NCT03860311: BULLET

BULLET: Bladder Ultrasound Limits Length (of Time), Expedites Treatment

Completed NA Results posted Last updated 1 June 2022

What this trial tests

NA trial testing Bladder Ultrasound in Point-of-Care Bladder Ultrasound in 45 participants. Completed in 1 May 2021.

Timeline

20 July 2019

Primary endpoint
1 May 2021

1 May 2021

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	45
Start date	20 July 2019
Primary completion	1 May 2021
Estimated completion	1 May 2021
Sites	1 location across United States

Drugs / interventions tested

• Bladder Ultrasound
• Standard of Care

Conditions studied

• Point-of-Care Bladder Ultrasound — all drugs for Point-of-Care Bladder Ultrasound →
• Urethral Catheter — all drugs for Urethral Catheter →

Sponsor

University of Alabama at Birmingham

Who can join

Adults 8 to 18, female only, with Point-of-Care Bladder Ultrasound or Urethral Catheter. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Successful Completion of Pelvic Ultrasound Primary · Baseline to 180 minutes

Time zero (order placed) to time completed (time pelvic ultrasound images are completed)

Group	Value	95% CI
Bladder Ultrasound	103.95	82.64 – 125.27
Standard of Care	92.82	80.29 – 105.35

Pain of Bladder Ultrasound vs. Pain of Bladder Catheter as Measured by Verbal Numerical Rating Scale (VNRS) Secondary · When bladder ultrasound performed OR when urinary catheter placed to time of completion of pelvic ultrasound, up to 180 minutes

All participating patients, in either arm, will be given a single-question on pain related to their receipt of bladder ultrasound(s) or bladder catheter. The VNRS uses a 0-10 scale accompanied by faces that pictorially represent the level of pain, 0 being no pain, and 10 being the worst pain. Measurements will start at time when bladder ultrasound(s) are performed OR time when bladder catheter is inserted) to time of completion (time pelvic ultrasound is completed).

Group	Value	95% CI
Bladder Ultrasound	3.60	2.14 – 5.06
Standard of Care	6.23	5.40 – 7.06

Sponsor's own description

In this study patients presenting to the pediatric ER with abdominal or pelvic complaints will be randomized to urethral bladder catheter or bladder ultrasound to compare time to completion of successful pelvic ultrasound, as determined by full visualization of uterus and ovaries.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.