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RecruitingNCT05989646Updated Apr 20, 2026

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

An interventional study of Sacral TENS in Urinary Incontinence, Daytime Wetting and Urination Disorders, sponsored by Aalborg University Hospital. Recruiting at 4 sites in Denmark. Open to participants aged 6 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by Aalborg University Hospital · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled May 2021, registered May 2023).
  • Started May 2021; still recruiting 5 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Not applicable
Ages
6 Years to 14 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

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

Keywords

  • Transcutaneous Electrical Nerve Stimulation
  • TENS
  • Functional Magnetic Resonance Imaging
  • fMRI
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In context

Urinary Incontinence

983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.

This study's planned enrollment of 65 is close to the median of 66 across 739 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Aalborg University Hospital is the lead sponsor of 198 studies on the registry; 41 are open to participants now.

Browse Aalborg University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
65 participants (estimated)

Study arms

  • Experimental
    Transcutaneous Electric Nerve Stimulation (TENS)

    Sacral TENS

    Device: Sacral TENS

Interventions

  • DeviceSacral TENS

    Sacral TENS applied two hours daily for 10 weeks

    Also known as: Urotherapy

06

What researchers measure

Primary outcomes

  1. Activity in brain areas controlling the bladder

    Blood Oxygen Level Dependent (BOLD)-signals on functional MRIs, compared between children with Overactive Bladder and Daytime Urinary Incontinence and children without bladder symptoms.

    Time frame: Baseline

  2. Change in activity in brain areas controlling the bladder after TENS-treatment

    Blood Oxygen Level Dependent (BOLD)-signals on functional MRIs, compared between responders and non-responders to TENS-treatment.

    Time frame: Baseline AND immediately after the intervention

Secondary outcomes

  1. Structural differences on MRI among children with OAB and DUI and healthy children

    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)

    Time frame: Baseline

  2. Differences in Quality of Life (QoL) between children with OAB and DUI and healthy children

    Assessment of QoL using WHO-5 among children with OAB and DUI and compare to QoL among children without bladder symptoms.

    Time frame: Baseline

  3. Change in WHO-5 score among children with OAB and DUI at baseline and 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.

    Time frame: Baseline AND immediately after the intervention

  4. Change in PinQ score among children with OAB and DUI at baseline and 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.

    Time frame: Baseline AND immediately after the intervention

  5. Change in WHO-5 score among children with OAB and DUI compared among responders and non-responders to sacral TENS treatment.

    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.

    Time frame: Immediately after the intervention

  6. Change in PinQ score among children with OAB and DUI compared among responders and non-responders to sacral TENS treatment.

    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.

    Time frame: Immediately after the intervention

  7. Differences in maximum voided volume among responders and non-responders to sacral TENS treatment

    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.

    Time frame: Baseline AND immediately after the intervention

  8. Differences in voiding frequency among responders and non-responders to sacral TENS treatment

    Differences in voiding frequency as assessed by the frequency and volume chart, compared among responders and non-responders to sacral TENS treatment.

    Time frame: Baseline AND immediately after the intervention

  9. Differences in VAS Urgency among responders and non-responders to sacral TENS treatment

    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.

    Time frame: Baseline AND immediately after the intervention

  10. Differences in urinary incontinence severity scores among responders and non-responders to sacral TENS treatment

    Differences in urinary incontinence severity scores as assessed by Dry Pie, compared among responders and non-responders to sacral TENS treatment.

