Penthrox in Rezūm BPH

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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04029012

Enrollment

Registered

2019-07-23

Start date

2019-09-10

Completion date

2020-02-14

Last updated

2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, BPH

Brief summary

Open-labeled, single-centre study

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.

Interventions

DRUGMethoxyflurane

Methoxyflurane inhaler before Rezum procedure

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026