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The Role of Clean Intermittent Catheterization in Patients Undergoing Radiotherapy After Radical Hysterectomy for Cervical Cancer

Primary Purpose

Uterine Cervical Neoplasms

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Clean Intermittent Catheterization
Indwelling catheterization
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Cervical Neoplasms focused on measuring Cervical cancer, Radiotherapy, Clean intermittent catheterization, Bladder function

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Older than 18 and younger than 65; ② Have normal independent judgment ability; ③ According to the staging standard of International Federation of Obstetrics and gynecology (FIGO) in 2009, the preoperative staging was stage Ⅰ A1 -Ⅱ A2; ④ Patients who need postoperative radiotherapy according to the provisions of NCCN clinical practice guide for cervical cancer in 2015; ⑤ Residual urine volume is more than 100ml.

Exclusion Criteria:

① Extensive hysterectomy with bladder repair; ② Urinary tract infection has occurred at the time of admission / transfer; ③ Hydronephrosis; ④ Patients with contraindications to intermittent catheterization; ⑤ Do not agree to participate in this clinical study; ⑥ Patients with communication difficulties. -

Sites / Locations

  • Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

The control group

The study group

Arm Description

The control group received routine indwelling catheterization, the catheter was continuously opened, and the indwelling catheter was replaced every 7 days. When the bladder function returned to normal, the catheter was removed.

The observation group, namely intermittent catheterization group, was given one-to-one training and education to patients and their families before the implementation of the project. Frequency and timing of intermittent catheterization: it is recommended to catheterize once every 4 hours and no more than 6 times every 24 hours. If the residual urine volume decreases, the number of catheterization can be appropriately reduced; Before each catheterization, urinate by yourself. The derived urine volume is the residual urine volume. The total amount of urine shall not exceed the safe capacity of the bladder.

Outcomes

Primary Outcome Measures

the recovery rate of bladder function
At the end of radiotherapy, the recovery rate of bladder function in the observation group was higher than that in the control group (P < 0.05)

Secondary Outcome Measures

the incidence of urinary tract infection
During the radiotherapy, the incidence of urinary tract infection in the observation group was significantly less than that in the control group (P = 0).
the bladder volume
At the end of radiotherapy, the bladder volume of the two groups decreased compared with that before radiotherapy. However, there was no significant difference between two groups (P > 0.05).

