Clinical Study on Disposable Sterile Urinary Catheter

Not Applicable

Terminated

• Conditions: Urinary Tract Infection; Urinary Catheters
• Interventions: Device: super smooth antibacterial urinary catheter; Device: disposable urinary catheter

• Registration Number: NCT05651217
• Lead Sponsor: Shandong Branden Med.Device Co.,Ltd

Brief Summary

This study is a multicenter, randomized controlled study, with the urinary tract infection rate at the time of catheter insertion for 1 week as the primary end point. By comparing the clinical safety and effectiveness of two kinds of urethral catheters, to evaluate the clinical application effect of one kind of urethral catheters.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-11
• Primary Completion: 2021-09-12
• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-14
• Status Verified: 2023-02
• Study Completion: 2023-02-10
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• 18-80 year old patients;
• Retained catheter ≥ 7 days;
• Patients who were conscious and had good communication skills and volunteered to participate in the study.

Exclusion Criteria

• Pregnant and lactating female patients;
• Diabetes patients;
• Patients allergic to sulfadiazine, silica gel and stainless steel;
• Urethral malformation, acute urethral injury, prostate disease, intermittent catheterization, suprapubic cystostomy and other patients who are not suitable for catheterization;
• Patients who have used urinary catheters for a long time or had catheters retained within one week;
• Patients who are participating in other clinical trials that interfere with this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	super smooth antibacterial urinary catheter	Patients in this group used super smooth antibacterial urinary catheter
trial group	disposable urinary catheter	Patients in this group used the disposable urinary catheter

Primary Outcome Measures

Name	Time	Method
Urinary tract infection rate	one week	In accordance with the "Diagnostic Criteria for Catheter associated Urinary Tract Infection" in the "Technical Guidelines for the Prevention and Control of Catheter associated Urinary Tract Infection (Trial)" formulated and issued by the Ministry of Health in 2011. Although the patient has no symptoms, he or she has endoscopic examination or catheterization within one week. If the number of Gram positive cocci colonies in urine culture ≥ 10 has 4 cfu/ml, and the number of Gram negative bacilli colonies ≥ 10 has 5 cfu/ml, he or she should be diagnosed as asymptomatic bacteriuria. If the patient has urinary tract irritation symptoms such as frequent urination, urgent urination, and painful urination, or has lower abdominal tenderness, renal area percussion pain, with or without fever (\>38.0 ℃), it is symptomatic bacteriuria.

Secondary Outcome Measures

Name	Time	Method
Incidence of device related adverse events	one week	The safety of clinical use of the device was evaluated based on the incidence of adverse events related to the device that occurred after the subject placed the tube. Including: balloon leakage, rupture, catheter self falling off, difficulty in pulling out catheter, catheter blockage, urine retention, urine leakage, hematuria, urethral injury, etc; It can be judged according to clinical experience, and imaging methods can be used when necessary.
Success rate of catheterization	10 minutes after catheterization	The success of catheterization is based on the evaluation of each instrument, which can be placed at the catheterization site as expected and catheterization can be carried out smoothly.
time of catheter duration	one week	Time from insertion to removal of catheter
rate of device defect rate	10 minutes after catheterization	The package is damaged, the balloon cannot be inflated, and the balloon leaks or breaks
level of urethral irritation	one week	Level 0, no discomfort at all; Grade I, slight discomfort, but tolerable; Grade II, moderate discomfort, intolerable, urgency of urination, urethral pain, abdominal distension; Grade III, severe discomfort, extremely intolerable, obvious distension of lower abdomen, urethral pain, urgency of urination, and the desire to pull out the catheter, accompanied by restlessness, increased heart rate, and elevated blood pressure.
rating of operation convenience	10 minutes after catheterization	Including excellent: very convenient, good: relatively convenient, poor: poor convenience
rate of packaging integrity	10 minutes after catheterization

Trial Locations

Locations (1)

Liaoning Cancer Hospital & institute; 🇨🇳 Dalian, Liaoning, China