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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05898919
• Other study ID #: HCDUTCM_2022056
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2022
• Est. completion date: July 6, 2023

Study information

• Verified date: July 2023
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: July 6, 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications
• Postoperative Urinary Retention
• Urinary Retention

Intervention

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.
• Sham acupuncture
Participants will receive sham acupuncture at sham points.

Drug:
• Neostigmine Injectable Product
Neostigmine was injected once after postoperative urinary retention.

Locations

Country	Name	City	State
China	Hospital of Chengdu University of Traditional Chinese Medicine	Chengdu

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The volume of first of urination	This outcome measures the total volume of the first urination after surgery.	Immediately after first urination
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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