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Active, not recruiting Not applicable

Bladder Stimulation Technique for Urine Collection in the Pediatric Emergency Department

NCT07654725 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-02-01
Last updated
2026-06-22

Condition(s) studied

Urinary Tract Infections in ChildrenDiagnostic Techniques, Urological

Investigational drug(s) / intervention(s)

Bladder Stimulation TechniqueTraditional Urine Bag Application

Bladder Stimulation Technique: In the intervention group, the Bladder Stimulation Technique (BST) was performed. The infant was held safely suspended in the air by their armpits by a researcher to relax the abdominal muscles. The physician then initiated a stimulation cycle consisting of 30 seconds of gentle paravertebral (lower back) massage, followed immediately by 30 seconds of light suprapubic (lower abdomen) tapping. This 1-minute cycle was repeated continuously for a maximum of 5 minutes. The moment the natural voiding reflex was triggered and the infant began to urinate, a midstream urine sample was directly caught into a sterile specimen container

Traditional Urine Bag Application: The current standard care method for urine collection in non-toilet-trained infants. The infant's perineal area is cleaned, and a standard, sterile pediatric adhesive urine collection bag is attached. The infant is then closely monitored in the emergency department until spontaneous natural voiding occurs into the bag.

Study summary

The purpose of this prospective, quasi-experimental study is to evaluate the efficacy of the Bladder Stimulation Technique (BST) compared to the traditional urine collection bag method in non-toilet-trained infants presenting to the Pediatric Emergency Department. The primary objective is to determine whether BST can significantly reduce urine contamination rates and the time required for successful sample collection. By comparing these two non-invasive methods, the study aims to provide a faster, cleaner, and more reliable diagnostic approach to solve the operational challenges of urine collection in acute pediatric care

Eligibility

Sex
ALL
Min age
0 Days
Max age
6 Months
Healthy volunteers
No
Inclusion Criteria: * Infants strictly under 6 months of age. * Patients presenting to the pediatric emergency department who require a urine sample collection for any clinical indication (e.g., fever without a source, suspected urinary tract infection). * Infants who are able to be fed orally or enterally (as the protocol requires the procedure to be performed 20 minutes after feeding to ensure bladder volume). * Presence of informed written consent from a parent or legal guardian. Exclusion Criteria: * Infants aged 6 months or older. * Patients requiring immediate life-saving resuscitation or those who are hemodynamically unstable. * Patients with known congenital anomalies of the genitourinary tract. * Patients with known neurological disorders that may affect normal bladder function or voiding reflexes (e.g., neural tube defects, spina bifida). * Presence of skin lesions, active infections, trauma, or surgical incisions in the paravertebral (lower back) or suprapubic (lower abdomen) areas that would contraindicate physical massage and tapping. * Patients with any clinical contraindication to feeding. * Refusal of parental consent.

Primary outcome measure(s)

  • Success Rate of the Bladder Stimulation Technique and Influencing Factors — From the start of the stimulation maneuver until at least 1 cc of urine is obtained (maximum of 5 minutes)
    The primary objective is to evaluate the percentage of successful urine collections, strictly defined as obtaining at least 1 cc (mL) of clean-catch midstream urine, achieved specifically by using bladder stimulation maneuvers (paravertebral massage and suprapubic tapping). Additionally, this outcome evaluates the clinical and demographic factors (e.g., patient age, gender, weight) that influence the success of this specific maneuver.

Trial sites (1)

FacilityCityRegionStatus
Istanbul Medeniyet University Istanbul Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07654725 on ClinicalTrials.gov ↗ ← All trials in Turkey