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NCT Number: NCT07535619

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

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.

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Key information

Conditions

Urinary Incontinence Behavior Behavioral Symptoms Daytime Wetting Diurnal Enuresis Elimination Disorders Enuresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pediatrics, Aalborg University Hospital, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

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

    Time frame: 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.

  6. Change in the perineal/preputial microbiota concurrently with non-pharmacological and pharmacological treatment of daytime urinary incontinence.

    Time frame: 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.

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

    Time frame: 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.

  8. Change in the voided urinary microbiota among healthy children with increasing age and puberty stage.

    Time frame: 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).

  9. Change in the perineal/preputial microbiota among healthy children with increasing age and puberty stage.

    Time frame: 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).

  10. Change in the fecal microbiota among healthy children with increasing age and puberty stage.

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Kristina Thorsteinsson, MD

CONTACT

[email protected]

+4597663372

Søren Hagstrøm, MD, PhD

CONTACT

[email protected]

+4597663400

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

  • Aarhus University Hospital
  • Regional Hospital West Jutland
  • Regionshospital Nordjylland

Registry information

Official study title

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.

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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