Clinical Study on Disposable Sterile Urinary Catheter

NCT05651217 | Terminated

• 1 other identifier: B201703
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Catheters; Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Success rate of catheterization

  10 minutes after catheterization

• level of urethral irritation

  10 minutes after catheterization

• level of urethral irritation

  72 hours

• level of urethral irritation

  one week

• Incidence of device related adverse events

  72 hours

Study Arms (2)

trial group

EXPERIMENTAL

Patients in this group used the disposable urinary catheter

Device: disposable urinary catheter

control group

ACTIVE COMPARATOR

Patients in this group used super smooth antibacterial urinary catheter

Device: super smooth antibacterial urinary catheter

Interventions

disposable urinary catheter DEVICE

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).

trial group

super smooth antibacterial urinary catheter DEVICE

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)

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Branden Med.Device Co.,Ltd: lead

Study Sites (1)

Liaoning Cancer Hospital & institute

Dalian, Liaoning, 110042, China

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 14, 2022
• Study Start: December 11, 2019
• Primary Completion: September 12, 2021
• Study Completion: February 10, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)