Bladder and Bowel Dysfunction in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Number of participants with reduction in weekly episodes of urinary incontinence
研究概览
简要总结
Background:
Bladder and bowel dysfunction (BBD) is characterized by lower urinary tract symptoms accompanied by bowel complaints. BBD is a common condition in childhood. The present treatment strategy for BBD is a step-wise approach starting with management of bowel symptoms before initiation of standard urotherapy and further medical treatment of LUTS symptoms. This is, however, based on clinical experience and few retrospective, non-randomized studies and high-level evidence of the succession of the elements in treatment of BBD children is missing.
Our microbiome, and its role in health and disease, has gained increased focus during the past years. Studies suggest the urine and gut microbiome to be critical for maintenance of a well-functioning bladder- and bowel system. The microbiome in children is only sparsely investigated and its role in BBD is to the investigator's knowledge still unexplored.
Study 1:
Aim: To investigate if combination therapy is more effective in treating urinary incontinence in BBD children.
Materials and methods: A prospective randomized multicentre study on children with BBD (n=100) between 5-14 years and 9 months old. They are randomized to: 1) Medical treatment of bowel symptoms (n=50) or 2) Medical treatment of bowel symptoms combined with standard urotherapy.
The effect of treatment will be evaluated after 3 months. Primary endpoint: Resolution of incontinence after treatment. Secondary endpoint: Improved quality of life after successful treatment of urinary incontinence.
Study 2:
Aim: To investigate the urofecal microbiome in children with BBD
Materials and methods:
- A cohort study to investigate, whether the urofecal microbiome can predict response to treatment and whether it changes during treatment period
- A case control study to investigate whether the urofecal microbiome is different in children with BBD and recurrent UTI 's and children with BBD without recurrent UTI 's.
The study population consists of children with BBD included in study 1. A urine-, stool sample and a perineum swab will be collected from all participants before and after treatment. Bacterial DNA will be extracted and the microbiome will be determined.
Perspectives:
BBD is a common condition in childhood. It is associated with a considerable psychological burden and a risk of more severe physical complications.
The studies will provide basic knowledge about characteristics of the BBD patients and contribute new information about the optimal treatment of BBD children.
详细描述
Background Bladder and bowel dysfunction (BBD) is characterised by lower urinary tract symptoms (LUTS) accompanied by bowel complaints, primarily functional constipation and/or faecal incontinence. To standardise the terminology used for BBD, LUTS symptoms related to the disease have been defined by International Children's Continence Society (ICCS).
The prevalence of BBD is probably underestimated but studies suggest BBD to be present in up to 20 % of school children and to represent up to 40% of paediatric urology consults.
Embryological, anatomical and functional interactions between the rectum and urinary bladder are well known. Bladder and bowel are anatomically closely related and share innervation from the parasympathetic S2-S4 and sympathetic L1-L3 nerve roots.
Research on successful treatment of BBD is sparse, with only few retrospective, non-randomized studies, documenting that treatment of defecation problems in children with BBD enhances successful management of lower urinary tract disturbances such as daytime urinary incontinence (DUI), enuresis and urinary tract infections (UTI's). Based on this knowledge and clinical experience, the present treatment strategy for children with BBD is a step-wise approach starting with management of bowel symptoms before initiation of standard urotherapy and further medical treatment of LUTS symptoms. Standard urotherapy encompasses information and demystification of the disorder along with behavioural modification such as timed voiding, proper voiding posture, avoidance of holding manoeuvers and balanced fluid intake. Standard urotherapy is well-established as first-line treatment for children with LUTS. However, high-level evidence of the succession of the elements in treatment of BBD children is missing.
BBD is commonly associated with vesicoureteral reflux (VUR) and recurrent UTI's, which may lead to renal scarring , kidney failure and hypertension. It is a potential cause of significant physical and psychosocial burden for children and families. Therefore, optimization of treatment is critical to avoid secondary comorbidities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 5-14 years and 9 months at time of inclusion
- •Diagnosed with urinary incontinence and/or enuresis nocturna defined by the ICCS criteria
- •Diagnosed with constipation and/or faecal incontinence defined by the ROME IV criteria
- •Normal clinical examination
- •Parents/guardian can understand the written and spoken information
- •Informed assent to participation from both parents/guardian
排除标准
- •Neuropathic or anatomical abnormalities in the urinary tract or gastrointestinal canal
- •Earlier surgical intervention of the urinary tract (except circumcision)
- •Neurological illness or earlier cerebral surgical intervention
- •On-going urinary tract infection
- •On-going treatment with anticholinergics and/or β3-adenoceptoragonist
- •On-going treatment with laxatives in correct dosage (PEG3350 1-2 g/kg/day)
- •Inflammatory bowel disease
- •Other disorder affection bladder or bowel function
- •For Study 2 (microbiome): Systemic antibiotics within the past 3 months
研究组 & 干预措施
Treatment of constipation and/or faecal incontinence combined with urotherapy
Medical treatment of bowel symptoms in accordance with the guidelines of The European Society for Paediatric Gastroenterology, Hepatology and Nutrition combined with standard urotherapy in accordance with International Children's Continence Society (ICCS)
干预措施: Urotherapy (Behavioral)
Treatment of constipation and/or faecal incontinence
Medical treatment of bowel symptoms in accordance with the guidelines of The European Society for Paediatric Gastroenterology, Hepatology and Nutrition
干预措施: Polyethylene Glycol 3350 (Drug)
Treatment of constipation and/or faecal incontinence combined with urotherapy
Medical treatment of bowel symptoms in accordance with the guidelines of The European Society for Paediatric Gastroenterology, Hepatology and Nutrition combined with standard urotherapy in accordance with International Children's Continence Society (ICCS)
干预措施: Polyethylene Glycol 3350 (Drug)
结局指标
主要结局
Number of participants with reduction in weekly episodes of urinary incontinence
时间窗: Evaluation after 3 months of treatment
No-response: \<50% reduction, Partial response: 50 to 99% reduction, Complete response: 100% reduction.
次要结局
- Number of participants with a change in quality of life after succesful treatment of urinary incontinence(Evaluation after 3 months of treatment)