Actively Recruiting

Phase Not Applicable
Age: 6Years - 14Years
All Genders
Healthy Volunteers
NCT05989646

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

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

65

Participants Needed

4

Research Sites

343 weeks

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

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.

CONDITIONS

Official 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
  • Overactive Bladder as defined by International Children's Continence Society criteria (cases only)
  • At least 2 urinary incontinence episodes 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 medications affecting brain function
  • Previous treatment with Enuresis Alarm or Transcutaneous Electrical Nerve Stimulation
  • Prior or current use of mirabegron or oxybutynin
  • Current urinary tract infection
  • Current constipation per Rome IV criteria or fecal incontinence
  • Claustrophobia
  • Presence of metallic items contraindicating MRI
  • Abnormal uroflowmetry (healthy participants only)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

S

Søren Hagstrøm, MD, PhD

CONTACT

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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