COMPARISON OF KOHLI AND FOLEY CATHETERS IN SUPRAPUBIC CATHETER PATIENTS

Not Applicable

• Conditions: Catheter Infection; Complications; Catheter
• Interventions: Device: Kohli vs Foley catheter

• Registration Number: NCT03897959
• Lead Sponsor: Nellie Medical, LLC

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.

Study Timeline

• Status Verified: 2019-03
• Study Start: 2019-03-03
• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-03-28
• Last Update Submitted: 2019-03-28
• Study First Posted: 2019-04-01
• Last Update Posted: 2019-04-01
• Primary Completion: 2020-04-30
• Study Completion: 2020-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Kohli vs Foley Study	Kohli vs Foley catheter	Compare various performance characteristics of two urinary catheters.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Boston Urogynecology; 🇺🇸 Wellesley, Massachusetts, United States