UrinalysisNCT03801720
UltraWee: Ultrasound Bladder Stimulation
A study testing Ultrasound in people with Urinalysis, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
The UltraWee study is a prospective randomized controlled trial used to compare the success rate of and time to obtaining a urine sample in pre-continent children between standard clean catch urine (CCU) method and using ultrasound stimulation clean catch methods. Read more about this study
- Who is it for?
- Ages 1 month to 36 months
- Conditions the study is for
- Urinalysis
- What is being tested?
- Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2019to 13 Apr 2023
- Phase
- Interventional
- 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 1 month to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pre-continent children
- Children between the ages of 1 month and 36 months
- Children who require a urine sample as part of their workup
- Children who are seen in the emergency department at University Hospital Downtown Campus
Who cannot join
- Children who are continent
- Children who are in foster care or who are wards of the state
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: UltraWee: Ultrasound Bladder Stimulation to Help With Clean Catch Urine in Pre-Continent Children
The UltraWee study is a prospective randomized controlled trial used to compare the success rate of and time to obtaining a urine sample in pre-continent children between standard clean catch urine (CCU) method and using ultrasound stimulation clean catch methods. The objectives of this study are to see if ultrasound stimulation increases success rate of micturition, decreases time to micturition, and decreases the use of more invasive techniques for urine collection.
Read the detailed description
Standard procedure for obtaining urine samples in the pediatrics emergency department consists of a clean catch urine (CCU). For those patients who are still pre-continent, this involves cleaning the genitourinary (GU) area with betadine followed with waiting with a specimen cup for the patient to produce urine.
Currently, the CCU technique has had mixed success rates of micturition, some studies showing as low as 12% success rate. Because of the mixed success rates, often times these patients are subjected to the discomfort and trauma of a urinary catheter. Catheterization also occurs in patients with clinical conditions that require urine samples under time sensitive conditions.
Less invasive ways of urine collections have been recently studied. The Quick-Wee study was a novel study that showed a promising alternative to obtaining urine samples in pre-continent children when compared to the CCU sample. This method served as a noninvasive way to obtain a urine sample, thus preventing uncomfortable and traumatic urinary catheterizations and improving parent satisfaction scores.
The investigators hope to study the effectiveness of another technique for obtaining a urine sample without urinary catheterization: ultrasound stimulation. By incorporating ultrasound evaluation of the bladder, the UltraWee study hopes to decrease the number of failed attempts at obtaining a urine sample in pre-continent children less than thirty-six months of age.
The UltraWee study will be a prospective randomized controlled trial comparing success rate of and time to obtaining a urine sample in pre-continent children between standard clean catch urine method and using ultrasound stimulation clean catch methods. The objective of this study is to see if ultrasound stimulation increases success rate and decreases time to micturition.
- Conditions
- Urinalysis
- Being tested
- Ultrasound
- Keywords
- Clean Catch Urine (CCU), Catherterization, Ultrasound, Micturition, Urine Collection, Pre-Continent Children, Pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundOther
Using ultrasound stimulation to induce micturition.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Utilize standard practice for obtaining a CCU in pre-continent children; this consists of cleaning the GU area with betadine and waiting 5 minutes for micturition to occur. |
| Experimental Group | Experimental | Consists of cleaning the GU area with betadine followed by using an ultrasound probe to apply cool ultrasound gel and subprapubic pressure to the patient to induce micturition. Receives: Other: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of miturition
Recorded act of successfully initiating miturition/urination
Measured: Less than 5 minutes
Time to Miturition
Recorded time to miturition
Measured: 0-5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start29 Jan 2019
- Primary completion13 Apr 2023
- Study completion13 Apr 2023
Why it stopped: Study was suspended due to COVID. Investigators no long feel that completion of the study is feasible and have permanently terminated the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrinalysisStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincent Calleo, State University of New York - Upstate Medical University
- Investigators
- Vincent Calleo, MD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801720
- Sponsor's protocol ID
- 1190457
- Status last verified
- Dec 2023
- First submitted
- 14 Dec 2018
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UltraWee: Ultrasound Bladder Stimulation to Help With Clean Catch Urine in Pre-Continent Children
- ClinicalTrials.gov ID
- NCT03801720
- Acronym / sponsor ID
- 1190457
- Conditions
- Urinalysis
- Keywords
- Clean Catch Urine (CCU), Catherterization, Ultrasound, Micturition, Urine Collection, Pre-Continent Children, Pediatrics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was suspended due to COVID. Investigators no long feel that completion of the study is feasible and have permanently terminated the study.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 13 Apr 2023 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 11 Jan 2019 (actual)
- 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.
