Gene Expression in the Overactive Bladder in Children

NCT ID: NCT02086058

Last Updated: 2015-12-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-11-30

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.

Conditions

Overactive Bladder; Children

Keywords

overactive bladder; daytime urinary incontinence; children; gene expression

Study Design

• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luise Borch, M.D

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

Center for child incontinence, Aarhus University hospital

Aarhus, Aarhus N, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Luise Borch, M.D

Role: CONTACT

Phone: +45 22 92 55 02

Email: luise.borch@ki.au.dk

Other Identifiers

GeneOAB

Identifier Type: -

Identifier Source: org_study_id