ChiCTR-INR-16007766已完成治疗新技术临床试验
針灸用於處理華人婦女小便失禁問題之隨機研究
Department of Obstetrics and Gynaecology1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 1990年1月1日最近更新:
试验速览
- 阶段
- 治疗新技术临床试验
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Subjective outcome of the urinary incontinence at 12 week
研究概览
简要总结
針灸用於處理華人婦女小便失禁問題
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 随机平行对照
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- Female
入选标准
- •All women presented to the Urogynaecology clinic for urinary incontinence; and who are diagnosed kidney asthenia after the assessment by the Traditional Chinese Medicine Practitioner.
排除标准
- •include women in pregnancy or plan to be pregnant within the study period, allergy to metal, uncontrolled diabetes mellitus or uncontrolled hypertension and cardiovascular diseases, history of pelvic floor injury, pelvic radiation or who currently have pelvic organ prolapse that may affect the urinary incontinence symptoms, mental incapacity that would preclude completion of the questionnaire, diagnosis other than kidney asthenia by a registered Traditional Chinese Medicine practitioner and those who refuse to join.
研究组 & 干预措施
Two groups
acupuncture, 30 minutes per visit 6 visits once a week versus pelvic floor exercise (pelvic floor muscle contraction) 10 contractions per set, 10 seconds per contraction, 3 sets per day
结局指标
主要结局
Subjective outcome of the urinary incontinence at 12 week
时间窗: at 12 week
Subjective outcome of the urinary incontinence at 24 week
时间窗: at 24 week
次要结局
- UDI-6 and IIQ-7 scores(at 6, 12, 18, 24, 30, 36, 42 ,48 week)
- VAS score(at 6, 12, 18, 24, 30, 36, 42 ,48 week)
- Mean number of incontinence episodes over 24 hours(at 6, 12, 18, 24, 30, 36, 42 ,48 week)
- Severity of incontinence episodes(at 6, 12, 18, 24, 30, 36, 42 ,48 week)
- Complications of acupuncture(during acupuncture treatment session)
- Compliance of pelvic floor exercise(at 6, 12, 18, 24, 30, 36, 42 ,48 week)
- Need for medical treatment or surgical treatment for urinary incontinence(at 6, 12, 18, 24, 30, 36, 42 ,48 week)
研究者
研究点 (1)
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