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UltraWee: Ultrasound Bladder Stimulation

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ClinicalTrials.gov Identifier: NCT03801720
Recruitment Status : Enrolling by invitation
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Vincent Calleo, State University of New York - Upstate Medical University

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.

Condition or disease Intervention/treatment Phase
Urinalysis Other: Ultrasound Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: UltraWee: Ultrasound Bladder Stimulation to Help With Clean Catch Urine in Pre-Continent Children
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 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.
Experimental: 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.
Other: Ultrasound
Using ultrasound stimulation to induce micturition.




Primary Outcome Measures :
  1. Incidence of miturition [ Time Frame: Less than 5 minutes ]
    Recorded act of successfully initiating miturition/urination

  2. Time to Miturition [ Time Frame: 0-5 minutes ]
    Recorded time to miturition



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801720


Locations
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Vincent Calleo, MD State University of New York - Upstate Medical University

Responsible Party: Vincent Calleo, Principal Investigator, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT03801720     History of Changes
Other Study ID Numbers: 1190457
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vincent Calleo, State University of New York - Upstate Medical University:
Clean Catch Urine (CCU)
Catherterization
Ultrasound
Micturition
Urine Collection
Pre-Continent Children
Pediatrics