Urinary CatheterNCT06230042
Catheter in the Prevention of Urinary Tract Infections and Crystallization Study(CPUTICS)
A study testing Types of catheters in people with Urinary Catheter, run by Shanghai East Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Catheter
- What is being tested?
- Types of catheters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age greater than 18 years;
- indwelling urinary catheter for ≥14 days;
- fully understand the clinical trial protocol and sign the informed consent;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai East Hospital, Tongji University School of Medicine
Shanghai, 200120
shuaidong wang, 15102100859, wangshuaidong_wsd@163.com
haifeng wang, 13681750891, kuohaiandrew2000@vip.sina.com.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Urinary Catheter
- Being tested
- Types of catheters
- Keywords
- urinary tract infections, urinary tract crystallization
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Types of cathetersOther
One type of catheters were used for patients
| Study group | Role | What they receive |
|---|---|---|
| Parylene-Coated Catheter | Experimental | The type of catheter used during a patient's indwelling urinary catheterization is Parylene-Coated Catheter Receives: Other: Types of catheters |
| Silicone Catheter | Active comparator | The type of catheter used during a patient's indwelling urinary catheterization is Silicone Catheter Receives: Other: Types of catheters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 14 after catheterization
Secondary outcomes (2)
Evaluation of urethral irritation response
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.
Measured: Day 1 after catheterization
Measuring the temperature of bladder urine
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.
Measured: the Day 3,Day 7, Day 10 and Day 14 after catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion15 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary CatheterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- haifeng wang, Principal investigator, Shanghai East Hospital of Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230042
- Sponsor's protocol ID
- CPUTICS-01
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parylene-Coated Versus Silicone Catheters in the Prevention of Urinary Tract Infections and Crystallization: A Single-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06230042
- Acronym / sponsor ID
- CPUTICS-01
- Conditions
- Urinary Catheter
- Keywords
- urinary tract infections, urinary tract crystallization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 15 Feb 2024 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parylene-Coated Catheter | Experimental | Other: Types of cathetersThe type of catheter used during a patient's indwelling urinary catheterization is Parylene-Coated Catheter |
| Silicone Catheter | Active comparator | Other: Types of cathetersThe type of catheter used during a patient's indwelling urinary catheterization is Silicone Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age greater than 18 years;
- indwelling urinary catheter for ≥14 days;
- fully understand the clinical trial protocol and sign the informed consent;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Types of cathetersOne type of catheters were used for patients | Other | Parylene-Coated Catheter, Silicone Catheter |
Primary outcome
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.
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.
2 secondary outcomes
Evaluation of urethral irritation response
Time frame: Day 1 after catheterization
Measuring the temperature of bladder urine
Time frame: the Day 3,Day 7, Day 10 and Day 14 after catheterization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
haifeng wang principal investigator
Shanghai East Hospital of Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Types of catheters in people with Urinary Catheter, run by Shanghai East Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shuaidong wang (15102100859, wangshuaidong_wsd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catheter-Associated Urinary Tract Infection (CAUTI) Incidence (time frame: the Day 3,Day 7, Day 10 and Day 14 after catheterization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.