RecruitingNot Applicable

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

Denmark65 participantsStarted 2021-05-05

Plain-language 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.

Who can participate

Age range6 Years – 14 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Activity in brain areas controlling the bladder

Timeframe: Baseline

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

Timeframe: Baseline AND immediately after the intervention

Trial details

NCT IDNCT05989646

SponsorAalborg University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Kristina Thorsteinsson, MD

+4597663372 uroforsk@rn.dk