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

Recruiting now · Not applicable

Conditions studied: Urinary Incontinence, Daytime Wetting, Urination Disorders, Urination Involuntary, Urologic Diseases, Lower Urinary Tract Symptoms, Urological Manifestations, Behavioral Symptoms, Mental Disorders, Elimination Disorders

In brief

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.

Key facts

Study ID

NCT05989646

Run by

Aalborg University Hospital

People needed

65

Starts

2021-05-05

Expected to finish

2027-12-01

Last updated by the study team

2026-04-20

Who can join

Age: 6 and older, up to 14. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Department of Pediatrics, Aalborg University Hospital — Aalborg, Denmark (enrolling)
• 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

Full record on ClinicalTrials.gov

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