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Urinary IncontinenceNCT05989646

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

A study testing Sacral TENS in people with Urinary Incontinence and Daytime Wetting, run by Aalborg University Hospital at 4 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 14 yearsHealthy volunteers can take part
What is being tested?
Sacral TENS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
4 sitesDenmark
Study dates
5 May 2021to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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).

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kristina Thorsteinsson, MD contact

+4597663372

uroforsk@rn.dk

Søren Hagstrøm, MD, PhD contact

+4597663400

uroforsk@rn.dk

Denmark4 sites, 4 recruiting

  • Department of Pediatrics, Aalborg University Hospital

    Aalborg, 9000

    Kristina Thorsteinsson, MD, +4597660477, uroforsk@rn.dk

    Recruiting

  • Department of Pediatrics, Aarhus University Hospital

    Aarhus, 8200

    Konstantinos Kamperis, MD, PhD, +4578430000, kostas.kamperis@clin.au.dk

    Not yet recruiting

  • Department of Pediatrics, Regional Hospital West Jutland

    Herning, 7400

    Luise Borch, MD, PhD, luise.borch@rm.dk

    Not yet recruiting

  • Department of Pediatrics, North Denmark Regional Hospital

    Hjørring, 9800

    Mette Line Roed, MD, PhD, mld@rn.dk

    Not yet recruiting

Other trials in Denmark

About this study

Official title: 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.

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).

Being tested
Sacral TENS
Keywords
Transcutaneous Electrical Nerve Stimulation, TENS, Functional Magnetic Resonance Imaging, fMRI
Medical subject headings
Urinary Incontinence, Diurnal Enuresis, Urination Disorders, Nocturnal Enuresis, Urologic Diseases, Lower Urinary Tract Symptoms, Urological Manifestations, Behavioral Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacral TENSDevice

    Also called Urotherapy

    Sacral TENS applied two hours daily for 10 weeks

Study groups in NCT05989646
Study groupRoleWhat they receive
Transcutaneous Electric Nerve Stimulation (TENS)ExperimentalSacral TENS
Receives: Device: Sacral TENS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: Baseline AND immediately after the intervention

Secondary outcomes (10)

  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)

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline AND immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start5 May 2021
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
Cross-sectional and interventional cohort study
Masking
None (open label)
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05989646
Sponsor's protocol ID
N-20210004
Status last verified
Apr 2026
First submitted
31 May 2023
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Sacral TENS in people with Urinary Incontinence and Daytime Wetting, run by Aalborg University Hospital at 4 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kristina Thorsteinsson, MD (+4597663372, uroforsk@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Activity in brain areas controlling the bladder (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05989646, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.

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