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Trial record 89 of 159 for:    Urinary Tract Infections | Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

Foley Catheter vs a Self-contained Valved Urinary Catheter

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ClinicalTrials.gov Identifier: NCT03178734
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
charbel salamon, Atlantic Health System

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.

Condition or disease Intervention/treatment Phase
Catheter-Related Infections Urinary Tract Infections Urogynecologic Surgery Device: Foley Catheter vs Self-Contained Valved Catheter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Foley Catheter vs a Self-contained Valved Urinary Catheter for Patients Who Are Being Discharged Home With a Catheter After Urogynecologic Procedures
Actual Study Start Date : July 22, 2016
Estimated Primary Completion Date : September 1, 2019

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. Number of urinary tract infections [ Time Frame: Up to 4 weeks after surgery ]
    Number of urine cultures positive for infection (taken at voiding trial visit and post-operative visit).


Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: Up to 5 days after surgery ]
    Foley satisfaction questionnaire will be collected at post-operative voiding trial office visit.

  2. Number of days until spontaneous void/Number of calls for device-related issues [ Time Frame: Up to 4 weeks after surgery ]
    Number of days until spontaneous void and number of call for device-related issues.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178734


Locations
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United States, New Jersey
Atlantic Urogynecology Associates Recruiting
Morristown, New Jersey, United States, 07960
Contact: Caroline Sabatino, MPH, CCRP    973-971-7361      
Principal Investigator: Charbel G Salamon, MD, MS         
Sponsors and Collaborators
charbel salamon
Investigators
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Principal Investigator: Charbel G Salamon, MD, MS Atlantic Health System

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Responsible Party: charbel salamon, Charbel Salamon, MD, MS, FACOG, Atlantic Health System
ClinicalTrials.gov Identifier: NCT03178734     History of Changes
Other Study ID Numbers: 908398
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Catheter-Related Infections
Urologic Diseases