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Foley Catheter vs a Self-contained Valved Urinary Catheter

Primary Purpose

Catheter-Related Infections, Urinary Tract Infections, Urogynecologic Surgery

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Foley Catheter vs Self-Contained Valved Catheter
Sponsored by
charbel salamon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Catheter-Related Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Atlantic Urogynecology Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Indwelling Foley Catheter

Self-Contained Valved Catheter

Arm Description

These patients will have a traditional foley catheter with attached drainage bag (Indwelling Foley Catheter).

These patients will have a BARD Flip Flo Catheter Valve attached to the original foley catheter (Self-Contained Valved Catheter).

Outcomes

Primary Outcome Measures

Number of urinary tract infections
Number of urine cultures positive for infection (taken at voiding trial visit and post-operative visit).

Secondary Outcome Measures

Patient satisfaction
Foley satisfaction questionnaire will be collected at post-operative voiding trial office visit.
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.

Full Information

First Posted
May 11, 2017
Last Updated
July 26, 2020
Sponsor
charbel salamon
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1. Study Identification

Unique Protocol Identification Number
NCT03178734
Brief Title
Foley Catheter vs a Self-contained Valved Urinary Catheter
Official Title
Foley Catheter vs a Self-contained Valved Urinary Catheter for Patients Who Are Being Discharged Home With a Catheter After Urogynecologic Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 22, 2016 (Actual)
Primary Completion Date
June 14, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
charbel salamon

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter-Related Infections, Urinary Tract Infections, Urogynecologic Surgery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study aim is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter vs a valved catheter in patients who are being discharged home with a catheter after urogynecologic proecures via a Randomized Clinical Trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indwelling Foley Catheter
Arm Type
Other
Arm Description
These patients will have a traditional foley catheter with attached drainage bag (Indwelling Foley Catheter).
Arm Title
Self-Contained Valved Catheter
Arm Type
Other
Arm Description
These patients will have a BARD Flip Flo Catheter Valve attached to the original foley catheter (Self-Contained Valved Catheter).
Intervention Type
Device
Intervention Name(s)
Foley Catheter vs Self-Contained Valved Catheter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of urinary tract infections
Description
Number of urine cultures positive for infection (taken at voiding trial visit and post-operative visit).
Time Frame
Up to 4 weeks after surgery
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
Foley satisfaction questionnaire will be collected at post-operative voiding trial office visit.
Time Frame
Up to 5 days after surgery
Title
Number of days until spontaneous void/Number of calls for device-related issues
Description
Number of days until spontaneous void and number of call for device-related issues.
Time Frame
Up to 4 weeks after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charbel G Salamon, MD, MS
Organizational Affiliation
Atlantic Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlantic Urogynecology Associates
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34184246
Citation
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.
Results Reference
derived

Learn more about this trial

Foley Catheter vs a Self-contained Valved Urinary Catheter

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