Brain Activity Among Children With Overactive Bladder and Daytime Urinary Incontinence and Healthy Children

Launched by AALBORG UNIVERSITY HOSPITAL · Aug 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how brain activity is different in children with Overactive Bladder (OAB) and Daytime Urinary Incontinence (DUI) compared to healthy children who do not have any bladder issues. The goal is to see if the brain areas that control bladder function behave differently in these two groups of children. Additionally, the study will explore whether a treatment called sacral transcutaneous electric nerve stimulation (TENS) can help improve bladder control and how it affects the brain.

To be part of this study, children must be between the ages of 2 and 5 years and have been diagnosed with OAB, experiencing at least two wetting episodes a week. Healthy children without any bladder symptoms are also invited to participate. Participants will undergo a type of brain scan called functional magnetic resonance imaging (fMRI) to measure brain activity before and after a 10-week treatment with TENS. Healthy children will only have the brain scan once at the beginning. It’s important to note that children with certain medical conditions, previous surgeries, or who are currently experiencing infections may not be eligible for this trial. This study aims to better understand bladder control in children and potentially improve treatments for those with OAB and DUI.

Gender

ALL

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).