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.
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.
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.
Single group
Sacral TENS
DeviceSacral TENS applied two hours daily for 10 weeks
Activity in brain areas controlling the bladder
Blood Oxygen Level Dependent (BOLD)-signals on functional MRIs, compared between children with Overactive Bladder and Daytime Urinary Incontinence and children without bladder symptoms.
Change in activity in brain areas controlling the bladder after TENS-treatment
Blood Oxygen Level Dependent (BOLD)-signals on functional MRIs, compared between responders and non-responders to TENS-treatment.
Structural differences on MRI among children with OAB and DUI and healthy children
Volume of brain areas involved in bladder control (e.g. lateral nuclei in pons, prefrontal cortex, anterior cingulate cortex (ACC), insula, periaqueductal grey (PAG), the pontine micturition center (PMC), and hypothalamus)
Differences in Quality of Life (QoL) between children with OAB and DUI and healthy children
Assessment of QoL using WHO-5 among children with OAB and DUI and compare to QoL among children without bladder symptoms.
Change in WHO-5 score among children with OAB and DUI at baseline and after the intervention.
Assessment of QoL using WHO-5 among children with OAB and DUI prior to and after ten weeks of sacral TENS-treatment. WHO-5 (World Health Organization Quality of Life Brief Version) is a validated tool, assessing QoL as a total percent-score (range 0-100). A high score indicates better QoL.
Change in PinQ score among children with OAB and DUI at baseline and after the intervention.
Assessment of QoL using PinQ among children with OAB and DUI prior to and after ten weeks of sacral TENS treatment. PinQ (Pediatric Incontinence Questionnaire) is a validated tool, assessing QoL as a total score (range 0-80). A lower score indicates better QoL.
Click on the lead sponsor to view all of their trials.
Aalborg University Hospital
Lead sponsor
Aarhus University Hospital
Collaborator
Regional Hospital West Jutland
Collaborator
Regionshospital Nordjylland
Collaborator
