Clinical trial NCT06230042: Catheter in the Prevention of Urinary Tract Infections and Crystallization Study(CPUTICS)
Official title: Parylene-Coated Versus Silicone Catheters in the Prevention of Urinary Tract Infections and Crystallization: A Single-Center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Urinary Catheter
Keywords: urinary tract infections
urinary tract crystallization
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Catheter-Associated Urinary Tract Infection (CAUTI) Incidence
timeFrame: the Day 3,Day 7, Day 10 and Day 14 after catheterization
measure: Crystal deposits on the inner wall of the catheter
timeFrame: Day 14 after catheterization
Secondary outcomes:
measure: Evaluation of urethral irritation response
timeFrame: Day 1 after catheterization
measure: Measuring the temperature of bladder urine
timeFrame: the Day 3,Day 7, Day 10 and Day 14 after catheterization
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital, Tongji University School of Medicine
Study officials:
affiliation: Shanghai East Hospital,Tongji University School of Medicine
name: haifeng wang
role: PRINCIPAL_INVESTIGATOR
References: