The Role of Clean Intermittent Catheterization in Patients Undergoing Radiotherapy After Radical Hysterectomy for Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT05410444|
Recruitment Status : Completed
First Posted : June 8, 2022
Last Update Posted : June 8, 2022
|Condition or disease||Intervention/treatment||Phase|
|Uterine Cervical Neoplasms||Device: Clean Intermittent Catheterization Device: Indwelling catheterization||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Application of Intermittent Catheterization in Patients With Micturition Dysfunction After Postoperative Radiotherapy for Cervical Cancer|
|Actual Study Start Date :||July 1, 2018|
|Actual Primary Completion Date :||December 1, 2020|
|Actual Study Completion Date :||March 1, 2021|
Active Comparator: The control group
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.
Device: Indwelling catheterization
A catheter is inserted into the bladder through the urethra to drain urine. The catheter has been left in the patient's body.
Experimental: The study group
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.
Device: Clean Intermittent Catheterization
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.
- the recovery rate of bladder function [ Time Frame: 3 years ]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)
- the incidence of urinary tract infection [ Time Frame: 3 years ]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 [ Time Frame: 3 years ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05410444
|China, Zhejiang, China,|
|Zhejiang Cancer Hospital|
|Hangzhou, Zhejiang, China,, China, 310022|
|Principal Investigator:||wang chunlan||Zhejiang Cancer Hospital|