Acupuncture for Catheter-Related-Bladder Discomfort After Transurethral Surgery
- Conditions
- Catheter-related-bladder Discomfort
- Interventions
- Other: AcupunctureOther: Sham Acupuncture
- Registration Number
- NCT06196437
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acupuncture 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. Sham acupuncture 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.
- Primary Outcome Measures
Name Time Method Severity of CRBD 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 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)
- Secondary Outcome Measures
Name Time Method Types of additional adjuvant drugs for CRBD From date of randomization until the date of catheter removal , assessed up to 7 days by reviewing the clinical chart
Postoperative quality of life was evaluated-PPBC 24, 48, and 72 hours after surgery assessed by the Patient Perception of Bladder Condition (from 0 to 6score), the questionnaire includes 1 question, the higher scores means worse outcome.
Length of hospital stay At the time of patient discharge (assessed up to day 14) by reviewing the clinical chart
Doses of additional adjuvant drugs for CRBD From date of randomization until the date of catheter removal , assessed up to 7 days by reviewing the clinical chart
Postoperative quality of life was evaluated-QoL 24, 48, and 72 hours after surgery assessed by the IPSS-quality of life(from 0 to 6score), the questionnaire includes 1 question, the higher scores means worse outcome.
Incidence of moderate to severe CRBD 24, 48, and 72 hours after surgery participants will wear an electronic counter to record the number of episodes of CRBD, they 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, 2 to 3 score would be identifited moderate to severe CRBD.
Lower urinary tract symptoms-IPSS Before surgery, 1 week after surgery, and 12 weeks after surgery assessed by the International Prostate Symptom Score,(from 0 to 35score), the questionnaire includes 7 questions, the higher scores means worse outcome.
Lower urinary tract symptoms-OABSS Before surgery, 1 week after surgery, and 12 weeks after surgery assessed by the Overactive Bladder Symptom Score,(from 0 to 15score), the questionnaire includes 4 questions, the higher scores means worse outcome.
Duration of indwelling catheter At the time of catheter removal (assessed up to 7 days) by reviewing the clinical chart
Postoperative quality of life was evaluated- VAS 24, 48, and 72 hours after surgery assessed by the visual analogue scale(from 0 to 10score), the questionnaire includes 1 question, the higher scores means worse outcome.
uroflowmetry Before surgery, 1 week after surgery, and 12 weeks after surgery uroflowmetry test
Trial Locations
- Locations (1)
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
🇨🇳Beijing, Beijing, China