Study Title: Uterine Artery Embolisation versus Myomectomy for the treatment of uterine fibroids: a clinical, psychological and economic evaluation.

Introduction
You are invited to take part in a clinical study to compare a technique called uterine artery embolisation (UAE) with conventional surgical treatment (myomectomy) of fibroids of the uterus (womb).

What is the purpose of this study?
Fibroid embolisation has not yet been fully evaluated in a scientific manner and the purpose of this trial is to evaluate the efficacy of this new form of treatment by comparing it with conventional surgical treatment. The results of this study will be published in a medical journal and will help other doctors to decide which form of treatment is better for other patients. No patient would be identified by name in any publication resulting from this study and patient anonymity will be maintained at all times. We plan to recruit 350 women into this trial.

What will happen to me if I take part?
If you decide to take part in the trial, you will be asked to sign a consent form to say that you understand the trial and that you are willing to take part. If you agree to take part you will be randomly allocated to one of the two treatment groups, i.e. embolisation or surgery. This process is called "randomisation" and is like "tossing a coin". It is important that treatment allocation is performed on a randomised basis and therefore neither you nor your doctor can choose in advance which type of treatment you will receive. Therefore, before taking part in the trial you must be prepared to accept either form of treatment. You will have a 50% chance of being allocated to the embolisation group and 50% chance of being treated by surgery.

If you are randomised to the surgical group you will have a conventional operation (myomectomy) under general anaesthesia. You will have an opportunity to discuss the operation with your doctor. Myomectomy can be performed either through a cut in the tummy or by removing it via the neck of the womb (hysteroscopic myomectomy). Sometimes the bleeding is heavy enough to require hysterectomy although this is unusual. Infection occasionally occurs after the operation.

If you are allocated to the embolisation treatment group the procedure will be performed in the radiology department by a doctor trained in this technique (radiologist). You will be given a sedative and an injection of a strong painkiller prior to the procedure. The procedure is performed under local anaesthetic and involves placing a small plastic tube or catheter in the artery in the groin. The catheter is then manipulated into each artery supplying the fibroid(s) and then the arteries are blocked off by injecting small particles of a substance called Ivalon, which remains in the arteries permanently. After the first uterine artery is blocked you will be given a further painkilling injection and once the second artery is blocked the catheter will be removed. It is necessary to press on the groin for 5 10 minutes afterwards to prevent any bleeding problems. The procedure is usually completed within one hour.
You will experience some pain and discomfort during and after the procedure but you will be able to give yourself small quantities of a powerful painkiller with a special "patient-controlled analgesia" (PCA) pump. Using this most patients' pain is adequately controlled. Pelvic discomfort is usually experienced for less than 24 hours. If symptoms persist beyond that time then you will be given oral painkillers to take at home. Most patients are discharged from hospital in less than 48 hours.

In order to assess both forms of treatment several blood tests, ultrasound and magnetic resonance (MR) scans and questionnaires will be performed before and after your treatment.
The MR scan is a special scan of the pelvis, which allows accurate assessment of the number and position of the fibroids in the womb. An MR scan does not involve radiation but uses a strong magnetic field to produce pictures of the body. Before your MR scan you will be asked whether you have any metallic implants in your body, such as a heart pacemaker, artificial heart valve, surgical clips in the head, joint replacement or contraceptive coil. These can interfere with the images produced and it may not be safe to perform an MR scan with certain types of metallic implants. The scan is completely painless and there are no known risks or side effects. You will be asked to lie still in the scanner for 10 15 minutes. The scanner can be very noisy and hearing protection will be given. You will be able to contact the radiographer at all times during the scan if you need assistance.

Before treatment you will be asked to complete a menstrual diary to assess the length of your menstrual cycle and the heaviness of your periods. You will also be asked to record pain symptoms daily using a simple scoring system. A questionnaire will be completed to assess other symptoms such as abdominal pain and bladder problems. Further questionnaires will be completed to evaluate your general health and quality of life. These will be repeated at 6 and 12 after treatment.

Blood tests will be performed before treatment to assess whether you are anaemic and to measure your hormone levels. These will be repeated at 6 and 12 months after treatment. Each blood test involves taking the equivalent of 2 tablespoons of blood. There may be slight discomfort and a little bruising where the blood is taken from your arm.

After you have had your treatment a research doctor will follow you up for a period of 12 months. Although the funding of the trial is limited we would like to continue to follow you up by a postal questionnaire at yearly intervals up to 5 years after treatment. You are free to withdraw from the trial at any time without giving a reason why. This will in no way affect your future medical care.

