Intra-operative Loop Diuretics to Improve Same-day Discharge Rates After HoLEP
Study Details
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. .
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Loop Diuretic (Furosemide) This group of patients will receive 20mg of IV furosemide during the morcellation phase of their HoLEP. |
Drug: Furosemide
20mg of IV furosemide injection during the morcellation phase of HoLEP
Other Names:
|
| No Intervention: Control This group of patients will not receive 20mg of IV furosemide during the morcellation phase of their HoLEP. |
Outcome Measures
Primary Outcome Measures
- Same-day discharge [90-days]
Rate of successful same-day discharge after HoLEP
- Same-day catheter removals [90-days]
Rate of successful same-day catheter removals after HoLEP
Secondary Outcome Measures
- Adverse medical events (hematuria) [90-days]
Rate of unplanned Emergency Department (ED) visits/clinic visits related to bleeding/admission/clot evacuation
- Adverse medical events (fluid absorption) [90-days]
Rate of transurethral resection (TUR) syndrome, vision changes, seizure, hyponatremia, electrolyte abnormality
- Duration of post-operative hematuria [90-days]
(days)
- Difference in operative efficiency (enucleation, morcellation, and overall) [90-days]
(minutes/gram)
- Length of hospital stay [90-days]
(hours)
- Overall complications [90-days]
Clavien-Dindo Classification
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Northwestern University
Investigators
- Principal Investigator: Amy E Krambeck, MD, Northwestern Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- STU00217795