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

Study Overview
=================
Brief Summary
-----------------
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. .

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.

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

Conditions
-----------------
BPH With Urinary Obstruction, BPH, Hematuria, Same Day Discharge

Intervention / Treatment
-----------------
* Drug: Furosemide


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized 1:1
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Loop Diuretic (Furosemide)<br>This group of patients will receive 20mg of IV furosemide during the morcellation phase of their HoLEP. | Drug: Furosemide<br>* 20mg of IV furosemide injection during the morcellation phase of HoLEP<br>* Other names: Loop diuretic;|
| No Intervention: Control<br>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 |