drugset / Trial / NCT07017452
Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2025-08
- Primary completion
- 2025-12
- Completion
- 2026-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 325 mg | Oral |
| Subject | Lorazepam | Small molecule | 1 mg | Oral |
| Subject | Methoxyflurane | Small molecule | 3 ml | Inhaled |
| Subject | Oxycodone | Other / unclassified | 7.5 mg | Oral |