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

NCT06230042 | Unknown DMC

• 1 other identifier: CPUTICS-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Catheter

Keywords

urinary tract infections; urinary tract crystallization

Outcome Measures

Primary Outcomes (2)

• 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

• Crystal deposits on the inner wall of the catheter

  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 Outcomes (2)

• Evaluation of urethral irritation response

  Day 1 after catheterization

• Measuring the temperature of bladder urine

  the Day 3,Day 7, Day 10 and Day 14 after catheterization

Study Arms (2)

Parylene-Coated Catheter

EXPERIMENTAL

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

Other: Types of catheters

Silicone Catheter

ACTIVE COMPARATOR

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

Other: Types of catheters

Interventions

Types of catheters OTHER

One type of catheters were used for patients

Parylene-Coated Catheter; Silicone Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age greater than 18 years;
• indwelling urinary catheter for ≥14 days;
• fully understand the clinical trial protocol and sign the informed consent;

You may not qualify if:

• patients with confirmed urinary tract infection before indwelling urinary catheter;
• those with renal dysfunction;
• those who are allergic to silicone or silicone material;
• those with low immunity susceptible to infection;
• those who have participated in other clinical trials within 3 months;
• others who are judged by the investigator to be unsuitable for clinical trials;

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, 200120, China

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• haifeng wang

  Shanghai East Hospital,Tongji University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

shuaidong wang

CONTACT

15102100859; wangshuaidong_wsd@163.com

haifeng wang

CONTACT

13681750891; kuohaiandrew2000@vip.sina.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2024
• Study Completion: February 15, 2024
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available after publication with no end date

Locations

CN (1)