Investigating brain activity in children with overactive bladder and urinary incontinence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to explore the differences in brain activity between children suffering from Overactive Bladder (OAB) and Daytime Urinary Incontinence (DUI) and healthy children. It will utilize functional magnetic resonance imaging (fMRI) to assess brain areas controlling bladder function before and after a 10-week treatment with sacral transcutaneous electrical nerve stimulation (TENS). The study will recruit children with OAB and DUI from pediatric departments, while healthy children will only undergo baseline fMRI assessments. The research seeks to understand the central mechanisms of TENS in relation to bladder control in children.

Why it matters

Who can join: the full rules

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).

Where it's running

• Department of Pediatrics, Aalborg University Hospital
  Aalborg, Denmark Recruiting
• Department of Pediatrics, Aarhus University Hospital
  Aarhus, Denmark Not yet recruiting
• Department of Pediatrics, Regional Hospital West Jutland
  Herning, Denmark Not yet recruiting
• Department of Pediatrics, North Denmark Regional Hospital
  Hjørring, Denmark Not yet recruiting

Study contacts

• Study coordinator: Kristina Thorsteinsson, MD
• Email: uroforsk@rn.dk
• Phone: +4597663372

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.