Benign Prostate Hypertrophy(BPH)Phase 3NCT07017452
Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia
A Phase 3 study testing Methoxyflurane - Penthrox, Percocet Pill and Lorazepam (drug) in people with Benign Prostate Hypertrophy(BPH), run by University of Manitoba at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostate Hypertrophy(BPH)
- What is being tested?
- Methoxyflurane - Penthrox, Percocet Pill and Lorazepam (drug)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2025to Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Men's Health Clinic Manitoba
Winnipeg, Manitoba, R3K 1M3
Premal Patel, MD, 204-221-4476, ppatel5@hsc.mb.ca
Premal Patel, MD
About this study
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
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.
Read the 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)
- Being tested
- Methoxyflurane - Penthrox, Control, Percocet Pill, Lorazepam (drug)
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methoxyflurane - PenthroxDrug
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.
ControlOther
This intervention will be the control group only, receiving deep IV sedation.
Percocet PillDrug
Percocet will be given in conjunction with methoxyfluorane and lorazepam
Lorazepam (drug)Drug
Lorazepam will be given in conjunction with penthrox and percocet.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm-Penthrox | Experimental | Participants can begin using penthrox 10 minutes prior to procedure start, given its median onset time of 5 minutes Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately post-procedure
Secondary outcomes (4)
Safety of Procedure
The safety of combination vs deep intravenous sedation during Rezum will be measured by accounting for adverse event encountered during the procedure.
Measured: At time of procedure and post-procedure
Cost-effectiveness,
We will compare the costs associated with the procedure in both arms to see if there is any difference.
Measured: 1 month post-procedure
Anxiety levels
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
Measured: Pre-Procedure on day of procedure
Patient satisfaction
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.
Measured: Immediately post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study startAug 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate Hypertrophy(BPH)Studies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Premal Patel, MD, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017452
- Sponsor's protocol ID
- HS27031
- Status last verified
- Jun 2025
- First submitted
- 1 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07017452
- Acronym / sponsor ID
- HS27031
- Conditions
- Benign Prostate Hypertrophy(BPH)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm-Penthrox | Experimental | Drug: Methoxyflurane - Penthrox, Drug: Percocet Pill, Drug: Lorazepam (drug)Participants can begin using penthrox 10 minutes prior to procedure start, given its median onset time of 5 minutes |
| Control arm | Placebo comparator | Other: ControlPatients will receive standard of care during their rezum procedure which consists of deep IV sedation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methoxyflurane - PenthroxPenthrox 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. | Drug | Intervention arm-Penthrox |
| ControlThis intervention will be the control group only, receiving deep IV sedation. | Other | Control arm |
| Percocet PillPercocet will be given in conjunction with methoxyfluorane and lorazepam | Drug | Intervention arm-Penthrox |
| Lorazepam (drug)Lorazepam will be given in conjunction with penthrox and percocet. | Drug | Intervention arm-Penthrox |
Primary outcome
Post-Procedural Pain
Time frame: 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.
4 secondary outcomes
Safety of Procedure
Time frame: At time of procedure and post-procedure
Cost-effectiveness,
Time frame: 1 month post-procedure
Anxiety levels
Time frame: Pre-Procedure on day of procedure
Patient satisfaction
Time frame: Immediately post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methoxyflurane - Penthrox, Percocet Pill and Lorazepam (drug) in people with Benign Prostate Hypertrophy(BPH), run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Premal Patel, MD (204-221-4476, ppatel5@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Procedural Pain (time frame: Immediately post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.