Clinical trial NCT07017452: Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia
Official title: Methoxyflurane + Lorazepam + Percocet (Per os) vs Deep Intravenous Sedation: A Non-inferiority Randomized Controlled Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Benign Prostate Hypertrophy(BPH)
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Post-Procedural Pain
timeFrame: Immediately post-procedure
Secondary outcomes:
measure: Safety of Procedure
timeFrame: At time of procedure and post-procedure
measure: Cost-effectiveness,
timeFrame: 1 month post-procedure
measure: Anxiety levels
timeFrame: Pre-Procedure on day of procedure
measure: Patient satisfaction
timeFrame: Immediately post-procedure
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Men's Health Clinic Manitoba
state: Manitoba
Study officials:
References: