准
- •women suffering from illnesses which limit physical activity (cardiac, respiratory, psychiatric or neurological disorders)
- •pelvic surgery within the last 6 months
- •post hysterectomy or oophorectomy genital prolapse grade 3 or higher
结局指标
主要结局
change in the quantity of urinary leakage, measured by the one hour pad test
时间窗: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention
To examine whether the Paula method intervention is more effective than PFMT in reducing urinary leakage in menopausal women with SUI
次要结局
- improvement of sexual function(1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention)
- change in the urinary leakage questionnaires, measured by ICIQ-UI and QUID(1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention)
- improvement of quality of life(1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention)