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New treatment option for Urinary Incontinence
Official title Brain Activity Among Children With Overactive Bladder and Daytime Urinary Incontinence and Healthy Children
ClinicalTrials.gov ID: NCT05989646
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 14. Healthy volunteers may be eligible.
You may be able to join 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 likely can't join 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.
See the full eligibility 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, Denmark
- Aarhus, Denmark
- Herning, Denmark
- Hjørring, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 14 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, Denmark; Aarhus, Denmark; Herning, Denmark; Hjørring, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.