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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Participants will receive acupuncture.
Participants will receive sham acupuncture.
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGFrequency of CRBD
participants will wear an electronic counter to record the number of episodes of Catheter-Related-Bladder Discomfort (CRBD)
Time frame: 24, 48, and 72 hours after surgery
Severity of CRBD
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.
Time frame: 24, 48, and 72 hours after surgery
Incidence of moderate to severe CRBD
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.
Time frame: 24, 48, and 72 hours after surgery
Lower urinary tract symptoms-IPSS
assessed by the International Prostate Symptom Score,(from 0 to 35score), the questionnaire includes 7 questions, the higher scores means worse outcome.
Time frame: Before surgery, 1 week after surgery, and 12 weeks after surgery
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Lower urinary tract symptoms-OABSS
assessed by the Overactive Bladder Symptom Score,(from 0 to 15score), the questionnaire includes 4 questions, the higher scores means worse outcome.
Time frame: Before surgery, 1 week after surgery, and 12 weeks after surgery
Duration of indwelling catheter
by reviewing the clinical chart
Time frame: At the time of catheter removal (assessed up to 7 days)
Length of hospital stay
by reviewing the clinical chart
Time frame: At the time of patient discharge (assessed up to day 14)
Types of additional adjuvant drugs for CRBD
by reviewing the clinical chart
Time frame: From date of randomization until the date of catheter removal , assessed up to 7 days
Doses of additional adjuvant drugs for CRBD
by reviewing the clinical chart
Time frame: From date of randomization until the date of catheter removal , assessed up to 7 days
Postoperative quality of life was evaluated-PPBC
assessed by the Patient Perception of Bladder Condition (from 0 to 6score), the questionnaire includes 1 question, the higher scores means worse outcome.
Time frame: 24, 48, and 72 hours after surgery
Postoperative quality of life was evaluated- VAS
assessed by the visual analogue scale(from 0 to 10score), the questionnaire includes 1 question, the higher scores means worse outcome.
Time frame: 24, 48, and 72 hours after surgery
Postoperative quality of life was evaluated-QoL
assessed by the IPSS-quality of life(from 0 to 6score), the questionnaire includes 1 question, the higher scores means worse outcome.
Time frame: 24, 48, and 72 hours after surgery
uroflowmetry
uroflowmetry test
Time frame: Before surgery, 1 week after surgery, and 12 weeks after surgery