CClinicalTrials.gg
CompletedNCT05898919Updated Jul 10, 2023

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

A Phase 2 interventional study of Acupuncture and Sham acupuncture in Postoperative Complications and Postoperative Urinary Retention, sponsored by Chengdu University of Traditional Chinese Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-07-10.

Sponsored by Chengdu University of Traditional Chinese Medicine · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Mar 2022, registered May 2023).
Phase
Phase 2
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Postoperative Complications
  • Postoperative Urinary Retention
03

In context

Urinary Retention

235 studies on the registry are indexed under Urinary Retention; 39 are open to participants now.

This study's enrollment of 92 is close to the median of 95 across 185 interventional studies indexed under Urinary Retention.

Browse Urinary Retention studies →

Lead sponsor

Chengdu University of Traditional Chinese Medicine is the lead sponsor of 57 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
92 participants (actual)

Study arms

  • Experimental
    Acupuncture

    Other: Acupuncture

  • Placebo comparator
    Sham acupuncture

    Other: Sham acupuncture

  • Active comparator
    Neostigmine

    Drug: Neostigmine Injectable Product

Interventions

  • OtherAcupuncture

    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.

  • OtherSham acupuncture

    Participants will receive sham acupuncture at sham points.

  • DrugNeostigmine Injectable Product

    Neostigmine was injected once after postoperative urinary retention.

06

What researchers measure

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.

    Time frame: Immediately after first urination

Secondary outcomes

  1. The volume of first of urination

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

    Time frame: Immediately after first urination

  2. Bladder residual urine volume

    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.

  3. Urination Score

    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.

  4. Abdominal symptom score

    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.

  5. Visual analogue score after surgery

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

    Time frame: 2 hours after treatment.

  6. 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.

    Time frame: 48 hours after treatment

07

Study locations

1 site
  • Hospital of Chengdu University of Traditional Chinese Medicine
    Chengdu, 610000, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05898919
Lead sponsor
Chengdu University of Traditional Chinese Medicine
Responsible party
Hui Zheng (Clinical Professor, Chengdu University of Traditional Chinese Medicine) — Principal investigator
First posted
Jun 12, 2023
Start date
Mar 1, 2022
Primary completion
May 25, 2023
Completion
Jul 6, 2023
Last update
Jul 10, 2023

Study contacts

Min Chen, MD
principal investigator · Hospital of Chengdu University of Traditional Chinese Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion