Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia
This study is investigating different ways to manage pain during a common procedure called Rezum, which is used to treat enlarged prostates (also known as Benign Prostate Hyperplasia or BPH). The main goal is to see if taking a combination of pain medicines by mouth (Penthrox, Percocet, and Lorazepam) is as good as, or not much worse than, a deeper sedation given through a vein for keeping patients comfortable. Participants will either receive the oral medication combination or the intravenous sedation just before the Rezum procedure. The study will look at how well the pain is controlled and check for any side effects afterwards. It's designed to understand the best approach for managing pain during this procedure for men in the UK.
At a glance
What is this study about?
This study is all about making you as comfortable as possible if you need a procedure called 'Rezum' for an enlarged prostate. The prostate is a small gland that can grow larger as men get older, which sometimes causes problems with peeing. The Rezum procedure uses gentle steam to shrink the prostate back to a more normal size.
Because the Rezum procedure can be a bit uncomfortable, doctors usually give you medicine to help with pain. This study is comparing two different ways to do that. One way involves taking a few pain medicines by mouth and inhaling a pain reliever just before the procedure. The other way is a deeper sedation given through a drip (an IV) into your arm, where you'll be more asleep during the procedure.
The main aim is to see if the oral pain relief option is just as good, or almost as good, as the deeper sedation at keeping you comfortable and pain-free during the Rezum treatment. Finding an effective and safe way to manage pain is really important for patients, and this study helps doctors understand the best choices for you.
Key takeaways
- This study compares two ways to manage pain during Rezum for enlarged prostates.
- One method uses oral pain relief, the other uses deeper sedation through an IV.
- It aims to find the best way to keep patients comfortable.
- Participation involves taking medication, the Rezum procedure, and follow-up calls.
- The study lasts about four weeks after your procedure.
Who may be eligible?
This study is looking for men aged 18 or older who are already scheduled to have the Rezum procedure for an enlarged prostate. You must be able to understand the study and agree to take part.
There are some reasons why you wouldn't be able to join. For example, if you're taking certain medications that could harm your kidneys or liver, or if you've already used a specific pain inhaler (Penthrox) often recently. You also can't join if you have known allergies to any of the medicines being used in the study, or certain heart, lung, or kidney problems. If you have a specific genetic condition that affects how you react to some anaesthetics, you also wouldn't be able to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a man aged 18 or older?
- Are you scheduled for a Rezum procedure for an enlarged prostate?
- Do you have any conditions affecting your kidneys or liver?
- Are you allergic to any common pain medicines or anaesthetics?
- Have you used a Penthrox inhaler recently (within the last 3 weeks)?
What does participation involve?
If you decide to take part, you'll be assigned to one of two groups by chance. One group will receive pain relief medicines to take by mouth (a tablet of Percocet and Lorazepam 30 minutes before, and then you'll learn how to use a Penthrox inhaler just 5 minutes before the procedure). The other group will be given deeper sedation through a drip in your arm, supervised by an anaesthetist.
Both groups will then have the Rezum procedure as planned. Immediately after the procedure, you'll be asked to rate your pain. A nurse will also call you the next day to check on you and ask about any side effects. Four weeks after the procedure, you'll get another call to see how satisfied you are with the outcome of the surgery. The total duration of your active participation, including follow-up, will be about four weeks after the procedure.
Potential risks and benefits
Locations (1)
- Men's Health Clinic ManitobaVerified postcodeWinnipeg, Canada
Common questions
What is an enlarged prostate?
An enlarged prostate, also called BPH, happens when the prostate gland grows in size as men get older, which can cause problems with urinating.
What is the Rezum procedure?
Rezum is a treatment for enlarged prostate where steam is used to shrink the prostate tissue, helping to relieve urinary symptoms.
What does a 'control' group mean in a study?
A control group usually receives the standard treatment or a comparison treatment, which helps researchers understand if the new treatment is better or different.
Will I know which pain relief I'm getting?
No, this study is 'unblinded,' meaning both you and the doctors involved will know whether you are receiving the oral pain medication or the deeper sedation.
What if I have an allergic reaction to a medicine?
Before you join, the study team will carefully check your medical history for any known allergies to the medicines being used to ensure your safety.
How to find out more
Premal Patel, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.