Donepezil Prevents Urinary Retention After Extensive Total Hysterectomy

Early Phase 1

• Conditions: Urinary Retention After Procedure
• Interventions: Other: Usual care; Drug: Donepezil

• Registration Number: NCT05540977
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

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.

Study Timeline

• Status Verified: 2022-07
• Study Start: 2022-08-01
• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-14
• Last Update Submitted: 2022-09-14
• Study First Posted: 2022-09-15
• Last Update Posted: 2022-09-15
• Primary Completion: 2023-05-31
• Study Completion: 2023-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	Usual care
Donepezil	Donepezil	Patients 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.

Primary Outcome Measures

Name	Time	Method
The incidence of urinary retention (residual urine volume < 100ml)	No more than 6 weeks	Residual urine volume

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China