The Voided Urinary, Perineal, and Faecal Microbiota Among Children and Adolescents - the PpUF-study.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-17
SponsorAalborg University Hospital

About this trial

The aim of this study is to investigate whether the voided urinary, perineal/preputial, and the fecal microbiota are different between children suffering from Overactive Bladder (OAB) and Daytime Urinary Incontinence (DUI) compared to age- and gender-matched healthy children without bladder symptoms. Moreover, the study aims to investigate if the microbiota is different according to the severity of DUI and if the microbiota is changed throughout treatment of DUI. A follow-up study will as well be performed on healthy children to investigate how the microbiota evolves with increasing age and pubertal stage. Children with OAB and DUI will be recruited from involved pediatric departments, and specimen in the form of urine, perineal/preputial swabs, and feces will be collected according to the protocol.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Overactive bladder as per International Children's Continence Society criteria (cases only).

At least two wet days per week (cases only).

No prior pharmacological treatment of OAB and DUI (cases only).

No lower urinary tract symptoms (healthy participants only).

Disqualifiers

No known urogenital abnormality affecting the lower urinary tract function.

No known gastrointestinal or neurological diseases.

No use of systemic drugs within five half-lives of the drug.

No use of systemic antibiotics within three months before inclusion

Trial population

The study population consists of 70 children with overactive bladder and daytime urinary incontinence and 40 healthy children without bladder symptoms. Children with OAB and DUI will be recruited from the involved pediatric departments, whereas healthy children without bladder symptoms will be recruited from the community.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

110 Participants
are grouped into 2 trial groups
Group A: Children with Daytime Urinary Incontinence
Group B: Healthy children

Trial outcomes

Primary outcomes

1

Differences in the voided urinary microbiota between children with overactive bladder and daytime urinary incontinence and healthy children without bladder symptoms.

Comparison of alpha (within sample diversity) and beta diversity (between sample diversity) of the voided urinary microbiota between children with overactive bladder and daytime urinary incontinence and healthy children without bladder symptoms.

Time frame
Baseline
2

Differences in the perineal/preputial microbiota between children with overactive bladder and daytime urinary incontinence and healthy children without bladder symptoms.

Comparison of alpha (within sample diversity) and beta diversity (between sample diversity) of the perineal/preputial microbiota between children with overactive bladder and daytime urinary incontinence and healthy children without bladder symptoms.

Time frame
Baseline
3

Differences in the fecal microbiota between children with overactive bladder and daytime urinary incontinence and healthy children without bladder symptoms.

Comparison of alpha (within sample diversity) and beta diversity (between sample diversity) of the fecal microbiota between children with overactive bladder and daytime urinary incontinence and healthy children without bladder symptoms.

Time frame
Baseline
4

Differences in the voided urinary microbiota depending on severity of daytime urinary incontinence.

Comparison of alpha (within sample diversity) and beta diversity (between sample diversity) according to severity of daytime urinary incontinence. Children with incontinence will be grouped based on urinary incontinence severity score (assessed by the dry pie) and incontinence episodes (assessed by the frequency and volume chart).

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aalborg University Hospital

Lead sponsor

Aarhus University Hospital

Collaborator

Regional Hospital West Jutland

Collaborator

Regionshospital Nordjylland

Collaborator