Actively Recruiting

Phase 3
Age: 18Years - 89Years
MALE
Healthy Volunteers
ID05620784

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

Led by Northwestern University · Updated on 2023-09-13

138

Participants Needed

1

Research Sites

60 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of intravenous loop diuretics, specifically 20mg of furosemide, during Holmium Laser Enucleation of the Prostate (HoLEP) for men with benign prostatic hypertrophy (BPH). HoLEP is recognized as a size-independent treatment for BPH and is recommended by the American Urological Association. The study aims to determine if giving furosemide during the morcellation phase affects the rates of same-day discharge after surgery. In this randomized, double-blind trial, participants are assigned to receive either 20mg of IV furosemide during the morcellation phase of their HoLEP procedure or no furosemide during this phase. The purpose is to compare how these two approaches influence recovery and discharge timing. Patients, surgeons, and care teams remain unaware of the group assignments to ensure unbiased results. Participants will be monitored for outcomes such as same-day discharge rates and same-day catheter removal within 90 days after surgery. Researchers will also track adverse events like hematuria and fluid absorption, operative efficiency, length of hospital stay, and overall complications. The study includes patient questionnaires and follows patients for safety and recovery over a 90-day period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 89Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged 18 to 89 years
  • Scheduled to undergo Holmium Laser Enucleation of the Prostate (HoLEP)
  • Willing to sign the Informed Consent Form
  • Able to read, understand, and complete patient questionnaires
Not Eligible

You will not qualify if you...

  • Allergy or hypersensitivity to furosemide or other loop diuretics
  • Anuric patients or those with liver failure
  • Patients undergoing concurrent ureteroscopy with or without laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery during HoLEP
  • Anticipated need for perineal urethrostomy during HoLEP
  • Patients not undergoing catheter removal and voiding trial at Northwestern Memorial Hospital

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery

Duration - Day of surgery

Participants undergo Holmium Laser Enucleation of the Prostate (HoLEP) with or without the administration of 20mg of IV furosemide during the morcellation phase.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - Up to 90 days post-surgery

Participants are monitored for recovery, hematuria, catheter removal, and complications after surgery.

Follow-up visits as per routine care, including catheter removal and monitoring

Trial Site Locations

Total: 1 location

1

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

N

Nicholas S Dean, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline Amendment 2020.

J Kellogg Parsons, Philipp Dahm, Tobias S Köhler...

https://pubmed.ncbi.nlm.nih.gov/32698710

Same Day Discharge is a Successful Approach for the Majority of Patients Undergoing Holmium Laser Enucleation of the Prostate.

Deepak K Agarwal, Tim Large, Yan Tong...

https://pubmed.ncbi.nlm.nih.gov/33414073