Acupuncture for Catheter-Related-Bladder Discomfort After Transurethral Surgery

Efficacy of Acupuncture on Catheter-Related-Bladder Discomfort After Transurethral Surgery： A Random Control Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Catheter-related-bladder Discomfort
• Intervention / Treatment: Other: Acupuncture; Other: Sham Acupuncture

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ran Pang, MD; Phone Number: +8610-88001040; Email: pangran2002@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
      • Contact: Ran Pang, MD; Phone Number: +8610-88001040; Email: pangran2002@sina.com
      • Principal Investigator: Ran Pang, MD
      • Sub-Investigator: Fenqing Cao, MB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Acupuncture; Participants will receive acupuncture.
Sham Comparator: 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.	Other: Sham Acupuncture; Participants will receive sham acupuncture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	24, 48, and 72 hours after surgery

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 24, 2023
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Urethral Diseases; Urethral Obstruction; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neck Obstruction
• Other Study ID Numbers: 2023-KY-109

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No