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The production of control group products is stopped, and the control group products cannot be obtained
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| trial group | Experimental | Patients in this group used the disposable urinary catheter |
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| control group | Active Comparator | Patients in this group used super smooth antibacterial urinary catheter |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| level of urethral irritation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liaoning Cancer Hospital & institute | Dalian | Liaoning | 110042 | China |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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) |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| time of catheter duration | Time from insertion to removal of catheter | one week |
| rating of operation convenience | Including excellent: very convenient, good: relatively convenient, poor: poor convenience | 10 minutes after catheterization |
| rate of packaging integrity | 10 minutes after catheterization |
| rate of device defect rate | The package is damaged, the balloon cannot be inflated, and the balloon leaks or breaks | 10 minutes after catheterization |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |