Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Manitoba

About this trial

The primary aim of the study is to show that methoxyflurane-lorazepam-percocet combination administrated 'per os' is non inferior to deep intravenous sedation in achieving analgesia during Rezum convective radiofrequency water vapor thermal therapy for the management of benign prostate hyperplasia (BPH). We propose to conduct a single-centered, unblinded, randomized controlled trial designed after consulting ICH Guidelines for Good Clinical Practice as well the regulations set by the Biomedical Research Ethics Board, University of Manitoba.

Eligibility criteria

Qualifiers

Able to provide an informed consent.

Age ≥ 18 years

Biological males identified with male sexual organs.

Scheduled for convective radiofrequency water vapor thermal therapy (REZUM) for the management of benign prostate hyperplasia.

Disqualifiers

Concomitant use of nephrotoxic and/or hepatoxic agents.

Use of ≥ 6 ml Penthrox withing the previous 3 weeks.

Known allergies and/or adverse events due to penthrox, other halogenated anesthetics, percocet (oxycodone + acetaminophen), lorazepam, lidocaine, midazolam, ketamine, remifentanil and propofol

History of genetic susceptibility to malignant hyperthermia.

Trial design

Treatments tested in this trial

  • Methoxyflurane - Penthrox
  • Control
  • Percocet Pill
  • Lorazepam (drug)

Treatment groups

48 Participants
are divided into 2 treatment groups

Sponsors and collaborators