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临床试验/ChiCTR-INR-16010048
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

  1. 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;
  2. 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

发起方
Health and Medical Research Fund

研究点 (1)

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