Clinical Study on Disposable Sterile Urinary Catheter

Urinary Tract Infection Clinical Trial

Official title:

A Multicenter, Prospective, Randomized Controlled Clinical Study to Evaluate the Safety and Effectiveness of Disposable Sterile Urinary Catheter

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05651217
• Other study ID #: B201703
• Status: Terminated
• Phase: N/A
• Start date: December 11, 2019
• Est. completion date: February 10, 2023

Study information

• Verified date: February 2023
• Source: Shandong Branden Med.Device Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 136
• Est. completion date: February 10, 2023
• Est. primary completion date: September 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Urinary Catheters
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Device:
• disposable urinary catheter
The trial group was intervened with disposable sterile urinary catheter. The model of the trial group includes two chamber type (Fr8, Fr10, Fr12, Fr14, Fr16, Fr18, Fr20, Fr22, Fr24) and three chamber type (Fr16, Fr18, Fr20, Fr22, Fr24).
• super smooth antibacterial urinary catheter
the control group was intervened with ultra smooth antibacterial catheter. The control group models include single chamber (6Fr, 8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, 24Fr), double chamber (6Fr, 8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, 24Fr, 26Fr, 28Fr, 30Fr), and three chamber (16Fr, 18Fr, 20Fr, 22Fr, 24Fr, 26Fr)

Locations

Country	Name	City	State
China	Liaoning Cancer Hospital & institute	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Branden Med.Device Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary tract infection rate	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.	one week
Secondary	Success rate of 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.	10 minutes after catheterization
Secondary	level of urethral irritation	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.	10 minutes after catheterization
Secondary	level of urethral irritation	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.	72 hours
Secondary	level of urethral irritation	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.	one week
Secondary	Incidence of device related adverse events	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.	72 hours
Secondary	Incidence of device related adverse events	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.	one week
Secondary	time of catheter duration	Time from insertion to removal of catheter	one week
Secondary	rating of operation convenience	Including excellent: very convenient, good: relatively convenient, poor: poor convenience	10 minutes after catheterization
Secondary	rate of packaging integrity		10 minutes after catheterization
Secondary	rate of device defect rate	The package is damaged, the balloon cannot be inflated, and the balloon leaks or breaks	10 minutes after catheterization