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

April 15, 2026 updated by: Kristina Thorsteinsson, Aalborg University Hospital

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.

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.

Study Overview

Status

Recruiting

Conditions

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

  1. 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.
  2. if the bacterial composition of the voided urinary, the perineal/preputial, and the fecal microbiota differs according to the severity of DUI.
  3. 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 Type

Observational

Enrollment (Estimated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kristina Thorsteinsson, MD
  • Phone Number: +4597663372
  • Email: uroforsk@rn.dk

Study Contact Backup

  • Name: Søren Hagstrøm, MD, PhD
  • Phone Number: +4597663400
  • Email: uroforsk@rn.dk

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Recruiting
        • Department of Pediatrics, Aalborg University Hospital
        • Contact:
          • Kristina Thorsteinsson, MD
          • Phone Number: +4597663372
          • Email: uroforsk@rn.dk
      • Aarhus, Denmark, 8200
        • Not yet recruiting
        • Department of Pediatrics, Aarhus University Hospital
        • Contact:
      • Herning, Denmark, 7400
        • Recruiting
        • Department of Pediatrics, Regional Hospital West Jutland
        • Contact:
      • Hjørring, Denmark, 9800
        • Not yet recruiting
        • Department of Pediatrics, North Denmark Regional Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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.
Baseline
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).
Baseline
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.
Baseline AND 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after enrolment.
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.
Baseline AND 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after enrolment.
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.
Baseline AND 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after enrolment.
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).
Baseline AND 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after enrolment.
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).
Baseline AND 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after enrolment.
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).
Baseline AND 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after enrolment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University Hospital

Collaborators

Aarhus University Hospital
Regional Hospital West Jutland
Regionshospital Nordjylland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

August 4, 2023

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20200070

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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