Catheter-related-bladder Discomfort
Conditions
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.
Interventions
OTHERAcupuncture
Participants will receive acupuncture.
OTHERSham Acupuncture
Participants will receive sham acupuncture.
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Length of hospital stay | At the time of patient discharge (assessed up to day 14) | by reviewing the clinical chart |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| uroflowmetry | Before surgery, 1 week after surgery, and 12 weeks after surgery | uroflowmetry test |
| 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 |
| 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. |
Countries
China
Contacts
Primary ContactRan Pang, MD
Outcome results
None listed