NCT03897959

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2019

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

April 1, 2019

Status Verified

March 1, 2019

Enrollment Period

1.2 years

First QC Date

March 25, 2019

Last Update Submit

March 28, 2019

Conditions

Catheter InfectionComplications; Catheter

Keywords

suprapubic, urinary catheter

Outcome Measures

Primary Outcomes (1)

  • Suprapubic catheter blockage - failure to drain

    To determine whether an indwelling suprapubic low profile Kohli Atraumatic Catheter causes less patient-reported mucous plugging than a traditional indwelling suprapubic Foley catheter.

    1 year

Secondary Outcomes (2)

  • Suprapubic catheter pain

    1 year

  • Suprapubic catheter urinary tract infection (UTI)

    1 year

Study Arms (1)

Kohli vs Foley Study

OTHER

Compare various performance characteristics of two urinary catheters.

Device: Kohli vs Foley catheter

Interventions

Kohli vs Foley catheterDEVICE

Alternative suprapubic catheter used for bladder drainage.

Kohli vs Foley Study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Inability to provide informed consent
  • No catheter associated discomfort or problems with mucous plugging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Urogynecology

Wellesley, Massachusetts, 02481, United States

RECRUITING

Central Study Contacts

Ronald D Adams, MS

CONTACT

7758007300info@kohlicatheter.com

Neeraj Kohli, MD

CONTACT

617-340-6446nkohli@bostonurogyn.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2019

First Posted

April 1, 2019

Study Start

March 3, 2019

Primary Completion

April 30, 2020

Study Completion

May 30, 2020

Last Updated

April 1, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)