Effectiveness and Safety of Acupuncture for Overactive Bladder in Adults: A Random Control Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in number of micturition episodes per 24 hours
研究概览
简要总结
The purpose of this study is to assess the effectiveness and safety of acupuncture for treating overactive bladder in adults.
详细描述
This randomized, controlled trial is aimed to assess the effectiveness and safety of acupuncture in the treatment of overactive bladder (OAB) in adults. Eligible participants will be randomly allocated to acupuncture or 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
- Parallel
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Present symptoms of urinary frequency and urgency for more than 3 months.
- •With a total score of more than 3 points on the overactive Bladder Symptom Score (OABSS) and a score of more than 2 points on question 3 of OABSS.
排除标准
- •With other lower urinary tract disorders (e.g. urinary tract infection, bladder outlet obstruction, neurogenic bladder, interstitial cystitis, etc.)
- •With previous pelvic floor surgery or a post-void residual urine volume more than 100 mL.
- •With neurological disease or psychiatric illness.
- •Taking medications affecting lower urinary tract function.
- •With contraindications to acupuncture.
- •Pregnant women.
研究组 & 干预措施
Acupuncture
Participants will receive acupuncture.
干预措施: Acupuncture (Other)
Sham acupuncture
Participants will receive sham acupuncture.
干预措施: Sham acupuncture (Other)
结局指标
主要结局
Change in number of micturition episodes per 24 hours
时间窗: Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)
Assessed by 72 h bladder diary
次要结局
- Change in mean volume voided per micturition(Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up))
- Number of daytime micturition episodes per 24 hours(Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up))
- Urinary MCP-1/Cr level(Before treatment (baseline), 8 week (post-treatment))
- Change in OAB-q SF questionnaire(Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up))
- Urinary NGF/Cr level(Before treatment (baseline), 8 week (post-treatment))
- Number of nocturia episodes per 24 hours(Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up))
- Urinary BDNF/Cr level(Before treatment (baseline), 8 week (post-treatment))
- Number of urinary urgency episodes per 24 hours(Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up))
- Change in OABSS questionnaire(Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up))
研究者
Ran Pang
Professor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences