ChiCTR-INR-16010048进行中(未招募)治疗新技术临床试验
針刺治療膀胱過度活躍症的臨床試驗研究
Health and Medical Research Fund1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年3月1日最近更新:
试验速览
- 阶段
- 治疗新技术临床试验
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 7-day voiding diary
研究概览
简要总结
- to evaluate the effectiveness of acupuncture treatment for patients with OAB on the reduction of the frequency of incontinence episodes as derived from 7-day voiding diary;
- to evaluate whether acupuncture treatment could improve the subjective symptoms in patients with OAB.
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 随机平行对照
- 盲法
- Double
入排标准
- 年龄范围
- 60 至 90(—)
- 性别
- All
入选标准
- •Both male and female elderly at the age between 60 to 90 years old;
- •Diagnosed as OAB wet-type (3 or more episodes of incontinence in the past 4 weeks that are no stress-incontinence) according to the diagnosis criteria of the ICS;Physically and mentally able to complete the 7-day voiding diary, Urinary Distress Inventory (UDI-6) and Incontinence Impact questionnaire (IIQ7)
- •Able to give written inform consent (by patients themselves or by caretaker).
排除标准
- •OAB symptom caused by stroke or spinal injury;
- •Life threatening infection;
- •Unconsciousness or severe cognition deficits;
- •Dementia caused by Alzheimer’s disease or other neurodegenerative diseases;
- •Undergone incontinence surgery previously;
- •On short-term active diuretic treatment or taking diuretic medication;
- •Had previously received acupuncture treatment for any medical conditions;
- •Patients who are on drug treatment for OAB;
- •Patients who diagnosed as stress urinary incontinence;
- •Suffering the following diseases: untreated urinary tract infection, urogenital tumors, prostate tumor, benign prostatic hyperplasia, chronic urinary retention.
研究组 & 干预措施
Two groups
Acupuncture 30-minute for 8 weeks versus Sham acupuncture without penetrating into skin for 8 weeks
结局指标
主要结局
7-day voiding diary
时间窗: baseline, the end of treatment (2 months after inclusion) and at the follow-up period (3 months after treatment completion)
次要结局
- Urine NGF level(baseline, the end of treatment (2 months after inclusion) and at the follow-up period (3 months after treatment completion))
研究者
研究点 (1)
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