Status:
RECRUITING
Bladder and Bowel Dysfunction in Children
Lead Sponsor:
University of Aarhus
Conditions:
Bladder and Bowel Dysfunction
Eligibility:
All Genders
5-15 years
Phase:
NA
Brief Summary
Background: Bladder and bowel dysfunction (BBD) is characterized by lower urinary tract symptoms accompanied by bowel complaints. BBD is a common condition in childhood. The present treatment strateg...
Detailed Description
Background Bladder and bowel dysfunction (BBD) is characterised by lower urinary tract symptoms (LUTS) accompanied by bowel complaints, primarily functional constipation and/or faecal incontinence. To...
Eligibility Criteria
Inclusion
- Age 5-14 years and 9 months at time of inclusion
- Diagnosed with urinary incontinence and/or enuresis nocturna defined by the ICCS criteria
- Diagnosed with constipation and/or faecal incontinence defined by the ROME IV criteria
- Normal clinical examination
- Parents/guardian can understand the written and spoken information
- Informed assent to participation from both parents/guardian
Exclusion
- Neuropathic or anatomical abnormalities in the urinary tract or gastrointestinal canal
- Earlier surgical intervention of the urinary tract (except circumcision)
- Neurological illness or earlier cerebral surgical intervention
- On-going urinary tract infection
- On-going treatment with anticholinergics and/or β3-adenoceptoragonist
- On-going treatment with laxatives in correct dosage (PEG3350 1-2 g/kg/day)
- Inflammatory bowel disease
- Other disorder affection bladder or bowel function
- For Study 2 (microbiome): Systemic antibiotics within the past 3 months
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05318365
Start Date
September 1 2022
End Date
December 1 2025
Last Update
May 8 2024
Active Locations (3)
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1
Aalborg University Hospital
Aalborg, Denmark, 9000
2
Aarhus University Hospital
Aarhus, Denmark, 8000
3
Goedstrup Regional Hospital
Herning, Denmark, 7400