Retained Urine Volume and Bacteriuria in Traditional Versus Vented Urine Drainage Systems

University of Florida

Status and phase: Withdrawn; Phase 1

Conditions: Bacteriuria

Treatments: Device: Non-vented urinary drainage system; Device: Vented urinary drainage system

Study type: Interventional

Funder types: Other

Identifiers

NCT02052674

201300634

Details and patient eligibility

About

The purpose of this study is to see if there are differences in urine drainage between two types of indwelling bladder catheter systems (Foley catheter) in hospitalized patients. The difference between the two catheters is that one catheter is vented (the study catheter) and the other is a standard non-vented catheter. The vented catheter may drain urine better than a standard non-vented catheter.

If a vented catheter drains the bladder better than a non-vented catheter it may lower the risk of retained urine in the bladder which could help prevent urinary tract infections.

Full description

During hospitalization, while in the surgical intensive care unit beginning the day after surgery, measurements of the subject's urine drainage system will be taken at daily study visits: retained urine volume, dependent loops, incidence of bacteriuria, and thigh diameter.

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled for a planned surgery
• Anticipated indwelling bladder catheter placement for greater than 24 hours
• Anticipated post-op admission to a surgical ICU

Exclusion criteria

• Unstable renal function as self-reported
• Anticipated bandaged postoperative suprapubic incisions
• Anatomical deformity that precludes appropriate suprapubic access for ultrasound bladder scanning
• Surgical procedure that prevents accurate core body temperature by any means other than by bladder temperature

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Vented urinary drainage system

Experimental group

Description:

This group will be catheterized with a vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.

Treatment:

Device: Vented urinary drainage system

Non-vented urinary drainage system

Active Comparator group

Description:

This group will be catheterized with a non-vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.

Treatment:

Device: Non-vented urinary drainage system