Health TrialsbyHealthPanel

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

ConditionsBPH With Urinary ObstructionBPHHematuriaSame Day Discharge
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18-89
SponsorNorthwestern University

About this trial

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. .

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Males 18 -89 undergoing HoLEP

Willing to sign the Informed Consent Form

Able to read, understand, and complete patient questionnaires.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Furosemide

    Drug

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

Treatment groups

138 Participants
are divided into 2 treatment groups
Group A: Loop Diuretic (Furosemide)Experimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Same-day discharge

Rate of successful same-day discharge after HoLEP

Time frame
90-days
2

Same-day catheter removals

Rate of successful same-day catheter removals after HoLEP

Time frame
90-days

Secondary outcomes

1

Adverse medical events (hematuria)

Rate of unplanned Emergency Department (ED) visits/clinic visits related to bleeding/admission/clot evacuation

Time frame
90-days
2

Adverse medical events (fluid absorption)

Rate of transurethral resection (TUR) syndrome, vision changes, seizure, hyponatremia, electrolyte abnormality

Time frame
90-days
3

Duration of post-operative hematuria

(days)

Time frame
90-days
4

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

(minutes/gram)

Time frame
90-days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Source ClinicalTrials.gov
Apply now