Brain Activity Among Children With Overactive Bladder and Daytime Urinary Incontinence and Health… (NCT05989646) | Clinical Trial Compass
RecruitingNot Applicable
Brain Activity Among Children With Overactive Bladder and Daytime Urinary Incontinence and Healthy Children
Denmark65 participantsStarted 2021-05-05
Plain-language summary
The aim of this study is to investigate whether the activity in brain areas controlling the bladder is different among children suffering from Overactive Bladder (OAB) and Daytime Urinary Incontinence (DUI) compared to age- and gender-matched healthy children without bladder symptoms. Moreover, the aim is to investigate if sacral transcutaneous electric nerve stimulation (TENS) has a central mechanism of action. Children with OAB and DUI will be recruited from involved pediatric departments, and functional magnetic resonance imaging (fMRI) will be performed before and after 10 weeks of sacral TENS. In healthy children without bladder symptoms, only the baseline fMRI will be performed.
Who can participate
Age range
6 Years – 14 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:
* Overactive Bladder as per International Children's Continence Society criteria (cases only).
* At least 2 incontinence episodes per week (cases only).
* No urinary tract symptoms (healthy participants only).
* More than 3 daily urinations.
* Normal clinical examination.
Exclusion Criteria:
* Known urogenital abnormality affecting the lower urinary tract function.
* Prior surgery in the urinary tract (except circumcision).
* Known neurological diseases or prior cerebral surgery.
* Known neuropsychiatric disorders or suspicion of those by screening.
* Treatment with pharmacological agents affecting the brain function.
* Prior treatment with Enuresis Alarm or Transcutaneous Electrical Nerve Stimulation.
* Prior or current treatment with mirabegron or oxybutynin.
* Current urinary tract infection.
* Current constipation according to Rome IV-criteria or faecal incontinence.
* Claustrophobia.
* Metallic items in the body contraindicating MRI-scans.
* Abnormal uroflowmetry (healthy participants only).
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
Activity in brain areas controlling the bladder
Timeframe: Baseline
2
Change in activity in brain areas controlling the bladder after TENS-treatment
Timeframe: Baseline AND immediately after the intervention