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POCUS Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound

Point-of-Care-Ultrasound Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02923245
Enrollment
120
Registered
2016-10-04
Start date
2015-09-30
Completion date
2016-11-05
Last updated
2019-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Pain, Pelvic Pain

Brief summary

The purpose of this study is to assess the accuracy and utility of point-of-care ultrasound (POCUS) of the bladder compared to patient's sensation of bladder fullness in predicting the ability to successfully perform a comprehensive transabdominal pelvic ultrasound in the pediatric Emergency Department (ED). We hypothesize that POCUS can more accurately and more quickly determine adequate bladder fullness to successfully perform transabdominal pelvic ultrasound than patient's perception of bladder fullness.

Detailed description

Ultrasound (US) is the preferred imaging modality in the pediatric ED in the diagnostic evaluation of girls with suspected pelvic pathology. In the transabdominal approach, urine acts as a sonographic acoustic window to image the adnexa and uterus, but this requires a full bladder. Many high acuity pelvic pathologies presenting to the pediatric ED have significant morbidity and mortality associated with delays in diagnosis. Despite this, diagnostic pelvic US is often delayed by the need to fill the bladder, awaiting a patient's report of subjective sensation of bladder fullness. Images of the bladder using POCUS can be easily obtained at the bedside by emergency physicians, providing a quick assessment of the size and shape of the bladder that may be a more accurate, objective measure of bladder fullness. We aim to assess the utility of POCUS of the bladder compared to patient's sensation of bladder fullness in this clinical scenario. This is a pragmatic, randomized controlled trial of a convenience sample of girls being treated in a pediatric ED who present with an indication for transabdominal pelvic US. Patients will be randomized to two groups: 1. Standard of care group - Patients will be given consecutive IV fluid boluses until sensation of maximum bladder fullness followed by transabdominal pelvic US performed by a radiologist or US technician. 2. Experimental group - Patients will be given consecutive IV fluid boluses until a full bladder is visualized by the ED physician on POCUS followed by transabdominal pelvic US performed by a radiologist or US technician. Patients in both groups will be assessed at 30-minute intervals for sensation of bladder fullness on a 0-4 Likert Scale, total volume of IVF given per kilogram, and POCUS of the bladder. Overall time between initial ordering of transabdominal pelvic US (Time 0) to the time the patient went for successful US will be recorded and compared between the two groups. Success rate of first attempt at transabdominal pelvic US will also be recorded and compared between the two groups.

Interventions

OTHERpoint-of-care ultrasound

Sponsors

Lifespan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
8 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Girls age 8-18 presenting to the pediatric Emergency Department who need transabdominal pelvic ultrasound as determined by their treating providers

Exclusion criteria

* History of genitourinary or pelvic anomalies (e.g. neurogenic bladder, urogenital malformation, ambiguous genitalia, Turner Syndrome, ureterocele, bladder diverticulum, imperforate hymen); history of pelvic surgery * Critically ill patients who are unable to consent * Sensation of maximal bladder fullness/need to void at time of start of the study * Nonverbal patients or severe cognitive or language delay

Design outcomes

Primary

MeasureTime frameDescription
Median Fill-To-Done (FTD) Timeon same day as study enrollmentMedian time from enrollment to successful completion of TAPUS

Secondary

MeasureTime frame
Number of Participants Who Had a Successful Transabdominal Pelvic Ultrasound (TAPUS) on First Attempton same day as study enrollment

Other

MeasureTime frameDescription
TAPUS Resultday of enrollment
Number of Participants Receiving IV Narcotics in the Emergency Departmentday of enrollment
Inter-rater Agreementat close of studyAgreement between the POCUS sonographer and the blinded reviewer
Disposition From EDday of enrollment
Total IV Fluids Given Prior to TAPUSday of enrollment

Countries

United States

Participant flow

Participants by arm

ArmCount
POCUS
Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until a full bladder is visualized by the ED physician on POCUS or the patient endorses maximal bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician. point-of-care ultrasound
60
Usual Care
Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until the patient endorses sensation of maximum bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.
60
Total120

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studyultrasound order was cancelled21

