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

Urinary Catheter Clinical Trial

Official title:

Parylene-Coated Versus Silicone Catheters in the Prevention of Urinary Tract Infections and Crystallization: A Single-Center Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06230042
• Other study ID #: CPUTICS-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: February 15, 2024

Study information

• Verified date: January 2024
• Source: Shanghai East Hospital
• Contact: shuaidong wang
• Phone: 15102100859
• Email: wangshuaidong_wsd[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: February 15, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Infections
• Urinary Catheter
• Urinary Tract Infections

Intervention

Other:
• Types of catheters
One type of catheters were used for patients

Locations

Country	Name	City	State
China	Shanghai East Hospital, Tongji University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai East Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Catheter-Associated Urinary Tract Infection (CAUTI) Incidence	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.	the Day 3,Day 7, Day 10 and Day 14 after catheterization
Primary	Crystal deposits on the inner wall of the catheter	? 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. ? Record the details and number of blockages that occurred during the indwelling catheterization period, and calculate the blockage rate of the two groups.	Day 14 after catheterization
Secondary	Evaluation of urethral irritation response	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.	Day 1 after catheterization
Secondary	Measuring the temperature of bladder urine	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.	the Day 3,Day 7, Day 10 and Day 14 after catheterization