Not yet recruitingOBSERVATIONAL

Case Control Study to Investigate the Use of Urethral Pressure Profile Measurement in Children

This study is investigating a new test called 'urethral pressure profile' to understand how the bladder's 'tap' muscle, called the sphincter, works in children. The sphincter controls when urine is held or released. Sometimes, this muscle is too weak, leading to leaks, or too strong, making it hard to pee properly. Currently, doctors get indirect clues about the sphincter. This new test gives more direct information. The study will measure this in children with normal sphincters, and those with weak or overactive ones, to set up normal ranges. This will help doctors give more targeted and effective treatments for children with bladder problems.

At a glance

Status

Not yet recruiting

Sponsor

King's College London

Enrolment target

Start

01 Mar 2024

Estimated completion

01 Mar 2028

Dysfunctional Voiding Stress Incontinence, Urinary

What is this study about?

Bladder problems, like accidentally wetting yourself or having trouble peeing, are quite common in children and can be very upsetting. Your bladder works like a storage tank and a tap. The 'tap' is a muscle called the sphincter. When you need to hold pee, the sphincter is closed. When you pee, it opens up. If this tap doesn't work correctly – being too weak or too strong – it can cause problems like leaks (incontinence) or difficulty emptying the bladder fully.

Doctors often start with simple tests to check bladder function. However, sometimes these tests don't give enough information, and more detailed tests are needed. These might involve putting small tubes (catheters) into the bladder to measure pressure. While these tests are good at checking the bladder muscle itself, they don't always give a clear picture of how the 'tap' muscle (sphincter) is working.

This study aims to investigate a more direct test for the sphincter called a 'urethral pressure profile'. This test is already used in adults, but we don't have clear normal values for children. Researchers want to define what 'normal' looks like in children, as well as what they see when the sphincter is too weak or too strong. This will help doctors understand specific sphincter problems better and, in turn, lead to much more targeted and effective treatments for children who are struggling with bladder control issues. The test involves inserting a special, thin tube, so it will only be done when a child is already having another necessary procedure or surgery under general anaesthetic.

Key takeaways

New test explored for children's bladder 'tap' muscle (sphincter).
Aims to create normal values for bladder function in children.
Could lead to more tailored treatments for wetting or peeing problems.
Test done only during existing procedures under anaesthetic.
Open to children aged 7-16 with specific bladder conditions or for comparison.

Who may be eligible?

This study is looking for children and young people aged between 7 and 16 years old. They are interested in three groups: children with healthy bladders who are already having another bladder-related surgery, children whose bladders are emptying poorly because their sphincter muscle is too active, and children who leak urine because their sphincter muscle is too weak.

For children with healthy bladders, they should have no major bladder symptoms or daytime wetting, and no recent history of kidney stones or frequent urine infections. For those with overactive or underactive sphincter muscles, they would usually be undergoing a specific bladder test called videocystometry as part of their routine care, and their previous tests would have shown certain patterns of bladder function.

Children cannot take part if an adult responsible for them cannot give consent, or if they have had previous surgery on their bladder opening or tube. Also, certain other bladder conditions or illnesses like cerebral palsy or specific metabolic diseases would mean they couldn't join. There are also specific reasons related to certain types of sedation that might exclude a child, for example, if they have conditions where gas could get trapped in their body.

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 between 7 and 16 years old?
Is your child already having a bladder procedure under general anaesthetic?
Does your child have specific bladder problems like wetting or difficulty peeing, or a normally functioning bladder?
Does your child have other serious bladder or health conditions that aren't specifically part of the study?
Is a parent or guardian available to give consent for your child to join?

Answer every question to see your result.

What does participation involve?

If your child takes part, the urethral pressure profile test will be done at a children's hospital. This test involves inserting a special, thin tube. Because of this, it will only be carried out at the same time as another necessary procedure, like a videocystometry test or bladder surgery, while your child is already under general anaesthetic. This means your child won't need to have an extra anaesthetic just for this study.

The study will observe and record the results of this test. There are no additional visits required beyond what your child would already have for their scheduled procedure. This is a measurement study, so there are no medications given as part of the research. The study plans to gather information from children over a three-year period.

Potential risks and benefits

Taking part in this study could eventually help other children with bladder problems by improving how doctors diagnose and treat them. While this study doesn't offer direct treatment, the information gathered might help guide your child's doctors in the future. The main risk is that the test involves inserting a tube, but this will only happen when your child is already having another procedure under general anaesthetic, which helps to minimise discomfort. As with any study, you are free to change your mind and withdraw your child from the research at any time without giving a reason, and this will not affect your child's medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Evelina London Children's Hosital
Verified postcode
London, United Kingdom

Common questions

What is the 'sphincter'?

The sphincter is a muscle at the bottom of your bladder that acts like a 'tap' to control when you hold pee and when you let it out.

Why is this study important for my child?

This study aims to develop better ways to understand and treat bladder problems in children by getting more direct information about how their bladder 'tap' muscle works.

Will my child need extra procedures?

No, the special test for this study will only be done if your child is already having another necessary procedure or surgery under general anaesthetic.

Who is running this study?

This research is being carried out by medical professionals at a children's hospital.

Can I change my mind about my child participating?

Yes, you can decide to withdraw your child from the study at any time, and it won't affect their medical care.

How to find out more

arash taghizadeh, MBBS

arash.taghizadeh@gstt.nhs.uk +44 2071884610 Official trial record

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