Can Acupoint Low Intensity Shockwave Therapy Improve Bladder Voiding Efficiency: A Pilot Study.
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
- Bladder Voiding Efficiency (BVE)
研究概览
简要总结
With the increasing of the elderly population, patients with urinary dysfunction caused by inefficiency of bladder emptying becomes much often than before. However, the current treatments for this kind of bladder dysfunction are limited and unsatisfactory. Low-intensity extracorporeal shockwave therapy (LiESWT) is a very popular emerging treatment in recent years, and abundant of literatures have confirmed that this treatment is safe and effective in myofascial pain and male erectile dysfunction. Recently, many animal experiments have showed that LiESWT could improve urinary dysfunction caused by bladder dysfunction. Taiwan based studies also reported that LiESWT could improve symptoms of overactive bladder. LiESWT is a non-drug, low-invasive and high-safety treatment, which is very suitable for elderly patients. In this study investigator combine the LiESWT and acupuncture to treat the patients with underactive bladder. Investigator hypothesize that LiESWT could improve bladder voiding efficiency.
详细描述
This is a randomized controlled trial, the inclusion criteria are the patients more than 20 years old and bladder voiding efficiency less than 70%, this trial will enroll 60 male and 40 female , total 100 patients. The male will be randomly assigned into three groups(Group-1, Group-2, Group-3) by ratio 1:1:1, and the female will be randomly assigned into two groups (Group-1, Group-2) by ratio 1:1. Group-1: LiESWT on acupoint CV-4, and bilateral ST-28 once a week for 8 weeks, Group-2: LiESWT on acupoint CV-4 and bilateral acupoint SP-6 once a week for 8 weeks, Group-3: Treatment with oral tamsulosin 0.2mg per-day for 8 weeks. The primary outcome is the improvement of bladder voiding efficiency. The secondary outcomes are global response assessment scale, the improvement of maximum uroflow rate, post-voiding residual urine amount, total score of international prostate symptom score.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Bladder voiding efficiency is less than 70%.
排除标准
- •Patient who has history active pelvic malignancy without treatment.
- •Acute urinary tract infection.
- •Active infective lesion on treatment site.
- •Open wound on treatment site.
研究组 & 干预措施
Group-1
Low intensive shockwave therapy 1000 shocks on each acupoint (CV-4, and bilateral ST-28) once a week for 8 weeks.
干预措施: Low Intensity Shockwave Therapy (LiSWT) (Procedure)
Group-2
Low intensive shockwave therapy 1000 shocks on each acupoint (CV-4, and bilateral SP-6) once a week for 8 weeks.
干预措施: Low Intensity Shockwave Therapy (LiSWT) (Procedure)
Group-3
Oral tamsulosin 0.2mg once daily for 8 weeks.
干预措施: Tamsulosin (Drug)
结局指标
主要结局
Bladder Voiding Efficiency (BVE)
时间窗: Baseline, Week 4, Week 8, Week 12
Bladder Voiding Efficiency (BVE) is the ratio of the voiding volume of urine over total bladder urine volume
次要结局
- Global Response Assessment scale(Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12.)
- Total score of international prostate symptom score(Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12.)
- Maximum uroflow rate(Baseline, Week 4, Week 8, Week 12)
- Post-Voiding Residual urine amount(Baseline, Week 4, Week 8, Week 12)
研究者
Jing-Dung, SHEN
Director of Urology
Taichung Armed Forces General Hospital