Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2019-01-29
2023-04-13
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Control Group
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.
No interventions assigned to this group
Experimental Group
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.
Ultrasound
Using ultrasound stimulation to induce micturition.
Interventions
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Ultrasound
Using ultrasound stimulation to induce micturition.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Children who are in foster care or who are wards of the state
1 Month
36 Months
ALL
No
Sponsors
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State University of New York - Upstate Medical University
OTHER
Responsible Party
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Vincent Calleo
Principal Investigator
Principal Investigators
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Vincent Calleo, MD
Role: PRINCIPAL_INVESTIGATOR
State University of New York - Upstate Medical University
Locations
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SUNY Upstate Medical University
Syracuse, New York, United States
Countries
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Other Identifiers
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1190457
Identifier Type: -
Identifier Source: org_study_id