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COMPARISON OF KOHLI AND FOLEY CATHETERS IN SUPRAPUBIC CATHETER PATIENTS

N

Nellie Medical

Status

Unknown

Conditions

Complications; Catheter
Catheter Infection

Treatments

Device: Kohli vs Foley catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT03897959
KVF2019

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Kohli vs Foley Study
Other group
Description:
Compare various performance characteristics of two urinary catheters.
Treatment:
Device: Kohli vs Foley catheter

Trial contacts and locations

1

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Central trial contact

Neeraj Kohli, MD; Ronald D Adams, MS

Data sourced from clinicaltrials.gov

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