Conversion of Evidence and Applied Research on Intermittent Catheterization After Radical Hysterectomy

In this study, the investigators summarize the existing best evidence of intermittent catheterization in patients after radical cervical cancer surgery from the perspective of clinical translation of evidence through systematic search, evaluation and evidence integration, construct a nursing protocol of intermittent catheterization for patients after radical cervical cancer surgery based on the best evidence combined with the clinical context, and explore the clinical application effect of the above nursing protocol. It will provide a reference basis for the development of the standardization and management of intermittent catheterization for postoperative patients with cervical cancer in China, as well as the development of guidelines for intermittent catheterization after radical cervical cancer surgery.

Study Overview

• Status: Recruiting
• Conditions: Intermittent Catheterization; Conversion of Evidence
• Intervention / Treatment: Behavioral: intermittent catheterization protocol based on the best evidence

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lu Xing; Phone Number: +8619827473462; Email: xinglu_0707@163.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Second University Hospital, Sichuan University
      • Contact: Lu Xing; Phone Number: +8619827473462; Email: xinglu_0707@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≧ 18 years old
• Radical cervical cancer surgery and intermittent catheterization were performed at the Institute's hospital
• Patients or their family members can operate a smartphone
• No cognitive or psychiatric disorders, and can communicate effectively

Exclusion Criteria:

• People with serious heart, brain, lung and other important organ diseases
• People with water, electrolyte, acid-base balance disorders at the beginning of intermittent catheterization
• People with previous serious renal diseases, bladder and urethra surgery
• People with urinary tract infections
• People who did not complete all interventions or data collection
• People who voluntarily withdrew from the study or died during the study period;
• Refuse to participate in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A best evidence-based protocol for intermittent catheterization	Behavioral: intermittent catheterization protocol based on the best evidence; A best evidence-based protocol for intermittent catheterization after radical cervical cancer surgery
No Intervention: Routine intermittent catheterization care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of urinary complications	the occurrence of urologic complications within 2 months after discharge of the patients from the hospital for follow-up, which in this study included urinary tract infections, urethral injuries, bladder stones, hydronephrosis	Within 2 months of discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intermittent Catheterization Compliance Scale	A questionnaire was used to investigate patients' adherence to carrying out intermittent catheterization before the intervention, immediately after the intervention, and 1 month after discharge from the hospital. Higher scores indicate better adherence.	Pre-intervention, immediately post-intervention, and 1 month post-discharge
12-Item Short Form Survey	A questionnaire was used to investigate patients' quality of life before and immediately after the intervention and 1 month after discharge. Higher scores indicate better quality of life.	Pre-intervention, immediately post-intervention, and 1 month post-discharge
Self-Rating Anxiety Scale	A questionnaire was used to investigate patients' anxiety before and immediately after the intervention and 1 month after discharge from the hospital. Higher scores indicate greater anxiety.	Pre-intervention, immediately post-intervention, and 1 month post-discharge
Intermittent Catheterization Confidence Scale	A questionnaire was used to investigate patients' self-efficacy before and immediately after the intervention and 1 month after discharge from the hospital. Higher scores indicate greater confidence.	Pre-intervention, immediately post-intervention, and 1 month post-discharge
Utilization of health services	Follow-up to record the number of unplanned readmissions, outpatient visits, and emergency room visits within 2 months of discharge and to evaluate the patient's health service utilization	Within 2 months of discharge

Collaborators and Investigators

• Sponsor: West China Second University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 10, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 20, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No