A Multicenter, Prospective, Randomized Controlled Clinical Study to Evaluate the Safety and Effectiveness of Disposable Sterile Urinary Catheter
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- Urinary tract infection rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Urinary tract infection rate
Time Frame: 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 Outcomes
- Incidence of device related adverse events(one week)
- Success rate of catheterization(10 minutes after catheterization)
- time of catheter duration(one week)
- rate of device defect rate(10 minutes after catheterization)
- level of urethral irritation(one week)
- rating of operation convenience(10 minutes after catheterization)
- rate of packaging integrity(10 minutes after catheterization)