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

NCT07017452 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: HS27031
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Post-Procedural Pain

  Post procedural pain measured using the Numeric Rating Scale for pain. Higher scores on this measurement indicate worser outcomes. Maximum value of 10 and a minimum value of 10 can be reported on this scale.

  Immediately post-procedure

Secondary Outcomes (4)

• Safety of Procedure

  At time of procedure and post-procedure

• Cost-effectiveness,

  1 month post-procedure

• Anxiety levels

  Pre-Procedure on day of procedure

• Patient satisfaction

  Immediately post-procedure

Study Arms (2)

Intervention arm-Penthrox

EXPERIMENTAL

Participants can begin using penthrox 10 minutes prior to procedure start, given its median onset time of 5 minutes

Drug: Methoxyflurane - Penthrox; Drug: Percocet Pill; Drug: Lorazepam (drug)

Control arm

PLACEBO COMPARATOR

Patients will receive standard of care during their rezum procedure which consists of deep IV sedation.

Other: Control

Interventions

Methoxyflurane - Penthrox DRUG

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.

Intervention arm-Penthrox

Control OTHER

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

Control arm

Percocet Pill DRUG

Percocet will be given in conjunction with methoxyfluorane and lorazepam

Intervention arm-Penthrox

Lorazepam (drug) DRUG

Lorazepam will be given in conjunction with penthrox and percocet.

Intervention arm-Penthrox

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide an informed consent.
• Age ≥ 18 years
• Biological males identified with male sexual organs.
• Scheduled for convective radiofrequency water vapor thermal therapy (REZUM) for the management of benign prostate hyperplasia.

You may not qualify if:

• Concomitant use of nephrotoxic and/or hepatoxic agents.
• Use of ≥ 6 ml Penthrox withing the previous 3 weeks.
• Known allergies and/or adverse events due to penthrox, other halogenated anesthetics, percocet (oxycodone + acetaminophen), lorazepam, lidocaine, midazolam, ketamine, remifentanil and propofol
• History of genetic susceptibility to malignant hyperthermia.
• Presence of clinically significant respiratory depression, cardiovascular instability, renal or hepatic impairment
• Altered level of consciousness due to any cause.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Men's Health Clinic Manitoba

Winnipeg, Manitoba, R3K 1M3, Canada

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

oxycodone-acetaminophen; Lorazepam; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Premal Patel, MD

CONTACT

204-221-4476; ppatel5@hsc.mb.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education

Model Details: Single-centered, unblinded, randomized controlled trial. Two arms, one is the intervention arm which will receive Penthrox with a combination of Percocet and Lorazepam. The control arm will receive the standard of care during the rezum procedure which is deep IV sedation.

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: June 12, 2025
• Study Start: August 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

CA (1)