Trial Outcomes & Findings for BULLET: Bladder Ultrasound Limits Length (of Time), Expedites Treatment (NCT NCT03860311)

NCT ID: NCT03860311

Last Updated: 2022-06-01

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: Baseline to 180 minutes
• Results posted on: 2022-06-01

Participant Flow

Participant milestones

Measure	Bladder Ultrasound The bladder ultrasound group will undergo point-of-care ultrasound upon enrollment, and bladder ultrasound will be repeated every 30 minutes, unless the patient's bladder is full at time of initial scan. Bladder Ultrasound: Bladder fullness will be assessed upon enrollment and if not full, the patient will receive hydration, determined by treating physician, and the bladder ultrasound will be repeated every 30 minutes until the patient states that the bladder is "full," or until bladder is deemed full based on a previously validated bladder fullness qualitative scale, at which point patients in this group will proceed to undergo pelvic ultrasound.	Standard of Care Bladder (Urethral) Catheter group. The standard of care group will undergo placement of a urethral bladder catheter to allow retrograde filling of the bladder. Standard of Care: Per institution protocol, patients in the standard of care group will have urethral (bladder) catheter placed immediately after the order for pelvic ultrasound and will undergo retrograde bladder filling as determined by the radiologist/ultrasonographer to the point necessary to fully visualize pelvic structures.
Overall Study STARTED	22	23
Overall Study COMPLETED	22	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Bladder Ultrasound n=22 Participants The bladder ultrasound group will undergo point-of-care ultrasound upon enrollment, and bladder ultrasound will be repeated every 30 minutes, unless the patient's bladder is full at time of initial scan. Bladder Ultrasound: Bladder fullness will be assessed upon enrollment and if not full, the patient will receive hydration, determined by treating physician, and the bladder ultrasound will be repeated every 30 minutes until the patient states that the bladder is "full," or until bladder is deemed full based on a previously validated bladder fullness qualitative scale, at which point patients in this group will proceed to undergo pelvic ultrasound.	Standard of Care n=23 Participants Bladder (Urethral) Catheter group. The standard of care group will undergo placement of a urethral bladder catheter to allow retrograde filling of the bladder. Standard of Care: Per institution protocol, patients in the standard of care group will have urethral (bladder) catheter placed immediately after the order for pelvic ultrasound and will undergo retrograde bladder filling as determined by the radiologist/ultrasonographer to the point necessary to fully visualize pelvic structures.	Total n=45 Participants Total of all reporting groups
Age, Continuous	15.33 years STANDARD_DEVIATION 1.98 • n=5 Participants	14.7 years STANDARD_DEVIATION 2.183 • n=7 Participants	15.00 years STANDARD_DEVIATION 2.091 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	23 participants n=7 Participants	45 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 180 minutes

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

Outcome measures

Measure	Bladder Ultrasound n=22 Participants The bladder ultrasound group will undergo point-of-care ultrasound upon enrollment, and bladder ultrasound will be repeated every 30 minutes, unless the patient's bladder is full at time of initial scan. Bladder Ultrasound: Bladder fullness will be assessed upon enrollment and if not full, the patient will receive hydration, determined by treating physician, and the bladder ultrasound will be repeated every 30 minutes until the patient states that the bladder is "full," or until bladder is deemed full based on a previously validated bladder fullness qualitative scale, at which point patients in this group will proceed to undergo pelvic ultrasound.	Standard of Care n=23 Participants Bladder (Urethral) Catheter group. The standard of care group will undergo placement of a urethral bladder catheter to allow retrograde filling of the bladder. Standard of Care: Per institution protocol, patients in the standard of care group will have urethral (bladder) catheter placed immediately after the order for pelvic ultrasound and will undergo retrograde bladder filling as determined by the radiologist/ultrasonographer to the point necessary to fully visualize pelvic structures.
Time to Successful Completion of Pelvic Ultrasound	103.95 minutes Interval 82.64 to 125.27	92.82 minutes Interval 80.29 to 105.35

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Bladder Ultrasound n=22 Participants The bladder ultrasound group will undergo point-of-care ultrasound upon enrollment, and bladder ultrasound will be repeated every 30 minutes, unless the patient's bladder is full at time of initial scan. Bladder Ultrasound: Bladder fullness will be assessed upon enrollment and if not full, the patient will receive hydration, determined by treating physician, and the bladder ultrasound will be repeated every 30 minutes until the patient states that the bladder is "full," or until bladder is deemed full based on a previously validated bladder fullness qualitative scale, at which point patients in this group will proceed to undergo pelvic ultrasound.	Standard of Care n=23 Participants Bladder (Urethral) Catheter group. The standard of care group will undergo placement of a urethral bladder catheter to allow retrograde filling of the bladder. Standard of Care: Per institution protocol, patients in the standard of care group will have urethral (bladder) catheter placed immediately after the order for pelvic ultrasound and will undergo retrograde bladder filling as determined by the radiologist/ultrasonographer to the point necessary to fully visualize pelvic structures.
Pain of Bladder Ultrasound vs. Pain of Bladder Catheter as Measured by Verbal Numerical Rating Scale (VNRS)	3.60 units on a scale Interval 2.14 to 5.06	6.23 units on a scale Interval 5.4 to 7.06

Adverse Events

Bladder Ultrasound

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Stephen Ruffenach

UAB

Phone: 5202707665

Email: stephenruffenach@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place