The Voided Urinary, Perineal, and Faecal Microbiota Among Children and Adolescents With Overactive Bladder and Daytime Urinary Incontinence and Healthy Children and Adolescents - the PpUF-study.

Aalborg University Hospital4 sites in 1 country110 target enrollmentStarted: December 14, 2022Last updated: April 17, 2026

ConditionsUrinary Incontinence Daytime Wetting Urination Disorders Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Elimination Disorders Behavioral Symptoms

Overview

Phase: Not Applicable
Status: Recruiting
Sponsor: Aalborg University Hospital
Enrollment: 110
Locations: 4
Primary Endpoint: Differences in the voided urinary microbiota between children with overactive bladder and daytime urinary incontinence and healthy children without bladder symptoms.

Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Overview

Brief Summary

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.

Detailed Description

In Denmark, Daytime Urinary Incontinence (DUI) affects up to 22 % of children aged 5-7 years and 4.5 % of children aged 11-15 years. The most common cause of DUI is an idiopathic overactive bladder (OAB), leading to urgency (sudden desire to void) and frequency (frequent urinations). The cause of OAB among children and adolescents is not yet fully understood, however, studies among adults suggest dysbiosis of the voided and fecal microbiota as a possible explanation of OAB and DUI. This possible explanation is strengthen by the overlap in the symptomatology of OAB and urinary tract infections. Whether a different bacterial composition of the voided urinary, the perineal/preputial, and the fecal microbiota is evident for children with OAB and DUI compared to healthy children without bladder symptoms is yet to be elucidated.

The objectives of the present study are to investigate

if the bacterial composition of the voided urinary, the perineal/preputial, and the fecal microbiota differs between children with OAB and DUI and healthy children without bladder symptoms.
if the bacterial composition of the voided urinary, the perineal/preputial, and the fecal microbiota differs according to the severity of DUI.
if the bacterial composition of the voided urinary, the perineal/preputial, and the fecal microbiota alters concurrently with the treatment of DUI.

Moreover the objective of the study is to investigate how the microbiota changes with increasing age and pubertal stage.

Methods:

The study consists of three sub-studies. Sub-study one is a cross-sectional study comparing the microbiota of children with OAB and DUI and healthy children. The two other sub-studies are cohort follow-up-studies investigating the microbiota of children with OAB and DUI and healthy children without bladder symptoms, respectively. Seventy children with OAB and DUI and 40 healthy children without bladder symptoms will be recruited. Besides specimen collection (urine, swabs from the perineum (girls) and preputium (boys), and feces), the study participants and/or their parents are asked to fill in questionnaires, frequency and volume charts, and Dry Pies.

All children participating in the first sub-study are invited to enter the cohort follow-up-study. From participants with OAB and DUI willing to enter the follow-up-study, urine samples, swabs from the perineum/preputium, and fecal samples will be collected before initiating a new treatment modality of daytime urinary incontinence, and healthy children will be invited to a follow-up every 6 months until adulthood.

Study Design

Study Type: Observational
Observational Model: Cohort
Time Perspective: Prospective

Eligibility Criteria

Ages: 5 Years to 17 Years (Child)
Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•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).
•Negative urine dipstick test

Exclusion Criteria

•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
•No current urinary tract infection.
•No urinary tract infection within the last three months prior to inclusion.
•No current constipation.
•Abnormal uroflowmetry (healthy participants only).

Arms & Interventions

Children with Daytime Urinary Incontinence

Children, aged 5-17 years, who suffers from overactive bladder (OAB) and daytime urinary incontinence (DUI).

Healthy children

Children, aged 5-17 years, who are healthy and have no bladder symptoms.

Outcomes

Primary Outcomes

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

Time Frame: Baseline

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.

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

Time Frame: Baseline

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.

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

Time Frame: Baseline

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.

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

Time Frame: Baseline

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).

Change in the voided urinary microbiota concurrently with non-pharmacological and pharmacological treatment of daytime urinary incontinence.