CClinicalTrials.gg
CompletedNCT05410444Updated Jun 8, 2022

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

An interventional study of Clean Intermittent Catheterization and Indwelling catheterization in Uterine Cervical Neoplasms, sponsored by Zhejiang Cancer Hospital. Completed at 1 site in China. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-06-08.

Sponsored by Zhejiang Cancer Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 11 months after the study started (first participant enrolled Jul 2018, registered Jun 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Uterine Cervical Neoplasms

Keywords

  • Cervical cancer
  • Radiotherapy
  • Clean intermittent catheterization
  • Bladder function
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 80 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Zhejiang Cancer Hospital is the lead sponsor of 271 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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. -

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceClean 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.

  • DeviceIndwelling catheterization

    A catheter is inserted into the bladder through the urethra to drain urine. The catheter has been left in the patient's body.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 3 years

Secondary outcomes

  1. 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).

    Time frame: 3 years

  2. 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).

    Time frame: 3 years

07

Study locations

1 site
  • Zhejiang Cancer Hospital
    Hangzhou, Zhejiang, China, 310022, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05410444
Lead sponsor
Zhejiang Cancer Hospital
Responsible party
Yin ZhuoMin (MD, Zhejiang Cancer Hospital) — Principal investigator
First posted
Jun 8, 2022
Start date
Jul 1, 2018
Primary completion
Dec 1, 2020
Completion
Mar 1, 2021
Last update
Jun 8, 2022

Study contacts

wang chunlan
principal investigator · Zhejiang Cancer Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion