Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05410444 |
| Other study ID # |
ZJCH-RCT |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2018 |
| Est. completion date |
March 1, 2021 |
Study information
| Verified date |
June 2022 |
| Source |
Zhejiang Cancer Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
