CompletedInterventional

Feasibility of conducting a randomised controlled trial (RCT) comparing invasive (catheter or needle) and non-invasive (clean catch/urine caught in a pot) urine sampling techniques in children under 16 years old with a suspected urinary tract infection

Doctors often need to collect urine from children to check for urinary tract infections (UTIs). There are different ways to do this, such as catching urine in a pot (non-invasive) or using a small tube (catheter) or needle (invasive). This study, called FROG, aims to see if it's practical to conduct a larger trial comparing these methods in children under 16 with suspected UTIs. The goal is to understand which method is best for children in the UK. This first step explores what works in a study setting, including gathering opinions from parents, children, and healthcare staff, and looking at the practicalities and challenges of recruiting families to such a trial.

At a glance

Status

Completed

Sponsor

Queen's University Belfast

Enrolment target

100

Start

08 Jun 2025

Estimated completion

04 Jun 2026

Urinary tract infection

What is this study about?

When children get a suspected urinary tract infection (UTI), doctors often need to collect a urine sample to find out what's causing it. There are several ways to get this sample, some are non-invasive, like catching the wee in a pot, and others are invasive, like using a very thin tube (called a catheter) or a needle to get the urine directly from the bladder. Different countries have different rules about which method to use.

Here in the UK, we need to understand which method is best for children and young people. Some methods might be better at avoiding contamination, which means the sample gives a clearer result. This study, called 'FROG', is the first step towards answering that question. It's a 'feasibility' study, which means we're checking if a bigger study comparing these urine collection methods would actually be possible to do.

The FROG study will involve three main parts. First, we'll see if it's practical to ask families to take part in a study where children are randomly assigned to have their urine collected in different ways. Second, we'll talk to parents, children, and healthcare staff to understand their thoughts and feelings about the different collection methods and about taking part in research. Finally, we'll bring everyone together to discuss what we've learned and design the best possible larger study for the future.

Key takeaways

This study aims to find the best way to collect urine samples from children with suspected UTIs.
It's a 'feasibility study' to plan a larger trial.
It compares invasive (tube/needle) and non-invasive (pot) urine collection.
Input is gathered from children, parents, and healthcare staff.
Participation involves sharing data, answering questions, or taking part in discussions.
There are small risks involved with invasive procedures.

Who may be eligible?

This study is looking for a few different groups of people.

For the main part of the study (Work Package 1), we're inviting children under 16 who have a suspected urinary tract infection and can't wee into a pot reliably on their own (meaning they're not toilet-trained for this type of sample).

For the other parts of the study (Work Packages 2 & 3), we're interested in talking to parents or guardians of children under 16 (and children aged 7 to 15 themselves) who were either asked to join the main study or who have needed a urine test for a suspected UTI in hospital in the last three years. We also want to hear from healthcare staff, like doctors, nurses, and other health professionals, who either help with this study or work with children who need urine tests for UTIs.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child under 16 years old?
Does your child need a urine test for a suspected UTI?
Is your child unable to wee into a pot by themselves?
Are you a parent/guardian of a child under 16 who might need a urine test for UTI?
Are you a healthcare professional involved in children's care or research?

Answer every question to see your result.

What does participation involve?

If your child takes part in the main study (Work Package 1), they might be asked to have their urine collected in an invasive way (using a catheter or a needle) or a non-invasive way (catching wee in a pot). You would be asked to share your child's medical information, answer a few short questions about the urine collection method used, and complete a questionnaire 3 to 6 months later. If you're involved in the other parts of the study (Work Packages 2 or 3), you might be asked to fill out a questionnaire, take part in an interview, or join a group discussion (focus group) to share your thoughts and experiences. The total time for your involvement would depend on which part of the study you participate in, but it generally involves answering questions or sharing your thoughts rather than ongoing appointments.

Potential risks and benefits

Those taking part in interviews for Work Package 2 will receive an Amazon voucher as a thank you. For children undergoing invasive urine collection methods (Work Package 1), there's a chance of discomfort or pain during the procedure. There's also a very small risk of damage to the bladder or the tube where urine leaves the body. Remember, you can choose to withdraw from the study at any time without it affecting your child's medical care.

Locations (6)

Royal Belfast Hospital for Sick Children
Approximate
Belfast, Northern Ireland
Leicester Royal Infirmary
Approximate
Leicester, England
John Radcliffe Hospital
Approximate
Oxford, England
Birmingham Childrens Hospital
Approximate
Birmingham, England
University College London Hospital
City only
London, England
Bristol Royal Hospital for Children
Unverified
Bristol, England

Common questions

What is a 'feasibility study'?

It's a small study done to see if a bigger, more definite study is possible and how best to design it.

What is an 'invasive' urine sample?

It means collecting urine by putting a thin tube into the bladder (catheter) or using a needle directly into the bladder.

What is a 'non-invasive' urine sample?

It means collecting urine in a pot while your child is peeing, often called a 'clean catch'.

Will my child be randomly chosen for a collection method?

Yes, if they participate in Work Package 1, the method would be chosen randomly, like flipping a coin.

Who is paying for this study?

The study is funded by the National Institute for Health and Care Research (NIHR) in the UK.

How to find out more

Paula Taylor Miller

FROG@nictu.hscni.net +44 (0)28 9615 1447 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.