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

Tongji University

Status: Not yet enrolling

Conditions: Urinary Catheter

Treatments: Other: Types of catheters

Study type: Interventional

Funder types: Other

Identifiers

NCT06230042

CPUTICS-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Parylene-Coated Catheter

Experimental group

Description:

The type of catheter used during a patient's indwelling urinary catheterization is Parylene-Coated Catheter

Treatment:

Other: Types of catheters

Silicone Catheter

Active Comparator group

Description:

The type of catheter used during a patient's indwelling urinary catheterization is Silicone Catheter

Treatment:

Other: Types of catheters