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Bladder Morphology Using 2 Different Catheter Designs

10. april 2017 oppdatert av: Lennox Hoyte, MD, The Pelvic Floor Institute

Bladder Morphology Using 2 Different Catheter Designs Foley Catheter vs. Cystosure Urinary Access System

Demonstrate and compare the 3D morphology of the bladder wall in full and drained states with 2 different kinds of bladder catheters in place. (Foley Catheter vs. Cystosure Catheter)

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The Foley catheter has been the mainstay of bladder drainage for many decades. There has been little design change despite risks associated with Foley catheter use including cather associated Urinary Tract Infections(UTIs). However, recent incentives and penalties related to iatrogenic bladder infections have encouraged healthcare providers to search for ways to decrease catheter-associated infections. Data suggests that the design of the traditional Foley catheter may be responsible for bladder mucosal injury due to contact with the drainage tip, which in turn contribute to bladder infections associated with long term indwelling Foley catheter usage. The Cystosure catheter is an FDA approved bladder drainage device, with a shortened drainage port, designed to avoid contact with the bladder mucosa. It is postulated that the lack of contact with the mucosa would decrease mucosal injury, possibly leading to decreased incidence of catheter related bladder infections. Early sheep bladder microscopy studies have suggested that the Cystosure catheter produces significantly less mucosal injury compared to the Foley catheter following a short period of indwelling bladder catheterization. The present study is designed to compare bladder wall geometry around the drainage balloon in the Foley versus the Cystosure drainage catheters in living women. It is hypothesized that the "tip-less" cystosure catheter will have a smoother, more continuous bladder contour around the drainage port, compared to the traditional Foley catheter tip.

Studietype

Intervensjonell

Registrering (Forventet)

3

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Florida
      • Tampa, Florida, Forente stater, 33609
        • Rekruttering
        • The Pelvic Floor Institute
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Lennox Hoyte, MD, MSEECS

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

21 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • Pelvic Floor Institute patients aged between 21 and 70 years of age, who are able to speak and understand English, who are not currently pregnant, or had a pregnancy in the previous 6 months.

Exclusion Criteria:

  • Women with claustrophobia or any contraindication to undergoing an MRI scan will be excluded. Similarly, women with hip, knee, or shoulder replacements will be excluded because of the need for urethral catheterization. Women with significant mitral valve prolapse will also be excluded for the same reason. Women with history of 3 or more culture-documented UTIs over the last 12 months will be excluded. Women who are unable or unwilling to give informed consent will also be excluded. Women who are unable to tolerate 300 cc of fluid in the bladder will be excluded. Women with a nitrite-positive urinalysis at the time of study enrollment will be excluded until they can demonstrate a negative urine culture.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Arm 1

Women who agree to participate will undergo a standard high resolution, thin slice pelvic floor static/dynamic MRI study, first with a full bladder, and after the bladder is emptied. Bladder filling and drainage will be performed sequentially, using each of the 2 catheter types (Cystosure Urinary Access Catheter and Foley Catheter). During bladder emptying, a cine video scan will be taken at the midsagittal plane to show the dynamics of the bladder fluid and walls during emptying. Each subject will serve as their own control.

Interventions are listed in the "Interventions" Section.
Enhet: Cystosure Urinary Access System

  1. Demonstrate the 3D bladder wall anatomy with 300 cc of fluid infused with each of the following bladder drainage mechanisms

    1. The traditional Foley catheter (Catheter A)
    2. The novel FDA approved Cystosure catheter (Catheter B)

  2. Compare the fluid flow pattern during bladder drainage for

    1. The traditional Foley catheter (Catheter A)
    2. The novel FDA approved Cystosure catheter (Catheter B)

  3. Compare the 3D bladder wall anatomy after emptying the bladder with

    1. The traditional Foley catheter (Catheter A)
    2. The novel FDA approved Cystosure catheter (Catheter B)
Andre navn:
  • Emmy Medical Cystosure Urinary Access System 10-200
Enhet: Foley Catheter

  1. Demonstrate the 3D bladder wall anatomy with 300 cc of fluid infused with each of the following bladder drainage mechanisms

    1. The traditional Foley catheter (Catheter A)
    2. The novel FDA approved Cystosure catheter (Catheter B)

  2. Compare the fluid flow pattern during bladder drainage for

    1. The traditional Foley catheter (Catheter A)
    2. The novel FDA approved Cystosure catheter (Catheter B)

  3. Compare the 3D bladder wall anatomy after emptying the bladder with

    1. The traditional Foley catheter (Catheter A)
    2. The novel FDA approved Cystosure catheter (Catheter B)
Andre navn:
  • BARD Medical Foley Catheter

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Bladder shape after emptying
Tidsramme: 1 month
Bladder shape after emptying using both catheters will be assessed. The 3D reconstructed images will be compared to determine if there are any differences in bladder shape in full and empty states between the 2 catheter types.
1 month

Samarbeidspartnere og etterforskere

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

Sponsor

The Pelvic Floor Institute

Samarbeidspartnere

Cystosure
Innovative Research Inc.

Etterforskere

  • Hovedetterforsker: Lennox Hoyte, MD, MSEECS, The Pelvic Floor Institute

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 (Forventet)

1. april 2017

Primær fullføring (Forventet)

1. mai 2017

Studiet fullført (Forventet)

1. juni 2017

Datoer for studieregistrering

Først innsendt

30. mars 2017

Først innsendt som oppfylte QC-kriteriene

4. april 2017

Først lagt ut (Faktiske)

11. april 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. april 2017

Sist bekreftet

1. april 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 03082017

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

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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