Acupuncture for Catheter-Related-Bladder Discomfort After Transurethral Surgery

NCT06196437 | Recruiting

• 1 other identifier: 2023-KY-109
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter-related-bladder Discomfort

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Incidence of moderate to severe CRBD

  24, 48, and 72 hours after surgery

• Lower urinary tract symptoms-IPSS

  Before surgery, 1 week after surgery, and 12 weeks after surgery

• Lower urinary tract symptoms-OABSS

  Before surgery, 1 week after surgery, and 12 weeks after surgery

• Duration of indwelling catheter

  At the time of catheter removal (assessed up to 7 days)

• Length of hospital stay

  At the time of patient discharge (assessed up to day 14)

Study Arms (2)

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.

Other: Acupuncture

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.

Other: Sham Acupuncture

Interventions

Acupuncture OTHER

Participants will receive acupuncture.

Acupuncture

Sham Acupuncture OTHER

Participants will receive sham acupuncture.

Sham acupuncture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Ran Pang, MD

CONTACT

+8610-88001040; pangran2002@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 9, 2024
• Study Start: August 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

CN (1)