What side effects are associated with this type of intervention?

The most common treatment for ovarian torsion is surgical intervention, either through laparoscopy or laparotomy. The side effects of these surgical treatments can include infection, bleeding, damage to surrounding organs, and postoperative pain. Additionally, there may be risks associated with anesthesia, such as allergic reactions or respiratory issues. Recovery from surgery can also involve temporary discomfort and limited physical activity.

What prior FDA approvals exist?

Ovarian torsion is primarily treated through surgical intervention to untwist the affected ovary and restore blood flow. There are no FDA-approved pharmacological treatments for ovarian torsion, and diuretics like furosemide are not relevant to its management.

What other types of research exist?

For managing associated conditions like ascites or edema in ovarian torsion patients, Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors and eplerenone are promising alternatives to furosemide.

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Furosemide for Bladder Preparation in Pelvic Ultrasounds

Q: What is the mechanism of action of this treatment?

The most common treatments for ovarian torsion involve surgical procedures like laparoscopy or laparotomy to untwist the ovary and restore blood flow. This is critical for patients because timely intervention can save the ovary, preserving its function and fertility. While furosemide, a diuretic, is not directly related to ovarian torsion treatment, both conditions highlight the importance of prompt medical attention to prevent long-term damage.

Phase < 1

Waitlist Available

Led By Candice Jersey, D.O.

Research Sponsored by Connecticut Children's Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Must not have

Patients deemed to be critically ill (e.g. Mental status changes, signs of end organ damage, hypotension)

History of renal, genitourinary, or pelvic anomalies (e.g. Chronic kidney disease, anuria, vesicoureteral reflux, ureteral obstruction, urologic reconstructive surgery, suprapubic or pelvic surgery, indwelling urethral catheter, oophorectomy, bicornate uterus)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of intervention until final disposition, about 6 hours

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Furosemide may cause increased urination, dehydration risks, electrolyte imbalances (like low potassium), and possible allergic reactions if there's a sulfonamide medication allergy.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am critically ill with symptoms like confusion, organ damage, or low blood pressure.

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I have had kidney, urinary, or pelvic problems or surgeries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of intervention until final disposition, about 6 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of intervention until final disposition, about 6 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of intervention until final disposition, about 6 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The time from initiation of the intervention to the time that the bladder reaches large, ovoid shape on POCUS exam

Secondary study objectives

Number and nature of all reports of adverse events related to furosemide administration

The correlation between bladder volume as calculated on POCUS exam of a large, ovoid bladder and bladder volume as reported by bladder scanner

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: FurosemideExperimental Treatment1 Intervention

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

Group II: IV fluidsPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Furosemide

FDA approved

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ovarian torsion involve surgical procedures like laparoscopy or laparotomy to untwist the ovary and restore blood flow. This is critical for patients because timely intervention can save the ovary, preserving its function and fertility. While furosemide, a diuretic, is not directly related to ovarian torsion treatment, both conditions highlight the importance of prompt medical attention to prevent long-term damage.

Conservative laparoscopic management of adnexal torsion based on a 17-year follow-up experience.