Chronic Indwelling Foley and Catheter Associated Trauma (CIF-CAT) Study

To determine whether an indwelling low profile Kohli Atraumatic Catheter causes less macro-morphologic inflammation and edema to the bladder mucosa than a traditional indwelling Foley catheter as assess by computerized image analysis.

Study Overview

• Status: Unknown
• Conditions: Bladder Infections and Inflammations
• Intervention / Treatment: Device: cystoscopy

Detailed Description

The Kohli Atraumatic Catheter similarly aims to reduce bladder mucosal trauma with its low profile pancake shaped balloon versus the ovoid balloon of a traditional Foley catheter. The Kohli Atraumatic Catheter has a short, opened-ended tip that minimally protrudes through a patented low-profile donut-shaped balloon. The combination of the low profile and reduced tip length prevents the catheter from contacting the bladder walls and thereby minimize disruption of the bladder surface mucus layer and trauma to the urothelium - theoretically reducing the chance of bacterial invasion. A trial in which sheep were randomized to a traditional indwelling Foley catheter or a prototype Kohli Atraumatic Catheter demonstrated a dramatic reduction in both bladder wall trauma and edema. The ulcerated area dropped from 7.2% to 1.8% (75%) and the edema from 26.9% to 13.0% (52%).

Statistical Analysis To compare the effects of 2 catheter types, data will be analyzed using the general linear models tools from SAS/STAT software and presented as means ± standard error of the mean. The model will include 2 catheter types, inflamed vs non-inflamed areas, and their interactions.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James A Greenberg, MD; Phone Number: 781-910-1968; Email: JAGREENBERG@partners.org
• Study Contact Backup: Name: Ronald Adams, MSME; Phone Number: 5089445166; Email: ron@cystosure.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men or Women older than age 18
• Indwelling Foley urinary catheter for at least 30 days prior to entry with anticipation for continued indwelling urinary catheterization for at least 30 days after entry into the study.

Exclusion Criteria:

• Inability to provide informed consent
• Unwilling or medically inappropriate for cystoscopy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cystoscopic Inspection; Comparison of bladder damage with traditional Foley catheter and the Kohli Atraumatic catheter. Interventions: cystoscopy	Device: cystoscopy; Comparison of bladder mucosa via cystoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bladder mucosa damage assessment via computerized image analysis	Macro-morphologic inflammation and edema assessment of bladder mucosa using computerized image analysis. Image Analysis Technique Image of each bladder will be analyzed using FLIR Research IR Software (FLIR Systems Inc., Wilsonville, OR) to determine the proportion of inflamed areas characterized by red surface including hemorrhage and ulceration, and edema (eg, swollen smooth surface) out of total bladder area.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bladder mucosa damage urologist visual assessment	Visual macro-morphologic inflammation and edema assessment of bladder mucosa by experienced urologists familiar with the assessment of bladder diseases. Images and videos from a first visit where the traditional Foley catheter has been in place will be compared to those from a subsequent cystoscopy. Urologists will be blinded as to the catheter associated with each block of images captured during the cystoscopy.	30 days
Patient discomfort via Numeric Pain Rating Scale	A numeric pain rating scale chart will be completed by each patient for comparison of patient discomfort with a traditional indwelling Foley catheter in patients with chronic indwelling Foley catheters. The scale runs from 0 "No Pain" to 5 "Moderate Pain" and 10 "Worst Possible Pain." More information on the scale can be seen here "https://www.physio-pedia.com/Numeric_Pain_Rating_Scale" There are no Subscales and the marked score for first assessment will be compared to 2nd assessment to assess any changes in patient comfort with the two different catheters.	30 days

Collaborators and Investigators

• Sponsor: Nellie Medical, LLC

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: December 27, 2018
• First Submitted That Met QC Criteria: December 28, 2018
• First Posted (Actual): January 2, 2019

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: bladder mucosal trauma
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Cystitis; Inflammation
• Other Study ID Numbers: CIFCAT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No