Back to resultsClinical Study on Disposable Sterile Urinary Catheter
Primary Purpose
Urinary Catheters, Urinary Tract Infection
Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
disposable urinary catheter
super smooth antibacterial urinary catheter
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Catheters
Eligibility Criteria
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.
Sites / Locations
- Liaoning Cancer Hospital & institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
trial group
control group
Arm Description
Patients in this group used the disposable urinary catheter
Patients in this group used super smooth antibacterial urinary catheter
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
time of catheter duration
Time from insertion to removal of catheter
rating of operation convenience
Including excellent: very convenient, good: relatively convenient, poor: poor convenience
rate of packaging integrity
rate of device defect rate
The package is damaged, the balloon cannot be inflated, and the balloon leaks or breaks
Full Information
NCT ID
NCT05651217
First Posted
December 1, 2022
Last Updated
February 16, 2023
Sponsor
Shandong Branden Med.Device Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05651217
Brief Title
Clinical Study on Disposable Sterile Urinary Catheter
Official Title
A Multicenter, Prospective, Randomized Controlled Clinical Study to Evaluate the Safety and Effectiveness of Disposable Sterile Urinary Catheter
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
The production of control group products is stopped, and the control group products cannot be obtained
Study Start Date
December 11, 2019 (Actual)
Primary Completion Date
September 12, 2021 (Actual)
Study Completion Date
February 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shandong Branden Med.Device Co.,Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Catheters, Urinary Tract Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
trial group
Arm Type
Experimental
Arm Description
Patients in this group used the disposable urinary catheter
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Patients in this group used super smooth antibacterial urinary catheter
Intervention Type
Device
Intervention Name(s)
disposable urinary catheter
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
super smooth antibacterial urinary catheter
Intervention Description
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)
Primary Outcome Measure Information:
Title
Urinary tract infection rate
Description
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.
Time Frame
one week
Secondary Outcome Measure Information:
Title
Success rate of catheterization
Description
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.
Time Frame
10 minutes after catheterization
Title
level of urethral irritation
Description
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.
Time Frame
10 minutes after catheterization
Title
level of urethral irritation
Description
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.
Time Frame
72 hours
Title
level of urethral irritation
Description
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.
Time Frame
one week
Title
Incidence of device related adverse events
Description
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 Frame
72 hours
Title
Incidence of device related adverse events
Description
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 Frame
one week
Title
time of catheter duration
Description
Time from insertion to removal of catheter
Time Frame
one week
Title
rating of operation convenience
Description
Including excellent: very convenient, good: relatively convenient, poor: poor convenience
Time Frame
10 minutes after catheterization
Title
rate of packaging integrity
Time Frame
10 minutes after catheterization
Title
rate of device defect rate
Description
The package is damaged, the balloon cannot be inflated, and the balloon leaks or breaks
Time Frame
10 minutes after catheterization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Liaoning Cancer Hospital & institute
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study on Disposable Sterile Urinary Catheter
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