Gene Expression in the Overactive Bladder in Children
17. december 2015 opdateret af: University of Aarhus
Gene Expression in the Bladder in Children With an Overactive Bladder and Daytime Urinary Incontinence
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.
Studieoversigt
Status
Ukendt
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Forventet)
46
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Aarhus N
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Aarhus, Aarhus N, Danmark, 8200
- Rekruttering
- Center for child incontinence, Aarhus University hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
5 år til 80 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Up- and down regulation of genes expressed in the bladder
Tidsramme: collection of bladder material and analysis will take approximately 2 years
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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.
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collection of bladder material and analysis will take approximately 2 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Luise Borch, M.D, University of Aarhus
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2013
Primær færdiggørelse (Forventet)
1. september 2016
Studieafslutning (Forventet)
1. november 2016
Datoer for studieregistrering
Først indsendt
6. marts 2014
Først indsendt, der opfyldte QC-kriterier
11. marts 2014
Først opslået (Skøn)
13. marts 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. december 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. december 2015
Sidst verificeret
1. december 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GeneOAB
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .