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Completed

NCT Number: NCT05898919

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

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.

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Key information

Conditions

Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Urinary Retention

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, 610000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sham Acupuncture

Other

Participants will receive sham acupuncture at sham points.

Neostigmine Injectable Product

Drug

Neostigmine was injected once after postoperative urinary retention.

Primary outcomes

  1. The time to first urination after surgery

    Time frame: Immediately after first urination

    This outcome records the time period from the end of surgery to the immediately first urination.

Secondary outcomes

  1. The volume of first of urination

    Time frame: Immediately after first urination

    This outcome measures the total volume of the first urination after surgery.

  2. Bladder residual urine volume

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

    This outcome measures the bladder residual urine volume using the ultrasound measurement.

  3. Urination Score

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

    The urination score ranges from 0 to 4 points. A higher score indicates more difficult to urinate.

  4. Abdominal symptom score

    Time frame: Before treatment, 0.5, 1, and 2 hours after treatment.

    The abdominal symptom score ranges from 0 to 3 points. A higher score indicates worse abdominal symptoms.

  5. Visual analogue score after surgery

    Time frame: 2 hours after treatment.

    The visual analogue score ranges from 0 to 10 cm. A higher score indicates more painful symptoms.

  6. Adverse effects

    Time frame: 48 hours after treatment

    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.

Sponsors and collaborators

Lead sponsor

Chengdu University of Traditional Chinese Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 12, 2023
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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