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

NCT ID: NCT07017452

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-06-30

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.

Detailed Description

Participants who belong to the experimental arm will be given a single 'per os' dose of percocet (325mg acetaminophen + 7.5mg oxycodone) and lorazepam 1 mg, 30 minutes prior to the procedure. Patients will receive education on how to use the Penthrox inhaler device. Inside the operating room, the subject would self-inhale the methoxyflurane 5 minutes prior to the procedure. All these steps will be supervised by the clinical research nurse. Each participant will be administered with 3ml of methoxyflurane which is poured into the inhaler. Participants who were randomized to the control arm will receive deep intravenous sedation under the supervision of a trained anesthetist. A combination of midazolam, ketamine, remifentanil and propofol will be administered using an intravenous line. The quantity of these medications will be calculated by the anesthetist based on clinical judgement and also takes into account the physical characteristic of the subject. Both the groups receive the same Rezum water vapor therapy and the number of Rezum injections depends on the clinical judgement of the urologist performing the procedure. Immediately, post the procedure, the self-reported pain of the patient will be recoded using the NRS. A phone call follow-up would be done the following day to record any adverse events caused due to the procedure. Four weeks post the procedure, a phone call follow-up would be done to understand the patient satisfaction after the surgery.

Conditions

Benign Prostate Hypertrophy(BPH)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention arm-Penthrox

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

Group Type: EXPERIMENTAL

Methoxyflurane - Penthrox

Intervention Type: 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.

Percocet Pill

Intervention Type: DRUG

Percocet will be given in conjunction with methoxyfluorane and lorazepam

Lorazepam (drug)

Intervention Type: DRUG

Lorazepam will be given in conjunction with penthrox and percocet.

Control arm

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

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

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

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.

Intervention Type: DRUG

Control

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

Intervention Type: OTHER

Percocet Pill

Percocet will be given in conjunction with methoxyfluorane and lorazepam

Intervention Type: DRUG

Lorazepam (drug)

Lorazepam will be given in conjunction with penthrox and percocet.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Premal Patel, MD

Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Men's Health Clinic Manitoba

Winnipeg, Manitoba, Canada

Countries

Canada

Central Contacts

Premal Patel, MD

Role: CONTACT

ppatel5@hsc.mb.ca

204-221-4476

Facility Contacts

Premal Patel, MD

Role: primary

ppatel5@hsc.mb.ca

204-221-4476

Other Identifiers

HS27031

Identifier Type: -

Identifier Source: org_study_id