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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-08-01

Brief Summary

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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. .

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Detailed Description

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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.

Conditions

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BPH With Urinary Obstruction BPH Hematuria Same Day Discharge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized 1:1

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

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Loop Diuretic (Furosemide)

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

Group Type EXPERIMENTAL

Furosemide

Intervention Type DRUG

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Furosemide

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

Intervention Type DRUG

Other Intervention Names

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Lasix Loop diuretic

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes