Overview

Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia

Status:
NOT_YET_RECRUITING

Trial end date:
2026-06-01

Target enrollment:

Participant gender:

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.

Phase:

PHASE3

Details

Lead Sponsor:

University of Manitoba

Treatments:

Lorazepam
oxycodone-acetaminophen
Pharmaceutical Preparations