A Comparative Analysis of Portable Bladder Scanner to Determine Age/ Volume Specific Accuracy in … (NCT04543552) | Clinical Trial Compass
CompletedNot Applicable
A Comparative Analysis of Portable Bladder Scanner to Determine Age/ Volume Specific Accuracy in 0-6 Years of Children
South Korea34 participantsStarted 2017-11-13
Plain-language summary
As a part of the urodynamic studies, urinary catheterization is inserted to measure residual urine, however, it has shown to be an invasive procedure, cause urinary tract infection, and traumatic experience. Bladder scan has been introduced as an alternative and non-invasive method to measure urine residual in the bladder.
Who can participate
Age range
1 Month – 6 Years
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:
* Under the age of 6 years old.
* Urodynamic study is scheduled to due to suspected changes in the bladder function or shape.
* Those who understand and sign the informed consent form.
Exclusion Criteria:
* Subjects with surgical history of the bladder.
* Constant leaking of the urine due to bladder neck contracture.
* Any congenital abnormalities that induce changes in the shape of the bladder.
* Unsuitable to participate in the study at the discretion of the principal investigator.
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
Scanned bladder volume
Timeframe: Immediately after procedure (urodynamics studies)
2
Estimated Post Void Residue
Timeframe: Immediately after procedure (urodynamics studies)
3
Drainage volume
Timeframe: Immediately after procedure (urodynamics studies)