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Gene Expression in the Overactive Bladder in Children

17. desember 2015 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Studietype

Observasjonsmessig

Registrering (Forventet)

46

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Aarhus N
      • Aarhus, Aarhus N, Danmark, 8200
        • Rekruttering
        • Center for child incontinence, Aarhus University hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

5 år til 80 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Up- and down regulation of genes expressed in the bladder
Tidsramme: collection of bladder material and analysis will take approximately 2 years
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Luise Borch, M.D, University of Aarhus

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2013

Primær fullføring (Forventet)

1. september 2016

Studiet fullført (Forventet)

1. november 2016

Datoer for studieregistrering

Først innsendt

6. mars 2014

Først innsendt som oppfylte QC-kriteriene

11. mars 2014

Først lagt ut (Anslag)

13. mars 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

18. desember 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. desember 2015

Sist bekreftet

1. desember 2015

Mer informasjon

Begreper knyttet til denne studien

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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