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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | 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. |
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| Sham acupuncture | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | Participants will receive acupuncture. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of CRBD | participants will wear an electronic counter to record the number of episodes of Catheter-Related-Bladder Discomfort (CRBD) | 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. | 24, 48, and 72 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ran Pang, MD | Contact | +8610-88001040 | pangran2002@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital, China Academy of Chinese Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100053 | China |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Sham Acupuncture |
| Other |
Participants will receive sham acupuncture. |
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| 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. | Before surgery, 1 week after surgery, and 12 weeks after surgery |
| 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. | Before surgery, 1 week after surgery, and 12 weeks after surgery |
| Duration of indwelling catheter | by reviewing the clinical chart | At the time of catheter removal (assessed up to 7 days) |
| Length of hospital stay | by reviewing the clinical chart | At the time of patient discharge (assessed up to day 14) |
| Types of additional adjuvant drugs for CRBD | by reviewing the clinical chart | 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 | 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. | 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. | 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. | 24, 48, and 72 hours after surgery |
| uroflowmetry | uroflowmetry test | Before surgery, 1 week after surgery, and 12 weeks after surgery |