Full Information

First Posted
June 2, 2022
Last Updated
June 2, 2022
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05410444
Brief Title
The Role of Clean Intermittent Catheterization in Patients Undergoing Radiotherapy After Radical Hysterectomy for Cervical Cancer
Official Title
Application of Intermittent Catheterization in Patients With Micturition Dysfunction After Postoperative Radiotherapy for Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Through a prospective, randomized and controlled research design method, this study implemented intermittent catheterization for patients with urinary dysfunction after postoperative radiotherapy of cervical cancer, formulated a reasonable bladder rehabilitation training plan, reduced the amount of residual urine, restored bladder function as soon as possible, reduced the incidence of urinary complications and readmission rate, and improved the quality of life of patients, To comprehensively evaluate the application value of intermittent catheterization in patients with micturition dysfunction after postoperative radiotherapy for cervical cancer.
Detailed Description
In this study, patients with postoperative radiotherapy for cervical cancer complicated with voiding dysfunction in the Department of gynecology and oncology radiotherapy of our hospital from July 2018 to December 2020 were selected as the research objects. At the beginning of the study, a total of 80 people were randomly divided into two groups: 40 cases in the observation group and 40 cases in the control group. The observation group implemented intermittent catheterization and formulated a reasonable bladder rehabilitation training plan, and the control group received routine indwelling catheterization. The observation group gave one-to-one training and education to patients and their families before the implementation of the project, including 1. Watching the operation video of intermittent catheterization for female patients. 2. The nurse demonstrated on the simulator. 3. Distribution of drinking water and urination plan, such as paper urination plan, etc. Drinking water plan: patients are required to drink about 1800ml-2000ml of water every day, including drinking water, soup, fruit, etc. it is recommended that the water intake for three meals in the morning, noon and evening is 400ml respectively, and about 200ml water is taken between meals. 200ml water is taken 2 hours after dinner, and no water is taken 2-3 hours before going to bed. Frequency and timing of intermittent catheterization: it is recommended to catheterize once every 4 hours and no more than 6 times every 24 hours. If the residual urine volume decreases, the number of catheterization can be appropriately reduced; Before each catheterization, urinate by yourself. The derived urine volume is the residual urine volume. The total amount of urine shall not exceed the safe capacity of the bladder. 4. The nurse guides the catheterization with hands on the patient until the patient or family members fully master the operation. 5. Nurses add wechat to patients or their families to answer patients' questions and solve operational problems at any time; For three consecutive days after the beginning of intermittent catheterization, patients need to take photos and upload their drinking water and urination diaries every day. Nurses assess the existing risks and deficiencies, give guidance and continue to follow up. 6. If the residual urine volume of the patient is less than 100ml or less than 20% of the safe capacity of the bladder for 3 consecutive days, it is judged that the bladder function has been restored and intermittent catheterization can be stopped. 7. In case of adverse events during the implementation of the project, such as urinary tract infection and impaired renal function, it is necessary to communicate with the doctor in time to decide whether to continue intermittent catheterization. During radiotherapy, the bladder function of the observation group and the control group was evaluated every 7 days until the end of radiotherapy. All patients need to fill in SF-36 questionnaire before and after radiotherapy. In principle, the questionnaire star or paper questionnaire is required to be filled in by the patients themselves. For those who can communicate but can not read and fill in by themselves, the family members shall assist in completing it together. All options of the scale are required to be the opinions of the patients themselves. Drinking water and urination diary records shall be completed by patients and their families. The general information of patients is completed by medical staff at the end of radiotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms
Keywords
Cervical cancer, Radiotherapy, Clean intermittent catheterization, Bladder function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The control group
Arm Type
Active Comparator
Arm Description
The control group received routine indwelling catheterization, the catheter was continuously opened, and the indwelling catheter was replaced every 7 days. When the bladder function returned to normal, the catheter was removed.
Arm Title
The study group
Arm Type
Experimental
Arm Description
The observation group, namely intermittent catheterization group, was given one-to-one training and education to patients and their families before the implementation of the project. Frequency and timing of intermittent catheterization: it is recommended to catheterize once every 4 hours and no more than 6 times every 24 hours. If the residual urine volume decreases, the number of catheterization can be appropriately reduced; Before each catheterization, urinate by yourself. The derived urine volume is the residual urine volume. The total amount of urine shall not exceed the safe capacity of the bladder.
Intervention Type
Device
Intervention Name(s)
Clean Intermittent Catheterization
Intervention Description
Under clean conditions, the method of regularly inserting the urinary catheter into the bladder through the urethra and emptying the urine regularly is called clean intermittent catheterization.
Intervention Type
Device
Intervention Name(s)
Indwelling catheterization
Intervention Description
A catheter is inserted into the bladder through the urethra to drain urine. The catheter has been left in the patient's body.
Primary Outcome Measure Information:
Title
the recovery rate of bladder function
Description
At the end of radiotherapy, the recovery rate of bladder function in the observation group was higher than that in the control group (P < 0.05)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
the incidence of urinary tract infection
Description
During the radiotherapy, the incidence of urinary tract infection in the observation group was significantly less than that in the control group (P = 0).
Time Frame
3 years
Title
the bladder volume
Description
At the end of radiotherapy, the bladder volume of the two groups decreased compared with that before radiotherapy. However, there was no significant difference between two groups (P > 0.05).
Time Frame
3 years

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Older than 18 and younger than 65; ② Have normal independent judgment ability; ③ According to the staging standard of International Federation of Obstetrics and gynecology (FIGO) in 2009, the preoperative staging was stage Ⅰ A1 -Ⅱ A2; ④ Patients who need postoperative radiotherapy according to the provisions of NCCN clinical practice guide for cervical cancer in 2015; ⑤ Residual urine volume is more than 100ml. Exclusion Criteria: ① Extensive hysterectomy with bladder repair; ② Urinary tract infection has occurred at the time of admission / transfer; ③ Hydronephrosis; ④ Patients with contraindications to intermittent catheterization; ⑤ Do not agree to participate in this clinical study; ⑥ Patients with communication difficulties. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wang chunlan
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang, China,
ZIP/Postal Code
310022
Country
China

12. IPD Sharing Statement

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The Role of Clean Intermittent Catheterization in Patients Undergoing Radiotherapy After Radical Hysterectomy for Cervical Cancer

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