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Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia
Sponsor: University of Manitoba
Summary
The primary aim of the study is to show that methoxyflurane-lorazepam-percocet combination administrated 'per os' is non inferior to deep intravenous sedation in achieving analgesia during Rezum convective radiofrequency water vapor thermal therapy for the management of benign prostate hyperplasia (BPH). We propose to conduct a single-centered, unblinded, randomized controlled trial designed after consulting ICH Guidelines for Good Clinical Practice as well the regulations set by the Biomedical Research Ethics Board, University of Manitoba.
Official title: Methoxyflurane + Lorazepam + Percocet (Per os) vs Deep Intravenous Sedation: A Non-inferiority Randomized Controlled Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2025-08
Completion Date
2026-06
Last Updated
2025-06-12
Healthy Volunteers
Yes
Conditions
Interventions
Methoxyflurane - Penthrox
Penthrox is a brand name for a drug called methoxyflurane. It is an inhaled analgesic (pain-relieving) agent used primarily for the relief of moderate to severe pain, typically in emergency medical situations or during minor medical procedures. Penthrox is administered by inhaling the vapors through a hand-held inhaler device. It acts quickly to provide pain relief and has a relatively short duration of action.
Control
This intervention will be the control group only, receiving deep IV sedation.
Percocet Pill
Percocet will be given in conjunction with methoxyfluorane and lorazepam
Lorazepam (drug)
Lorazepam will be given in conjunction with penthrox and percocet.
Locations (1)
Men's Health Clinic Manitoba
Winnipeg, Manitoba, Canada