Furosemide for Bladder Preparation in Pelvic Ultrasounds

Overseen By Lynn-Ann Sorbol

Age: < 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: Connecticut Children's Medical Center

Must not be taking: Diuretics

Disqualifiers: Renal anomalies, Chronic illnesses, Pregnancy, others

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 30

Duration: 3 hours

42 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if furosemide can help fill the bladder faster when given with IV fluids. It targets females aged 8 to 18 who need a pelvic ultrasound to check for ovarian torsion. Furosemide increases urine production, which helps fill the bladder quickly. Furosemide has been used to improve the quality of urinary bladder filling in CT urography examinations.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have used diuretics in the past year, you may not be eligible to participate.

What data supports the effectiveness of the drug Furosemide for bladder preparation in pelvic ultrasounds?

Research shows that Furosemide, a diuretic (a drug that helps the body get rid of excess water), improves the visualization of the urinary tract in imaging tests like CT urography and ultrasonography. This suggests it could help in preparing the bladder for clearer pelvic ultrasound images. ^{1 2 3 4 5}

Is furosemide generally safe for use in humans?

Furosemide, also known as Lasix, is generally considered safe for use in humans. Studies have shown that it can be used without major side effects in various medical imaging procedures, such as improving visualization in CT scans, and it is commonly used to manage conditions like fluid retention. ^{1 5 6 7 8}

How does the drug furosemide differ from other treatments for bladder preparation in pelvic ultrasounds?

Furosemide is unique for bladder preparation in pelvic ultrasounds because it is a diuretic (a drug that increases urine production), which helps fill the bladder more quickly and effectively compared to simply drinking water. This can be particularly useful in situations where patients have difficulty filling their bladder adequately for the ultrasound. ^{2 9 10 11 12}

Research Team

Candice Jersey, D.O.

Principal Investigator

Connecticut Children's Medical Center

Eligibility Criteria

This trial is for girls aged 8-18 who need a pelvic ultrasound in the emergency department to check for ovarian torsion. They must be able to consent or have a guardian who can, and not be critically ill, pregnant, on diuretics recently, or have kidney/genitourinary issues.

Inclusion Criteria

I can sign the consent form myself, or my guardian can if I'm under 18.

I am a girl aged 8-18 going for a pelvic ultrasound for ovarian torsion.

Exclusion Criteria

I feel my bladder is full at the time of signing up.

I cannot take Furosemide due to an allergy, severe dehydration, low blood pressure, electrolyte issues, or kidney disease.

I have a chronic illness or a serious condition affecting my body's systems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 hours

Treatment

Participants receive either IV fluids alone or IV fluids with furosemide to expedite bladder filling

3 hours

Continuous monitoring every 30 minutes

Follow-up

Participants are monitored for adverse events and bladder volume correlation after treatment

6 hours

Treatment Details

Interventions

• Furosemide

Trial Overview The study is testing if Furosemide helps fill the bladder quicker than just IV fluids for better ultrasound imaging. It's comparing these two methods in young females awaiting pelvic ultrasounds.

Participant Groups

Group I: Furosemide Experimental Treatment 1 Intervention

Participants will receive a 20mL/kg (max 1000mL) IV fluid bolus and a 0.1mg/kg (max 5mg) furosemide dose

Group II: IV fluids Placebo Group 1 Intervention

Participants will receive a 20mL/kg (max 1000mL) IV fluid bolus and an IV fluid flush

Who Is Running the Clinical Trial?

Connecticut Children's Medical Center

Lead Sponsor

Trials

76

Recruited

30,000+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of quality of urinary bladder filling in CT urography with different doses of furosemide in the work-up of patients with macroscopic hematuria. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Bladder neck anatomy and mobility: effect of vaginal ultrasound probe. [2019]

3. Poland pubmed.ncbi.nlm.nih.gov

Influence of diuretic (furosemide) on contrast medium distribution in computed tomography urography of high-grade hydronephrosis in children. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Diuretic Enhanced Ultrasonography in the Diagnosis of Pyeloureteral Obstruction. [2020]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Pharmacoechography]. [2015]

6. Germany pubmed.ncbi.nlm.nih.gov

Impact of forced diuresis with furosemide and hydration on the halo artefact and intensity of tracer accumulation in the urinary bladder and kidneys on [68Ga]Ga-PSMA-11-PET/CT in the evaluation of prostate cancer patients. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Effects of furosemide on ureteral diameter and attenuation using computed tomographic excretory urography in normal dogs. [2019]

8. England pubmed.ncbi.nlm.nih.gov

The effect of furosemide dose timing on bladder activity in oncology imaging with 18F-fluorodeoxyglucose PET/CT. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Revisiting the utility of prenatal ultrasound in the routine workup of first febrile UTI: A systematic review and meta-analysis of the negative predictive value of prenatal ultrasound for identification of urinary tract abnormalities after first febrile urinary tract infection in children. [2023]

10. England pubmed.ncbi.nlm.nih.gov

The utility of a bladder scan protocol using a portable ultrasonographic device in subacute stroke patients. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Iatrogenic water intoxication after pelvic ultrasonography imaging. [2016]

12. United States pubmed.ncbi.nlm.nih.gov

Use of furosemide in pregnancies complicated by oligohydramnios. [2015]