Effect of Active vs. Passive Voiding Trials on Time to Discharge, Urinary Tract Infection, and Urinary Retention

Phase 3

Completed

• Conditions: Urinary Retention; Urinary Tract Infections
• Interventions: Procedure: Passive Voiding Trial; Procedure: Active Voiding Trial

• Registration Number: NCT02886143
• Lead Sponsor: University of Virginia

Brief Summary

Urinary retention is a common problem, particularly in hospitalized patients. When a Foley catheter is removed, a patient must be monitored for urinary retention. The usual method is a passive voiding trial where the catheter is removed, the bladder fills with urine and the patient is monitored for voiding over approximately 6 hours. Another option is an active voiding trial where the bladder is filled with saline before the catheter is removed and the patient is immediately assisted to void. This study seeks to determine the effect of active vs passive voiding trials on time to hospital discharge, rate of urinary tract infections, and rate or urinary retention in the general hospitalized population.

Detailed Description

The intervention to be tested is an active voiding trial, where the bladder is filled with saline before the catheter is removed and the patient is immediately assisted to void.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-10
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Study First Submitted: 2016-07-31
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-28
• Last Update Submitted: 2016-08-28
• Study First Posted: 2016-09-01
• Last Update Posted: 2016-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

Inclusion Criteria

• Admission to one of three hospital units at the University of Virginia (5 Central, 6 West, or the Short Stay Unit)
• Patient has a Foley urethral catheter in place
• The physician has ordered the Foley urethral catheter to be discontinued
• 18 years of age and older

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Exclusion Criteria

• Age less than 18 years
• Prisoners
• Women who are pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Passive Voiding Trial	Passive Voiding Trial	For patients randomized to receive a passive voiding trial, the urinary catheter will be removed, the bladder will fill with urine naturally, and the patient will be assisted to void when he or she reports the urge. To ensure uniformity in the intervention, all voiding trials in the study will be supervised by an experienced nurse who will ensure that the protocol is followed.
Active Voiding Trial (instillation of sterile saline)	Active Voiding Trial	Patients randomized to receive an active voiding trial will have the bladder filled with 250-400 cc of sterile saline (or until the bladder was full) via the lumen of the urinary catheter before the urinary catheter is removed. The patient will then be immediately assisted to void. Physician teams will follow a standardized algorithm for the management of urinary retention arising during the study.

Primary Outcome Measures

Name	Time	Method
time from removal of Foley catheter until hospital discharge	approximately one day	time from removal of the Foley catheter until the patient physically leaves the hospital

Secondary Outcome Measures

Name	Time	Method
Urinary retention	within 2 weeks of hospital discharge	inability to urinate requiring urethral catheterization within 2 weeks of hospital discharge. This will be determined by asking the patient the number of times he or she has had a urethral catheter inserted in the 2 weeks since the catheter was removed
urinary tract infection	within 2 weeks of hospital discharge	urinary tract infection within 2 weeks of hospital discharge based on the National Surgical Quality Improvement Program (NSQIP) definition (one of two of the following): 1. One of the following: (fever (\>38 C), urgency, frequency, dysuria, or suprapubic tenderness) AND urine culture of \>10\^5 colonies/mL urine with no more than 2 species of organisms; 2. Two of the following (fever (\>38 C), urgency, frequency, dysuria, or suprapubic tenderness) AND any of the following: (dipstick test positive for leukocyte esterase and/or nitrite, pyuria (\>10 white blood cells (WBC)/mL or \>3 WBC/hpf of unspun urine), organisms seen on Gram stain of unspun urine, two urine cultures with repeated isolation of the same uropathogen with \>10\^2 colonies/mL urine in non-voided specimens, urine culture with \<10\^5 colonies/mL urine of single uropathogen in patient being treated with appropriate antimicrobial therapy, physician's diagnosis, physician institutes appropriate antimicrobial therapy)