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Furosemide for Benign Prostatic Hyperplasia

Phase 3

Recruiting

Led By Amy E Krambeck, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Males 18-89 undergoing HoLEP

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90-days

Awards & highlights

Study Summary

This trial studies whether furosemide reduces hospital stay after HoLEP, a size-independent treatment for BPH.

Who is the study for?

This trial is for males aged 18-89 who are undergoing a procedure called HoLEP for benign prostatic hypertrophy. They must be willing to consent, able to complete questionnaires, and not have any allergies to loop diuretics like furosemide. It's not for those with liver failure, anuria (no urine output), or having additional surgeries at the same time.Check my eligibility

What is being tested?

The study is testing whether giving a loop diuretic drug called Furosemide during surgery can help patients go home the same day after their prostate surgery (HoLEP). Patients will either receive this medication or they won't, to see if there's a difference in discharge rates.See study design

What are the potential side effects?

Furosemide may cause dehydration, low blood pressure, electrolyte imbalances (like low potassium), dizziness upon standing up too fast, and possibly increased urine production which is its intended effect.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a man aged 18-89 scheduled for HoLEP surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90-days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90-days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90-days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

General hair removal - epilation

Same-day discharge

Secondary outcome measures

Adverse medical events (fluid absorption)

Hematuria

Difference in operative efficiency (enucleation, morcellation, and overall)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Loop Diuretic (Furosemide)Experimental Treatment1 Intervention

This group of patients will receive 20mg of IV furosemide during the morcellation phase of their HoLEP.

Group II: ControlActive Control1 Intervention

This group of patients will not receive 20mg of IV furosemide during the morcellation phase of their HoLEP.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Furosemide

2015

Completed Phase 4

~4240

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,589 Previous Clinical Trials

916,988 Total Patients Enrolled

Amy E Krambeck, MDPrincipal InvestigatorNorthwestern Medicine

1 Previous Clinical Trials

100 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly participants accepted into this trial's protocol?

"The specified age range for participants in this medical trial is 18 to 89 years old."

Answered by AI

To what extent can Furosemide be hazardous for participants?

"Our Power team has assigned a 3-rating to Loop Diuretic (Furosemide) in terms of safety because the available evidence demonstrates its efficacy and multiple layers of security."

Answered by AI

What is the current size of this clinical trial's participant base?

"Correct. According to the information hosted by clinicaltrials.gov, this experiment is actively seeking participants and was first posted on March 1st 2023 before being updated most recently on the 21st of that same month. 138 individuals are required from a single site for full enrolment in the trial."

Answered by AI

Is there an opportunity to join this trial at the present moment?

"Accurate. According to clinicaltrials.gov, this medical trial began on March 1st 2023 and was last updated on March 21st of the same year. The study is currently admitting 138 patients from a single location."

Answered by AI

Is it possible for me to take part in this clinical investigation?

"This clinical trial is recruiting 138 participants aged between 18 and 89 who have hematuria. Participants must also fulfil the following requirements: male gender, undergoing HoLEP, willing to sign an Informed Consent Form, literate enough to complete patient questionnaires."

Answered by AI

What is the main goal of this medical experiment?

"This 90-day medical trial seeks to evaluate same-day catheter removals and measure potential adverse events such as rate of Transurethral Resection Syndrome, alterations in vision, seizures, hyponatremia or electrolyte imbalance. Secondary outcomes include duration of postoperative hematuria (in days) and the difference in operative efficiency for enucleation/morcellation operations (measured in minutes per gram)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intra-operative Loop Diuretics to Improve Same-day Discharge Rates After HoLEP

Amy Krambeck 2023. "Intra-operative Loop Diuretics to Improve Same-day Discharge Rates After HoLEP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05620784.

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