COMPARISON OF KOHLI AND FOLEY CATHETERS IN SUPRAPUBIC CATHETER PATIENTS

Catheter Infection Clinical Trial

Official title:

FOLEY VERSUS KOHLI FOR SUPRAPUBIC CATHETER ASSOCIATED PROBLEMS STUDY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03897959
• Other study ID #: KVF2019
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2019
• Est. completion date: May 30, 2020

Study information

• Verified date: March 2019
• Source: Nellie Medical, LLC
• Contact: Ronald D Adams, MS
• Phone: 7758007300
• Email: info[@]kohlicatheter.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catheter Infection
• Complications; Catheter

Intervention

Device:
• Kohli vs Foley catheter
Alternative suprapubic catheter used for bladder drainage.

Locations

Country	Name	City	State
United States	Boston Urogynecology	Wellesley	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Nellie Medical, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suprapubic catheter blockage - failure to drain	To determine whether an indwelling suprapubic low profile Kohli Atraumatic Catheter causes less patient-reported mucous plugging than a traditional indwelling suprapubic Foley catheter.	1 year
Secondary	Suprapubic catheter pain	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.	1 year
Secondary	Suprapubic catheter urinary tract infection (UTI)	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.	1 year