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

NCT ID: NCT02886143

Last Updated: 2016-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-07-31

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.

Conditions

Urinary Retention; Urinary Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active Voiding Trial (instillation of sterile saline)

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.

Group Type: EXPERIMENTAL

Active Voiding Trial

Intervention Type: PROCEDURE

Nursing protocol:

1. Instill 250-400 cc of STERILE SALINE via the lumen of the Foley catheter into the bladder via gravity drainage or slow push

2. Clamp the Foley

3. Deflate the catheter balloon and remove the catheter from the bladder.

4. Record the amount of saline that was instilled into the bladder.

5. Immediately assist the patient to void. Report the amount instilled and the amount voided to the physician within one hour a. Unless the patient reports extreme bladder fullness or pain, give the patient one hour to urinate

7. If the patient fails the voiding trial, the physician will decide to do in and out catheterization or place a new Foley catheter

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.

Group Type: ACTIVE_COMPARATOR

Passive Voiding Trial

Intervention Type: PROCEDURE

Nursing protocol:

1. Deflate the catheter balloon and remove the catheter from the bladder.

2. Record the time that the catheter was removed and the time the patient is due to void (approximately 6 hours).

3. 5. If the patient has not voided within 5 hours, assist the patient to try to void.

6. If the patient is unable to void, is only voiding in small amounts, or reports fullness or abdominal pain, perform a bladder scan.

7. If the patient has not voided after 6 hours, report this to the physician along with the results of the bladder scan 8. The physician will decide to do in and out catheterization or place a new Foley catheter

Interventions

Active Voiding Trial

Nursing protocol:

1. Instill 250-400 cc of STERILE SALINE via the lumen of the Foley catheter into the bladder via gravity drainage or slow push

2. Clamp the Foley

3. Deflate the catheter balloon and remove the catheter from the bladder.

4. Record the amount of saline that was instilled into the bladder.

5. Immediately assist the patient to void. Report the amount instilled and the amount voided to the physician within one hour a. Unless the patient reports extreme bladder fullness or pain, give the patient one hour to urinate

7. If the patient fails the voiding trial, the physician will decide to do in and out catheterization or place a new Foley catheter

Intervention Type: PROCEDURE

Passive Voiding Trial

Nursing protocol:

1. Deflate the catheter balloon and remove the catheter from the bladder.

2. Record the time that the catheter was removed and the time the patient is due to void (approximately 6 hours).

3. 5. If the patient has not voided within 5 hours, assist the patient to try to void.

6. If the patient is unable to void, is only voiding in small amounts, or reports fullness or abdominal pain, perform a bladder scan.

7. If the patient has not voided after 6 hours, report this to the physician along with the results of the bladder scan 8. The physician will decide to do in and out catheterization or place a new Foley catheter

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Tracey Krupski, MD

Vice Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tracey L Krupski, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

References

Mills JT, Rapp DE, Shaw NM, Hougen HY, Agard HE, Case RM Jr, McMurry TL, Schenkman NS, Krupski TL. Effect of active versus passive void trials on time to patient discharge, urinary tract infection, and urinary retention: a randomized clinical trial. World J Urol. 2020 Sep;38(9):2247-2252. doi: 10.1007/s00345-019-03005-0. Epub 2019 Nov 15.

Reference Type: DERIVED

PMID: 31732771 (View on PubMed)

Other Identifiers

18345

Identifier Type: -

Identifier Source: org_study_id