Actively Recruiting

Phase Not Applicable
Age: 6Years - 14Years
All Genders
Healthy Volunteers
ID05989646

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

Led by Aalborg University Hospital · Updated on 2026-04-20

65

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Aalborg University Hospital

Lead Sponsor

A

Aarhus University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to explore brain activity in children with Overactive Bladder (OAB) and Daytime Urinary Incontinence (DUI) compared to healthy children of similar age and gender. It also investigates whether sacral transcutaneous electric nerve stimulation (TENS) influences brain areas controlling the bladder. The study focuses on children aged 6 to 14 years, as brain activity related to bladder control has not yet been studied in this group, though adult studies suggest increased brain activity may be a factor in OAB and DUI. Participants include children with OAB and DUI who will receive sacral TENS treatment applied for two hours daily over 10 weeks. The study involves two main parts: a cross-sectional comparison between affected and healthy children and an interventional cohort study where children with symptoms undergo sacral TENS. Imaging sessions include structural MRI and functional MRI scans with both full and empty bladder states, performed before and after the treatment. Healthy children will have only baseline imaging. During the study, children and/or their parents complete various assessments including frequency and volume charts, screening tools for attention deficit hyperactivity disorder and autism spectrum disorders, and quality of life questionnaires. Researchers will measure brain activity changes, structural brain differences, and quality of life changes before and after treatment. The primary outcomes focus on brain activity at baseline and after TENS, with secondary outcomes assessing quality of life and urinary symptoms. The study is conducted under careful monitoring to ensure safety and data quality.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 6Years - 14Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 6 to 14 years
  • Diagnosed with Overactive Bladder according to International Children's Continence Society criteria (cases only)
  • At least 2 episodes of urinary incontinence per week (cases only)
  • No urinary tract symptoms (healthy participants only)
  • More than 3 urinations daily
  • Normal clinical examination
Not Eligible

You will not qualify if you...

  • Known urogenital abnormalities affecting lower urinary tract function
  • Prior urinary tract surgery (except circumcision)
  • Known neurological diseases or prior brain surgery
  • Known or suspected neuropsychiatric disorders
  • Treatment with drugs affecting brain function
  • Previous treatment with Enuresis Alarm or Transcutaneous Electrical Nerve Stimulation
  • Current or prior treatment with mirabegron or oxybutynin
  • Current urinary tract infection
  • Current constipation or fecal incontinence
  • Claustrophobia
  • Metallic objects in the body that prevent MRI
  • Abnormal uroflowmetry in healthy participants only

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo MRI scans and complete assessments including frequency and volume charts, and questionnaires to evaluate brain activity and bladder function.

1 visit (in-person)

Implementation

Duration - 10 weeks

Participants with Overactive Bladder and Daytime Urinary Incontinence receive sacral Transcutaneous Electrical Nerve Stimulation (TENS) treatment applied two hours daily for 10 weeks.

Daily TENS treatment at home with periodic check-ins

Diagnostic Evaluation

Duration - 1 day

Participants undergo follow-up MRI scans and complete the same assessments to evaluate changes in brain activity and bladder function after TENS treatment.

1 visit (in-person)

Trial Site Locations

Total: 4 locations

1

Department of Pediatrics, Aalborg University Hospital

Aalborg, Denmark, 9000

Actively Recruiting

2

Department of Pediatrics, Aarhus University Hospital

Aarhus, Denmark, 8200

Not Yet Recruiting

3

Department of Pediatrics, Regional Hospital West Jutland

Herning, Denmark, 7400

Not Yet Recruiting

4

Department of Pediatrics, North Denmark Regional Hospital

Hjørring, Denmark, 9800

Not Yet Recruiting

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Research Team

K

Kristina Thorsteinsson, MD

S

Søren Hagstrøm, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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Published Research Related To This Trial

Prevalence of nocturia and fecal and urinary incontinence and the association to childhood obesity: a study of 6803 Danish school children.

T C Warner, U Baandrup, R Jacobsen...

https://pubmed.ncbi.nlm.nih.gov/30930018

Prevalence and associated factors of overactive bladder in Korean children 5-13 years old: a nationwide multicenter study.

Jae Min Chung, Sang Don Lee, Dong Il Kang...

https://pubmed.ncbi.nlm.nih.gov/18829077