Penthrox in Rezūm BPH

Dean Elterman

Status and phase: Completed; Phase 4

Conditions: BPH; Pain

Treatments: Drug: Methoxyflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT04029012

Penthrox in Rezūm BPH

Details and patient eligibility

About

Open-labeled, single-centre study

Full 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.

Enrollment: 10 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Penthrox

Experimental group

Description:

methoxyflurane inhaler (Penthrox) to be used 5 minutes (+/- 1 minutes) before procedure, and continuously breathing in the inhaler throughout the procedure.

Treatment:

Drug: Methoxyflurane