Recruiting
Phase 3

Loop Diuretics

Sponsor:

Northwestern University

Code:

NCT05620784

Conditions

BPH With Urinary Obstruction

BPH

Hematuria

Same Day Discharge

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Furosemide

Study Details

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. .

Conditions

BPH With Urinary Obstruction

BPH

Hematuria

Same Day Discharge

Study ID

NCT05620784

Start date

Mar 1, 2023

Status verified date

Sep, 2023

Completion date

Aug 1, 2024

Anticipated

Primary completion date

Jun 6, 2023

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

138 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Loop Diuretic (Furosemide)

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

no intervention: Control

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

Interventions

Furosemide

20mg of IV furosemide injection during the morcellation phase of HoLEP

Primary outcome measure

  • Same-day discharge [ Time Frame: 90-days ]
  • Same-day catheter removals [ Time Frame: 90-days ]

Central Contacts and Locations

Central contacts

Nicholas S Dean, MD

7806906285nicholas.dean@northwestern.edu

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Nicholas Dean, MD

nicholas.dean@nm.org

Alyssa McDonald

alyssa.mcdonald@northwestern.edu

More Information

Sponsor

Northwestern University

Last update posted

Sep 13, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-11. This information was provided to ClinicalTrials.gov by Northwestern University on 2023-09-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.