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Donepezil Prevents Urinary Retention After Extensive Total Hysterectomy

Primary Purpose

Urinary Retention After Procedure

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Donepezil
Usual care
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Retention After Procedure focused on measuring Donepezil, Cervical cancer, Urinary Retention

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Donepezil

Usual care

Arm Description

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.

Usual care

Outcomes

Primary Outcome Measures

The incidence of urinary retention (residual urine volume < 100ml)
Residual urine volume

Secondary Outcome Measures

Full Information

First Posted
September 9, 2022
Last Updated
September 14, 2022
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05540977
Brief Title
Donepezil Prevents Urinary Retention After Extensive Total Hysterectomy
Official Title
Effect of Donepezil on Prevention of Postoperative Urinary Retention in Patients Undergoing Extensive Total Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
July 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention After Procedure
Keywords
Donepezil, Cervical cancer, Urinary Retention

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Donepezil
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Other
Arm Description
Usual care
Intervention Type
Drug
Intervention Name(s)
Donepezil
Intervention Description
Donepezil 5mg QN
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual care
Primary Outcome Measure Information:
Title
The incidence of urinary retention (residual urine volume < 100ml)
Description
Residual urine volume
Time Frame
No more than 6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 At the time of inclusion, patients with urinary tract infection had a history of urinary tract diseases (stones, congenital malformations, etc.) Patients with intraoperative injury of urinary system, or postoperative ureteral fistula and vesicovaginal fistula.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qing Chen, MD
Phone
+8613602826099
Email
sumsqing@139.com
Facility Information:
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qing Chen, Master
Phone
13602826099
Email
sumsqing@139.com
First Name & Middle Initial & Last Name & Degree
Meimei Guan, Master
Phone
18825135814
Email
623979652@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Donepezil Prevents Urinary Retention After Extensive Total Hysterectomy

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