UltraWee: Ultrasound Bladder Stimulation

NCT03801720 | Terminated

• 1 other identifier: 1190457
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinalysis

Keywords

Clean Catch Urine (CCU); Catherterization; Ultrasound; Micturition; Urine Collection; Pre-Continent Children; Pediatrics

Outcome Measures

Primary Outcomes (2)

• Incidence of miturition

  Recorded act of successfully initiating miturition/urination

  Less than 5 minutes

• Time to Miturition

  Recorded time to miturition

  0-5 minutes

Study Arms (2)

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.

Other: Ultrasound

Interventions

Ultrasound OTHER

Using ultrasound stimulation to induce micturition.

Experimental Group

Eligibility Criteria

• Age: 1 Month - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Vincent Calleo, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: January 11, 2019
• Study Start: January 29, 2019
• Primary Completion: April 13, 2023
• Study Completion: April 13, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)