Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05620784

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–89 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Alyssa McDonald

CONTACT

[email protected]

Nicholas Dean, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Furosemide

Drug

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

Other names: Lasix, Loop diuretic

Primary outcomes

  1. Same-day discharge

    Time frame: 90-days

    Rate of successful same-day discharge after HoLEP

  2. Same-day catheter removals

    Time frame: 90-days

    Rate of successful same-day catheter removals after HoLEP

Secondary outcomes

  1. Adverse medical events (hematuria)

    Time frame: 90-days

    Rate of unplanned Emergency Department (ED) visits/clinic visits related to bleeding/admission/clot evacuation

  2. Adverse medical events (fluid absorption)

    Time frame: 90-days

    Rate of transurethral resection (TUR) syndrome, vision changes, seizure, hyponatremia, electrolyte abnormality

  3. Duration of post-operative hematuria

    Time frame: 90-days

    (days)

  4. Difference in operative efficiency (enucleation, morcellation, and overall)

    Time frame: 90-days

    (minutes/gram)

  5. Length of hospital stay

    Time frame: 90-days

    (hours)

  6. Overall complications

    Time frame: 90-days

    Clavien-Dindo Classification

Study contacts

Contact information is provided by the study sponsor or research team.

Nicholas S Dean, MD

CONTACT

[email protected]

7806906285

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Nov 17, 2022
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.