Sacral TENS: Sacral TENS applied two hours daily for 10 weeks
Study summary
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
Sex
ALL
Min age
6 Years
Max age
14 Years
Healthy volunteers
Accepted
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).
Primary outcome measure(s)
Activity in brain areas controlling the bladder — Baseline 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 — Baseline AND immediately after the intervention Blood Oxygen Level Dependent (BOLD)-signals on functional MRIs, compared between responders and non-responders to TENS-treatment.
Trial sites (4)
Facility
City
Region
Status
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
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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