Point-of-Care Bladder UltrasoundBULLETNCT03860311
BULLET: Bladder Ultrasound Limits Length (of Time), Expedites Treatment
A study testing Bladder Ultrasound in people with Point-of-Care Bladder Ultrasound and Urethral Catheter, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years, women only
- Conditions the study is for
- Point-of-Care Bladder Ultrasound, Urethral Catheter
- What is being tested?
- Bladder Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2019to 1 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 8yr-18yrs
- Female
- Likely to have order placed for transabdominal pelvic ultrasound/ovarian ultrasound
- No history of pelvic or bladder reconstructive surgery
Who cannot join
- Pregnancy (known)
- Critically ill patients
- Patients with known renal or genitourinary structural abnormalities or prior pelvic/genitourinary surgery
- Chronic renal disease
- Patients presenting outside the defined treatment windows
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
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.
Read the detailed description
In this study, we will enroll female pediatric emergency department (ED) patients presenting with a diagnosis of abdominal pain who may have a transabdominal pelvic ultrasound ordered by their treating physician (or nurse practitioner). In order to maximize the visualization of organs deep within the pelvis such as the ovaries and uterus, the patient's bladder must be full. The current practice at our institution, as well as numerous others, is to have a bladder catheter placed immediately when a transabdominal pelvic ultrasound is ordered, and then to fill the bladder in a retrograde manner in order to provide enhanced visualization of the pelvic structures. The process of inserting a bladder catheter into a pediatric patient is an invasive procedure which can be traumatic and painful to the patient. Additionally, if the patient's bladder is already full, this procedure may be unnecessary.
In this study, a point-of-care bladder ultrasound will be performed, upon enrollment of a patient by a study bedside sonographer (our pediatric emergency department nurse practitioners), to assess degree of bladder fullness. This measurement will then be repeated serially while the patient is receiving hydration and the ultrasound will be performed when the bladder is full. We hypothesize that this work flow will result in an equivalent time to transabdominal pelvic ultrasound completion and will reduce the number of potentially traumatic and painful, invasive urethral bladder catheterizations.
- Being tested
- Bladder Ultrasound, Standard of Care
- Keywords
- Ovarian Torsion, Point-of-Care, Pelvic pain, Bedside Ultrasound
- Medical subject headings
- Ovarian Torsion, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder UltrasoundDevice
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Bladder Ultrasound | Experimental | 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. Receives: Device: Bladder Ultrasound |
| Standard of Care | Active comparator | Bladder (Urethral) Catheter group. The standard of care group will undergo placement of a urethral bladder catheter to allow retrograde filling of the bladder. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Successful Completion of Pelvic Ultrasound
Time zero (order placed) to time completed (time pelvic ultrasound images are completed)
Measured: Baseline to 180 minutes
Secondary outcomes (1)
Pain of Bladder Ultrasound vs. Pain of Bladder Catheter as Measured by Verbal Numerical Rating Scale (VNRS)
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).
Measured: When bladder ultrasound performed OR when urinary catheter placed to time of completion of pelvic ultrasound, up to 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start20 Jul 2019
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Point-of-Care Bladder UltrasoundStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Ruffenach, University of Alabama at Birmingham
- Investigators
- Kathleen R Richard, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860311
- Sponsor's protocol ID
- IRB-300002071
- Acronym
- BULLET
- Status last verified
- May 2022
- First submitted
- 28 Feb 2019
- Last updated
- 1 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BULLET: Bladder Ultrasound Limits Length (of Time), Expedites Treatment
- ClinicalTrials.gov ID
- NCT03860311
- Acronym / sponsor ID
- BULLET / IRB-300002071
- Keywords
- Ovarian Torsion, Point-of-Care, Pelvic pain, Bedside Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 20 Jul 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Posted 1 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study, we will enroll female pediatric emergency department (ED) patients presenting with a diagnosis of abdominal pain who may have a transabdominal pelvic ultrasound ordered by their treating physician (or nurse practitioner). In order to maximize the visualization of organs deep within the pelvis such as the ovaries and uterus, the patient's bladder must be full. The current practice at our institution, as well as numerous others, is to have a bladder catheter placed immediately when a transabdominal pelvic ultrasound is ordered, and then to fill the bladder in a retrograde manner in order to provide enhanced visualization of the pelvic structures. The process of inserting a bladder catheter into a pediatric patient is an invasive procedure which can be traumatic and painful to the patient. Additionally, if the patient's bladder is already full, this procedure may be unnecessary.
In this study, a point-of-care bladder ultrasound will be performed, upon enrollment of a patient by a study bedside sonographer (our pediatric emergency department nurse practitioners), to assess degree of bladder fullness. This measurement will then be repeated serially while the patient is receiving hydration and the ultrasound will be performed when the bladder is full. We hypothesize that this work flow will result in an equivalent time to transabdominal pelvic ultrasound completion and will reduce the number of potentially traumatic and painful, invasive urethral bladder catheterizations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bladder Ultrasound | Experimental | Device: Bladder UltrasoundThe 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. |
| Standard of Care | Active comparator | Other: Standard of CareBladder (Urethral) Catheter group. The standard of care group will undergo placement of a urethral bladder catheter to allow retrograde filling of the bladder. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 8yr-18yrs
- Female
- Likely to have order placed for transabdominal pelvic ultrasound/ovarian ultrasound
- No history of pelvic or bladder reconstructive surgery
Key exclusion criteria (5 listed)
- Pregnancy (known)
- Critically ill patients
- Patients with known renal or genitourinary structural abnormalities or prior pelvic/genitourinary surgery
- Chronic renal disease
- Patients presenting outside the defined treatment windows
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bladder UltrasoundBladder 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. | Device | Bladder Ultrasound |
| Standard of CarePer 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. | Other | Standard of Care |
Primary outcome
Time to Successful Completion of Pelvic Ultrasound
Time frame: Baseline to 180 minutes
Time zero (order placed) to time completed (time pelvic ultrasound images are completed)
1 secondary outcome
Pain of Bladder Ultrasound vs. Pain of Bladder Catheter as Measured by Verbal Numerical Rating Scale (VNRS)
Time frame: When bladder ultrasound performed OR when urinary catheter placed to time of completion of pelvic ultrasound, up to 180 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen R Richard, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder Ultrasound in people with Point-of-Care Bladder Ultrasound and Urethral Catheter, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Successful Completion of Pelvic Ultrasound (time frame: Baseline to 180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.