Penthrox in Rezūm BPH

Study Overview
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Brief Summary
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Open-labeled, single-centre study

Detailed Description
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Patients who have elected Convective Thermal Therapy using Rezūm System for the management of their BPH and fulfilled inclusion and exclusion criteria will sign informed consent form for the study. Patient will use Methoxyflurane inhaler (Penthrox™) on top of standard oral analgesia including oral lorazepam, oral Percocet® (oxycodone and acetaminophen) or oxycodone immediate-release, and intra-urethral lidocaine gel (Xylocaine®). Intravenous propofol will be used as rescue analgesia.

Official Title
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A Pilot Study to Assess Efficacy and Safety of Methoxyflurane for Pain Control During Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH)

Conditions
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BPH, Pain

Intervention / Treatment
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* Drug: Methoxyflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects of ≥ 18 years of age Patient who has elected Convective Thermal Therapy using Rezūm System for the management of their benign prostatic hyperplasia. No contra-indication on using Methoxyflurane inhaler (Penthrox™). Willing and able to accurately complete the required questionnaires. Willing and able to provide signed and dated informed consent. Exclusion Criteria: Ongoing use of analgesic agents for chronic pain. Concomitant use of nephrotoxic agents. INR > 4. Use of Methoxyflurane inhaler (Penthrox™) within the previous 3 months. Known allergy to Lorazepam, Percocet/ Oxycodone, or Xylocaine® gel. Known personal or familial hypersensitivity to Methoxyflurane inhaler (Penthrox™) or other halogenated anesthetics. Clinically significant respiratory depression, cardiovascular instability, renal or hepatic impairment. An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol. Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives. A history of liver dysfunction after previous Methoxyflurane inhaler (Penthrox™) use or other halogenated anesthetics.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Penthrox<br>methoxyflurane inhaler (Penthrox) to be used 5 minutes (+/- 1 minutes) before procedure, and continuously breathing in the inhaler throughout the procedure. | Drug: Methoxyflurane<br>* Methoxyflurane inhaler before Rezum procedure<br>* Other names: Penthrox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Visual Analog Scale (VAS) from the range of 0-10 (0 represents no pain, 10 represents maximum pain) | immediately after final injection of Rezūm treatment |