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Clinical Trials in Denmark / NCT07535619
Recruiting Observational

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

NCT07535619 · tracked via the Priya Life Science Denmark tracker
Sponsor
Aalborg University Hospital
Phase
Observational
Started
2022-12-14
Last updated
2026-04-17

Condition(s) studied

Urinary IncontinenceDaytime WettingUrination DisordersUrologic DiseasesLower Urinary Tract SymptomsUrological ManifestationsElimination DisordersBehavioral Symptoms

Study 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.

Eligibility

Sex
ALL
Min age
5 Years
Max age
17 Years
Healthy volunteers
Accepted
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).

Primary outcome measure(s)

  • Differences in the voided urinary microbiota between children with overactive bladder and daytime urinary incontinence and healthy children without bladder symptoms. — 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. — 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. — 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. — 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. — Baseline AND 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after enrolment.
    Comparison of alpha (within sample diversity) and beta diversity (between sample diversity) of samples collected when initiating a new treatment (non-pharmacological or pharmacological) of daytime urinary incontinence.
  • Change in the perineal/preputial microbiota concurrently with non-pharmacological and pharmacological treatment of daytime urinary incontinence. — Baseline AND 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after enrolment.
    Comparison of alpha (within sample diversity) and beta diversity (between sample diversity) of samples collected when initiating a new treatment (non-pharmacological or pharmacological) of daytime urinary incontinence.
  • Change in the fecal microbiota concurrently with non-pharmacological and pharmacological treatment of daytime urinary incontinence. — Baseline AND 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after enrolment.
    Comparison of alpha (within sample diversity) and beta diversity (between sample diversity) of samples collected when initiating a new treatment (non-pharmacological or pharmacological) of daytime urinary incontinence.
  • Change in the voided urinary microbiota among healthy children with increasing age and puberty stage. — Baseline AND 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after enrolment.
    Comparison of alpha (within sample diversity) and beta diversity (between sample diversity) between healthy children in different age groups and with different pubertal stage (Tanner stage).
  • Change in the perineal/preputial microbiota among healthy children with increasing age and puberty stage. — Baseline AND 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after enrolment.
    Comparison of alpha (within sample diversity) and beta diversity (between sample diversity) between healthy children in different age groups and with different pubertal stage (Tanner stage).
  • Change in the fecal microbiota among healthy children with increasing age and puberty stage. — Baseline AND 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after enrolment.
    Comparison of alpha (within sample diversity) and beta diversity (between sample diversity) between healthy children in different age groups and with different pubertal stage (Tanner stage).

Trial sites (4)

FacilityCityRegionStatus
Department of Pediatrics, Aalborg University Hospital Aalborg Denmark Recruiting
Department of Pediatrics, Aarhus University Hospital Aarhus Denmark Not Yet Recruiting
Department of Pediatrics, Regional Hospital West Jutland Herning Denmark Recruiting
Department of Pediatrics, North Denmark Regional Hospital Hjørring Denmark Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07535619 on ClinicalTrials.gov ↗ ← All trials in Denmark