Clinical trial NCT02086058: Gene Expression in the Overactive Bladder in Children
Official title: Gene Expression in the Bladder in Children With an Overactive Bladder and Daytime Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overactive Bladder
Children
Keywords: overactive bladder
daytime urinary incontinence
children
gene expression
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
First posted: 2014-03-13
Enrollment: 46
Sex: ALL
Minimum age (years): 5
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Up- and down regulation of genes expressed in the bladder
timeFrame: collection of bladder material and analysis will take approximately 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Center for child incontinence, Aarhus University hospital
state: Aarhus N
Study officials:
affiliation: University of Aarhus
name: Luise Borch, M.D
role: PRINCIPAL_INVESTIGATOR
References: