Clinical trial NCT06196437: Acupuncture for Catheter-Related-Bladder Discomfort After Transurethral Surgery
Official title: Efficacy of Acupuncture on Catheter-Related-Bladder Discomfort After Transurethral Surgery： A Random Control Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Catheter-related-bladder Discomfort
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of CRBD
timeFrame: 24, 48, and 72 hours after surgery
measure: Severity of CRBD
timeFrame: 24, 48, and 72 hours after surgery
Secondary outcomes:
measure: Incidence of moderate to severe CRBD
timeFrame: 24, 48, and 72 hours after surgery
measure: Lower urinary tract symptoms-IPSS
timeFrame: Before surgery, 1 week after surgery, and 12 weeks after surgery
measure: Lower urinary tract symptoms-OABSS
timeFrame: Before surgery, 1 week after surgery, and 12 weeks after surgery
measure: Duration of indwelling catheter
timeFrame: At the time of catheter removal (assessed up to 7 days)
measure: Length of hospital stay
timeFrame: At the time of patient discharge (assessed up to day 14)
measure: Types of additional adjuvant drugs for CRBD
timeFrame: From date of randomization until the date of catheter removal , assessed up to 7 days
measure: Doses of additional adjuvant drugs for CRBD
timeFrame: From date of randomization until the date of catheter removal , assessed up to 7 days
measure: Postoperative quality of life was evaluated-PPBC
timeFrame: 24, 48, and 72 hours after surgery
measure: Postoperative quality of life was evaluated- VAS
timeFrame: 24, 48, and 72 hours after surgery
measure: Postoperative quality of life was evaluated-QoL
timeFrame: 24, 48, and 72 hours after surgery
measure: uroflowmetry
timeFrame: Before surgery, 1 week after surgery, and 12 weeks after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
References: