Catheter in the Prevention of Urinary Tract Infections and Crystallization Study(CPUTICS)

Not Applicable

Not yet recruiting

• Conditions: Urinary Catheter
• Interventions: Other: Types of catheters

• Registration Number: NCT06230042
• Lead Sponsor: Shanghai East Hospital

Brief Summary

This is a single-center randomized controlled trial in comparison of Parylene-Coated versus Silicone Catheters in the Prevention of Urinary Tract Infections and Crystallization.

Detailed Description

This study was a single-center randomized controlled trial, enrolling patients with indwelling urinary catheterization time greater than 2 weeks, and comparing the incidence of urinary tract infections in the two groups with different indwelling urinary catheter times by retaining mid-stream urine specimens for bacterial cultures on the 3rd, 7th, 10th, and 14th days after urinary catheter placement. And after removal of the urinary catheter,1-cm sections were taken from the head end and center of each urinary catheter, and the crystal deposition inside the catheter was observed using a scanning electron microscope. The incidence of urinary tract infections and crystal deposition on the inner wall of the catheter were compared between the patients in the matte catheter group (Parylene-coated) and the patients in the glossy catheter group (plain silicone) during the period of catheterization, so as to evaluate the effectiveness of the two types of catheters in the clinical application.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-01-27
• Last Update Submitted: 2024-01-27
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-29
• Study Start: 2024-02-01
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

1. age greater than 18 years;
2. indwelling urinary catheter for ≥14 days;
3. fully understand the clinical trial protocol and sign the informed consent;

Exclusion Criteria

1. patients with confirmed urinary tract infection before indwelling urinary catheter;
2. those with renal dysfunction;
3. those who are allergic to silicone or silicone material;
4. those with low immunity susceptible to infection;
5. those who have participated in other clinical trials within 3 months;
6. others who are judged by the investigator to be unsuitable for clinical trials;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parylene-Coated Catheter	Types of catheters	The type of catheter used during a patient's indwelling urinary catheterization is Parylene-Coated Catheter
Silicone Catheter	Types of catheters	The type of catheter used during a patient's indwelling urinary catheterization is Silicone Catheter

Primary Outcome Measures

Name	Time	Method
Catheter-Associated Urinary Tract Infection (CAUTI) Incidence	the Day 3,Day 7, Day 10 and Day 14 after catheterization	The mid-stream urine specimens on the 3rd, 7th, 10th and 14th days after catheterization were taken for bacterial culture to compare the incidence of urinary tract infections in the two groups at different times of indwelling urinary catheterization.; Diagnostic criteria: patients with urinary tract infections that occurred after indwelling urinary catheterization, or within 48 h of catheter removal. Urine bacterial culture of Gram-positive cocci colonies ≥104cfu/ml and Gram-negative bacilli colonies ≥105cfu/ml was judged as urinary tract infection.
Crystal deposits on the inner wall of the catheter	Day 14 after catheterization	① After removing the urinary catheter, a 1-cm section was taken from the head end and the center of each urinary catheter, and the crystal deposition inside the catheter was observed using a scanning electron microscope, and the average scores of the two groups were calculated according to the scores in the table below, comparing the effectiveness of the two groups of urinary catheters in preventing crystallization. ② Record the details and number of blockages that occurred during the indwelling catheterization period, and calculate the blockage rate of the two groups.

Secondary Outcome Measures

Name	Time	Method
Evaluation of urethral irritation response	Day 1 after catheterization	Patients were asked about their feelings after 24h of indwelling catheterization, and the occurrence of urethral irritation reaction was recorded according to their subjective feelings.
Measuring the temperature of bladder urine	the Day 3,Day 7, Day 10 and Day 14 after catheterization	The temperature of bladder urine was detected and recorded by connecting the machine end of the temperature measuring probe to the corresponding interface of the monitor on the 3rd, 7th, 10th, and 14th days after the patient's indwelling urinary catheter.

Trial Locations

Locations (1)

Shanghai East Hospital, Tongji University School of Medicine; 🇨🇳 Shanghai, China