What are the risks and discomforts?
Surgery
If you receive myomectomy the risks of the procedure include those of a general anaesthetic, and the potential problems related to surgery i.e. pain, bleeding and wound infection. Your doctors will warn you that a myomectomy may occasionally lead to severe bleeding problems, requiring hysterectomy.

Embolisation
Damage to other organs can be caused by inaccurate embolisation but with careful technique this is very rare.

You will experience some pain during and after the procedure, the severity of which will vary from woman to woman. However, you will be given pain relief which will include a specialized pump via which you yourself can control the pain relief you get depending on the amount of pain you experience (patient controlled analgesia - PCA). Hospital admission is usually less than 48 hours. You may experience discomfort for a week or so after the embolisation, but this is managed effectively with simple pain killers taken by mouth, which you will be given before you leave hospital.

Approximately 20% of patients will experience a vaginal discharge for some time after the procedure and occasionally this can persist for up to 6 weeks. This does not usually require specific treatment but you should contact your GP or trial research doctor promptly if you develop symptoms of fever or pain. They will arrange the necessary tests and may refer you to the gynaecology clinic for an early appointment. 2 8% of patients may expel a fibroid (or fragments of a fibroid) through the vagina after embolisation. This is rare but is more likely to occur with fibroids that lie partly within the uterine cavity. If this should happen to you, please contact your GP or research doctor promptly as it may be necessary for you to be admitted to hospital for treatment for this complication.

An early menopause occurs after fibroid embolisation in about 5% of patients. This is most likely to occur in older women who are nearing the natural menopause. Your doctor may advise hormone replacement treatment if this complication occurs. In the younger woman, the risk of an early menopause is estimated to be about 1%. You will need to take this into consideration if you are planning a future pregnancy.

Uterine artery embolisation and fertility / pregnancy:

The potential complications of embolisation can impair fertility. These include the 1% risk of an early menopause, and infection leading to Fallopian tube damage and hysterectomy. The effects of fibroid embolisation on future pregnancy are uncertain at present. There may be long term implications for the health and development of offspring born to women who have undergone embolisation. If adverse effects on the blood flow to the womb and afterbirth occur following embolisation (although currently there is no evidence that they do), this may interfere with the growth of the baby in the womb, may predispose to premature labour and excessive bleeding following delivery, all of which may have long-term detrimental effects on the child. For these reasons, at present women are advised not to try to conceive after embolisation. Those women actively seeking to conceive, or receiving fertility treatment, will not be recruited into this trial. To put the issue into perspective, there have been reports of fertility restoration and successful delivery of normally grown infants following embolisation, but the number of reported live births following fibroid embolisation is very small.

Infection is a rare but potentially serious problem.

What about confidentiality?
Your medical notes and the information obtained from this study will be reviewed only by the doctors, research nurses and authorized staff directly connected with the study. All information will be treated as strictly confidential and will only be used for the purpose of this study. Your anonymity will be maintained at all times.

What are the potential benefits of taking part in this study?
You will not benefit directly by participating in this study. This study will determine whether uterine artery embolisation is as effective as myomectomy in the treatment of uterine fibroids. This will allow appropriate advice to be given to other patients with fibroids.

Will I receive payment for taking part in this study?
You will not be paid for taking part in this study. Travel will be arranged or reimbursed for you to attend for tests and follow up visits out with your standard medical care. You doctor or nurse will advise you about travel arrangements.

Would I receive compensation if I were harmed as a result of taking part in this study?
If you are harmed by taking part in this research project, there are no special compensation arrangements. If you are harmed due to someone's negligence, then you may have grounds for a legal action but you may have to pay for it. Regardless of this, if you wish to complain about any aspect of the way you have been approached or treated during the course of this study, the normal National Health complaints mechanisms will be available to you.

Would taking part in this study affect my private health insurance in any way?
Participation in this study would not affect your private health insurance but if you are randomised to the embolisation group, the procedure will be performed in an NHS hospital as suitable specialized X ray equipment is not always available in private hospitals. If you are randomised to the surgical treatment group you could have the operation performed in a private hospital if you prefer. If you have private medical insurance you could choose to recuperate after either form of treatment in a private hospital.

Who should I contact for further information?
If you have any concerns now or at any point during the study, please contact :

1. Clinical Research Fellow (Dr Nassera Banu): 020 8672 1255, bleep 7559
2. Gynaecologist (Mr I T Manyonda) : telephone 020 8725 3663
3. Radiologist (Dr Anna-Maria Belli) : telephone 020 8725 1481