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The Effect of Sonographic Bladder Compressive Technique for Bag Urine Collection in Pediatrics

The Effect of Sonographic Bladder Compressive Stimulation Technique for Bag Urine Collection in Pediatrics: Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03152851
Enrollment
80
Registered
2017-05-15
Start date
2016-11-01
Completion date
2019-03-31
Last updated
2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infections

Brief 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 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

Interventions

PROCEDUREPressure stimulus group

Sponsors

Seoul National University Hospital
CollaboratorOTHER
Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
3 Months to 35 Months
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
The urine collection timeup to 2 hoursThe urine collection time

Secondary

MeasureTime frameDescription
The antibiotic administration timeup to 1 dayThe antibiotic administration time
Emergency department(ED) length of stay timeup to 1 dayEmergency department(ED) length of stay time
Comparison between the patients who were diagnosed as actual urinary tract infections and those who were not.up to 1 dayComparison between the patients who were diagnosed as actual urinary tract
Complicationsup to 1 monthComplications

Countries

South Korea

Contacts

Primary ContactYOOJIN CHOI, MD
choiyj0729@naver.com82-10-9360-9468

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026