Clinical Trials Directory

Trials / Terminated

TerminatedNCT03801720

UltraWee: Ultrasound Bladder Stimulation

UltraWee: Ultrasound Bladder Stimulation to Help With Clean Catch Urine in Pre-Continent Children

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
4 (actual)
Sponsor
State University of New York - Upstate Medical University · Academic / Other
Sex
All
Age
1 Month – 36 Months
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERUltrasoundUsing ultrasound stimulation to induce micturition.

Timeline

Start date
2019-01-29
Primary completion
2023-04-13
Completion
2023-04-13
First posted
2019-01-11
Last updated
2023-12-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03801720. Inclusion in this directory is not an endorsement.