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.
Daytime Urinary Incontinence (DUI) is a common condition among children affecting 2.1-21.8 % of children aged 4.5-17 years. DUI is most often caused by a functional overactive bladder (OAB) leading to urgent desire to void (urgency) and frequent urinations (frequency). In some children with functional OAB and DUI, the bladder detrusor is overactive when performing a urodynamic investigation, but this is not evident for all children suffering from OAB and DUI. The etiology of OAB and DUI is not yet fully established and might be multifactorial. A few studies among adults have shown that adult women with OAB and DUI has more activity in brain areas controlling the bladder compared to adult women without bladder symptoms. Moreover, one study among adult women has shown a decrease in brain activity in areas controlling the bladder after sacral TENS treatment. This has led to a hypothesis that increased activity in the brain is a pathophysiological mechanism of OAB and DUI. Brain activity among children with OAB and DUI has not yet been investigated. Therefore, the objectives of this study is: 1. To investigate the activity in brain areas controlling the bladder among children with OAB and DUI and age- and gender-matched children without bladder symptoms AND 2. To investigate if sacral TENS has a centrally modulatory effect on the brain activity in areas controlling the bladder among children with OAB and DUI. Methods: The study consists of two sub-studies. The first sub-study is a cross-sectional study, whereas the second sub-study is an interventional cohort study. Forty-five children with OAB and DUI and 20 healthy children without bladder symptoms will be recruited. The study includes one structural MRI as well as two sessions of functional MRIs (only one functional MRI for healthy participants), one session prior to and after 10 weeks of sacral TENS treatment. The functional MRI session consist of a functional MRI with full bladder followed by a functional MRI with empty bladder. Moreover, the study participants and/or their parents are asked to fill in frequency and volume charts, Dry Pie, screening tools to rule out attention deficit hyperactivity disorder and autism spectrum disorders, and quality of life-questionnaires (WHO-5 and PinQ).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
65
Sacral TENS applied two hours daily for 10 weeks
Department of Pediatrics, Aalborg University Hospital
Aalborg, Denmark
RECRUITINGDepartment of Pediatrics, Aarhus University Hospital
Aarhus, Denmark
NOT_YET_RECRUITINGDepartment of Pediatrics, Regional Hospital West Jutland
Herning, Denmark
NOT_YET_RECRUITINGDepartment of Pediatrics, North Denmark Regional Hospital
Hjørring, Denmark
NOT_YET_RECRUITINGActivity 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.
Time frame: Baseline
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.
Time frame: Baseline AND immediately after the intervention
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)
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline AND immediately after the intervention
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.
Time frame: Baseline AND immediately after the intervention
Change in WHO-5 score among children with OAB and DUI compared among responders and non-responders to sacral TENS treatment.
Assessment of QoL using WHO-5 and compare among responders and non-responders to 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.
Time frame: Immediately after the intervention
Change in PinQ score among children with OAB and DUI compared among responders and non-responders to sacral TENS treatment.
Assessment of QoL using PinQ and compare among responders and non-responders to 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.
Time frame: Immediately after the intervention
Differences in maximum voided volume among responders and non-responders to sacral TENS treatment
Differences in maximum voided volume (MVV) in milliliters as assessed by the frequency and volume chart, compared among responders and non-responders to sacral TENS treatment.
Time frame: Baseline AND immediately after the intervention
Differences in voiding frequency among responders and non-responders to sacral TENS treatment
Differences in voiding frequency as assessed by the frequency and volume chart, compared among responders and non-responders to sacral TENS treatment.
Time frame: Baseline AND immediately after the intervention
Differences in VAS Urgency among responders and non-responders to sacral TENS treatment
Differences in VAS Urgency (visual analogue scale for urgency) in percent with a higher percent indicating a higher degree of urgency, compared among responders and non-responders to sacral TENS treatment.
Time frame: Baseline AND immediately after the intervention
Differences in urinary incontinence severity scores among responders and non-responders to sacral TENS treatment
Differences in urinary incontinence severity scores as assessed by Dry Pie, compared among responders and non-responders to sacral TENS treatment.
Time frame: Baseline AND immediately after the intervention
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