RecruitingNCT07535619

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

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.


Sponsor

Aalborg University Hospital

Enrollment

110 participants

Start Date

Dec 14, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 5 YearsMax Age: 17 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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).

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Locations(4)

Department of Pediatrics, Aalborg University Hospital

Aalborg, Denmark

Department of Pediatrics, Aarhus University Hospital

Aarhus, Denmark

Department of Pediatrics, Regional Hospital West Jutland

Herning, Denmark

Department of Pediatrics, North Denmark Regional Hospital

Hjørring, Denmark

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NCT07535619


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