About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Sacral TENS

Treatment groups

65 Participants
are divided into 1 treatment group

Locations

4
Department of Pediatrics, Aalborg University Hospital9000, Aalborg Denmark
Department of Pediatrics, Aarhus University Hospital8200, Aarhus Denmark
Department of Pediatrics, Regional Hospital West Jutland7400, Herning Denmark
Department of Pediatrics, North Denmark Regional Hospital9800, Hjørring Denmark

Sponsors and collaborators

Aalborg University Hospital

Lead sponsor

Aarhus University Hospital

Collaborator

Regional Hospital West Jutland

Collaborator

Regionshospital Nordjylland

Collaborator