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

University of Virginia

Status and phase: Completed; Phase 3

Conditions: Urinary Retention; Urinary Tract Infections

Treatments: Procedure: Passive Voiding Trial; Procedure: Active Voiding Trial

Study type: Interventional

Funder types: Other

Identifiers

NCT02886143

18345

Details and patient eligibility

About

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.

Full 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.

Enrollment: 274 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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274 participants in 2 patient groups

Active Voiding Trial (instillation of sterile saline)

Experimental group

Description:

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.

Treatment:

Procedure: Active Voiding Trial

Passive Voiding Trial

Active Comparator group

Description:

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.

Treatment:

Procedure: Passive Voiding Trial