Recruiting

Kohli vs. Foley

Sponsor:

Nellie Medical, LLC

Code:

NCT03897959

Conditions

Catheter Infection

Complications; Catheter

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Kohli vs Foley catheter

Study Details

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.

Conditions

Catheter Infection

Complications; Catheter

Study ID

NCT03897959

Start date

Mar 3, 2019

Status verified date

Mar, 2019

Completion date

May 30, 2020

Anticipated

Primary completion date

Apr 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Kohli vs Foley Study

Compare various performance characteristics of two urinary catheters.

Interventions

Kohli vs Foley catheter

Alternative suprapubic catheter used for bladder drainage.

Primary outcome measure

  • Suprapubic catheter blockage - failure to drain [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Ronald D Adams, MS

7758007300info@kohlicatheter.com

Neeraj Kohli, MD

617-340-6446nkohli@bostonurogyn.com

Locations

Boston Urogynecology

Recruiting

Wellesley, Massachusetts, United States, 02481

Contacts

Neeraj Kohli, MD

617-340-6446nkohli@bostonurogyn.com

Ronald D Adams, MS

775-800-7300info@kohlicatheter.com

More Information

Sponsor

Nellie Medical, LLC

Last update posted

Apr 1, 2019

Last verified

Mar, 2019

Keywords

  • suprapubic, urinary catheter

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nellie Medical, LLC on 2019-04-01.