COMPARISON OF KOHLI AND FOLEY CATHETERS IN SUPRAPUBIC CATHETER PATIENTS

Last updated: March 28, 2019
Sponsor: Nellie Medical, LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03897959
KVF2019
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Indwelling suprapubic Foley urinary catheter for at least 30 days prior to entry withanticipation for continued indwelling urinary catheterization for at least 30 daysafter entry into the study.

  • Catheter associated discomfort or difficulty with mucous plugging of the catheter.

Exclusion

Exclusion Criteria:

  • Inability to provide informed consent

  • No catheter associated discomfort or problems with mucous plugging

Study Design

Total Participants: 30
Study Start date:
March 03, 2019
Estimated Completion Date:
May 30, 2020

Study 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.

Connect with a study center

  • Boston Urogynecology

    Wellesley, Massachusetts 02481
    United States

    Active - Recruiting

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