RecruitingNot ApplicableNCT05989646

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

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

Sponsor

Aalborg University Hospital

Enrollment

65 participants

Start Date

May 5, 2021

Study Type

INTERVENTIONAL

Conditions

Urinary Incontinence Lower Urinary Tract Symptoms Urologic Diseases Mental Disorders Behavioral Symptoms Urological Manifestations Daytime Wetting Urination Disorders Elimination Disorders Urination Involuntary

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

Min Age: 6 YearsMax Age: 14 Years

Inclusion Criteria5

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 Criteria12

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).