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

August 4, 2023 updated by: Kristina Thorsteinsson, Aalborg University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Daytime Urinary Incontinence (DUI) is a common condition among children affecting 2.1-21.8 % of children aged 4.5-17 years. DUI is most often caused by a functional overactive bladder (OAB) leading to urgent desire to void (urgency) and frequent urinations (frequency). In some children with functional OAB and DUI, the bladder detrusor is overactive when performing a urodynamic investigation, but this is not evident for all children suffering from OAB and DUI. The etiology of OAB and DUI is not yet fully established and might be multifactorial.

A few studies among adults have shown that adult women with OAB and DUI has more activity in brain areas controlling the bladder compared to adult women without bladder symptoms. Moreover, one study among adult women has shown a decrease in brain activity in areas controlling the bladder after sacral TENS treatment. This has led to a hypothesis that increased activity in the brain is a pathophysiological mechanism of OAB and DUI. Brain activity among children with OAB and DUI has not yet been investigated.

Therefore, the objectives of this study is:

  1. To investigate the activity in brain areas controlling the bladder among children with OAB and DUI and age- and gender-matched children without bladder symptoms AND
  2. To investigate if sacral TENS has a centrally modulatory effect on the brain activity in areas controlling the bladder among children with OAB and DUI.

Methods: The study consists of two sub-studies. The first sub-study is a cross-sectional study, whereas the second sub-study is an interventional cohort study. Forty-five children with OAB and DUI and 20 healthy children without bladder symptoms will be recruited. The study includes one structural MRI as well as two sessions of functional MRIs (only one functional MRI for healthy participants), one session prior to and after 10 weeks of sacral TENS treatment. The functional MRI session consist of a functional MRI with full bladder followed by a functional MRI with empty bladder. Moreover, the study participants and/or their parents are asked to fill in frequency and volume charts, Dry Pie, screening tools to rule out attention deficit hyperactivity disorder and autism spectrum disorders, and quality of life-questionnaires (WHO-5 and PinQ).

Study Type

Interventional

Enrollment (Estimated)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kristina Thorsteinsson, MD
  • Phone Number: +4597663372
  • Email: uroforsk@rn.dk

Study Contact Backup

  • Name: Søren Hagstrøm, MD, PhD
  • Phone Number: +4597663400
  • Email: uroforsk@rn.dk

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Recruiting
        • Department of Pediatrics, Aalborg University Hospital
        • Contact:
          • Kristina Thorsteinsson, MD
          • Phone Number: +4597660477
          • Email: uroforsk@rn.dk
      • Aarhus, Denmark, 8200
        • Not yet recruiting
        • Department of Pediatrics, Aarhus University Hospital
        • Contact:
      • Herning, Denmark, 7400
        • Not yet recruiting
        • Department of Pediatrics, Regional Hospital West Jutland
        • Contact:
      • Hjørring, Denmark, 9800
        • Not yet recruiting
        • Department of Pediatrics, North Denmark Regional Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcutaneous Electric Nerve Stimulation (TENS)
Sacral TENS
Device: Sacral TENS
Sacral TENS applied two hours daily for 10 weeks
Other Names:
  • Urotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity in brain areas controlling the bladder
Time Frame: Baseline
Blood Oxygen Level Dependent (BOLD)-signals on functional MRIs, compared between children with Overactive Bladder and Daytime Urinary Incontinence and children without bladder symptoms.
Baseline
Change in activity in brain areas controlling the bladder after TENS-treatment
Time Frame: Baseline AND immediately after the intervention
Blood Oxygen Level Dependent (BOLD)-signals on functional MRIs, compared between responders and non-responders to TENS-treatment.
Baseline AND immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Structural differences on MRI among children with OAB and DUI and healthy children
Time Frame: Baseline
Volume of brain areas involved in bladder control (e.g. lateral nuclei in pons, prefrontal cortex, anterior cingulate cortex (ACC), insula, periaqueductal grey (PAG), the pontine micturition center (PMC), and hypothalamus)
Baseline
Differences in Quality of Life (QoL) between children with OAB and DUI and healthy children
Time Frame: Baseline
Assessment of QoL using WHO-5 among children with OAB and DUI and compare to QoL among children without bladder symptoms.
Baseline
Change in WHO-5 score among children with OAB and DUI at baseline and after the intervention.
Time Frame: Baseline AND immediately after the intervention
Assessment of QoL using WHO-5 among children with OAB and DUI prior to and after ten weeks of sacral TENS-treatment. WHO-5 (World Health Organization Quality of Life Brief Version) is a validated tool, assessing QoL as a total percent-score (range 0-100). A high score indicates better QoL.
Baseline AND immediately after the intervention
Change in PinQ score among children with OAB and DUI at baseline and after the intervention.
Time Frame: Baseline AND immediately after the intervention
Assessment of QoL using PinQ among children with OAB and DUI prior to and after ten weeks of sacral TENS treatment. PinQ (Pediatric Incontinence Questionnaire) is a validated tool, assessing QoL as a total score (range 0-80). A lower score indicates better QoL.
Baseline AND immediately after the intervention
Change in WHO-5 score among children with OAB and DUI compared among responders and non-responders to sacral TENS treatment.
Time Frame: Immediately after the intervention
Assessment of QoL using WHO-5 and compare among responders and non-responders to sacral TENS-treatment. WHO-5 (World Health Organization Quality of Life Brief Version) is a validated tool, assessing QoL as a total percent-score (range 0-100). A high score indicates better QoL.
Immediately after the intervention
Change in PinQ score among children with OAB and DUI compared among responders and non-responders to sacral TENS treatment.
Time Frame: Immediately after the intervention
Assessment of QoL using PinQ and compare among responders and non-responders to sacral TENS-treatment. PinQ (Pediatric Incontinence Questionnaire) is a validated tool, assessing QoL as a total score (range 0-80). A lower score indicates better QoL.
Immediately after the intervention
Differences in maximum voided volume among responders and non-responders to sacral TENS treatment
Time Frame: Baseline AND immediately after the intervention
Differences in maximum voided volume (MVV) in milliliters as assessed by the frequency and volume chart, compared among responders and non-responders to sacral TENS treatment.
Baseline AND immediately after the intervention
Differences in voiding frequency among responders and non-responders to sacral TENS treatment
Time Frame: Baseline AND immediately after the intervention
Differences in voiding frequency as assessed by the frequency and volume chart, compared among responders and non-responders to sacral TENS treatment.
Baseline AND immediately after the intervention
Differences in VAS Urgency among responders and non-responders to sacral TENS treatment
Time Frame: Baseline AND immediately after the intervention
Differences in VAS Urgency (visual analogue scale for urgency) in percent with a higher percent indicating a higher degree of urgency, compared among responders and non-responders to sacral TENS treatment.
Baseline AND immediately after the intervention
Differences in urinary incontinence severity scores among responders and non-responders to sacral TENS treatment
Time Frame: Baseline AND immediately after the intervention
Differences in urinary incontinence severity scores as assessed by Dry Pie, compared among responders and non-responders to sacral TENS treatment.
Baseline AND immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University Hospital

Collaborators

Aarhus University Hospital
Regional Hospital West Jutland
North Denmark Regional Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2021

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

August 4, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20210004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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