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)
1 other identifier
interventional
10
1 country
1
Brief Summary
Open-labeled, single-centre study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 pain
Started Sep 2019
Shorter than P25 for phase_4 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2019
CompletedFirst Posted
Study publicly available on registry
July 23, 2019
CompletedStudy Start
First participant enrolled
September 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2020
CompletedJanuary 24, 2022
January 1, 2022
5 months
July 19, 2019
January 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Penthrox
EXPERIMENTALmethoxyflurane inhaler (Penthrox) to be used 5 minutes (+/- 1 minutes) before procedure, and continuously breathing in the inhaler throughout the procedure.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dean Eltermanlead
Study Sites (1)
Can-Am HIFU Inc
Toronto, Ontario, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinician Investigator/ Urologist
Study Record Dates
First Submitted
July 19, 2019
First Posted
July 23, 2019
Study Start
September 10, 2019
Primary Completion
February 14, 2020
Study Completion
February 14, 2020
Last Updated
January 24, 2022
Record last verified: 2022-01