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

Acupuncture Versus Sham Acupuncture and Neostigmine for the Management of Postoperative Urinary Retention

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Postoperative Urinary Retention
• Intervention / Treatment: Other: Acupuncture; Other: Sham acupuncture; Drug: Neostigmine Injectable Product

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Chengdu, China, 610000
    • Hospital of Chengdu University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture	Other: Acupuncture; Acupuncture is a technique that inserts a needle into the acupuncture point to treat a condition. In this trial, we will use acupuncture to treat postoperative urinary retention.
Placebo Comparator: Sham acupuncture	Other: Sham acupuncture; Participants will receive sham acupuncture at sham points.
Active Comparator: Neostigmine	Drug: Neostigmine Injectable Product; Neostigmine was injected once after postoperative urinary retention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time to first urination after surgery	This outcome records the time period from the end of surgery to the immediately first urination.	Immediately after first urination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The volume of first of urination	This outcome measures the total volume of the first urination after surgery.	Immediately after first urination
Bladder residual urine volume	This outcome measures the bladder residual urine volume using the ultrasound measurement.	10 minutes before treatment, 0.5, 1, and 2 hours after treatment.
Urination Score	The urination score ranges from 0 to 4 points. A higher score indicates more difficult to urinate.	10 minutes before treatment, 0.5, 1, and 2 hours after treatment.
Abdominal symptom score	The abdominal symptom score ranges from 0 to 3 points. A higher score indicates worse abdominal symptoms.	Before treatment, 0.5, 1, and 2 hours after treatment.
Visual analogue score after surgery	The visual analogue score ranges from 0 to 10 cm. A higher score indicates more painful symptoms.	2 hours after treatment.
Adverse effects	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.	48 hours after treatment

Collaborators and Investigators

• Sponsor: Chengdu University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Min Chen, MD, Hospital of Chengdu University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): May 25, 2023
• Study Completion (Actual): July 6, 2023

Study Registration Dates

• First Submitted: May 27, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Postoperative Complications; Urinary Retention; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Parasympathomimetics; Neostigmine
• Other Study ID Numbers: HCDUTCM_2022056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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