Catheter Infection, Complications; Catheter
Conditions
Keywords
suprapubic, urinary catheter
Brief summary
The purpose of this medical research study is to compare two different urinary drainage catheters to see which has fewer problems with blockages and pain. The study involves completing 16 weekly 3-question surveys either online or by phone. The new catheters are FDA-approved and will be provided for FREE. No medications will be given.
Detailed description
The purpose of this study is to see if a redesign of the catheter to remove the extended tip of the conventional urinary catheter will reduce problems with catheter blockage or catheter-associated discomfort. By eliminating the extended tip, the bladder wall will no longer be subject to the tip rubbing on the bladder wall. This could lead to fewer problems with blockages and less irritation and trauma to the bladder lining. A reduction in trauma to the bladder wall could reduce pain, bladder inflammation/irritation and the risk of urinary tract infections.
Interventions
DEVICEKohli vs Foley catheter
Alternative suprapubic catheter used for bladder drainage.
Sponsors
Nellie Medical, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients will utilize existing urinary drainage catheter for 30 days and then switch to alternative for 30 days. Patient will repeat this cycle once more.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Indwelling suprapubic 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. * Catheter associated discomfort or difficulty with mucous plugging of the catheter.
Exclusion criteria
* Inability to provide informed consent * No catheter associated discomfort or problems with mucous plugging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Suprapubic catheter blockage - failure to drain | 1 year | To determine whether an indwelling suprapubic low profile Kohli Atraumatic Catheter causes less patient-reported mucous plugging than a traditional indwelling suprapubic Foley catheter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Suprapubic catheter pain | 1 year | To determine whether an indwelling suprapubic low profile Kohli Atraumatic Catheter causes less patient-defined discomfort than a traditional indwelling suprapubic Foley catheter. Pain will be accessed using a Visual Analog Pain scale. |
| Suprapubic catheter urinary tract infection (UTI) | 1 year | To determine whether an indwelling suprapubic low profile Kohli Atraumatic Catheter reduces catheter-associated urinary tract infections (CAUTI's) than a traditional indwelling suprapubic Foley catheter. Patient symptoms such as hematuria, lower abdomen discomfort, frequent, painful urination, and pelvic pressure will be used to diagnose the presence of UTI. |
Countries
United States
Contacts
Primary ContactRonald D Adams, MS
Backup ContactNeeraj Kohli, MD
Outcome results
None listed