Acupuncture for Postoperative Urinary Retention After Hemorrhoidectomy: a Randomized Controlled Trial
Primary Purpose
Postoperative Complications, Postoperative Urinary Retention
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Acupuncture
Sham acupuncture
Neostigmine Injectable Product
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Complications
Eligibility Criteria
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
Sites / Locations
- Hospital of Chengdu University of Traditional Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
Acupuncture
Sham acupuncture
Neostigmine
Arm Description
Outcomes
Primary Outcome Measures
The time to first urination after surgery
This outcome records the time period from the end of surgery to the immediately first urination.
Secondary Outcome Measures
The volume of first of urination
This outcome measures the total volume of the first urination after surgery.
Bladder residual urine volume
This outcome measures the bladder residual urine volume using the ultrasound measurement.
Urination Score
The urination score ranges from 0 to 4 points. A higher score indicates more difficult to urinate.
Abdominal symptom score
The abdominal symptom score ranges from 0 to 3 points. A higher score indicates worse abdominal symptoms.
Visual analogue score after surgery
The visual analogue score ranges from 0 to 10 cm. A higher score indicates more painful symptoms.
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.
Full Information
NCT ID
NCT05898919
First Posted
May 27, 2023
Last Updated
July 7, 2023
Sponsor
Chengdu University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05898919
Brief Title
Acupuncture for Postoperative Urinary Retention After Hemorrhoidectomy: a Randomized Controlled Trial
Official Title
Acupuncture Versus Sham Acupuncture and Neostigmine for the Management of Postoperative Urinary Retention
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
May 25, 2023 (Actual)
Study Completion Date
July 6, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chengdu University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Postoperative Urinary Retention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Title
Sham acupuncture
Arm Type
Placebo Comparator
Arm Title
Neostigmine
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham acupuncture
Intervention Description
Participants will receive sham acupuncture at sham points.
Intervention Type
Drug
Intervention Name(s)
Neostigmine Injectable Product
Intervention Description
Neostigmine was injected once after postoperative urinary retention.
Primary Outcome Measure Information:
Title
The time to first urination after surgery
Description
This outcome records the time period from the end of surgery to the immediately first urination.
Time Frame
Immediately after first urination
Secondary Outcome Measure Information:
Title
The volume of first of urination
Description
This outcome measures the total volume of the first urination after surgery.
Time Frame
Immediately after first urination
Title
Bladder residual urine volume
Description
This outcome measures the bladder residual urine volume using the ultrasound measurement.
Time Frame
10 minutes before treatment, 0.5, 1, and 2 hours after treatment.
Title
Urination Score
Description
The urination score ranges from 0 to 4 points. A higher score indicates more difficult to urinate.
Time Frame
10 minutes before treatment, 0.5, 1, and 2 hours after treatment.
Title
Abdominal symptom score
Description
The abdominal symptom score ranges from 0 to 3 points. A higher score indicates worse abdominal symptoms.
Time Frame
Before treatment, 0.5, 1, and 2 hours after treatment.
Title
Visual analogue score after surgery
Description
The visual analogue score ranges from 0 to 10 cm. A higher score indicates more painful symptoms.
Time Frame
2 hours after treatment.
Title
Adverse effects
Description
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.
Time Frame
48 hours after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Chen, MD
Organizational Affiliation
Hospital of Chengdu University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of Chengdu University of Traditional Chinese Medicine
City
Chengdu
ZIP/Postal Code
610000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Acupuncture for Postoperative Urinary Retention After Hemorrhoidectomy: a Randomized Controlled Trial
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