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Penthrox in Rezūm BPH - Pilot

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04029012
Recruitment Status : Not yet recruiting
First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Information provided by (Responsible Party):
Dean Elterman, Can-Am HIFU Inc.

Brief Summary:
Open-labeled, single-centre study

Condition or disease Intervention/treatment Phase
Pain BPH Drug: Methoxyflurane Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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)
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Penthrox
methoxyflurane inhaler (Penthrox)
Drug: Methoxyflurane
Methoxyflurane inhaler before Rezum procedure
Other Name: Penthrox

Primary Outcome Measures :
  1. Pain intensity [ Time Frame: immediately after final injection of Rezūm treatment ]
    Visual Analog Scale (VAS)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patient with BPH
Accepts Healthy Volunteers:   No

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.
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Responsible Party: Dean Elterman, Clinician Investigator/ Urologist, Can-Am HIFU Inc. Identifier: NCT04029012    
Other Study ID Numbers: Penthrox in Rezūm BPH - Pilot
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs