Clinical Study on Disposable Sterile Urinary Catheter
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: trial group Patients in this group used the disposable urinary catheter |
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).
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| Active Comparator: control group Patients in this group used super smooth antibacterial urinary catheter |
Device: 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)
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
- level of urethral irritation [10 minutes after catheterization]
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.
- level of urethral irritation [72 hours]
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.
- 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.
- Incidence of device related adverse events [72 hours]
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.
- 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.
- time of catheter duration [one week]
Time from insertion to removal of catheter
- 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]
- rate of device defect rate [10 minutes after catheterization]
The package is damaged, the balloon cannot be inflated, and the balloon leaks or breaks
Eligibility Criteria
Criteria
Inclusion Criteria:
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18-80 year old patients;
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Retained catheter ≥ 7 days;
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Patients who were conscious and had good communication skills and volunteered to participate in the study.
Exclusion Criteria:
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Pregnant and lactating female patients;
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Diabetes patients;
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Patients allergic to sulfadiazine, silica gel and stainless steel;
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Urethral malformation, acute urethral injury, prostate disease, intermittent catheterization, suprapubic cystostomy and other patients who are not suitable for catheterization;
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Patients who have used urinary catheters for a long time or had catheters retained within one week;
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Patients who are participating in other clinical trials that interfere with this trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Liaoning Cancer Hospital & institute | Dalian | Liaoning | China | 110042 |
Sponsors and Collaborators
- Shandong Branden Med.Device Co.,Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B201703