Baseline characteristics

CharacteristicPOCUSUsual CareTotal
Age, Continuous14.1 years
STANDARD_DEVIATION 2.43
14.7 years
STANDARD_DEVIATION 2.34
14.4 years
STANDARD_DEVIATION 2.39
Body Mass Index (BMI)23.0 kg/m2
STANDARD_DEVIATION 4.81
25.4 kg/m2
STANDARD_DEVIATION 6.57
24.2 kg/m2
STANDARD_DEVIATION 5.86
Chief Complaint
Abdominal Pain
56 Participants50 Participants106 Participants
Chief Complaint
Dysuria/flank pain/hematuria
5 Participants5 Participants10 Participants
Chief Complaint
Other
0 Participants3 Participants3 Participants
Chief Complaint
Vomiting
3 Participants3 Participants6 Participants
Race/Ethnicity, Customized
Hispanic
22 Participants14 Participants36 Participants
Race/Ethnicity, Customized
Non-Hispanic Black
5 Participants5 Participants10 Participants
Race/Ethnicity, Customized
Non-Hispanic White
31 Participants37 Participants68 Participants
Race/Ethnicity, Customized
Other
2 Participants4 Participants6 Participants
Region of Enrollment
United States
60 Participants60 Participants120 Participants
Sex: Female, Male
Female
60 Participants60 Participants120 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Time from TAPUS order by physician to study enrollment32.0 minutes34.5 minutes32.5 minutes
Time since last void126.5 minutes120.5 minutes125 minutes

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 600 / 60
other
Total, other adverse events
0 / 600 / 60
serious
Total, serious adverse events
0 / 600 / 60

Outcome results

Primary

Median Fill-To-Done (FTD) Time

Median time from enrollment to successful completion of TAPUS

Time frame: on same day as study enrollment

ArmMeasureValue (MEDIAN)
POCUSMedian Fill-To-Done (FTD) Time87.5 minutes
Usual CareMedian Fill-To-Done (FTD) Time139 minutes
95% CI: [23.4, 77.2]
Secondary

Number of Participants Who Had a Successful Transabdominal Pelvic Ultrasound (TAPUS) on First Attempt

Time frame: on same day as study enrollment

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
POCUSNumber of Participants Who Had a Successful Transabdominal Pelvic Ultrasound (TAPUS) on First Attempt58 Participants
Usual CareNumber of Participants Who Had a Successful Transabdominal Pelvic Ultrasound (TAPUS) on First Attempt50 Participants
p-value: 0.00695% CI: [5.3, 25]Test of proportions
Other Pre-specified

Disposition From ED

Time frame: day of enrollment

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
POCUSDisposition From EDTransferred1 Participants
POCUSDisposition From EDAdmit to ward11 Participants
POCUSDisposition From EDAdmitted to operating room5 Participants
POCUSDisposition From EDDischarged home43 Participants
Usual CareDisposition From EDTransferred0 Participants
Usual CareDisposition From EDDischarged home44 Participants
Usual CareDisposition From EDAdmitted to operating room5 Participants
Usual CareDisposition From EDAdmit to ward11 Participants
Other Pre-specified

Inter-rater Agreement

Agreement between the POCUS sonographer and the blinded reviewer

Time frame: at close of study

Population: 304 images were available for assessment of inter-rater reliability

ArmMeasureValue (NUMBER)
POCUSInter-rater Agreement0.83 weighted kappa
Other Pre-specified

Number of Participants Receiving IV Narcotics in the Emergency Department

Time frame: day of enrollment

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
POCUSNumber of Participants Receiving IV Narcotics in the Emergency Department21 Participants
Usual CareNumber of Participants Receiving IV Narcotics in the Emergency Department26 Participants
Other Pre-specified

TAPUS Result

Time frame: day of enrollment

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
POCUSTAPUS ResultAbnormal12 Participants
POCUSTAPUS ResultOther ovarian abnormality2 Participants
POCUSTAPUS ResultSimple ovarian cyst1 Participants
POCUSTAPUS ResultUterine anomaly0 Participants
POCUSTAPUS ResultOvarian torsion4 Participants
POCUSTAPUS ResultPathologic free fluid1 Participants
POCUSTAPUS ResultRuptured/hemorrhagic cyst5 Participants
POCUSTAPUS ResultHydrosalpinx1 Participants
POCUSTAPUS ResultNormal46 Participants
Usual CareTAPUS ResultHydrosalpinx0 Participants
Usual CareTAPUS ResultNormal48 Participants
Usual CareTAPUS ResultAbnormal11 Participants
Usual CareTAPUS ResultOvarian torsion2 Participants
Usual CareTAPUS ResultSimple ovarian cyst3 Participants
Usual CareTAPUS ResultRuptured/hemorrhagic cyst5 Participants
Usual CareTAPUS ResultOther ovarian abnormality0 Participants
Usual CareTAPUS ResultUterine anomaly1 Participants
Usual CareTAPUS ResultPathologic free fluid2 Participants
Other Pre-specified

Total IV Fluids Given Prior to TAPUS

Time frame: day of enrollment

ArmMeasureValue (MEAN)Dispersion
POCUSTotal IV Fluids Given Prior to TAPUS19.4 ml/KgStandard Deviation 15.1
Usual CareTotal IV Fluids Given Prior to TAPUS22.9 ml/KgStandard Deviation 13.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026