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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-02-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Urinary Catheter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The participant, the investigator and the outcomes assessor were all masked. Only the care provider who performed the anaesthesia were not blinded but they were not involved in the subsequent prostate biopsy, pain assessment, data collection and data analysis.

Study Groups

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Parylene-Coated Catheter

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

Group Type EXPERIMENTAL

Types of catheters

Intervention Type OTHER

One type of catheters were used for patients

Silicone Catheter

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

Group Type ACTIVE_COMPARATOR

Types of catheters

Intervention Type OTHER

One type of catheters were used for patients

Interventions

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Types of catheters

One type of catheters were used for patients

Intervention Type OTHER

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes