Urinary Tract InfectionsNCT03152851
The Effect of Sonographic Bladder Compressive Technique for Bag Urine Collection in Pediatrics
A study testing Pressure stimulus group in people with Urinary Tract Infections, run by Seoul National University Bundang Hospital at 2 sites in South Korea.
Trial summary
Aim: to shorten the time of urination by bladder pressure stimulation in children less than 36 months of age who need urinalysis to exclude or diagnose urinary tract infections and to speed up the start time of antibiotics treatment or to eliminate the overcrowding of emergency room(ER) by shortening the time of ER… Read more about this study
- Who is it for?
- Ages 3 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Pressure stimulus group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Nov 2016to 31 Mar 2019
- 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 3 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Body temperature of patients ≥ 38℃ reported by guardians
- No definite focus of fever detected by physical examination
- Guardian agrees to use urine bag(kismo) collection technique
Who cannot join
- Previous history of urinary tract infections
- Underlying urinary tract diseases (eg congenital anomalies, neuroblastomas, already diagnosed bladder ureters)
- ICU treatment indicated
- Newly diagnosed hydronephrosis on the day of visit
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
The Seoul National Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
YOOJIN CHOI, MD, 82-10-9360-9468, choiyj0729@naver.com
- Recruiting
Seoum national university
Seoul
Jaeyoon Jung, Dr, matewoos@gmail.com
About this study
Official title: The Effect of Sonographic Bladder Compressive Stimulation Technique for Bag Urine Collection in Pediatrics: Randomized Controlled Trial
Aim: to shorten the time of urination by bladder pressure stimulation in children less than 36 months of age who need urinalysis to exclude or diagnose urinary tract infections and to speed up the start time of antibiotics treatment or to eliminate the overcrowding of emergency room(ER) by shortening the time of ER stay.
Read the detailed description
- According to preassigned 1:1 randomization of 40 patients assigend to intervention group and other 40 patients assign to control group as follow.
- Get documented agreement from the caregiver if the patient meets the criteria.
- While the a nurse attaches a kismo to a patient, the researcher at the bedside measures the patient's bladder size as an maximal anteroposterior (AP) and transverse (T) diameter(cm)
- If the measured diameters (AP x T) is 2 X 2 or more, the research assistant check the assigned group of the patient.
- If the patient assigned to the intervention group, a pressure stimulus is applied once using an ultrasonic probe to the anteroposterior wall of the bladder until the anterior \& posterior wall meet.
- If the AP X T was less than 2 X 2, excluded from the study enrollment.
- During the study, caregivers and the assigned nurse will be blinded
- Conditions
- Urinary Tract Infections
- Being tested
- Pressure stimulus group
- 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.
Pressure stimulus groupProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Pressure stimulus group by ultrasound probe | Experimental | A pressure stimulus would be applied once using a device (ultrasound probe) to the anteroposterior wall of the bladder until the anterior \& posterior wall meet if the measured diameters (AP x T) is 2 X 2 or more by ultrasound Receives: Procedure: Pressure stimulus group |
| Non-pressure stimulus group | No intervention | No pressure stimulus would be given |
What is being measured
The primary outcome is the main question the study is designed to answer.
The urine collection time
The urine collection time
Measured: up to 2 hours
Secondary outcomes (4)
The antibiotic administration time
The antibiotic administration time
Measured: up to 1 day
Emergency department(ED) length of stay time
Emergency department(ED) length of stay time
Measured: up to 1 day
Comparison between the patients who were diagnosed as actual urinary tract infections and those who were not.
Comparison between the patients who were diagnosed as actual urinary tract
Measured: up to 1 day
Complications
Complications
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start1 Nov 2016
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital
- Responsible party
- Principal investigator, Hyuksool Kwon, Seoul National University Bundang Hospital
- Investigators
- JAEYOON JUNG, MD PhD, Principal investigator, The Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152851
- Sponsor's protocol ID
- B-1609-362-001
- Status last verified
- Apr 2018
- First submitted
- 10 May 2017
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sonographic Bladder Compressive Stimulation Technique for Bag Urine Collection in Pediatrics: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03152851
- Acronym / sponsor ID
- B-1609-362-001
- Conditions
- Urinary Tract Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Hospital
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 15 May 2017 (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.
Aim: to shorten the time of urination by bladder pressure stimulation in children less than 36 months of age who need urinalysis to exclude or diagnose urinary tract infections and to speed up the start time of antibiotics treatment or to eliminate the overcrowding of emergency room(ER) by shortening the time of ER stay.
Detailed description
- According to preassigned 1:1 randomization of 40 patients assigend to intervention group and other 40 patients assign to control group as follow.
- Get documented agreement from the caregiver if the patient meets the criteria.
- While the a nurse attaches a kismo to a patient, the researcher at the bedside measures the patient's bladder size as an maximal anteroposterior (AP) and transverse (T) diameter(cm)
- If the measured diameters (AP x T) is 2 X 2 or more, the research assistant check the assigned group of the patient.
- If the patient assigned to the intervention group, a pressure stimulus is applied once using an ultrasonic probe to the anteroposterior wall of the bladder until the anterior \& posterior wall meet.
- If the AP X T was less than 2 X 2, excluded from the study enrollment.
- During the study, caregivers and the assigned nurse will be blinded
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure stimulus group by ultrasound probe | Experimental | Procedure: Pressure stimulus groupA pressure stimulus would be applied once using a device (ultrasound probe) to the anteroposterior wall of the bladder until the anterior \& posterior wall meet if the measured diameters (AP x T) is 2 X 2 or more by ultrasound |
| Non-pressure stimulus group | No intervention | –No pressure stimulus would be given |
Who may qualify
- Ages
- 3 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Body temperature of patients ≥ 38℃ reported by guardians
- No definite focus of fever detected by physical examination
- Guardian agrees to use urine bag(kismo) collection technique
Key exclusion criteria (4 listed)
- Previous history of urinary tract infections
- Underlying urinary tract diseases (eg congenital anomalies, neuroblastomas, already diagnosed bladder ureters)
- ICU treatment indicated
- Newly diagnosed hydronephrosis on the day of visit
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 |
|---|---|---|
| Pressure stimulus group | Procedure or surgery | Pressure stimulus group by ultrasound probe |
Primary outcome
The urine collection time
Time frame: up to 2 hours
The urine collection time
4 secondary outcomes
The antibiotic administration time
Time frame: up to 1 day
Emergency department(ED) length of stay time
Time frame: up to 1 day
Comparison between the patients who were diagnosed as actual urinary tract infections and those who were not.
Time frame: up to 1 day
Complications
Time frame: up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- 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.
JAEYOON JUNG, MD PhD principal investigator
The Seoul National University Bundang Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure stimulus group in people with Urinary Tract Infections, run by Seoul National University Bundang Hospital at 2 sites 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 3 inclusion and 4 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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 YOOJIN CHOI, MD (82-10-9360-9468, choiyj0729@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The urine collection time (time frame: up to 2 hours). 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 18 Apr 2018.