UltraWee: Ultrasound Bladder Stimulation

Urinalysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03801720
• Other study ID #: 1190457
• Status: Terminated
• Phase: N/A
• Start date: January 29, 2019
• Est. completion date: April 13, 2023

Study information

• Verified date: December 2023
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 13, 2023
• Est. primary completion date: April 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Urinalysis

Intervention

Other:
• Ultrasound
Using ultrasound stimulation to induce micturition.

Locations

Country	Name	City	State
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of miturition	Recorded act of successfully initiating miturition/urination	Less than 5 minutes
Primary	Time to Miturition	Recorded time to miturition	0-5 minutes