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Completed

NCT Number: NCT02886143

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

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.

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Key information

Conditions

Urinary Retention Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Voiding Trial

Procedure

Nursing protocol:

  • Instill 250-400 cc of STERILE SALINE via the lumen of the Foley catheter into the bladder via gravity drainage or slow push
  • Clamp the Foley
  • Deflate the catheter balloon and remove the catheter from the bladder.
  • Record the amount of saline that was instilled into the bladder.
  • 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
  • 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

Procedure

Nursing protocol:

  • Deflate the catheter balloon and remove the catheter from the bladder.
  • Record the time that the catheter was removed and the time the patient is due to void (approximately 6 hours).
  • 5. If the patient has not voided within 5 hours, assist the patient to try to void.
  • If the patient is unable to void, is only voiding in small amounts, or reports fullness or abdominal pain, perform a bladder scan.
  • 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

Primary outcomes

  1. time from removal of Foley catheter until hospital discharge

    Time frame: approximately one day

    time from removal of the Foley catheter until the patient physically leaves the hospital

Secondary outcomes

  1. urinary tract infection

    Time frame: 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):

    • 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
    • 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)

  2. Urinary retention

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

Effect of Active vs. Passive Voiding Trials on Time to Patient Discharge, Rate of Urinary Tract Infection, and Rate of Urinary Retention: a Randomized, Controlled Clinical Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 1, 2016
Registry last updated
Sep 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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