Efficacy of Acupuncture on Catheter-Related-Bladder Discomfort After Transurethral Surgery： A Random Control Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Severity of CRBD
研究概览
简要总结
The purpose of this study is to assess the effectiveness of acupuncture for treating catheter-related-bladder discomfort in adults after bladder outlet obstruction surgery.
详细描述
This randomized, controlled trial is aimed to assess the effectiveness of acupuncture in the treatment of catheter-related-bladder discomfort (CRBD) in adults after bladder outlet obstruction surgery. 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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years old, signed informed consent
- •Clinical diagnosis of bladder neck obstruction or benign prostatic obstruction
- •Transurethral holmium laser resection of the prostate/transurethral cystoscopy posterior urethral decompression of the bladder neck was planned
排除标准
- •Patients undergoing lower urinary tract surgery due to other diseases
- •Complicated with urinary tract infection, urinary calculi, urethral stricture, neurogenic bladder, chronic interstitial cystitis
- •Receiving treatment for other medical conditions that may affect bladder function
- •Patients with severe heart, lung, cerebrovascular, liver, kidney, hematopoietic system and mental diseases
- •Patients with contraindications to acupuncture treatment or fear acupuncture treatment
研究组 & 干预措施
Acupuncture
Participants will receive acupuncture, five times per day form pre-operation to 3 days after operation. The selected acupoints include RN3,RN4, bilateral ST36,SP6,SP9 and LR3. All acupoints areas have been sterilized before acupuncture. needles (Ф0.30×50mm) will be directly inserted at a depth of 25-30 mm deep. Arrival of Qi by acupuncture and needle retaining for 20 minutes.
干预措施: Acupuncture (Other)
Sham acupuncture
Participants will receive shame acupuncture, five times per day form pre-operation to 3 days after operation. The selected non-acupoints nearby RN3,RN4, bilateral ST36, SP6,SP9 and LR3, All acupoints areas have been sterilized before acupuncture. needles (Ф0.30×50mm) will be directly inserted at a depth of 5 mm deep. Needle retaining for 20 minutes and without needle manipulation.
干预措施: Sham Acupuncture (Other)
结局指标
主要结局
Severity of CRBD
时间窗: 24, 48, and 72 hours after surgery
participants will be requested to describe the situations of CRBD, the severity will be evaluated by the principal investigator. the scoring system for catheter- related bladder discomfort measurement as 4 levels: 0 score, no discomfort; 1 score, mild discomfort only reported upon questioning; 2 score, moderate discomfort, urge to pass urine reported by the patient without questioning; 3 score, severe discomfort, ruge to pass uine accompanied by behavioral responses, such as flailing limbs, storng verbal responses, or attempt to pull out the catheter. The higher scores means worse outcome.
Frequency of CRBD
时间窗: 24, 48, and 72 hours after surgery
participants will wear an electronic counter to record the number of episodes of Catheter-Related-Bladder Discomfort (CRBD)
次要结局
- Types of additional adjuvant drugs for CRBD(From date of randomization until the date of catheter removal , assessed up to 7 days)
- Postoperative quality of life was evaluated-PPBC(24, 48, and 72 hours after surgery)
- Length of hospital stay(At the time of patient discharge (assessed up to day 14))
- Doses of additional adjuvant drugs for CRBD(From date of randomization until the date of catheter removal , assessed up to 7 days)
- Postoperative quality of life was evaluated-QoL(24, 48, and 72 hours after surgery)
- Incidence of moderate to severe CRBD(24, 48, and 72 hours after surgery)
- Lower urinary tract symptoms-IPSS(Before surgery, 1 week after surgery, and 12 weeks after surgery)
- Lower urinary tract symptoms-OABSS(Before surgery, 1 week after surgery, and 12 weeks after surgery)
- Duration of indwelling catheter(At the time of catheter removal (assessed up to 7 days))
- Postoperative quality of life was evaluated- VAS(24, 48, and 72 hours after surgery)
- uroflowmetry(Before surgery, 1 week after surgery, and 12 weeks after surgery)
研究者
Ran Pang
Professor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences