COMPARISON OF KOHLI AND FOLEY CATHETERS IN SUPRAPUBIC CATHETER PATIENTS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03897959|
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Catheter Infection Complications; Catheter||Device: Kohli vs Foley catheter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|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.|
|Masking:||None (Open Label)|
|Official Title:||FOLEY VERSUS KOHLI FOR SUPRAPUBIC CATHETER ASSOCIATED PROBLEMS STUDY|
|Actual Study Start Date :||March 3, 2019|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||May 30, 2020|
Kohli vs Foley Study
Compare various performance characteristics of two urinary catheters.
Device: Kohli vs Foley catheter
Alternative suprapubic catheter used for bladder drainage.
- Suprapubic catheter blockage - failure to drain [ Time Frame: 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.
- Suprapubic catheter pain [ Time Frame: 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) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897959
|Contact: Ronald D Adams, MSemail@example.com|
|Contact: Neeraj Kohli, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Wellesley, Massachusetts, United States, 02481|
|Contact: Neeraj Kohli, MD 617-340-6446 email@example.com|
|Contact: Ronald D Adams, MS 775-800-7300 firstname.lastname@example.org|