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

Phase 3

Not yet recruiting

• Conditions: Benign Prostate Hypertrophy(BPH)
• Interventions: Drug: Methoxyflurane - Penthrox; Other: Control; Drug: Percocet Pill; Drug: Lorazepam (drug)

• Registration Number: NCT07017452
• Lead Sponsor: University of Manitoba

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.

Study Timeline

• Study First Submitted: 2025-05-01
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-11
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-12
• Study Start: 2025-08
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm-Penthrox	Methoxyflurane - Penthrox	Participants can begin using penthrox 10 minutes prior to procedure start, given its median onset time of 5 minutes
Intervention arm-Penthrox	Percocet Pill	Participants can begin using penthrox 10 minutes prior to procedure start, given its median onset time of 5 minutes
Intervention arm-Penthrox	Lorazepam (drug)	Participants can begin using penthrox 10 minutes prior to procedure start, given its median onset time of 5 minutes
Control arm	Control	Patients will receive standard of care during their rezum procedure which consists of deep IV sedation.

Primary Outcome Measures

Name	Time	Method
Post-Procedural Pain	Immediately post-procedure	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.

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness,	1 month post-procedure	We will compare the costs associated with the procedure in both arms to see if there is any difference.
Safety of Procedure	At time of procedure and post-procedure	The safety of combination vs deep intravenous sedation during Rezum will be measured by accounting for adverse event encountered during the procedure.
Anxiety levels	Pre-Procedure on day of procedure	We will measure anxiety levels using the Amsterdam Pre-Operative Anxiety and Information Scale (APAIS). Higher scores indicate worser outcomes. Maximum value of 30 and a minimum value of 0. It is a 6 part questionnaire which each question is given on a likert scale from 1-5
Patient satisfaction	Immediately post-procedure	We will measure patient satisfaction using a likert scale single question patient satisfaction questionnaire. (higher scores indicate better outcomes). Maximum value of 5 and a minimum value of 0.

Trial Locations

Locations (1)

Men's Health Clinic Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada