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

Loop Diuretics During Morcellation to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP)

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. .

Study Overview

• Status: Recruiting
• Conditions: Hematuria; BPH; Same Day Discharge; BPH With Urinary Obstruction
• Intervention / Treatment: Drug: Furosemide

Detailed Description

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.

This single-center randomized controlled trial is designed to assess if there is a significant difference in same day discharge rates after Holmium Laser Enucleation of the Prostate (HoLEP). We currently attempt to perform HoLEP as a same-day discharge (SDD) procedure, however one of the main limiting factors in SDD is hematuria. Loop diuretics (furosemide) have been administered at the time of morcellation as a part of our HoLEP pathway to increase post-operative urinary output and reduce clinically significant gross hematuria and clot-formation. The objective of our study will be to assess if SDD rates are non-inferior in those patients who do not receive furosemide diuretics versus those that do.

Patients will be randomized 1:1 to 20mg of IV lasix versus control. Patients and the surgeon/post-operative care team (fellow, residents, and nursing team) will be blinded to the treatment allocation.

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Nicholas S Dean, MD; Phone Number: 7806906285; Email: nicholas.dean@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Nicholas Dean, MD; Email: nicholas.dean@nm.org
      • Contact: Alyssa McDonald; Email: alyssa.mcdonald@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Males 18 -89 undergoing HoLEP
• Willing to sign the Informed Consent Form
• Able to read, understand, and complete patient questionnaires.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Loop Diuretic (Furosemide); This group of patients will receive 20mg of IV furosemide during the morcellation phase of their HoLEP.	Drug: Furosemide; 20mg of IV furosemide injection during the morcellation phase of HoLEP; Other Names: Lasix; Loop diuretic
No Intervention: Control; This group of patients will not receive 20mg of IV furosemide during the morcellation phase of their HoLEP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Same-day discharge	Rate of successful same-day discharge after HoLEP	90-days
Same-day catheter removals	Rate of successful same-day catheter removals after HoLEP	90-days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse medical events (hematuria)	Rate of unplanned Emergency Department (ED) visits/clinic visits related to bleeding/admission/clot evacuation	90-days
Adverse medical events (fluid absorption)	Rate of transurethral resection (TUR) syndrome, vision changes, seizure, hyponatremia, electrolyte abnormality	90-days
Duration of post-operative hematuria	(days)	90-days
Difference in operative efficiency (enucleation, morcellation, and overall)	(minutes/gram)	90-days
Length of hospital stay	(hours)	90-days
Overall complications	Clavien-Dindo Classification	90-days

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Amy E Krambeck, MD, Northwestern Medicine

Publications and helpful links

General Publications

• Parsons JK, Dahm P, Kohler TS, Lerner LB, Wilt TJ. Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline Amendment 2020. J Urol. 2020 Oct;204(4):799-804. doi: 10.1097/JU.0000000000001298. Epub 2020 Jul 23.
• Agarwal DK, Large T, Tong Y, Stoughton CL, Damler EM, Nottingham CU, Rivera ME, Krambeck AE. Same Day Discharge is a Successful Approach for the Majority of Patients Undergoing Holmium Laser Enucleation of the Prostate. Eur Urol Focus. 2022 Jan;8(1):228-234. doi: 10.1016/j.euf.2020.12.018. Epub 2021 Jan 4.
• Kuo RL, Paterson RF, Kim SC, Siqueira TM Jr, Elhilali MM, Lingeman JE. Holmium Laser Enucleation of the Prostate (HoLEP): A Technical Update. World J Surg Oncol. 2003 Jun 6;1(1):6. doi: 10.1186/1477-7819-1-6.
• Elzayat E, Habib E, Elhilali M. Holmium laser enucleation of the prostate in patients on anticoagulant therapy or with bleeding disorders. J Urol. 2006 Apr;175(4):1428-32. doi: 10.1016/S0022-5347(05)00645-2.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): June 6, 2023
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: November 11, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Hemorrhage; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hematuria; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Membrane Transport Modulators; Furosemide; Diuretics; Sodium Potassium Chloride Symporter Inhibitors
• Other Study ID Numbers: STU00217795

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes