Foley Catheter vs a Self-contained Valved Urinary Catheter

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03178734
• Other study ID #: 908398
• Status: Completed
• Phase: N/A
• Start date: July 22, 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2020
• Source: Atlantic Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2019
• Est. primary completion date: June 14, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catheter-Related Infections
• Communicable Diseases
• Infection
• Urinary Tract Infections
• Urogynecologic Surgery

Intervention

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.

Locations

Country	Name	City	State
United States	Atlantic Urogynecology Associates	Morristown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
charbel salamon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient satisfaction	Foley satisfaction questionnaire will be collected at post-operative voiding trial office visit.	Up to 5 days after surgery
Secondary	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