Penthrox in Rezūm BPH - Pilot

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

Open-labeled, single-centre study

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dean Elterman
• Treatments: Methoxyflurane

Criteria

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.