Penthrox in Rezūm BPH

Pain Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04029012
• Other study ID #: Penthrox in Rezum BPH
• Status: Completed
• Phase: Phase 4
• Start date: September 10, 2019
• Est. completion date: February 14, 2020

Study information

• Verified date: January 2022
• Source: Can-Am HIFU Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Open-labeled, single-centre study

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 14, 2020
• Est. primary completion date: February 14, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male subjects of = 18 years of age

• Patient who has elected Convective Thermal Therapy using Rezum 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.

Related Conditions & MeSH terms

• BPH
• Pain

Intervention

Drug:
• Methoxyflurane
Methoxyflurane inhaler before Rezum procedure

Locations

Country	Name	City	State
Canada	Can-Am HIFU Inc	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dean Elterman

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 Rezum treatment