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

Nellie Medical

Status: Unknown

Conditions: Bladder Infections and Inflammations

Treatments: Device: cystoscopy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03790826

CIFCAT-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Cystoscopic Inspection

Experimental group

Description:

Comparison of bladder damage with traditional Foley catheter and the Kohli Atraumatic catheter. Interventions: cystoscopy

Treatment:

Device: cystoscopy