Foley Catheter vs a Self-contained Valved Urinary Catheter

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Catheter-Related Infections, Urinary Tract Infections, Urogynecologic Surgery

Intervention / Treatment
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* Device: Foley Catheter vs Self-Contained Valved Catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Indwelling Foley Catheter<br>These patients will have a traditional foley catheter with attached drainage bag (Indwelling Foley Catheter). | Device: Foley Catheter vs Self-Contained Valved Catheter<br>* 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.<br>|
| Other: Self-Contained Valved Catheter<br>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<br>* 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.<br>|

What is the study measuring?
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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 |