    Time frame: Baseline AND immediately after the intervention

07

Study locations

1 of 4 sites recruiting
08

References and documents

Publications

  • Warner TC, Baandrup U, Jacobsen R, Boggild H, Aunsholt Ostergaard PS, Hagstrom S. Prevalence of nocturia and fecal and urinary incontinence and the association to childhood obesity: a study of 6803 Danish school children. J Pediatr Urol. 2019 May;15(3):225.e1-225.e8. doi: 10.1016/j.jpurol.2019.02.004. Epub 2019 Feb 15. PubMed 30930018 ↗
  • von Gontard A, Overs C, Moritz AM, Thome-Granz S, Hussong J. Incontinence and headache in preschool children. Neurourol Urodyn. 2019 Nov;38(8):2280-2287. doi: 10.1002/nau.24134. Epub 2019 Aug 8. PubMed 31397011 ↗
  • Gur E, Turhan P, Can G, Akkus S, Sever L, Guzeloz S, Cifcili S, Arvas A. Enuresis: prevalence, risk factors and urinary pathology among school children in Istanbul, Turkey. Pediatr Int. 2004 Feb;46(1):58-63. doi: 10.1111/j.1442-200X.2004.01824.x. PubMed 15043666 ↗
  • Swithinbank LV, Heron J, von Gontard A, Abrams P. The natural history of daytime urinary incontinence in children: a large British cohort. Acta Paediatr. 2010 Jul;99(7):1031-6. doi: 10.1111/j.1651-2227.2010.01739.x. Epub 2010 Feb 25. PubMed 20199496 ↗
  • Xing D, Wang YH, Wen YB, Li Q, Feng JJ, Wu JW, Jia ZM, Yang J, Sihoe JD, Song CP, Hu HJ, Franco I, Wen JG. Prevalence and risk factors of overactive bladder in Chinese children: A population-based study. Neurourol Urodyn. 2020 Feb;39(2):688-694. doi: 10.1002/nau.24251. Epub 2019 Dec 5. PubMed 31804751 ↗
  • Chung JM, Lee SD, Kang DI, Kwon DD, Kim KS, Kim SY, Kim HG, Moon du G, Park KH, Park YH, Pai KS, Suh HJ, Lee JW, Cho WY, Ha TS, Han SW; Korean Enuresis Association. Prevalence and associated factors of overactive bladder in Korean children 5-13 years old: a nationwide multicenter study. Urology. 2009 Jan;73(1):63-7; discussion 68-9. doi: 10.1016/j.urology.2008.06.063. Epub 2008 Sep 30. PubMed 18829077 ↗
  • Franco I. Overactive bladder in children. Nat Rev Urol. 2016 Sep;13(9):520-32. doi: 10.1038/nrurol.2016.152. Epub 2016 Aug 17. PubMed 27530266 ↗
  • Fowler CJ, Griffiths D, de Groat WC. The neural control of micturition. Nat Rev Neurosci. 2008 Jun;9(6):453-66. doi: 10.1038/nrn2401. PubMed 18490916 ↗
  • Griffiths D, Tadic SD. Bladder control, urgency, and urge incontinence: evidence from functional brain imaging. Neurourol Urodyn. 2008;27(6):466-74. doi: 10.1002/nau.20549. PubMed 18092336 ↗
  • Griffiths D, Tadic SD, Schaefer W, Resnick NM. Cerebral control of the bladder in normal and urge-incontinent women. Neuroimage. 2007 Aug 1;37(1):1-7. doi: 10.1016/j.neuroimage.2007.04.061. Epub 2007 May 18. PubMed 17574871 ↗
  • Weissbart SJ, Bhavsar R, Rao H, Wein AJ, Detre JA, Arya LA, Smith AL. Specific Changes in Brain Activity during Urgency in Women with Overactive Bladder after Successful Sacral Neuromodulation: A Functional Magnetic Resonance Imaging Study. J Urol. 2018 Aug;200(2):382-388. doi: 10.1016/j.juro.2018.03.129. Epub 2018 Apr 6. PubMed 29630979 ↗
  • Zuo L, Chen J, Wang S, Zhou Y, Wang B, Gu H. Intra- and inter-resting-state networks abnormalities in overactive bladder syndrome patients: an independent component analysis of resting-state fMRI. World J Urol. 2020 Apr;38(4):1027-1034. doi: 10.1007/s00345-019-02838-z. Epub 2019 Jun 6. PubMed 31172280 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05989646
Lead sponsor
Aalborg University Hospital
Collaborators
Aarhus University Hospital, Regional Hospital West Jutland, Regionshospital Nordjylland
Responsible party
Kristina Thorsteinsson (Principal Investigator, Aalborg University Hospital) — Principal investigator
First posted
Aug 14, 2023
Start date
May 5, 2021
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Apr 20, 2026

Study contacts

Kristina Thorsteinsson, MD
Contact
uroforsk@rn.dk
+4597663372
Søren Hagstrøm, MD, PhD
Contact
uroforsk@rn.dk
+4597663400

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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