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

NCT05898919 | Completed Phase 2 DMC

• 1 other identifier: HCDUTCM_2022056
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications; Postoperative Urinary Retention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The volume of first of urination

  Immediately after first urination

• Bladder residual urine volume

  10 minutes before treatment, 0.5, 1, and 2 hours after treatment.

• Urination Score

  10 minutes before treatment, 0.5, 1, and 2 hours after treatment.

• Abdominal symptom score

  Before treatment, 0.5, 1, and 2 hours after treatment.

• Visual analogue score after surgery

  2 hours after treatment.

Study Arms (3)

Acupuncture

EXPERIMENTAL

Other: Acupuncture

Sham acupuncture

PLACEBO COMPARATOR

Other: Sham acupuncture

Neostigmine

ACTIVE COMPARATOR

Drug: Neostigmine Injectable Product

Interventions

Acupuncture OTHER

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.

Acupuncture

Sham acupuncture OTHER

Participants will receive sham acupuncture at sham points.

Sham acupuncture

Neostigmine Injectable Product DRUG

Neostigmine was injected once after postoperative urinary retention.

Neostigmine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

Study Sites (1)

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, 610000, China

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Min Chen, MD

  Chengdu University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 27, 2023
• First Posted: June 12, 2023
• Study Start: March 1, 2022
• Primary Completion: May 25, 2023
• Study Completion: July 6, 2023
• Last Updated: July 10, 2023

Record last verified: 2023-07

Locations

CN (1)