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.

Aalborg University Hospital4 个研究点分布在 1 个国家目标入组 110 人开始时间: 2022年12月14日最近更新: 2026年4月17日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: Aalborg University Hospital
入组人数: 110
试验地点: 4
主要终点: Differences in the voided urinary microbiota between children with overactive bladder and daytime urinary incontinence and healthy children without bladder symptoms.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 5 Years 至 17 Years（Child）
性别: All
接受健康志愿者: 是

入选标准

•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

排除标准

•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).

研究组 & 干预措施

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.

结局指标

主要结局

Differences in the voided urinary microbiota between children with overactive bladder and daytime urinary incontinence and healthy children without bladder symptoms.

时间窗: 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.

Differences in the perineal/preputial microbiota between children with overactive bladder and daytime urinary incontinence and healthy children without bladder symptoms.

时间窗: 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.

Differences in the fecal microbiota between children with overactive bladder and daytime urinary incontinence and healthy children without bladder symptoms.

时间窗: 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.

Differences in the voided urinary microbiota depending on severity of daytime urinary incontinence.

时间窗: 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).

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