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

NCT07017452 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-06-12

No results posted yet for this study

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.

Conditions

  • Benign Prostate Hypertrophy(BPH)

Interventions

DRUG

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.

OTHER

Control

This intervention will be the control group only, receiving deep IV sedation.

DRUG

Percocet Pill

Percocet will be given in conjunction with methoxyfluorane and lorazepam

DRUG

Lorazepam (drug)

Lorazepam will be given in conjunction with penthrox and percocet.

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2025-12-31
Completion
2026-06-30
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07017452 on ClinicalTrials.gov