Gene Expression in the Overactive Bladder in Children

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02086058
• Other study ID #: GeneOAB
• Status: Recruiting
• Phase: N/A
• First received: March 6, 2014
• Last updated: December 17, 2015
• Start date: November 2013
• Est. completion date: November 2016

Study information

• Verified date: December 2015
• Source: University of Aarhus
• Contact: Luise Borch, M.D
• Phone: +45 22 92 55 02
• Email: luise.borch[@]ki.au.dk
• Is FDA regulated: No
• Health authority: Denmark: The Danish Ethical Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: November 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 80 Years

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Children
• Diurnal Enuresis
• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence

Locations

Country	Name	City	State
Denmark	Center for child incontinence, Aarhus University hospital	Aarhus	Aarhus N

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	University Hospital, Ghent

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Up- and down regulation of genes expressed in the bladder	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	No