Donepezil Prevents Urinary Retention After Extensive Total Hysterectomy
Effect of Donepezil on Prevention of Postoperative Urinary Retention in Patients Undergoing Extensive Total Hysterectomy
1 other identifier
interventional
108
1 country
1
Brief Summary
Patients were randomly divided into experimental group and control group. The control group received routine postoperative treatment, while the experimental group took donepezil 5mg orally before going to bed every night from the first day after surgery. The catheter was removed and residual urine was measured in both groups 14 days after surgery, the catheter was successfully removed when the residual urine was less than 100ml. After 14 days, the patient was returned to the hospital for residual urine test, and the residual urine was repeated until the residual urine volume was less than or equal to 100ml. The incidence of postoperative urinary retention and adverse drug reactions were compared between the two groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Aug 2022
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2022
CompletedFirst Submitted
Initial submission to the registry
September 9, 2022
CompletedFirst Posted
Study publicly available on registry
September 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2023
CompletedSeptember 15, 2022
July 1, 2022
10 months
September 9, 2022
September 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence of urinary retention (residual urine volume < 100ml)
Residual urine volume
No more than 6 weeks
Study Arms (2)
Donepezil
EXPERIMENTALPatients were randomly divided into experimental group and control group. The experimental group received routine postoperative treatment and took donepezil 5mg orally before going to bed every night from the first day after surgery.
Usual care
OTHERUsual care
Interventions
Eligibility Criteria
You may qualify if:
- Age 18-80 years
- Patients who meet the diagnostic criteria of cervical cancer in the Guidelines for the Diagnosis and Treatment of Cervical Cancer (the Fourth Edition) and have been diagnosed by cervical biopsy or colposcopy
- Patients with surgical indications undergoing extensive abdominal total hysterectomy
- The person who signed the informed consent.
You may not qualify if:
- Allergic reaction to donepezil hydrochloride, piperidine derivatives or excipients in preparations
- Patients with "sick sinus syndrome" or other supraventricular heart conduction diseases
- Accompanied by serious liver, kidney and other organ dysfunction, serious infectious diseases
- Patients with a history of mental illness and communication disorders
- Patients with intraoperative injury of urinary system, or postoperative ureteral fistula and vesicovaginal fistula.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2022
First Posted
September 15, 2022
Study Start
August 1, 2022
Primary Completion
May 31, 2023
Study Completion
July 15, 2023
Last Updated
September 15, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share