Quick-Wee Versus Bladder Stimulation System to Collect Midstream Urine From Pre-continent Infants (NCT04587999) | Clinical Trial Compass
CompletedNot Applicable
Quick-Wee Versus Bladder Stimulation System to Collect Midstream Urine From Pre-continent Infants
Canada, France230 participantsStarted 2021-01-29
Plain-language summary
Urinary tract infections are common in infants. Obtaining urine from pre-continent children can be difficult and time consuming. The method of collection must balance reliability, speed, low rate of contamination, and invasiveness.
According to the American Academy of Pediatrics, midstream clean-catch urine is an acceptable method to diagnose urinary tract infections. However, it is impractical in pre-continent children.
Recently, two quick, safe and effective methods have been reported in the literature:
* The Quick-wee method: it consists in stimulating the suprapubic area with a cold and wet compress to obtain urines.
* The bladder stimulation method : the child is held under the armpits with legs dangling and a physician taps the suprapubic area and massages lumbar area alternatively.
However, advanced age, high weight, and level of discomfort during bladder stimulation were significantly associated with failure to obtain urines.
Who can participate
Age range
1 Year
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 under the age of 1 year, pre-continent, before walking
* For whom an urine sample is required for the diagnosis of a urinary tract infection, uropathy, nephropathy, metabolic disease
* Obtaining the authorization by one of the two parents or the holder of parental authority
* Affiliation to a national social security scheme
Exclusion Criteria:
* Do exhibiting signs of vital distress
* Withdrawal of informed consent by parents or holders of parental authority
* External genitalia or urinary tract malformation
* Bladder dysfunction
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
volume of urine collection to measure the effectiveness of two techniques
Timeframe: at the end of intervention completion, an average 30 minutes