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Clinical trial

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

ID
Name
HCDUTCM_2022056
Description
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.
Trial arms
Trial start
2022-03-01
Estimated PCD
2023-05-25
Trial end
2023-07-06
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Acupuncture
Sham acupuncture
Participants will receive sham acupuncture at sham points.
Arms:
Sham acupuncture
Neostigmine Injectable Product
Neostigmine was injected once after postoperative urinary retention.
Arms:
Neostigmine
Size
92
Primary endpoint
The time to first urination after surgery
Immediately after first urination
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 92, 'type': 'ACTUAL'}}
Updated at
2023-07-10

1 organization

1 product

2 indications

Organization
Chengdu University of Traditional Chinese Medicine
Product
Neostigmine
Indication
Postoperative Complications
Indication
Postoperative Urinary Retention