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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Complications, Postoperative Urinary Retention

Intervention / Treatment
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* Other: Acupuncture
* Other: Sham acupuncture
* Drug: Neostigmine Injectable Product


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br> | Other: Acupuncture<br>* 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.<br>|
| Placebo Comparator: Sham acupuncture<br> | Other: Sham acupuncture<br>* Participants will receive sham acupuncture at sham points.<br>|
| Active Comparator: Neostigmine<br> | Drug: Neostigmine Injectable Product<br>* Neostigmine was injected once after postoperative urinary retention.<br>|

What is the study measuring?
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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 |