The UltraWee study is a prospective randomized controlled trial used to compare the success rate of and time to obtaining a urine sample in pre-continent children between standard clean catch urine (CCU) method and using ultrasound stimulation clean catch methods. The objectives of this study are to see if ultrasound stimulation increases success rate of micturition, decreases time to micturition, and decreases the use of more invasive techniques for urine collection.
Detailed description
Standard procedure for obtaining urine samples in the pediatrics emergency department consists of a clean catch urine (CCU). For those patients who are still pre-continent, this involves cleaning the genitourinary (GU) area with betadine followed with waiting with a specimen cup for the patient to produce urine.
Currently, the CCU technique has had mixed success rates of micturition, some studies showing as low as 12% success rate. Because of the mixed success rates, often times these patients are subjected to the discomfort and trauma of a urinary catheter. Catheterization also occurs in patients with clinical conditions that require urine samples under time sensitive conditions.
Less invasive ways of urine collections have been recently studied. The Quick-Wee study was a novel study that showed a promising alternative to obtaining urine samples in pre-continent children when compared to the CCU sample. This method served as a noninvasive way to obtain a urine sample, thus preventing uncomfortable and traumatic urinary catheterizations and improving parent satisfaction scores.
The investigators hope to study the effectiveness of another technique for obtaining a urine sample without urinary catheterization: ultrasound stimulation. By incorporating ultrasound evaluation of the bladder, the UltraWee study hopes to decrease the number of failed attempts at obtaining a urine sample in pre-continent children less than thirty-six months of age.
The UltraWee study will be a prospective randomized controlled trial comparing success rate of and time to obtaining a urine sample in pre-continent children between standard clean catch urine method and using ultrasound stimulation clean catch methods. The objective of this study is to see if ultrasound stimulation increases success rate and decreases time to micturition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Utilize standard practice for obtaining a CCU in pre-continent children; this consists of cleaning the GU area with betadine and waiting 5 minutes for micturition to occur. |
| Experimental Group | Experimental | Other: UltrasoundConsists of cleaning the GU area with betadine followed by using an ultrasound probe to apply cool ultrasound gel and subprapubic pressure to the patient to induce micturition. |
Who may qualify
- Ages
- 1 month to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pre-continent children
- Children between the ages of 1 month and 36 months
- Children who require a urine sample as part of their workup
- Children who are seen in the emergency department at University Hospital Downtown Campus
Key exclusion criteria (2 listed)
- Children who are continent
- Children who are in foster care or who are wards of the state
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 |
|---|---|---|
| UltrasoundUsing ultrasound stimulation to induce micturition. | Other | Experimental Group |
Primary outcome
Incidence of miturition
Time frame: Less than 5 minutes
Recorded act of successfully initiating miturition/urination
Time to Miturition
Time frame: 0-5 minutes
Recorded time to miturition
Results and safety
The study was stopped early (reason given: Study was suspended due to COVID. Investigators no long feel that completion of the study is feasible and have permanently terminated the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- 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.
Vincent Calleo, MD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Urinalysis, run by State University of New York - Upstate Medical University at 1 site in United States.
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 2 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: stopped early, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study was stopped early (reason given: Study was suspended due to COVID. Investigators no long feel that completion of the study is feasible and have permanently terminated the study.). Results are not available in the source record.
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?
Incidence of miturition (time frame: Less than 5 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2023.