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

BPH Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05620784
• Other study ID #: STU00217795
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: September 2023
• Source: Northwestern University
• Contact: Nicholas S Dean, MD
• Phone: 7806906285
• Email: nicholas.dean[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: August 1, 2024
• Est. primary completion date: June 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• BPH
• BPH With Urinary Obstruction
• Hematuria
• Same Day Discharge

Intervention

Drug:
• Furosemide
20mg of IV furosemide injection during the morcellation phase of HoLEP

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Same-day discharge	Rate of successful same-day discharge after HoLEP	90-days
Primary	Same-day catheter removals	Rate of successful same-day catheter removals after HoLEP	90-days
Secondary	Adverse medical events (hematuria)	Rate of unplanned Emergency Department (ED) visits/clinic visits related to bleeding/admission/clot evacuation	90-days
Secondary	Adverse medical events (fluid absorption)	Rate of transurethral resection (TUR) syndrome, vision changes, seizure, hyponatremia, electrolyte abnormality	90-days
Secondary	Duration of post-operative hematuria	(days)	90-days
Secondary	Difference in operative efficiency (enucleation, morcellation, and overall)	(minutes/gram)	90-days
Secondary	Length of hospital stay	(hours)	90-days
Secondary	Overall complications	Clavien-Dindo Classification	90-days