Active not recruitingPHASE3INTERVENTIONAL

Phase III Study of MR-Guided Focused Ultrasound Surgery for the Treatment of Uterine Fibroids Compared to Myomectomy

This study is looking into the best way to treat uterine fibroids, which are common, non-cancerous growths in the womb that can cause pain and heavy bleeding. We are comparing two main treatments: focused ultrasound and surgery (myomectomy). Focused ultrasound uses sound waves to shrink the fibroids without cuts, while myomectomy is an operation to remove them. The goal is to find out if focused ultrasound is less invasive, reduces symptoms effectively, and offers a better experience for women whose fibroids haven't improved with other medicines. We want to understand if this newer approach can help women feel better with fewer disruptions to their lives.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Krankenhaus Nordwest

Enrolment target

127

Start

15 Jul 2020

Estimated completion

01 Oct 2025

Uterine Fibroids

What is this study about?

Many women experience uterine fibroids, which are common, non-cancerous growths inside the womb. While some women don't notice them, for others, fibroids can cause uncomfortable symptoms like heavy periods, pain, and pressure. When these symptoms significantly affect daily life and medicines haven't provided enough relief, doctors might suggest other treatments. This study aims to help us understand which treatment option might be best for you.

We are comparing two different approaches. One is a newer method called Magnetic Resonance-Guided Focused Ultrasound Surgery, often shortened to MRgFUS. This treatment uses strong sound waves, guided by detailed MRI scans, to heat and shrink the fibroids without making any cuts. The other option is a surgical procedure called myomectomy, where a surgeon removes the fibroids. This can be done through a small cut (laparoscopic) or a larger cut (open surgery).

By comparing these two treatments, we hope to learn if MRgFUS can offer a kinder, less invasive way to relieve your fibroid symptoms compared to surgery. We want to see if it leads to similar or even better symptom relief, faster recovery, and overall a more comfortable experience for patients. Your participation could help us improve care for many women in the future.

Key takeaways

This study compares focused ultrasound and surgery for painful uterine fibroids.
It aims to find out if focused ultrasound is less invasive and works well.
You must have troublesome fibroid symptoms not helped by medication.
Fibroids need to be a certain size and number to qualify.
Participation involves being randomly assigned to one of the treatments.
You’ll have regular check-ups to monitor your progress.

Who may be eligible?

To join this study, you would need to be a woman over 18 years old who is experiencing bothersome symptoms from uterine fibroids that haven't been helped enough by other medications. We'd check how much your symptoms affect you using a special questionnaire, and your score would need to be 40 or higher.

Doctors would need to be sure that treating your fibroids with focused ultrasound is possible and safe. This would involve detailed scans of your pelvis to look at the number, size, and position of your fibroids. Generally, you would need to have 5 or fewer fibroids, each not bigger than 10cm, and the total volume of all fibroids should be less than 400ml. You wouldn't be able to join if you've had surgery on your womb before, are pregnant, or have an infection.

It's important that you are generally healthy enough for both the focused ultrasound and surgery, and if you can get pregnant, you'd need to use effective contraception for a certain period. We would also take a careful look at your medical history to make sure it's safe for you 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 woman over 18 years old?
Do you have painful uterine fibroids that haven't responded well to medicines?
Have you *not* had surgery on your womb before?
Are you able to use reliable contraception if you can get pregnant?
Are your fibroids generally fewer than 5, each under 10cm across?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have a comprehensive health check, including scans, to confirm you meet all the criteria. If you are eligible, you will be randomly assigned to receive either the focused ultrasound treatment or myomectomy surgery. This is like flipping a coin to ensure a fair comparison between the treatments.

Before your treatment, you would have several appointments for assessments and preparations. After your procedure, there will be follow-up appointments over a period of time to monitor your recovery, check your symptoms, and see how well the treatment has worked. These follow-up visits might include scans and questionnaires. The total duration of your participation, including all follow-ups, would be explained in full before you agree to join. You will be fully informed about what each part involves before making any decisions.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. For you, the potential benefit could be access to a new treatment (focused ultrasound) that might be less invasive than surgery, or receiving established surgical care. Both treatments aim to significantly reduce your fibroid symptoms and improve your quality of life. However, like all medical procedures, focused ultrasound and myomectomy carry potential risks, such as discomfort, infection, or other side effects, which your medical team will discuss with you in detail. You are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (4)

Krankenhaus Nordwest
Verified postcode
Frankfurt am Main, Germany
FOKUS Radiologische Gemeinschaftspraxis
Verified postcode
Göttingen, Germany
Leipzig University
Verified postcode
Leipzig, Germany
Marienhospital
Verified postcode
Stuttgart, Germany

Common questions

What are uterine fibroids?

Uterine fibroids are common, harmless (non-cancerous) growths that develop in or around the womb. They can cause symptoms like heavy bleeding or pain for some women.

What is focused ultrasound?

Focused ultrasound is a treatment that uses strong sound waves, guided by MRI scans, to heat and shrink fibroids without needing any cuts or surgery.

What is myomectomy?

Myomectomy is an operation to remove uterine fibroids. It can be done through small cuts (laparoscopic) or a larger cut (open surgery).

Will I get to choose which treatment I receive?

No, if you join this study, you will be randomly assigned to either the focused ultrasound group or the myomectomy group. This helps us ensure a fair comparison.

How long will the study last if I join?

The full duration of your involvement, including all follow-up appointments, will be clearly explained to you before you agree to participate.