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Trial Title:
Donepezil Prevents Urinary Retention After Extensive Total Hysterectomy
NCT ID:
NCT05540977
Condition:
Urinary Retention After Procedure
Conditions: Official terms:
Urinary Retention
Donepezil
Conditions: Keywords:
Donepezil
Cervical cancer
Urinary Retention
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Donepezil
Description:
Donepezil 5mg QN
Arm group label:
Donepezil
Intervention type:
Other
Intervention name:
Usual care
Description:
Usual care
Arm group label:
Usual care
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.
Detailed description:
This study hypothesized that donepezil could effectively reduce the incidence of urinary
retention in cervical cancer patients after extensive total hysterectomy. A total of 108
patients with cervical cancer who underwent abdominal radical hysterectomy in our
department from June 1, 2022 to May 31, 2023 were randomly divided into two groups, the
experimental group (n = 54) and the control group (n = 54). The incidence of
postoperative urinary retention and adverse drug reactions were compared between the two
groups.
A. Screening accords with the standard set of subjects, abdominal widely whole palace
resection, BiXing random grouping, experimental group from the first day after oral
donnelly, pp every night before going to bed together 5 mg, two groups of patients with
the rest of the regular place Agreement (including antibiotics to 48 h, postoperative
indwelling catheterization, perineum wipe to wash the bid, wound dressing, etc.);
B. The catheter was removed and the residual urine was measured 14 days after operation.
The residual urine was ≤100ml, and the catheter was successfully removed. The patients in
the experimental group stopped taking the drug, and the residual urine was > 100ml.
C. Residual urine of patients with urinary retention was measured again 14 days later,
and the residual urine was ≤100ml. Patients in the experimental group stopped the drug,
and the residual urine was > 100ml. Intermittent catheterization was continued, and
patients in the experimental group continued to take the drug until the residual urine
volume was ≤100ml.
D. This cycle was carried out until the residual urine volume of the last enrolled
patient was less than 100ml. The incidence of postoperative urinary retention and adverse
drug reactions were compared between the two groups.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18-80 years
2. 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
3. Patients with surgical indications undergoing extensive abdominal total hysterectomy
4. The person who signed the informed consent.
Exclusion Criteria:
1. Allergic reaction to donepezil hydrochloride, piperidine derivatives or excipients
in preparations
2. Patients with "sick sinus syndrome" or other supraventricular heart conduction
diseases
3. Accompanied by serious liver, kidney and other organ dysfunction, serious infectious
diseases
4. Patients with a history of mental illness and communication disorders
5. At the time of inclusion, patients with urinary tract infection had a history of
urinary tract diseases (stones, congenital malformations, etc.)
6. Patients with intraoperative injury of urinary system, or postoperative ureteral
fistula and vesicovaginal fistula.
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Qing Chen, Master
Phone:
13602826099
Email:
sumsqing@139.com
Contact backup:
Last name:
Meimei Guan, Master
Phone:
18825135814
Email:
623979652@qq.com
Start date:
August 1, 2022
Completion date:
July 15, 2023
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05540977
