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

NCT05410444 | Completed DMC

• 1 other identifier: ZJCH-RCT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Cervical Neoplasms

Keywords

Cervical cancer; Radiotherapy; Clean intermittent catheterization; Bladder function

Outcome Measures

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)

  3 years

Secondary Outcomes (2)

• the incidence of urinary tract infection

  3 years

• the bladder volume

  3 years

Study Arms (2)

The control group

ACTIVE COMPARATOR

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

The study group

EXPERIMENTAL

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

Clean Intermittent Catheterization DEVICE

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 study group

Indwelling catheterization DEVICE

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

The control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China,, 310022, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Intermittent Urethral Catheterization

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Urinary Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• wang chunlan

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 8, 2022
• Study Start: July 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: June 8, 2022

Record last verified: 2022-06

Locations

CN (1)