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

NCT05989646 | Recruiting DMC

• 1 other identifier: N-20210004
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline

• 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.

  Baseline AND immediately after the intervention

Secondary Outcomes (10)

• Structural differences on MRI among children with OAB and DUI and healthy children

  Baseline

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

  Baseline

• Change in WHO-5 score among children with OAB and DUI at baseline and after the intervention.

  Baseline AND immediately after the intervention

• Change in PinQ score among children with OAB and DUI at baseline and after the intervention.

  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.

  Immediately after the intervention

Study Arms (1)

Transcutaneous Electric Nerve Stimulation (TENS)

EXPERIMENTAL

Sacral TENS

Device: Sacral TENS

Interventions

Sacral TENS DEVICE

Sacral TENS applied two hours daily for 10 weeks

Also known as: Urotherapy

Transcutaneous Electric Nerve Stimulation (TENS)

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aarhus University Hospital: collaborator
• Regional Hospital West Jutland: collaborator
• Regionshospital Nordjylland: collaborator

Study Sites (4)

Department of Pediatrics, Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Department of Pediatrics, Aarhus University Hospital

Aarhus, 8200, Denmark

NOT YET RECRUITING

Department of Pediatrics, Regional Hospital West Jutland

Herning, 7400, Denmark

NOT YET RECRUITING

Department of Pediatrics, North Denmark Regional Hospital

Hjørring, 9800, Denmark

NOT YET RECRUITING

Related Publications (12)

• 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.

  PMID: 30930018 BACKGROUND

• 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.

  PMID: 31397011 BACKGROUND

• 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.

  PMID: 15043666 BACKGROUND

• 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.

  PMID: 20199496 BACKGROUND

• 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.

  PMID: 31804751 BACKGROUND

• 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.

  PMID: 18829077 BACKGROUND

• 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.

  PMID: 27530266 BACKGROUND

• 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.

  PMID: 18490916 BACKGROUND

• 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.

  PMID: 18092336 BACKGROUND

• 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.

  PMID: 17574871 BACKGROUND

• 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.

  PMID: 29630979 BACKGROUND

• 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.

  PMID: 31172280 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence; Diurnal Enuresis; Urination Disorders; Nocturnal Enuresis; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Mental Disorders; Elimination Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Enuresis; Behavior

Central Study Contacts

Kristina Thorsteinsson, MD

CONTACT

+4597663372; uroforsk@rn.dk

Søren Hagstrøm, MD, PhD

CONTACT

+4597663400; uroforsk@rn.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Cross-sectional and interventional cohort study

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: August 14, 2023
• Study Start: May 5, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

DK (4)