Not yet recruitingNAINTERVENTIONAL

Comparison of Glue with Microparticles in Prostatic Artery Embolization

This study is for men with an enlarged prostate, also known as Benign Prostatic Hyperplasia (BPH). If you have BPH, your prostate gland can grow bigger, pressing on your bladder and making it harder to pee. This study looks at a treatment called prostatic artery embolisation (PAE), which is an alternative to surgery. PAE works by blocking the blood supply to the prostate gland, which then shrinks it. This trial wants to compare two different materials used to block the blood supply: a special medical 'glue' and tiny, microscopic beads. We want to find out which of these materials is more effective and safer for treating BPH symptoms. This research aims to help doctors choose the best treatment for patients in the future.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Almaviva Sante

Enrolment target

Start

01 Dec 2024

Estimated completion

31 May 2027

Benign Prostatic Hyperplasia

What is this study about?

This study is designed for men who have a common condition called Benign Prostatic Hyperplasia, or BPH. This simply means you have an enlarged prostate gland, which can cause annoying symptoms like needing to urinate (pee) more often, especially at night, or having trouble starting and stopping the flow.

Traditionally, surgery has been one way to treat BPH. However, there's a less invasive option called prostatic artery embolisation (PAE). This treatment involves blocking off the blood vessels that feed the prostate gland. When the blood supply is reduced, the prostate shrinks, which can relieve the pressure on your bladder and ease your symptoms. Doctors have been using PAE since 2012, and it has proven to be both safe and effective for many men.

Currently, the most common material used to block these blood vessels is a suspension of very tiny, microscopic beads. Recently, doctors have also started using a special medical 'glue' for this procedure, and initial findings suggest it might also be safe and work well. However, we don't have enough strong studies comparing the glue directly to the beads. This trial aims to do just that – to carefully compare the glue with the beads to see which one works better and has fewer side effects for men with an enlarged prostate.

Key takeaways

This study compares two materials (glue vs. tiny beads) for treating an enlarged prostate (BPH).
It aims to see which material is safer and more effective at shrinking the prostate.
PAE is a procedure that blocks the blood supply to the prostate, making it smaller.
Participants must be men aged 50-80 with BPH symptoms not helped by medication.
Your participation helps improve future BPH treatments.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for men aged between 50 and 80 years old who have symptoms of an enlarged prostate (BPH). You might be suitable if you've already tried medicines for your prostate, like tadalafil or alpha-blockers, and they haven't worked well for you or you couldn't tolerate them.

To be considered, your prostate size needs to be 40ml or larger, as measured by an MRI scan. We'll also check your symptoms using a common scoring system (IPSS) and measure your urine flow. These checks help us understand if your BPH is significantly affecting you.

However, you won't be able to join if you have certain other health issues. This includes serious problems with your kidneys or bladder (like large bladder diverticula or dilated kidneys), if there's a suspicion of prostate or bladder cancer, or if you've had a recent cancer diagnosis in those areas. You also can't participate if you have an active urine infection, or if you're already in another medical study.

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 between 50 and 80 years old?
Do you have symptoms of an enlarged prostate (BPH)?
Have your current prostate medicines (like tadalafil or alpha-blockers) not worked well for you?
Do you have a prostate size of 40ml or more (from a recent scan)?
Have you been diagnosed with prostate or bladder cancer in the last 6 months?
Do you currently have a urine infection?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have a series of appointments and checks. These will include MRI scans to measure your prostate, tests to check your urine flow, and symptom questionnaires to track how you're feeling. The main treatment involves a procedure where either the 'glue' or the tiny beads are used to block the blood flow to your prostate, depending on which group you are randomly assigned to.

After the procedure, you'll have follow-up visits to monitor your progress and check for any side effects. These visits will likely involve repeat scans and symptom assessments. Detailed information about the number and timing of appointments will be given to you by the study team. The total duration of your participation, including the treatment and all follow-up checks, will be carefully explained.

Potential risks and benefits

Taking part in this study may offer several benefits, such as receiving a potential treatment for your enlarged prostate that could improve your symptoms. You'll also be closely monitored by medical professionals, and your participation will help advance our understanding of the most effective treatments for BPH, potentially benefiting many others in the future. As with any medical procedure, there are potential risks, including side effects from the embolisation procedure such as pain, bruising, or a risk of infection, though serious complications are rare. All possible risks will be thoroughly explained by the study team. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Clinique de l'Alma
Verified postcode
Paris, France

Common questions

What is BPH?

BPH stands for Benign Prostatic Hyperplasia, which means your prostate gland has become enlarged as you've gotten older. It's not cancer, but it can cause problems with peeing.

What is prostatic artery embolisation (PAE)?

PAE is a procedure where doctors block off the blood vessels that supply the prostate. This causes the prostate to shrink, which can help ease symptoms of BPH.

What are 'glue' and 'microparticles'?

These are the two different materials used in the PAE procedure to block the blood vessels. 'Glue' is a special medical adhesive, and 'microparticles' are tiny beads.

Will I know which treatment I'm getting?

In this study, you will be randomly assigned to receive either the 'glue' or the 'microparticles'. This is similar to flipping a coin to ensure a fair comparison.

Is this treatment a cure for BPH?

PAE is a treatment to help reduce the size of your prostate and relieve your symptoms. It's an alternative to surgery, but like other BPH treatments, it aims to manage the condition.

How to find out more

Grégory AMOUYAL, MD

dr.gregory.amouyal@gmail.com + 33 6 80 70 40 40 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.