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

NCT05620784 | Recruiting Phase 3 FDA Drug

• 1 other identifier: STU00217795
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Same-day discharge

  Rate of successful same-day discharge after HoLEP

  90-days

• Same-day catheter removals

  Rate of successful same-day catheter removals after HoLEP

  90-days

Secondary Outcomes (6)

• Adverse medical events (hematuria)

  90-days

• Adverse medical events (fluid absorption)

  90-days

• Duration of post-operative hematuria

  90-days

• Difference in operative efficiency (enucleation, morcellation, and overall)

  90-days

• Length of hospital stay

  90-days

Study Arms (2)

Loop Diuretic (Furosemide)

EXPERIMENTAL

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

Drug: Furosemide

Control

NO INTERVENTION

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

Interventions

Furosemide DRUG

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

Also known as: Lasix, Loop diuretic

Loop Diuretic (Furosemide)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males 18 -89 undergoing HoLEP
• Willing to sign the Informed Consent Form
• Able to read, understand, and complete patient questionnaires.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (4)

• Parsons JK, Dahm P, Kohler TS, Lerner LB, Wilt TJ. Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline Amendment 2020. J Urol. 2020 Oct;204(4):799-804. doi: 10.1097/JU.0000000000001298. Epub 2020 Jul 23.

  PMID: 32698710 BACKGROUND

• Agarwal DK, Large T, Tong Y, Stoughton CL, Damler EM, Nottingham CU, Rivera ME, Krambeck AE. Same Day Discharge is a Successful Approach for the Majority of Patients Undergoing Holmium Laser Enucleation of the Prostate. Eur Urol Focus. 2022 Jan;8(1):228-234. doi: 10.1016/j.euf.2020.12.018. Epub 2021 Jan 4.

  PMID: 33414073 BACKGROUND

• Kuo RL, Paterson RF, Kim SC, Siqueira TM Jr, Elhilali MM, Lingeman JE. Holmium Laser Enucleation of the Prostate (HoLEP): A Technical Update. World J Surg Oncol. 2003 Jun 6;1(1):6. doi: 10.1186/1477-7819-1-6.

  PMID: 12818001 BACKGROUND

• Elzayat E, Habib E, Elhilali M. Holmium laser enucleation of the prostate in patients on anticoagulant therapy or with bleeding disorders. J Urol. 2006 Apr;175(4):1428-32. doi: 10.1016/S0022-5347(05)00645-2.

  PMID: 16516015 BACKGROUND

MeSH Terms

Conditions

Hematuria

Interventions

Furosemide; Sodium Potassium Chloride Symporter Inhibitors

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Diuretics; Natriuretic Agents; Physiological Effects of Drugs

Study Officials

• Amy E Krambeck, MD

  Northwestern Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas S Dean, MD

CONTACT

7806906285; nicholas.dean@northwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Only the clinical investigator and anesthesiologist/nurse anesthetist will be aware of treatment allocation. The care providers (surgeon, fellow, resident, and nursing team) and patient will be blinded to the treatment allocation. The outcomes assessor will be unblinded at the time of statistical analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of The Division of Endourology & Stone Disease

Model Details: Patients will be randomized 1:1

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 17, 2022
• Study Start: March 1, 2023
• Primary Completion: June 6, 2023
• Study Completion: August 1, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)