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

NCT07535619 | Recruiting DMC

• 1 other identifier: N-20200070
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Urinary Incontinence; Daytime Wetting; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Elimination Disorders; Behavioral Symptoms

Keywords

Voided Urinary Microbiota; Perineal Microbiota; Fecal Microbiota; Illumina MiSeq Sequencing

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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).

  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.

  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.

  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.

  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).

  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).

  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).

  Baseline AND 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after enrolment.

Study Arms (2)

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.

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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 current urinary tract infection.
• No current constipation.
• Abnormal uroflowmetry (healthy participants only).

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aarhus University Hospital: collaborator
• Regional Hospital West Jutland: collaborator
• Regionshospital Nordjylland: collaborator

Study Sites (4)

Department of Pediatrics, Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Department of Pediatrics, Aarhus University Hospital

Aarhus, 8200, Denmark

NOT YET RECRUITING

Department of Pediatrics, Regional Hospital West Jutland

Herning, 7400, Denmark

RECRUITING

Department of Pediatrics, North Denmark Regional Hospital

Hjørring, 9800, Denmark

NOT YET RECRUITING

Related Publications (8)

• 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.

  PMID: 30930018 BACKGROUND

• Austin 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.

  PMID: 25772695 BACKGROUND

• Xing 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.

  PMID: 31804751 BACKGROUND

• Chung 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.

  PMID: 18829077 BACKGROUND

• Franco I. Overactive bladder in children. Nat Rev Urol. 2016 Sep;13(9):520-32. doi: 10.1038/nrurol.2016.152. Epub 2016 Aug 17.

  PMID: 27530266 BACKGROUND

• Pearce 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.

  PMID: 26210757 BACKGROUND

• Karstens 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.

  PMID: 27512653 BACKGROUND

• Okamoto 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.

  PMID: 32419054 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

In this study, urine samples, fecal samples, and swabs from the perineum among girls and the preputium among boys will be collected and bacterial DNA from these will be analysed.

MeSH Terms

Conditions

Urinary Incontinence; Diurnal Enuresis; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Elimination Disorders; Behavioral Symptoms

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Enuresis; Behavior; Mental Disorders

Central Study Contacts

Kristina Thorsteinsson, MD

CONTACT

+4597663372; uroforsk@rn.dk

Søren Hagstrøm, MD, PhD

CONTACT

+4597663400; uroforsk@rn.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: April 17, 2026
• Study Start: December 14, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

DK (4)