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

Primary Purpose

BPH With Urinary Obstruction, BPH, Hematuria

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Furosemide
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BPH With Urinary Obstruction

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Loop Diuretic (Furosemide)

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Same-day discharge
Rate of successful same-day discharge after HoLEP
Same-day catheter removals
Rate of successful same-day catheter removals after HoLEP

Secondary Outcome Measures

Adverse medical events (hematuria)
Rate of unplanned Emergency Department (ED) visits/clinic visits related to bleeding/admission/clot evacuation
Adverse medical events (fluid absorption)
Rate of transurethral resection (TUR) syndrome, vision changes, seizure, hyponatremia, electrolyte abnormality
Duration of post-operative hematuria
(days)
Difference in operative efficiency (enucleation, morcellation, and overall)
(minutes/gram)
Length of hospital stay
(hours)
Overall complications
Clavien-Dindo Classification

Full Information

First Posted
November 11, 2022
Last Updated
September 11, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05620784
Brief Title
Intra-operative Loop Diuretics to Improve Same-day Discharge Rates After HoLEP
Official Title
Loop Diuretics During Morcellation to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
June 6, 2023 (Actual)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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. .
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BPH With Urinary Obstruction, BPH, Hematuria, Same Day Discharge

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized 1:1
Masking
ParticipantCare Provider
Masking Description
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.
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Loop Diuretic (Furosemide)
Arm Type
Experimental
Arm Description
This group of patients will receive 20mg of IV furosemide during the morcellation phase of their HoLEP.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group of patients will not receive 20mg of IV furosemide during the morcellation phase of their HoLEP.
Intervention Type
Drug
Intervention Name(s)
Furosemide
Other Intervention Name(s)
Lasix, Loop diuretic
Intervention Description
20mg of IV furosemide injection during the morcellation phase of HoLEP
Primary Outcome Measure Information:
Title
Same-day discharge
Description
Rate of successful same-day discharge after HoLEP
Time Frame
90-days
Title
Same-day catheter removals
Description
Rate of successful same-day catheter removals after HoLEP
Time Frame
90-days
Secondary Outcome Measure Information:
Title
Adverse medical events (hematuria)
Description
Rate of unplanned Emergency Department (ED) visits/clinic visits related to bleeding/admission/clot evacuation
Time Frame
90-days
Title
Adverse medical events (fluid absorption)
Description
Rate of transurethral resection (TUR) syndrome, vision changes, seizure, hyponatremia, electrolyte abnormality
Time Frame
90-days
Title
Duration of post-operative hematuria
Description
(days)
Time Frame
90-days
Title
Difference in operative efficiency (enucleation, morcellation, and overall)
Description
(minutes/gram)
Time Frame
90-days
Title
Length of hospital stay
Description
(hours)
Time Frame
90-days
Title
Overall complications
Description
Clavien-Dindo Classification
Time Frame
90-days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicholas S Dean, MD
Phone
7806906285
Email
nicholas.dean@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy E Krambeck, MD
Organizational Affiliation
Northwestern Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Dean, MD
Email
nicholas.dean@nm.org
First Name & Middle Initial & Last Name & Degree
Alyssa McDonald
Email
alyssa.mcdonald@northwestern.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32698710
Citation
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.
Results Reference
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PubMed Identifier
33414073
Citation
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.
Results Reference
background
PubMed Identifier
12818001
Citation
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.
Results Reference
background
PubMed Identifier
16516015
Citation
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.
Results Reference
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Intra-operative Loop Diuretics to Improve Same-day Discharge Rates After HoLEP

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