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Open-labeled, single-centre study
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Penthrox | Experimental | methoxyflurane inhaler (Penthrox) to be used 5 minutes (+/- 1 minutes) before procedure, and continuously breathing in the inhaler throughout the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxyflurane | Drug | Methoxyflurane inhaler before Rezum procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patient with BPH
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Can-Am HIFU Inc | Toronto | Ontario | Canada |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008733 | Methoxyflurane |
| ID | Term |
|---|---|
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
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