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

NCT05620784 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2023-09-13

No results posted yet for this study

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

Interventions

DRUG

Furosemide

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

Sponsors & Collaborators

Principal Investigators

  • Amy E Krambeck, MD · Northwestern Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2023-06-06
Completion
2024-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05620784 on ClinicalTrials.gov