Urinary IncontinenceNCT07535619
The Voided Urinary, Perineal, and Faecal Microbiota Among Children and Adolescents - the PpUF-study.
An observational study of Urinary Incontinence and Daytime Wetting, run by Aalborg University Hospital at 4 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Daytime Wetting, Urination Disorders
- How many people
- 110 participants
- Where
- 4 sitesDenmark
- Study dates
- 14 Dec 2022to Jun 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark4 sites, 4 recruiting
- Recruiting
Department of Pediatrics, Aalborg University Hospital
Aalborg, 9000
Kristina Thorsteinsson, MD, +4597663372, uroforsk@rn.dk
- Not yet recruiting
Department of Pediatrics, Aarhus University Hospital
Aarhus, 8200
Konstantinos Kamperis, MD, PhD, +4578450000, kostas.kamperis@clin.au.dk
- Recruiting
Department of Pediatrics, Regional Hospital West Jutland
Herning, 7400
Luise Borch, MD, PhD, +4578430000, luise.borch@rm.dk
- Not yet recruiting
Department of Pediatrics, North Denmark Regional Hospital
Hjørring, 9800
Mette Line Roed, MD, PhD, mld@rn.dk
About this study
Official 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.
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.
Read the 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.
- Conditions
- Urinary Incontinence, Daytime Wetting, Urination Disorders, Urologic Diseases, Lower Urinary Tract Symptoms, Urological Manifestations
- Keywords
- Voided Urinary Microbiota, Perineal Microbiota, Fecal Microbiota, Illumina MiSeq Sequencing
- Medical subject headings
- Urinary Incontinence, Diurnal Enuresis, Urination Disorders, Urologic Diseases, Lower Urinary Tract Symptoms, Urological Manifestations, Elimination Disorders, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Differences in the voided urinary microbiota between children with overactive bladder and daytime urinary incontinence and healthy children without bladder symptoms.
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.
Measured: Baseline
Differences in the perineal/preputial microbiota between children with overactive bladder and daytime urinary incontinence and healthy children without bladder symptoms.
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.
Measured: Baseline
Differences in the fecal microbiota between children with overactive bladder and daytime urinary incontinence and healthy children without bladder symptoms.
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.
Measured: Baseline
Differences in the voided urinary microbiota depending on severity of daytime urinary incontinence.
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).
Measured: Baseline
Change in the voided urinary microbiota concurrently with non-pharmacological and pharmacological treatment of daytime urinary incontinence.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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).
Measured: 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.
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).
Measured: 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.
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).
Measured: Baseline AND 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after enrolment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start14 Dec 2022
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Regional Hospital West Jutland, Regionshospital Nordjylland
- Responsible party
- Principal investigator, Kristina Thorsteinsson, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535619
- Sponsor's protocol ID
- N-20200070
- Status last verified
- Apr 2026
- First submitted
- 4 Aug 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Warner TC, Baandrup U, Jacobsen R, Boggild H, Aunsholt Ostergaard PS, Hagstrom S. Prevalence of nocturia and fecal and urinary incontinence and the association to childhood obesity: a study of 6803 Danish school children. J Pediatr Urol. 2019 May;15(3):225.e1-225.e8. doi: 10.1016/j.jpurol.2019.02.004. Epub 2019 Feb 15.
PubMed 30930018Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, Rittig S, Walle JV, von Gontard A, Wright A, Yang SS, Neveus T. The standardization of terminology of lower urinary tract function in children and adolescents: Update report from the standardization committee of the International Children's Continence Society. Neurourol Urodyn. 2016 Apr;35(4):471-81. doi: 10.1002/nau.22751. Epub 2015 Mar 14.
PubMed 25772695Xing D, Wang YH, Wen YB, Li Q, Feng JJ, Wu JW, Jia ZM, Yang J, Sihoe JD, Song CP, Hu HJ, Franco I, Wen JG. Prevalence and risk factors of overactive bladder in Chinese children: A population-based study. Neurourol Urodyn. 2020 Feb;39(2):688-694. doi: 10.1002/nau.24251. Epub 2019 Dec 5.
PubMed 31804751Chung JM, Lee SD, Kang DI, Kwon DD, Kim KS, Kim SY, Kim HG, Moon du G, Park KH, Park YH, Pai KS, Suh HJ, Lee JW, Cho WY, Ha TS, Han SW; Korean Enuresis Association. Prevalence and associated factors of overactive bladder in Korean children 5-13 years old: a nationwide multicenter study. Urology. 2009 Jan;73(1):63-7; discussion 68-9. doi: 10.1016/j.urology.2008.06.063. Epub 2008 Sep 30.
PubMed 18829077Franco I. Overactive bladder in children. Nat Rev Urol. 2016 Sep;13(9):520-32. doi: 10.1038/nrurol.2016.152. Epub 2016 Aug 17.
PubMed 27530266Pearce MM, Zilliox MJ, Rosenfeld AB, Thomas-White KJ, Richter HE, Nager CW, Visco AG, Nygaard IE, Barber MD, Schaffer J, Moalli P, Sung VW, Smith AL, Rogers R, Nolen TL, Wallace D, Meikle SF, Gai X, Wolfe AJ, Brubaker L; Pelvic Floor Disorders Network. The female urinary microbiome in urgency urinary incontinence. Am J Obstet Gynecol. 2015 Sep;213(3):347.e1-11. doi: 10.1016/j.ajog.2015.07.009. Epub 2015 Jul 23.
PubMed 26210757Karstens L, Asquith M, Davin S, Stauffer P, Fair D, Gregory WT, Rosenbaum JT, McWeeney SK, Nardos R. Does the Urinary Microbiome Play a Role in Urgency Urinary Incontinence and Its Severity? Front Cell Infect Microbiol. 2016 Jul 27;6:78. doi: 10.3389/fcimb.2016.00078. eCollection 2016.
PubMed 27512653Okamoto T, Hatakeyama S, Imai A, Yamamoto H, Yoneyama T, Mori K, Yoneyama T, Hashimoto Y, Nakaji S, Ohyama C. Altered gut microbiome associated with overactive bladder and daily urinary urgency. World J Urol. 2021 Mar;39(3):847-853. doi: 10.1007/s00345-020-03243-7. Epub 2020 May 17.
PubMed 32419054