Effects of High Intensity Focused Electromagnetic Therapy With Pelvic Floor Muscle Training on Urine Leakage and Quality of Life in Primipara or Multipara Women With Stress Urinary Incontinence: A Pilot for Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1-hour pad test
研究概览
简要总结
This study aimed to evaluate the impact of High-Intensity Focused Electromagnetic Therapy (HIFEM) combined with Pelvic Floor Muscle Training (PFMT) versus PFMT alone on urine leakage and quality of life in primiparous and multiparous women with stress urinary incontinence. Women aged 30 years or older exhibiting symptoms of stress urinary incontinence were randomized into two treatment groups. The experimental group received both HIFEM and PFMT, while the control group received only PFMT. The treatment continued for 6 weeks. Evaluations measured at baseline and post-intervention included the 1-hour Pad Test, the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF), and sonography to assess bladder neck movement.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primipara or Multipara women aged 30 years or older with symptoms of stress urinary incontinence;
排除标准
- •Those who had any contraindication for High-Intensity-Focused-Electromagnetic-Therapy (HIFEM);
- •prior surgery for incontinence;
- •taking drugs for bladder dysfunction or diuretics;
- •hormone therapy;
- •urgent or mixed urinary incontinence;
- •incontinence associated with a neurologic condition;
- •inability to perform voluntary pelvic floor muscle contractions;
- •cognitive impairment or dementia, major neurological disorders (such as stroke, cerebral palsy, multiple sclerosis);
- •inability to carry out the treatment or evaluation;
- •uncontrolled hypertension.
结局指标
主要结局
1-hour pad test
时间窗: Baseline and the end of the 6-week intervention
It measures the total amount of urine leakage by weighing the pad after performing several standardized activities over the course of an hour.
次要结局
- International Consultation on Urinary Incontinence questionnaire (ICIQ-UI-SF)(Baseline and the end of the 6-week intervention)
- Bladder neck movement(Baseline and the end of the 6-week intervention)
研究者
LIU FANG
Principal Investigator
Hong Kong Metropolitan University