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

Primary Purpose

Urinary Retention, Urinary Tract Infections

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Active Voiding Trial
Passive Voiding Trial
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Retention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Active Voiding Trial (instillation of sterile saline)

    Passive Voiding Trial

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    urinary tract infection
    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)
    Urinary retention
    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

    Full Information

    First Posted
    July 31, 2016
    Last Updated
    August 28, 2016
    Sponsor
    University of Virginia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02886143
    Brief Title
    Effect of Active vs. Passive Voiding Trials on Time to Discharge, Urinary Tract Infection, and Urinary Retention
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    July 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Virginia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Retention, Urinary Tract Infections

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    274 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active Voiding Trial (instillation of sterile saline)
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Passive Voiding Trial
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Active Voiding Trial
    Intervention Description
    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 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
    Intervention Name(s)
    Passive Voiding Trial
    Intervention Description
    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. 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
    Primary Outcome Measure Information:
    Title
    time from removal of Foley catheter until hospital discharge
    Description
    time from removal of the Foley catheter until the patient physically leaves the hospital
    Time Frame
    approximately one day
    Secondary Outcome Measure Information:
    Title
    urinary tract infection
    Description
    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)
    Time Frame
    within 2 weeks of hospital discharge
    Title
    Urinary retention
    Description
    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
    Time Frame
    within 2 weeks of hospital discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tracey L Krupski, MD, MPH
    Organizational Affiliation
    University of Virginia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31732771
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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