NCT05989646 Brain Activity Among Children With Overactive Bladder and Daytime Urinary Incontinence and Healthy Children
| NCT ID | NCT05989646 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aalborg University Hospital |
| Condition | Urinary Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 65 participants |
| Start Date | 2021-05-05 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 65 participants in total. It began in 2021-05-05 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05989646 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 14 Years, studying Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05989646 currently recruiting?
Yes, NCT05989646 is actively recruiting participants. Contact the research team at uroforsk@rn.dk for enrollment information.
Where is the NCT05989646 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus, Denmark, Herning, Denmark, Hjørring, Denmark.
Who is sponsoring the NCT05989646 clinical trial?
NCT05989646 is sponsored by Aalborg University Hospital. The trial plans to enroll 65 participants.