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
Who can participate
Age range
0 Days – 6 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Success Rate of the Bladder Stimulation Technique and Influencing Factors
Timeframe: From the start of the stimulation maneuver until at least 1 cc of urine is obtained (maximum of 5 minutes)