Investigating bladder and bowel dysfunction in children
Bladder and Bowel Dysfunction in Children
This study is testing a new treatment for bladder and bowel problems in kids aged 5 to 14 to see if combining certain therapies helps them feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 5 Years to 15 Years |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 3 sites (Aalborg and 2 other locations) |
| Trial ID | NCT05318365 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the effectiveness of combination therapy in treating bladder and bowel dysfunction (BBD) in children aged 5 to 14 years. BBD is characterized by lower urinary tract symptoms and bowel complaints, such as functional constipation and faecal incontinence. The research will assess the role of the gut and urine microbiome in managing these conditions, which have been underexplored in pediatric populations. The treatment approach includes the use of Polyethylene Glycol 3350 and urotherapy, following a step-wise management strategy.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 5 to 14 years diagnosed with urinary incontinence and/or constipation.
Not a fit: Patients with neuropathic or anatomical abnormalities in the urinary tract or gastrointestinal canal will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for children suffering from bladder and bowel dysfunction.
How similar studies have performed: While research on BBD treatment is sparse, previous studies suggest that addressing bowel issues can enhance urinary symptom management, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Aalborg and 2 other locations
- Aalborg University Hospital — Aalborg, Denmark (Not_yet_recruiting)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Goedstrup Regional Hospital — Herning, Denmark (Recruiting)
Study contacts
- Principal investigator: Soeren Hagstroem, Professor, MD — Department of Childhood and Adolescent Medicine, Aalborg University Hospital
- Study coordinator: Sofie Axelgaard, MD
- Email: sofiaxel@rm.dk
- Phone: +45 61460024
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.