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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02886143
Enrollment
274
Registered
2016-09-01
Start date
2015-10-31
Completion date
2016-07-31
Last updated
2016-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Retention, Urinary Tract Infections

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.

Interventions

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

PROCEDUREPassive 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

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
time from removal of Foley catheter until hospital dischargeapproximately one daytime from removal of the Foley catheter until the patient physically leaves the hospital

Secondary

MeasureTime frameDescription
urinary tract infectionwithin 2 weeks of hospital dischargeurinary 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)
Urinary retentionwithin 2 weeks of hospital dischargeinability 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026