Clinical trial NCT03801720: UltraWee: Ultrasound Bladder Stimulation
Official title: UltraWee: Ultrasound Bladder Stimulation to Help With Clean Catch Urine in Pre-Continent Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinalysis
Keywords: Clean Catch Urine (CCU)
Catherterization
Ultrasound
Micturition
Urine Collection
Pre-Continent Children
Pediatrics
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 4
Sex: ALL
Minimum age (years): 1
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Children who are continent
* Children who are in foster care or who are wards of the state

Primary outcomes:
measure: Incidence of miturition
timeFrame: Less than 5 minutes
measure: Time to Miturition
timeFrame: 0-5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Vincent Calleo, MD
role: PRINCIPAL_INVESTIGATOR
References: