Urinary RetentionPhase 3NCT02886143
Effect of Active vs. Passive Voiding Trials on Time to Discharge, Urinary Tract Infection, and Urinary Retention
A Phase 3 study testing Active Voiding Trial and Passive Voiding Trial in people with Urinary Retention and Urinary Tract Infections, run by University of Virginia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Retention, Urinary Tract Infections
- What is being tested?
- Active Voiding Trial and Passive Voiding Trial
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Jul 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age less than 18 years
- Prisoners
- Women who are pregnant
About this study
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
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.
Read the 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
- Being tested
- Active Voiding Trial, Passive Voiding Trial
- Medical subject headings
- Urinary Retention, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Voiding TrialProcedure or surgery
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 TrialProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Active Voiding Trial (instillation of sterile saline) | Experimental | 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. Receives: Procedure: Active Voiding Trial |
| Passive Voiding Trial | Active comparator | 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. Receives: Procedure: Passive Voiding Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
time from removal of Foley catheter until hospital discharge
time from removal of the Foley catheter until the patient physically leaves the hospital
Measured: approximately one day
Secondary outcomes (2)
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)
Measured: within 2 weeks of hospital discharge
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
Measured: within 2 weeks of hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startOct 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tracey Krupski, MD, University of Virginia
- Investigators
- Tracey L Krupski, MD, MPH, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886143
- Sponsor's protocol ID
- 18345
- Status last verified
- Aug 2016
- First submitted
- 31 Jul 2016
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31732771
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02886143
- Acronym / sponsor ID
- 18345
- Conditions
- Urinary Retention, Urinary Tract Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Voiding Trial (instillation of sterile saline) | Experimental | Procedure: Active Voiding TrialPatients 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. |
| Passive Voiding Trial | Active comparator | Procedure: Passive Voiding TrialFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Age less than 18 years
- Prisoners
- Women who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Voiding TrialNursing 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 | Procedure or surgery | Active Voiding Trial (instillation of sterile saline) |
| Passive Voiding TrialNursing 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 | Procedure or surgery | Passive Voiding Trial |
Primary outcome
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
2 secondary outcomes
urinary tract infection
Time frame: within 2 weeks of hospital discharge
Urinary retention
Time frame: within 2 weeks of hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
- Derived from this study: PubMed 31732771Mills 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracey L Krupski, MD, MPH principal investigator
University of Virginia
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active Voiding Trial and Passive Voiding Trial in people with Urinary Retention and Urinary Tract Infections, run by University of Virginia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time from removal of Foley catheter until hospital discharge (time frame: approximately one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02886143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2016.