Acupuncture for Postoperative Urinary Retention After Hemorrhoidectomy: a Randomized Controlled Trial

Phase 2

Completed

• Conditions: Postoperative Complications; Postoperative Urinary Retention
• Interventions: Other: Sham acupuncture; Drug: Neostigmine Injectable Product; Other: Acupuncture

• Registration Number: NCT05898919
• Lead Sponsor: Chengdu University of Traditional Chinese Medicine

Brief Summary

The goal of this study is to examine the efficacy of acupuncture in the management of acute postoperative urinary retention.

Clinical question:

Is acupuncture efficacious for postoperative urinary retention after hemorrhoidectomy compared with sham acupuncture and neostigmine.

Study design:

The participants who undergo hemorrhoidectomy and report postoperative urinary retention will receive one session of acupuncture or sham acupuncture or one injection of 1-mg neostigmine. The primary outcome was the time to first urination after surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2023-05-25
• Study First Submitted: 2023-05-27
• Study First Submitted QC: 2023-06-08
• Study First Posted: 2023-06-12
• Status Verified: 2023-07
• Study Completion: 2023-07-06
• Last Update Submitted: 2023-07-07
• Last Update Posted: 2023-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Aged between 18 and 65 years
• Meets the diagnostic criteria of postoperative urinary retention
• Received milligan-morgan hemorrhoidectomy and general anesthesia

Exclusion Criteria

• Received Diuretic drugs
• Organic diseases that cause urinary retention
• Severe infection in the urinary tract
• Has a history of adverse reaction to neostigmine
• Cognitive dysfunction that affects outcome assessment
• Being pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham acupuncture	Sham acupuncture	-
Neostigmine	Neostigmine Injectable Product	-
Acupuncture	Acupuncture	-

Primary Outcome Measures

Name	Time	Method
The time to first urination after surgery	Immediately after first urination	This outcome records the time period from the end of surgery to the immediately first urination.

Secondary Outcome Measures

Name	Time	Method
Visual analogue score after surgery	2 hours after treatment.	The visual analogue score ranges from 0 to 10 cm. A higher score indicates more painful symptoms.
Adverse effects	48 hours after treatment	The adverse events will recorded by the patients and evaluated by the physicians. And the adverse events will be classified into mild and severe. Mild adverse events need no additional medical care.
The volume of first of urination	Immediately after first urination	This outcome measures the total volume of the first urination after surgery.
Bladder residual urine volume	10 minutes before treatment, 0.5, 1, and 2 hours after treatment.	This outcome measures the bladder residual urine volume using the ultrasound measurement.
Urination Score	10 minutes before treatment, 0.5, 1, and 2 hours after treatment.	The urination score ranges from 0 to 4 points. A higher score indicates more difficult to urinate.
Abdominal symptom score	Before treatment, 0.5, 1, and 2 hours after treatment.	The abdominal symptom score ranges from 0 to 3 points. A higher score indicates worse abdominal symptoms.

Trial Locations

Locations (1)

Hospital of Chengdu University of Traditional Chinese Medicine; 🇨🇳 Chengdu, China