Urological DiseaseNCT04152720
Evaluate the Efficacy and Safety of Prevention of Infection Foley Catheter as Compared to Conventional Foley Catheter
A study testing Foley catheter in people with Urological Disease and Radical Cystectomy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Comparison of effectiveness and safety of infection prevention silicone urinary catheters and conventional catheters for patients scheduled to perform urinary catheterization after radical cystectomy for urological diseases for more than 2 weeks Want to prove the clinical efficacy and safety. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Urological Disease, Radical Cystectomy
- What is being tested?
- Foley catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Aug 2018to 30 Mar 2020
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 19 and 80 years old
- Persons requiring urethral catheterization for more than 2 weeks after surgery * due to urological diseases
- Radical cystectomy
- Subjects who voluntarily decided to participate and signed the written informed consent
- A person who can understand and follow the instructions and participate in the pre-clinical period.
Who cannot join
- A person with a congenital abnormality in the urinary or reproductive system
- Immunodeficiency disease (eg HIV infected)
- Urinary tract fistula
- Allergic history of the material used in the catheter
- Symptomatic UTI by baseline time point
- Dermatitis at the catheter insertion site
Show all 11Show fewer
- Pregnant or lactating women
- A person who does not agree to contraceptive * in a medically accepted manner until the end of the study and 4 weeks after the end of the study.
- Medically acceptable contraceptive methods: condoms, oral contraceptives lasting at least 12 weeks, injectable or injectable contraceptives, intrauterine contraceptives, etc.
- Inappropriate participation in the study, as determined by the investigator or investigator, as it may affect ethical or clinical trial results.
- Patients on anti-thrombotic medication (excluding low-dose aspirin (100 mg, up to 300 mg / day))
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Ja Hyeon Ku, M.D, Ph.D, 82-2-2072-0361, randyku@hanmail.net
About this study
Official title: A Randomized, Multi-center, Open, Active-controlled Prospective Design Pilot Clinical Study to Evaluate the Efficacy and Safety of Prevention of Infection Foley Catheter as Compared to Conventional Foley Catheter in Patient Who Underwent Radical Cystectomy for Urological Disease
Comparison of effectiveness and safety of infection prevention silicone urinary catheters and conventional catheters for patients scheduled to perform urinary catheterization after radical cystectomy for urological diseases for more than 2 weeks Want to prove the clinical efficacy and safety.
- Conditions
- Urological Disease, Radical Cystectomy
- Being tested
- Foley catheter
- Keywords
- CAUTI, Catheter-associated urinary tract infection, Prevention of infection Foley Catheter
- Medical subject headings
- Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley catheterDevice
If the subject is enrolled in this clinical trial, the test and control devices will be applied at baseline. All subjects will receive a urinary catheter at the site of the artificial bladder and the urethra after surgery, and temporary urinary replacement should be selected by the investigator at each institution in preparation for the possibility of postoperative blockage of the urinary catheter.
After surgery, urine analysis and culture are performed on the 4th and 7th day, and urine analysis and culture are performed before the urethral catheter removal on the 14th (2 weeks) and the urethral catheter is removed. At this time, the urethral catheter tip is cut about 5-8 cm and cultured.
| Study group | Role | What they receive |
|---|---|---|
| Prevention of infection Foley catheter | Active comparator | Not described Receives: Device: Foley catheter |
| Conventional Foley catheter | Active comparator | Not described Receives: Device: Foley catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) Incidence of catheter-associated urinary tract infection (CAUTI) * 2 weeks after urethral catheterization
Measured: 2 weeks
Secondary outcomes (5)
1) Period until catheter-associated urinary tract infection (CAUTI) occurs
Measured: 2 weeks
2) Incidence of Significant Bacterial Cultures in Urethral Catheter Tip Culture
Measured: 2 weeks
3) Catheter related complication rate
Measured: 2 weeks
4) Catheter-associated urinary tract infection 2 weeks after urethral catheter insertion in test and control groups
Measured: 2 weeks
5) Antibiotic administration period due to catheter-related urinary tract infection
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start3 Aug 2018
- Primary completion13 Nov 2019 (estimated)
- Study completion30 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urological DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ja Hyeon Ku, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152720
- Sponsor's protocol ID
- APL_P_01
- Status last verified
- Nov 2019
- First submitted
- 3 Nov 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-center, Open, Active-controlled Prospective Design Pilot Clinical Study to Evaluate the Efficacy and Safety of Prevention of Infection Foley Catheter as Compared to Conventional Foley Catheter in Patient Who Underwent Radical Cystectomy for Urological Disease
- ClinicalTrials.gov ID
- NCT04152720
- Acronym / sponsor ID
- APL_P_01
- Conditions
- Urological Disease, Radical Cystectomy
- Keywords
- CAUTI, Catheter-associated urinary tract infection, Prevention of infection Foley Catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Samsung Medical Center
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 13 Nov 2019 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 5 Nov 2019 (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.
Comparison of effectiveness and safety of infection prevention silicone urinary catheters and conventional catheters for patients scheduled to perform urinary catheterization after radical cystectomy for urological diseases for more than 2 weeks Want to prove the clinical efficacy and safety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevention of infection Foley catheter | Active comparator | Device: Foley catheter |
| Conventional Foley catheter | Active comparator | Device: Foley catheter |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between 19 and 80 years old
- Persons requiring urethral catheterization for more than 2 weeks after surgery * due to urological diseases
- Subjects who voluntarily decided to participate and signed the written informed consent
- A person who can understand and follow the instructions and participate in the pre-clinical period.
Key exclusion criteria (11 listed)
- A person with a congenital abnormality in the urinary or reproductive system
- Immunodeficiency disease (eg HIV infected)
- Urinary tract fistula
- Allergic history of the material used in the catheter
- Symptomatic UTI by baseline time point
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 |
|---|---|---|
| Foley catheterIf the subject is enrolled in this clinical trial, the test and control devices will be applied at baseline. All subjects will receive a urinary catheter at the site of the artificial bladder and the urethra after surgery, and temporary urinary replacement should be selected by the investigator at each institution in preparation for the possibility of postoperative blockage of the urinary catheter. After surgery, urine analysis and culture are performed on the 4th and 7th day, and urine analysis and culture are performed before the urethral catheter removal on the 14th (2 weeks) and the urethral catheter is removed. At this time, the urethral catheter tip is cut about 5-8 cm and cultured. | Device | Conventional Foley catheter, Prevention of infection Foley catheter |
Primary outcome
1) Incidence of catheter-associated urinary tract infection (CAUTI) * 2 weeks after urethral catheterization
Time frame: 2 weeks
5 secondary outcomes
1) Period until catheter-associated urinary tract infection (CAUTI) occurs
Time frame: 2 weeks
2) Incidence of Significant Bacterial Cultures in Urethral Catheter Tip Culture
Time frame: 2 weeks
3) Catheter related complication rate
Time frame: 2 weeks
4) Catheter-associated urinary tract infection 2 weeks after urethral catheter insertion in test and control groups
Time frame: 2 weeks
5) Antibiotic administration period due to catheter-related urinary tract infection
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foley catheter in people with Urological Disease and Radical Cystectomy, run by Seoul National University Hospital at 1 site in South Korea.
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 5 inclusion and 11 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 5 Nov 2019. 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 South Korea. 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 Ja Hyeon Ku, MD (82-2-2072-0361, randyku@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1) Incidence of catheter-associated urinary tract infection (CAUTI) * 2 weeks after urethral catheterization (time frame: 2 weeks). 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 5 Nov 2019.