An observational study in Urinary Incontinence, Daytime Wetting and Urination Disorders, sponsored by Aalborg University Hospital. Recruiting at 4 sites in Denmark. Open to participants aged 5 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Aalborg University Hospital · Observational
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.
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
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.
983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.
This study's planned enrollment of 110 is close to the median of 120 across 215 observational studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Aalborg University Hospital is the lead sponsor of 198 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Children, aged 5-17 years, who suffers from overactive bladder (OAB) and daytime urinary incontinence (DUI).
Children, aged 5-17 years, who are healthy and have no bladder symptoms.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline AND 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after enrolment.
Plan to share: Undecided
Started Dec 2022 (actual). Primary completion is estimated for Dec 2027, 60 months after the start.
Of 66 non-industry observational studies under Urinary Incontinence, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 50. This study's planned 60 months is above that.
Counting every sponsor, half of 74 studies reached it within 35 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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