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Refractory Urge Incontinence and Botox Injections

9. januar 2011 opdateret af: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The purpose of this study is to see whether Botox A (injected into the bladder muscle) can improve symptoms of urge incontinence that has not improved with usual medical treatments.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Women who suffer with urge incontinence may not get relief with usual medical treatment (such as medications or behavioral techniques). We plan to enroll women with refractory urge incontinence in centers across the US. Study participants will undergo cystoscopy (telescope look into the bladder) and injection of either Botox A or placebo. If symptoms are not adequately relieved, subjects participants will receive a second injection that is Botox A. Participants are interviewed monthly by study personnel to determine symptoms and health status.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

87

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35249
        • University of Alabama
    • California
      • La Jolla, California, Forenede Stater, 92037
        • USCD Medical Center
      • San Diego, California, Forenede Stater, 92120
        • Kaiser Permanente
    • Illinois
      • Maywood, Illinois, Forenede Stater, 60153
        • Loyola University
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • University of North Carolina
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic
    • Texas
      • Dallas, Texas, Forenede Stater, 35249
        • Ut Southwestern
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84132
        • Univeristy of Utah

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

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Adult women
  • Detrusor overactivity incontinence confirmed by urodynamic testing
  • Symptoms refractory to standard first- and second-line treatments
  • 6 or more urge incontinence episodes on 3-day bladder diary
  • Normal neurological examination

Exclusion Criteria:

  • Urinary retention
  • Allergy to Botox (Botulinum Toxin A)
  • Previous bladder treatment with Botox (Botulinum Toxin A) in the past year
  • Pregnancy or planning pregnancy within next year
  • Neurologic disease with impaired neurotransmission

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Botox A
up to two injections of 200 Units of intra-detrusor Botulinum Toxin A , which must be separated by at least eight weeks and no more than 52 weeks
Medicin: Botulinum Toxin A, bladder detrusor muscle injection
200 U provided as a total of 6 cc of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization. Injections will be spread out to equally cover the entire dome of the bladder, but spare the bladder trigone and ureteral orifices.
Andre navne:
  • Botox
Placebo komparator: Placebo
up to two injections of inactive injection (carrier saline), which must be separated by at least eight weeks and no more than 52 weeks
Medicin: Vehicle saline as placebo
A total of 6 cc of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization. Injections will be spread out to equally cover the entire dome of the bladder, but spare the bladder trigone and ureteral orifices

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to recurrence of detrusor overactivity incontinence symptoms
Tidsramme: 6 months
To allow sufficient time for the onset of action of botulinum toxin A, the earliest outcome measurement was 60 days after injection. Failure was defined as a patient global impression of improvement (PGI-I) score of 4 or greater, the commencement of any new treatment at any time after the first injection or increased intensity of previously established treatment for DOI.
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in incontinence episode frequency by bladder diary
Tidsramme: At 12 mos after first injection., but no less than 1 mo after second injection
based on the 3-day bladder diary completed pre-intervention and at 4 weeks post injection. A successful within-subject outcome will be defined as >75% reduction in the frequency of urge incontinence episodes compared to the baseline frequency.
At 12 mos after first injection., but no less than 1 mo after second injection
Incontinence-related and health-related quality of life
Tidsramme: At 12 mos after first injection, but no less than 1 mo after second injection.
measured by the Urinary Distress Inventory subscale of the PFDI/PFIQ, the PISQ, and SF-36 administered at 4 weeks after the initial injection and either prior to any re-treatment or at the completion of study participation, whichever is earlier.
At 12 mos after first injection, but no less than 1 mo after second injection.
Voiding dysfunction requiring catheterization
Tidsramme: throughout 12-month study
throughout 12-month study

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Efterforskere

  • Studiestol: Linda Brubaker, MD, Loyola University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

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. juni 2006

Primær færdiggørelse (Faktiske)

1. december 2007

Studieafslutning (Faktiske)

1. december 2007

Datoer for studieregistrering

Først indsendt

6. september 2006

Først indsendt, der opfyldte QC-kriterier

6. september 2006

Først opslået (Skøn)

8. september 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. januar 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. januar 2011

Sidst verificeret

1. oktober 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PFDN 12

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 .

Kliniske forsøg med Ufrivillig vandladning

Kliniske forsøg med Botulinum Toxin A, bladder detrusor muscle injection

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Nigeria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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