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