Investigating brain activity in children with overactive bladder and urinary incontinence

Brain Activity Among Children With Overactive Bladder and Daytime Urinary Incontinence and Healthy Children, and Modulation of Brain Activity by Transcutaneous Electrical Nerve Stimulation - a Functional Magnetic Resonance Imaging Study

This study is testing how brain activity differs in children with overactive bladder and urinary incontinence compared to healthy kids, to see if a new treatment can help improve their bladder control.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 65 (estimated)
• Ages: 6 Years to 14 Years
• Sex: All
• Sponsor: Aalborg University Hospital (other)
• Locations: 4 sites (Aalborg and 3 other locations)
• Trial ID: NCT05989646 on ClinicalTrials.gov

What this trial studies

This study aims to explore the differences in brain activity between children suffering from Overactive Bladder (OAB) and Daytime Urinary Incontinence (DUI) and healthy children. It will utilize functional magnetic resonance imaging (fMRI) to assess brain areas controlling bladder function before and after a 10-week treatment with sacral transcutaneous electrical nerve stimulation (TENS). The study will recruit children with OAB and DUI from pediatric departments, while healthy children will only undergo baseline fMRI assessments. The research seeks to understand the central mechanisms of TENS in relation to bladder control in children.

Who should consider this trial

Good fit: Ideal candidates include children aged 4.5-17 years diagnosed with Overactive Bladder and experiencing at least two incontinence episodes per week.

Not a fit: Patients with known urogenital abnormalities, neurological disorders, or those who have previously undergone treatments affecting bladder function may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for children suffering from urinary incontinence and enhance understanding of bladder control mechanisms.

How similar studies have performed: Previous studies in adults have shown promising results regarding brain activity changes after TENS treatment, but this specific approach in children is novel and has not been extensively tested.

Eligibility criteria

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).

Where this trial is running

Aalborg and 3 other locations

• 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)

Study contacts

• Study coordinator: Kristina Thorsteinsson, MD

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