Gene Expression in the Overactive Bladder in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Aarhus
Sponsor:
Collaborator:
University Hospital, Ghent
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT02086058
First received: March 6, 2014
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.


Condition
Overactive Bladder
Children

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Gene Expression in the Bladder in Children With an Overactive Bladder and Daytime Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Up- and down regulation of genes expressed in the bladder [ Time Frame: collection of bladder material and analysis will take approximately 2 years ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Bladder biopsies from the back-wall og the bladder.


Estimated Enrollment: 46
Study Start Date: November 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   5 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02086058

Contacts
Contact: Luise Borch, M.D +45 22 92 55 02 luise.borch@ki.au.dk

Locations
Denmark
Center for child incontinence, Aarhus University hospital Recruiting
Aarhus, Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
University Hospital, Ghent
Investigators
Principal Investigator: Luise Borch, M.D University of Aarhus
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02086058     History of Changes
Other Study ID Numbers: GeneOAB
Study First Received: March 6, 2014
Last Updated: March 11, 2014
Health Authority: Denmark: The Danish Ethical Committee

Keywords provided by University of Aarhus:
overactive bladder
daytime urinary incontinence
children
gene expression

Additional relevant MeSH terms:
Diurnal Enuresis
Enuresis
Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on July 22, 2014