What this study is
Holmium Laser Enucleation of the Prostate (HoLEP) is a size-independent treatment option for benign prostatic hypertrophy (BPH) as recommended by the American Urological Association (AUA) Guidelines. Loop diuretics (furosemide) have been given historically during the morcellation portion of HoLEP to promote urine production in the post-operative setting and to minimize the impact of fluid absorption during long periods of morcellation. The intra-operative use of 20mg IV furosemide in perioperative HoLEP pathways has been propagated with the dissemination of HoLEP across North America without evidence to support its routine administration. With increasing surgical efficiency from improvements in laser and morcellator technology, the role of intra-operative furosemide is unknown. This study is designed to assess if there is a significant difference in same day discharge rates after Holmium Laser Enucleation of the Prostate (HoLEP) with and without IV furosemide. .
What's being tested
- Furosemide
Intervention · DRUG
20mg of IV furosemide injection during the morcellation phase of HoLEP
Study details
- Official title
- Loop Diuretics During Morcellation to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP)
- Sponsor
- Northwestern University
- Conditions
- BPH With Urinary Obstruction · BPH · Hematuria · Same Day Discharge
- Enrolling
- 138 people
- Starts
- 2023-03-01
- Est. completion
- 2024-08-01
- Design
- Double-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 89 YearsSex MALEHealthy volunteers AcceptedYou may qualify if
- Males 18 -89 undergoing HoLEP
- Willing to sign the Informed Consent Form
- Able to read, understand, and complete patient questionnaires.
You can't join if
- Allergy or hypersensitivity to furosemide or other loop diuretic
- Anuric patients or patients with liver failure
- Patients having a concurrent ureteroscopy +/- laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery at the time of their HoLEP
- Anticipated need for perineal urethrostomy at the time of HoLEP
- Patient not undergoing catheter removal and voiding trial at Northwestern Memorial Hospital
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNorthwestern University
Chicago, Illinois, United States
- Nicholas Dean, MD · Contactnicholas.dean@nm.org
- Alyssa McDonald · Contactalyssa.mcdonald@northwestern.edu
Recruiting
Study team
Sponsor
Northwestern University
Study ID STU00217795
Principal investigator
Amy E Krambeck, MD
Northwestern Medicine
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.