Foley Catheter vs a Self-contained Valved Urinary Catheter

Foley Catheter vs a Self-contained Valved Urinary Catheter for Patients Who Are Being Discharged Home With a Catheter After Urogynecologic Procedures

The purpose of this study is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter verses a valved catheter in patients who are being discharged home with a catheter after urogynecologic procedures via a Randomized Clinical Trial.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections; Catheter-Related Infections; Urogynecologic Surgery
• Intervention / Treatment: Device: Foley Catheter vs Self-Contained Valved Catheter

Detailed Description

The purpose of this study is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter verses a valved catheter in patients who are being discharged home with a catheter after urogynecologic procedures via a Randomized Clinical Trial. Total number of participants will be 100. Inclusion criteria is all patients undergoing pelvic reconstructive surgery/anti-incontinence procedures who are planned to be discharged home with a catheter. Exclusion criteria is intra-operative bladder injury during index surgery; intra-operative complication requiring continuous bladder drainage; and/or dementia/altered cognitive function.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Atlantic Urogynecology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

All patients undergoing pelvic reconstructive surgery/anti-incontinence procedures who are planned to be discharged home with a catheter.

Exclusion Criteria:

• Intra-operative bladder injury during index surgery
• Intra-operative complication requiring continuous bladder drainage
• Dementia / altered cognitive function

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Indwelling Foley Catheter; These patients will have a traditional foley catheter with attached drainage bag (Indwelling Foley Catheter).	Device: Foley Catheter vs Self-Contained Valved Catheter; This study aims to compare UTI rates and patient satisfaction between an indwelling Foley catheter group (established SOC); and a relatively (FDA-approved) new valved addition to the Foley catheter which requires no drainage bag.
OTHER: Self-Contained Valved Catheter; These patients will have a BARD Flip Flo Catheter Valve attached to the original foley catheter (Self-Contained Valved Catheter).	Device: Foley Catheter vs Self-Contained Valved Catheter; This study aims to compare UTI rates and patient satisfaction between an indwelling Foley catheter group (established SOC); and a relatively (FDA-approved) new valved addition to the Foley catheter which requires no drainage bag.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of urinary tract infections	Number of urine cultures positive for infection (taken at voiding trial visit and post-operative visit).	Up to 4 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Foley satisfaction questionnaire will be collected at post-operative voiding trial office visit.	Up to 5 days after surgery
Number of days until spontaneous void/Number of calls for device-related issues	Number of days until spontaneous void and number of call for device-related issues.	Up to 4 weeks after surgery

Collaborators and Investigators

• Sponsor: charbel salamon
• Investigators: Principal Investigator: Charbel G Salamon, MD, MS, Atlantic Health System

Publications and helpful links

General Publications

• Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 22, 2016
• Primary Completion (ACTUAL): June 14, 2019
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: June 5, 2017
• First Posted (ACTUAL): June 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 26, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections; Catheter-Related Infections
• Other Study ID Numbers: 908398

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No