Combination Therapy With Chinese Herbal Formula, Yiqi Suoquan Granule, and Acupuncture for Female Mixed Urinary Incontinence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Change in incontinence episode per 24 h
研究概览
简要总结
The purpose of this study is to determine whether combination therapy with Chinese herbal formula, Yiqi Suoquan granule, and acupuncture is effective in the treatment of female mixed urinary incontinence.
详细描述
This factorial, randomized, controlled trial is aimed to assess the effectiveness of combination therapy with Chinese herbal formula, Yiqi Suoquan granule, and acupuncture in the treatment of female mixed urinary incontinence (MUI). Eligible participants will be randomly allocated to receiving combination therapy with Yiqi Suoquan granule and acupuncture, Yiqi Suoquan ganule plus sham acupuncture, placebo plus acupuncture, or placebo plus sham acupuncture.
To minimize the evaluation bias, the outcome assessors and statisticians will be masked to treatment allocation besides participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •(1) female, leaking with urgency and with physical activity, coughing or sneezing (MUI) for more than 1 year; (2) recorded more than 1 incontinent episode per 24 hours in their bladder diary
排除标准
- •(1) with acute urinary tract infection; (2) with bladder outlet obstruction, (3) with neurogenic bladder (4) with interstitial cystitis, (5) with pelvic organ prolapse more than stage 2 (6) previous anti-incontinence surgery or a post-void residual urine volume more than 100 mL.
结局指标
主要结局
Change in incontinence episode per 24 h
时间窗: 8 week (post-treatment) and 12 week (follow-up)
assessed by 72 h bladder diary
次要结局
- proportion of participants with more than 50% improvement in incontinence episodes per 24h(8 week (post-treatment))
- Change in I-QOL questionnaire(8 week (post-treatment) and 12 week (follow-up))
- Change in ICIQ-SF questionnaire(8 week (post-treatment) and 12 week (follow-up))
研究者
Ran Pang
Associate Professor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences