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

January 27, 2024 updated by: Shanghai East Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parylene-Coated Catheter
The type of catheter used during a patient's indwelling urinary catheterization is Parylene-Coated Catheter
Other: Types of catheters
One type of catheters were used for patients
Active Comparator: Silicone Catheter
The type of catheter used during a patient's indwelling urinary catheterization is Silicone Catheter
Other: Types of catheters
One type of catheters were used for patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catheter-Associated Urinary Tract Infection (CAUTI) Incidence
Time Frame: 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.
the Day 3,Day 7, Day 10 and Day 14 after catheterization
Crystal deposits on the inner wall of the catheter
Time Frame: 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.
Day 14 after catheterization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of urethral irritation response
Time Frame: 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.
Day 1 after catheterization
Measuring the temperature of bladder urine
Time Frame: 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.
the Day 3,Day 7, Day 10 and Day 14 after catheterization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai East Hospital

Investigators

  • Principal Investigator: Haifeng Wang, Shanghai East Hospital,Tongji University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

February 15, 2024

Study Registration Dates

First Submitted

January 18, 2024

First Submitted That Met QC Criteria

January 27, 2024

First Posted (Estimated)

January 29, 2024

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 27, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPUTICS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once available, the results of this trial will be disseminated to an international peer-reviewed journal and presentations at international or national academic conferences. The data will be made available upon request to researchers a) who provide a methodologically sound proposal and b) whose proposed use of the data has been approved by an independent ethical review committee.

IPD Sharing Time Frame

Data will become available after publication with no end date

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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