Gene Expression in the Overactive Bladder in Children

NCT02086058 | Unknown

• 1 other identifier: GeneOAB
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 5 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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:
• years of age or \>18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• University Hospital, Ghent: collaborator

Study Sites (1)

Center for child incontinence, Aarhus University hospital

Aarhus, Aarhus N, 8200, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bladder biopsies from the back-wall og the bladder.

MeSH Terms

Conditions

Urinary Bladder, Overactive; Diurnal Enuresis

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Enuresis; Urination Disorders; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Luise Borch, M.D

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luise Borch, M.D

CONTACT

+45 22 92 55 02; luise.borch@ki.au.dk

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 13, 2014
• Study Start: November 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

DK (1)