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Brain Activity Among Children With Overactive Bladder and Daytime Urinary Incontinence and Healthy Children

RecruitingNAAges 6 Years - 14 YearsAllAalborg University Hospital
NCT05989646 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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).
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What it tests

  • Sacral TENS
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Where

4 sites
Department of Pediatrics, Aalborg University Hospital
Aalborg, Denmark
Department of Pediatrics, Aarhus University Hospital
Aarhus, Denmark
Department of Pediatrics, Regional Hospital West Jutland
Herning, Denmark
Department of Pediatrics, North Denmark Regional Hospital
Hjørring, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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