Clinical Efficacy Evaluation of Electroacupuncture as Adjuvant Therapy for Female Patients With Overactive Bladder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Urinary tract related questionnair
研究概览
简要总结
Overactive bladder (OAB) is often accompanied by frequent urination and nocturia, and does not necessarily manifest as urge incontinence. Urgency to urinate and frequent urination can lead to psychological burdens, affect interpersonal relationships and reduce women's quality of life.
Treatment of OAB includes lifestyle changes, behavioral therapy, drug therapy, neuromodulation, botulinum toxin therapy, and surgical intervention. At present, anticholinergic drugs are usually the first-line treatment for OAB, but the side effects of dry mouth often lead to poor patient compliance.
Transcutaneous tibial nerve stimulation (PTNS) is a minimally invasive neuromodulation technique. Past studies have confirmed that PTNS has clinical efficacy in treating symptoms related to overactive bladder, while TCM's electroacupuncture is similar to PTNS. The main purpose of this study was to evaluate the specific acupoints in accordance with traditional Chinese medicine theory in women with OAB under conventional Western medicine treatment to evaluate the improvement of women's related urinary tract symptoms, quality of life and autonomic nervous system function.
详细描述
Overactive bladder (OAB) is often accompanied by frequent urination and nocturia, and does not necessarily manifest as urge incontinence. Urgency to urinate and frequent urination can lead to psychological burdens, affect interpersonal relationships and reduce women's quality of life.
Treatment of OAB includes lifestyle changes, behavioral therapy, drug therapy, neuromodulation, botulinum toxin therapy, and surgical intervention. At present, anticholinergic drugs are usually the first-line treatment for OAB, but the side effects of dry mouth often lead to poor patient compliance.
Transcutaneous tibial nerve stimulation (PTNS) is a minimally invasive neuromodulation technique. Past studies have confirmed that PTNS has clinical efficacy in treating symptoms related to overactive bladder, while TCM's electroacupuncture is similar to PTNS. The main purpose of this study was to evaluate the specific acupoints in accordance with traditional Chinese medicine theory in women with OAB under conventional Western medicine treatment to evaluate the improvement of women's related urinary tract symptoms, quality of life and autonomic nervous system function.
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
- Single (Participant)
盲法说明
The research is a single-blind randomized controlled human trial.The participant will divide into control group or experimental group randomly by random number table.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient aged 20-80 with overactive bladder.
排除标准
- •Patient has history of cancer, stroke, or hyperthyroidism..
- •Patient isn't willing to accept acupuncture or moxibustion treatment.
- •Patient who is pregnant or plan to pregnant.
- •Patient with urinary tract infection.
- •Patient who had injection of botulinum toxin (Botox®), PTNS or SMN treatment before.
- •Patient recieved acupuncture treatment before.
研究组 & 干预措施
Electroacupuncture group
The Electroacupuncture group received electroacupuncture at Baihui(GV20), bilateral Sanyinjiao(SP-6) and Fuliu points(KP-7).20 minutes of acupuncture.
Twice a week.
干预措施: electroacupuncture (Device)
Sham acupuncture group
The control group received placebo acupuncture.Except for placebo acupuncture, which won't penetrate the skin, the rest is the same as the Electroacupuncture group.
干预措施: sham acupuncture (Device)
结局指标
主要结局
Urinary tract related questionnair
时间窗: Study spans 8 weeks: initial data collection, biweekly collections, 1-week break after 6 weeks, final collection in week 8. 5 questionnaire rounds in total. Proposed timeline.
Measuring OAB scores to record the differ between two groups and time.Higher scores indicate more severe symptoms of overactive bladder syndrome.
King's Health Quality of Life Questionnaire(KHQ)
时间窗: Study spans 8 weeks: initial data collection, biweekly collections, 1-week break after 6 weeks, final collection in week 8. 5 questionnaire rounds in total. Proposed timeline.
Measuring KHQ scores to record the differ between two groups and time.Higher scores indicate more significant impact of bladder-related issues on quality of life.
Heart rate variability(HRV)
时间窗: Study spans 8 weeks: initial data collection, biweekly collections, 1-week break after 6 weeks, final collection in week 8. 5 questionnaire rounds in total. Proposed timeline.
Measuring HRV to record the differ between two groups and time.Whether the balance of the autonomic nervous system in HRV can also be used to infer the severity of OAB symptoms is also an observation target for the researchers.
次要结局
- Is the dose of the drug reduced?(Every week will record the dose that participants take.A total of 8 weeks.)
- Are the side effects reduced?(Every week will record side effects of taking medicine.A total of 8 weeks.)