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Canadian Cohort of Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH).

This study, called the Canadian Cohort of Convective Thermal Therapy, is gathering information on a treatment called Rezūm for men with an enlarged prostate, also known as Benign Prostatic Hyperplasia (BPH). BPH is a common condition where the prostate gland gets bigger and can cause bothersome urinary symptoms. The Rezūm treatment uses steam to reduce the size of the prostate. This study wants to understand how well Rezūm works for Canadian patients and if it helps improve their symptoms. It's collecting real-world information to help doctors make even better decisions about using this treatment in the future. If you are a man over 18, have BPH, and your doctor thinks Rezūm might be a good option for you, you might be able to take part.

At a glance

Status
Recruiting
Sponsor
Can-Am HIFU Inc.
Enrolment target
50
Start
07 Oct 2019
Estimated completion
31 Dec 2026

What is this study about?

This study is all about understanding how a treatment called Rezūm works for men in Canada who have a common condition called Benign Prostatic Hyperplasia, or BPH. In simple terms, BPH means your prostate gland, which is located just below your bladder, has become enlarged. This can lead to problems like needing to pee more often, especially at night, or having difficulty emptying your bladder properly. Rezūm is a treatment that uses steam to shrink parts of the prostate, which can help relieve these symptoms.

Doctors are keen to collect more information on how well Rezūm helps Canadian patients. By doing this, they can get a clearer picture of its effects on a larger group of people. This isn't a study where a new treatment is being tested for the very first time; instead, it's about seeing how an established treatment performs in everyday practice.

The main goal is to measure the clinical outcome, which means seeing if patients' symptoms improve, if their quality of life gets better, and if the treatment is generally safe and effective. The information gathered from this study will be valuable for doctors across Canada, helping them to better advise men with BPH about their treatment options.

Key takeaways

  • This study is for men in Canada with an enlarged prostate (BPH).
  • It's looking at how well the Rezūm treatment works for these patients.
  • Participation involves receiving Rezūm and likely completing questionnaires.
  • The goal is to gather more real-world information about the treatment.
  • You must be over 18 and considered a good candidate for Rezūm by your doctor.
  • You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you need to be a man aged 18 or older. You must have been diagnosed with an enlarged prostate, known as Benign Prostatic Hyperplasia (BPH), by your doctor. Your doctor must also believe that the Rezūm treatment is a suitable option for you.

It's important that you are willing and able to fill out any necessary questionnaires accurately. You also need to be willing to give your written permission (called informed consent) to take part after understanding all the details of the study.

There are a few reasons why someone might not be able to join. For example, if you have other health conditions that would make taking part unsafe for you, or if you find it hard to follow instructions or complete forms. If you're unable or unwilling to give your signed permission, you won't be able to participate.

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.

  1. Am I a man aged 18 or older?
  2. Have I been diagnosed with an enlarged prostate (BPH)?
  3. Has my doctor said Rezūm therapy might be a good option for me?
  4. Am I willing to fill out some forms or questionnaires?
  5. Am I able to give my signed permission to take part?
  6. Do I feel well enough to follow the study's requirements?
Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves is not fully described in the brief summary supplied. However, generally, if you join a study like this, you would typically have regular visits to your doctor or clinic. These visits are likely to include assessments of your prostate symptoms and overall health. You might be asked to fill out questionnaires to track how you are feeling and if your symptoms are improving. The Rezūm treatment itself would be given by your doctor as part of your normal care. You would then have follow-up appointments over a period of time to see how you are recovering and how well the treatment is working. The total duration of your participation would depend on the study's follow-up schedule.

Potential risks and benefits

Taking part in a study like this might offer benefits such as close monitoring of your health and symptoms, and contributing to important medical research that can help other patients in the future. Potential risks are generally associated with the Rezūm procedure itself, such as temporary discomfort, pain, or urinary symptoms, which your doctor should discuss with you thoroughly before the treatment. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • Dean Elterman
    Verified postcode
    Toronto, Canada· Recruiting

Common questions

What is BPH?

BPH stands for Benign Prostatic Hyperplasia, which means you have an enlarged prostate gland. It's a common condition in older men and can cause problems with urination.

What is Rezūm therapy?

Rezūm therapy is a treatment for BPH that uses steam to shrink parts of the enlarged prostate gland, which can help improve your urinary symptoms.

Will I get the Rezūm treatment if I join this study?

Yes, if you meet the study criteria and your doctor decides Rezūm is suitable for you, you would receive the treatment as part of your care within the study framework.

Do I have to live in Canada to join?

Yes, this specific study is focused on men in Canada who are receiving Rezūm therapy.

Can women join this study?

No, this study is only for men, as BPH is a condition that only affects biological males.

How to find out more

Iris Chan

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

Interested in taking part?

Register your interest

Share your details and the research team for "Canadian Cohort of Convective Thermal Therapy Using Rezūm Sy…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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