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Gene Expression in the Overactive Bladder in Children

2015年12月17日 更新者:University of Aarhus

Gene Expression in the Bladder in Children With an Overactive Bladder and Daytime Urinary Incontinence

The aim of this study (the hypothesis) is to identify differences in the gene expression profile in the bladder muscle and hereby gain greater knowledge about the muscular mechanisms that cause overactive bladder and daytime urinary incontinence in children older than 5 years. A secondary aim is to examine how this gene expression profile differs from children with a neurogenic overactive bladder and how the gene expression profile changes from childhood till adulthood. Such new knowledge will result in a more precisely targeted and hence effective treatment of overactive bladder.

The results will be obtained by retrieving bladder biopsies from children and adults suffering from an overactive bladder or a neurogenic bladder. These biopsies will undergo molecular analysis and the investigators will compare them with biopises from bladder healthy adults and children.

研究概览

地位

未知

研究类型

观察性的

注册 (预期的)

46

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Aarhus N
      • Aarhus、Aarhus N、丹麦、8200
        • 招聘中
        • Center for child incontinence, Aarhus University hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

5年 至 80年 (孩子、成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

We will include 3 groups of patients Group 1: children with an overactive bladder and daytime urinary incontinence Group 2: Children and adults with a neurogenic bladder Group 3: children and adults who have a healthy bladder

描述

Inclusion Criteria:

Group 1: Group 1 (non-neurogenic bladder/overactive bladder):

  • age 5-14 years of age
  • patients must have filled out 48-hour bladder diaries
  • a minimum of 4 micturitions per day (assessed from the bladder diaries)
  • functional daytime urinary incontinence
  • overactive bladder as defined by urgency
  • no signs of neurogenic bladder dysfunction on invasive urodynamics
  • a non-remarkable clinical examination
  • normal BMI (between 3-97 percentile)
  • informed oral and written consent from the child and both parents/legal guardian. In the informed consent the parents /legal guardian have given permission to the authorities (The Danish Ethical Committee), so that they may get information about the child during monitoring and quality inspection visits.
  • no effect of prior treatment of at least 6 months urotherapy
  • no effect of prior treatment of at least 3 months of anticholinergic treatment
  • planned to undergo a cystoscopy under anesthesia

Group 2:

  • 5-14 years of age or >18 years old
  • diagnosed with a neurogenic bladder (i.e. caused by myelomeningocele)
  • informed oral and written consent from the child and both parents/legal guardian. In the informed consent the parents /legal guardian have given permission to the authorities (The Danish Ethical Committee), so that they may get information about the child during monitoring and quality inspection visits.
  • planned to undergo a cystoscopy under anesthesia

Group 3:

  • age 5-14 years of age or >18 years old
  • a non-remarkable clinical examination
  • a normal voiding pattern
  • a minimum of 3 micturitions per day
  • planned to undergo a cystoscopy under anesthesia

Exclusion Criteria:

Group 1:

  • Neurological and/or anatomical abnormalities in the lower urinary tract
  • a medical history, clinical or biochemical tests that indicate that the child suffers from any type of disease (such as acute urinary infection or diabetes) or condition (such as pregnancy) influencing the child´s possibility of participating in the study, or that may effect the study parameters that are under examination.
  • ongoing fecal problems such as fecal incontinence or constipation
  • prior surgery involving the bladder
  • ongoing urinary tract infections
  • ongoing treatment with any type of medicine that may effect the study parameters that are under examination

Group 2:

  • a medical history, clinical or biochemical tests that indicate that the child suffers from any type of diseases (such as diabetes) or conditions (such as pregnancy) influencing the child´s possibility of participating in the study, or that may affect the study parameters that are under examination.
  • ongoing treatment with any type of medicine that may affect the study parameters that are under examination

Group 3:

  • Neurological and/or anatomical abnormalities in the lower urinary tract
  • urinary incontinence and an overactive bladder with urinary incontinence
  • a medical history, clinical or biochemical tests that indicate that the patient suffers from any type of disease (such as acute urinary tract infection or diabetes) or condition (such as pregnancy) influencing the patient´s possibility of participating in the study, or that may effect the study parameters that are under examination.
  • any type of bladder disease or any disease secondary affecting the bladder
  • prior bladder surgery
  • ongoing urinary tract infection
  • ongoing treatment with any type of medicine that may effect the study parameters that are under examination.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Up- and down regulation of genes expressed in the bladder
大体时间:collection of bladder material and analysis will take approximately 2 years
We will evaluate the gene expression (which genes are up- and/or down regulated) in the bladder in healthy children compared to children suffering from an overactive bladder. This gene expression will then be compared to the gene expression in bladder tissue from adults, to evaluate what happens in the bladder from childhood to adulthood.
collection of bladder material and analysis will take approximately 2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Luise Borch, M.D、University of Aarhus

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年11月1日

初级完成 (预期的)

2016年9月1日

研究完成 (预期的)

2016年11月1日

研究注册日期

首次提交

2014年3月6日

首先提交符合 QC 标准的

2014年3月11日

首次发布 (估计)

2014年3月13日

研究记录更新

最后更新发布 (估计)

2015年12月18日

上次提交的符合 QC 标准的更新

2015年12月17日

最后验证

2015年12月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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