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COMPARISON OF KOHLI AND FOLEY CATHETERS IN SUPRAPUBIC CATHETER PATIENTS

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ClinicalTrials.gov Identifier: NCT03897959
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Catheter Infection Complications; Catheter Device: Kohli vs Foley catheter Not Applicable

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.

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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)
Primary Purpose: Prevention
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

Arm Intervention/treatment
Kohli vs Foley Study
Compare various performance characteristics of two urinary catheters.
Device: Kohli vs Foley catheter
Alternative suprapubic catheter used for bladder drainage.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Ronald D Adams, MS 7758007300 info@kohlicatheter.com
Contact: Neeraj Kohli, MD 617-340-6446 nkohli@bostonurogyn.com

Locations
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United States, Massachusetts
Boston Urogynecology Recruiting
Wellesley, Massachusetts, United States, 02481
Contact: Neeraj Kohli, MD    617-340-6446    nkohli@bostonurogyn.com   
Contact: Ronald D Adams, MS    775-800-7300    info@kohlicatheter.com   
Sponsors and Collaborators
Nellie Medical, LLC

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Responsible Party: Nellie Medical, LLC
ClinicalTrials.gov Identifier: NCT03897959     History of Changes
Other Study ID Numbers: KVF2019
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nellie Medical, LLC:
suprapubic, urinary catheter