NCT03897959

COMPARISON OF KOHLI AND FOLEY CATHETERS IN SUPRAPUBIC CATHETER PATIENTS

FOLEY VERSUS KOHLI FOR SUPRAPUBIC CATHETER ASSOCIATED PROBLEMS STUDY

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Nellie Medical, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Catheter Infection
• Complications; Catheter

Interventions

Type	Name	Description
DEVICE	Kohli vs Foley catheter	Alternative suprapubic catheter used for bladder drainage.

Timeline

• Start date: 2019-03-03
• Primary completion: 2020-04-30
• Completion: 2020-05-30
• First posted: 2019-04-01
• Last updated: 2019-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study