Case Control Study to Investigate the Use of Urethral Pressure Profile Measurement in Children (NCT04147793) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Case Control Study to Investigate the Use of Urethral Pressure Profile Measurement in Children
United Kingdom36 participantsStarted 2024-03-01
Plain-language summary
The bladder has a muscle that acts like a tap called the sphincter. Just like a tap, when pee is stored the sphincter muscle is closed and during peeing the sphincter opens. Sometimes the sphincter tap does not work properly and can cause problems. If the sphincter is weak there can be urine leak (incontinence). If the sphincter is too strong bladder might not empty properly.
Children who require investigation of their urinary problems are usually assessed with non-invasive tests. Sometimes investigation is with a more invasive test videourodynamics or video cystometrogram (VCMG; this test requires the insertion of catheters into the bladder and rectum. This test provides only indirect information about sphincter function.
It would be helpful to have a more direct test of the sphincter. It will allow better targeted treatments of sphincter problems which are often therapeutically challenging. Urethral pressure profile is a test used in adults to assess the sphincter. Although it has been described in children normal values have not been described.
The research project is to define urethral pressure profile values in children and young people with normal, weak and overactive sphincters.
Urethral pressure profile measurement is invasive as it requires the insertion of a special catheter. It will therefore be performed at the time of other invasive procedures eg VCMG or urology surgery under general anaesthetic.
The study will be conducted at single site, which is a children's hospital. The study will be an observational case controlled study with three arms: controls, those with overactive sphincters and those with underactive sphincters. The study is intended to run over three years.
Who can participate
Age range
7 Years – 16 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 All subjects • Age 7-16 years inclusive
Controls
* Concurrent urological disease requiring surgery which includes cystoscopy
* No significant urinary symptoms
* No day-time urinary incontinence
* Urinary frequency 4-7 per day
* No history of recurrent urinary infections (more than two infections in previous year)
* Has not passed a renal tract stone
Overactive sphincter
* Require VCMG as part of their clinical care
* A prior diagnosis of dysfunctional voiding. This will have been made in a neurologically intact child following previous non-invasive bladder investigation including two representative urine flows that demonstrate the following (Austin et al., 2014):
* Intermittent and/or fluctuating flow rate
* Pelvic EMG activity during voiding
* either perform intermittent catheterisation or have no contraindication to Entonox sedation (see below)
Underactive sphincter
* Have either:
* Symptoms of stress urinary incontinence
* Or urinary incontinence with a neuropathic bladder
* Require VCMG as part of their clinical care.
* either perform intermittent catheterisation or have no contraindication to Entonox sedation (see below)
* For the UPP data to be included for analysis their videocystometry should demonstrate o Stress urinary incontinence: defined as involuntary leakage of urine during increased abdominal pressure, in the absence of a detrusor contraction (Austin et al., 2014)
Exclusion Criteria:
* Unaccompanied by adult with parental r…
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.