Postoperative ComplicationsPhase 2NCT05898919
Acupuncture for Postoperative Urinary Retention After Hemorrhoidectomy: a Randomized Controlled Trial
A Phase 2 study testing Acupuncture and Neostigmine Injectable Product in people with Postoperative Complications and Postoperative Urinary Retention, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Complications, Postoperative Urinary Retention
- What is being tested?
- Acupuncture and Neostigmine Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 6 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years
- Meets the diagnostic criteria of postoperative urinary retention
- Received milligan-morgan hemorrhoidectomy and general anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, 610000
About this study
Official title: Acupuncture Versus Sham Acupuncture and Neostigmine for the Management of Postoperative Urinary Retention
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.
- Being tested
- Acupuncture, Sham acupuncture, Neostigmine Injectable Product
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
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 acupunctureOther
Participants will receive sham acupuncture at sham points.
Neostigmine Injectable ProductDrug
Neostigmine was injected once after postoperative urinary retention.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Not described Receives: Other: Acupuncture |
| Sham acupuncture | Placebo comparator | Not described Receives: Other: Sham acupuncture |
| Neostigmine | Active comparator | Not described Receives: Drug: Neostigmine Injectable Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to first urination after surgery
This outcome records the time period from the end of surgery to the immediately first urination.
Measured: Immediately after first urination
Secondary outcomes (6)
The volume of first of urination
This outcome measures the total volume of the first urination after surgery.
Measured: Immediately after first urination
Bladder residual urine volume
This outcome measures the bladder residual urine volume using the ultrasound measurement.
Measured: 10 minutes before treatment, 0.5, 1, and 2 hours after treatment.
Urination Score
The urination score ranges from 0 to 4 points. A higher score indicates more difficult to urinate.
Measured: 10 minutes before treatment, 0.5, 1, and 2 hours after treatment.
Abdominal symptom score
The abdominal symptom score ranges from 0 to 3 points. A higher score indicates worse abdominal symptoms.
Measured: Before treatment, 0.5, 1, and 2 hours after treatment.
Visual analogue score after surgery
The visual analogue score ranges from 0 to 10 cm. A higher score indicates more painful symptoms.
Measured: 2 hours after treatment.
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.
Measured: 48 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Mar 2022
- Primary completion25 May 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Zheng, Chengdu University of Traditional Chinese Medicine
- Investigators
- Min Chen, MD, Principal investigator, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898919
- Sponsor's protocol ID
- HCDUTCM_2022056
- Status last verified
- Jul 2023
- First submitted
- 27 May 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Versus Sham Acupuncture and Neostigmine for the Management of Postoperative Urinary Retention
- ClinicalTrials.gov ID
- NCT05898919
- Acronym / sponsor ID
- HCDUTCM_2022056
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: Acupuncture |
| Sham acupuncture | Placebo comparator | Other: Sham acupuncture |
| Neostigmine | Active comparator | Drug: Neostigmine Injectable Product |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18 and 65 years
- Meets the diagnostic criteria of postoperative urinary retention
- Received milligan-morgan hemorrhoidectomy and general anesthesia
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAcupuncture 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. | Other | Acupuncture |
| Sham acupunctureParticipants will receive sham acupuncture at sham points. | Other | Sham acupuncture |
| Neostigmine Injectable ProductNeostigmine was injected once after postoperative urinary retention. | Drug | Neostigmine |
Primary outcome
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.
6 secondary outcomes
The volume of first of urination
Time frame: Immediately after first urination
Bladder residual urine volume
Time frame: 10 minutes before treatment, 0.5, 1, and 2 hours after treatment.
Urination Score
Time frame: 10 minutes before treatment, 0.5, 1, and 2 hours after treatment.
Abdominal symptom score
Time frame: Before treatment, 0.5, 1, and 2 hours after treatment.
Visual analogue score after surgery
Time frame: 2 hours after treatment.
Adverse effects
Time frame: 48 hours after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Chen, MD principal investigator
Chengdu University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acupuncture and Neostigmine Injectable Product in people with Postoperative Complications and Postoperative Urinary Retention, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to first urination after surgery (time frame: Immediately after first urination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.