Evaluation of the Functional Outcomes After Bilateral, 3D Ultrasound-guided Focal Thermal Ablation of the Prostate Transition Zone, in Patients with Benign Prostatic Hyperplasia-related Obstruction
This study is looking at a new, less invasive way to treat men suffering from an enlarged prostate, a common condition called Benign Prostatic Hyperplasia (BPH). If you have BPH, it can make it difficult to pee comfortably. Current surgeries can be effective but often come with side effects like sexual problems. This trial is exploring a special microwave heat treatment that uses 3D ultrasound guidance to precisely target and shrink parts of the prostate. The aim is to see if this new treatment can improve pee problems as effectively as current surgeries, but with fewer risks and a quicker recovery. It's a Phase 2 study, meaning it's still in the earlier stages of testing.
At a glance
What is this study about?
This study is all about finding a better way to help men who have an enlarged prostate, a common condition often called BPH. When your prostate gets bigger, it can press on your bladder and the tube that carries pee out of your body (the urethra). This can lead to annoying symptoms like needing to pee more often, especially at night, or having a weak stream. Existing surgeries can fix these problems, but they can be quite intensive and sometimes lead to side effects like ejaculation problems or issues with bladder control.
The researchers are investigating a new, more gentle approach. They are using a special technique called "targeted microwave ablation." This involves using precise heat, guided by detailed 3D ultrasound scans, to shrink the specific parts of the prostate that are causing problems. The hope is that this method will be just as good at relieving BPH symptoms as traditional surgery, but with fewer steps and a faster recovery.
This is a pilot study, which means it's one of the first times this specific treatment is being explored in this way. The main goal is to carefully see how well it works and if it's safe for men with BPH. If successful, this new treatment could offer a valuable option for many men looking for relief from their prostate symptoms without the bigger risks associated with more invasive operations.
Key takeaways
- Tests a gentler heat treatment for enlarged prostate.
- Aims to relieve pee problems with fewer side effects than surgery.
- Uses advanced 3D ultrasound guidance for precision.
- May offer a quicker recovery than traditional operations.
- Designed for men over 40 with significant prostate symptoms.
Who may be eligible?
This study is looking for men aged 40 or older who have symptoms from an enlarged prostate and would normally consider surgery. Your prostate needs to be a certain size (not too small, not too big) and your urine flow speed and symptom scores will be checked to make sure you're a good fit. You'll also need to be well enough for a light anaesthetic.
There are several reasons why you might not be able to join. For example, if you've had prostate surgery before, have certain nerve problems affecting your bladder, or a history of prostate cancer. You also can't take part if you have a very narrow urethra or if you've received radiation therapy to your tummy area.
Importantly, you need to be able to understand what the study involves and be happy to give your permission to participate. Also, you must be associated with the French national social security system for this particular study, as it's taking place in France, and be able to come to all the planned appointments.
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 over 40 years old?
- Do you have problems peeing due to an enlarged prostate, and would you normally consider surgery?
- Do you not have a history of prostate cancer or previous prostate surgery?
- Are you able to attend appointments and give your permission to take part?
- Are you suitable for light or general anaesthesia?
What does participation involve?
If you decide to take part in this study, you will have a special procedure where a thin needle is guided into your prostate using 3D ultrasound scans. This needle delivers targeted heat to shrink the enlarged areas of your prostate. This procedure is usually done under light anaesthetic or general anaesthetic. You'll have regular check-ups and assessments afterwards to see how your symptoms are improving and to ensure you're recovering well. The overall time you'll be involved in the study isn't specified, but it will include the procedure and follow-up appointments.
Potential risks and benefits
Locations (1)
- Hôpital CochinVerified postcodeParis, France· Recruiting
Common questions
What is an 'enlarged prostate'?
It's when your prostate gland gets bigger as you get older, which can make it hard to pee comfortably.
What does 'microwave ablation' mean?
It's a way of using precise heat from microwaves to carefully shrink parts of the prostate.
Is this a new type of treatment?
Yes, it's a newer approach that aims to be less invasive than traditional prostate surgeries.
Will I have to stay in hospital?
This treatment is often done as an outpatient, meaning you might not need to stay overnight.
What happens if the treatment doesn't work for me?
The study team will monitor your progress closely, and they will discuss other available treatments with you if this one isn't effective.
How to find out more
Nicolas BARRY DELONGCHAMPS, MD, PHD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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