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Bladder Morphology Using 2 Different Catheter Designs

10 avril 2017 mis à jour par: 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)

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

Phase

N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

États-Unis
- Florida
  - Tampa, Florida, États-Unis, 33609
    - Recrutement
    - The Pelvic Floor Institute
    - Contact:
      
      Lennox Hoyte, MD, MSEECS
      
      Numéro de téléphone: 813-551-3540
      
      E-mail: lhoyte@mypfi.org
    - Contact:
      
      Jerry B Owens
      
      Numéro de téléphone: 877-876-2972
      
      E-mail: innovativeresearchinc@gmail.com
    - Chercheur principal:
      
      Lennox Hoyte, MD, MSEECS

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

21 ans à 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Objectif principal: Science basique
Répartition: N / A
Modèle interventionnel: Affectation à un seul groupe
Masquage: Aucun (étiquette ouverte)

Nombre de bras

Armes et Interventions

Groupe de participants / Bras	Intervention / Traitement
Autre: 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.	Dispositif: Cystosure Urinary Access System Demonstrate the 3D bladder wall anatomy with 300 cc of fluid infused with each of the following bladder drainage mechanisms The traditional Foley catheter (Catheter A) The novel FDA approved Cystosure catheter (Catheter B) Compare the fluid flow pattern during bladder drainage for The traditional Foley catheter (Catheter A) The novel FDA approved Cystosure catheter (Catheter B) Compare the 3D bladder wall anatomy after emptying the bladder with The traditional Foley catheter (Catheter A) The novel FDA approved Cystosure catheter (Catheter B) Autres noms: Emmy Medical Cystosure Urinary Access System 10-200 Dispositif: Foley Catheter Demonstrate the 3D bladder wall anatomy with 300 cc of fluid infused with each of the following bladder drainage mechanisms The traditional Foley catheter (Catheter A) The novel FDA approved Cystosure catheter (Catheter B) Compare the fluid flow pattern during bladder drainage for The traditional Foley catheter (Catheter A) The novel FDA approved Cystosure catheter (Catheter B) Compare the 3D bladder wall anatomy after emptying the bladder with The traditional Foley catheter (Catheter A) The novel FDA approved Cystosure catheter (Catheter B) Autres noms: BARD Medical Foley Catheter

Groupe de participants / Bras

Intervention / Traitement

Autre: 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.

Dispositif: Cystosure Urinary Access System

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)
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)
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)

Autres noms:

Emmy Medical Cystosure Urinary Access System 10-200

Dispositif: Foley Catheter

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)
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)
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)

Autres noms:

BARD Medical Foley Catheter

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Bladder shape after emptying Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

The Pelvic Floor Institute

Collaborateurs

Cystosure

Innovative Research Inc.

Les enquêteurs

Chercheur principal: Lennox Hoyte, MD, MSEECS, The Pelvic Floor Institute

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Anticipé)

1 avril 2017

Achèvement primaire (Anticipé)

1 mai 2017

Achèvement de l'étude (Anticipé)

1 juin 2017

Dates d'inscription aux études

Première soumission

30 mars 2017

Première soumission répondant aux critères de contrôle qualité

4 avril 2017

Première publication (Réel)

11 avril 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 avril 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 avril 2017

Dernière vérification

1 avril 2017

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

03082017

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Bladder Morphology Using 2 Different Catheter Designs