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

Phase 3

Recruiting

• Conditions: BPH With Urinary Obstruction; BPH; Hematuria; Same Day Discharge
• Interventions: Drug: Furosemide

• Registration Number: NCT05620784
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study First Submitted: 2022-11-11
• Study First Submitted QC: 2022-11-11
• Study First Posted: 2022-11-17
• Study Start: 2023-03-01
• Primary Completion: 2023-06-06
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 138

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Loop Diuretic (Furosemide)	Furosemide	This group of patients will receive 20mg of IV furosemide during the morcellation phase of their HoLEP.

Primary Outcome Measures

Name	Time	Method
Same-day discharge	90-days	Rate of successful same-day discharge after HoLEP
Same-day catheter removals	90-days	Rate of successful same-day catheter removals after HoLEP

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States