Outpatient Transcervical ultrasound guided Radiofrequency Treatment of Uterine Fibroids (SONATA)

What is Sonata Fibroid Ablation?

SONATA or Sonography-Guided Transcervical Fibroid Ablation is an incision-free (no cuts or scars) treatment for women with symptomatic uterine fibroids who wish to preserve their wombs. It is normally performed during a clinic appointment allowing women to return to activities of daily living quickly. An ultrasound device that can enter the womb (uterus) is used to locate individual fibroids. Radiofrequency energy is then delivered directly to the fibroid(s). The treated fibroids shrink over time to relieve symptoms. In a clinical study, half of the women returned to normal activity the next day, with an average of about 2 days.

• 90% of patients reported less bleeding at 3 months.
• 95% of patients reported less bleeding at 12 months.
• 94% of patients were still satisfied with their treatment after 3 years.
• 92% of patient did not need further surgical treatment after 3 years.

Before your procedure

Please make sure to bring a urine sample to your appointment. It will be tested for infection and a pregnancy test will be performed.

You do not need to fast for this procedure. It is advisable to have something to eat 1 – 2 hours before your appointment time and to wear loose, comfortable clothing.

Take simple pain relief such as paracetamol (1 g dose) or ibuprofen (400 mg dose) an hour before the procedure. If you are allergic to medications such as ibuprofen you can take codeine either prescribed by your GP or bought from a Chemists. Do not take more than the recommended dose of these medications and let the doctor doing the procedure know what medication you took and at what time. If you are on regular pain relief medication, please continue with your usual treatment; do not take additional treatment.

We want you to be as comfortable as possible for this procedure. If you have not taken adequate pain relief before your procedure this may delay or lead to the cancellation of your appointment.

You will be asked to complete a questionnaire asking questions about the symptoms your are experiencing and effect they have on your life.

What happens during the procedure?

SONATA involves inserting a device into your womb through your cervix. One part of the device is an ultrasound which is used to locate your fibroids. The other part is a specially designed probe that uses radiofrequency energy to treat the fibroid. This probe treats a very specific area at one time. Therefore, is you have a large fibroid or more than one fibroid you may need multiple treatments in one session. The treated fibroids will shrink over months but not disappear unless they are very small to begin with. As they shrink, most patients find that symptoms are improved or completely resolve.

What to expect from your clinic visit

A doctor or nurse will discuss your symptoms and any relevant issues that might affect the procedure, for example if you have had past treatment to your cervix (neck of the womb) because this could make entering your womb more challenging. They will explain the procedure including further pain relief options and answer any questions you may have. Your consent will be obtained before the procedure is performed.

You may be offered additional pain relief before or during the procedure.
Please inform the doctor/nurse if you have any allergies or have had a reaction to drugs or other tests in the past.

The doctor will perform the procedure. Two additional clinical staff members will provide support to you and assistance to the doctor.

You will be given privacy to get changed. You will be made to feel as comfortable as possible in the examination chair and need only remove your lower garments.

An instrument called a speculum (used when taking a smear) is placed in the vagina to view the cervix. The Sonata device is gently passed through the cervix into your womb. If you wish you can watch on the screen. During examination, a slight cramping feeling (similar to period pain), may be felt.

Any findings seen will be explained to you. The fibroid(s) will be identified using ultrasound scan and treatment using the radiofrequency probe will be delivered to individual fibroids after safety checks are performed. If at any stage you have any questions or want to pause or stop, please tell the team. They are there to support you.

After the procedure

The doctor/nurse will answer any questions you might have and offer advice on pain relief. You will be observed in our unit for a few minutes after the procedure.

Although you should feel well enough to walk travel and drive home, it is recommended that you have someone pick you up to get you home. Where possible, try to rest and relax for a few hours after your procedure.

You will be offered a telephone call to follow you up and assess your symptoms.

What to expect after the procedure

During the first 24 hours you will likely get cramping type pelvic pain, nausea, and a small amount of vaginal bleeding or brown discharge. This can persist for a few days although most women feel nearly back to normal 2 days after the procedure. Avoid the following activities for at least two weeks to minimise the risk of developing a pelvic infection:

• Swimming.
• Taking a bath (please shower instead).
• Penetrative sexual intercourse.
• Use of tampons.

Call our gynaecology acute treatment unit (GATU) if you are having converting symptoms after your Sonata treatment, such as:

• Severe pain.
• Vaginal bleeding.
• Persistent nausea or vomiting.
• Excessive bleeding (more than 4 fully soaked pads in 2 hours).
• Severe abdominal pain.
• Fever 38 degrees Celsius or above.
• Greenish or offensive vaginal discharge.

What are the main side effects of the procedure?

• Expected – Pelvic pain or discomfort, small vaginal bleeding/ brown discharge.
• Common (1/20) – feeling faint/giddy; unable to perform or complete the procedure, for example if the fibroids are found to be too large or too close to other organs that could be harmed during treatment.
• Uncommon (fewer than 1 in 20) – Failure to gain entry to uterine cavity, inability to complete the procedure, sepsis/ pelvic infection, fainting (vasovagal) ; Ineffective treatment resulting in needing further intervention (e.g. open myomectomy or hysterectomy); Equipment failure.
• Rare (fewer than 1 in 200)- Uterine perforation causing damage to bowel or bladder and/or resulting in further surgery (e.g laparoscopy, laparotomy) (rare- no cases reported so far for Sonata); Allergic reaction to local anaesthetic.

Pregnancy and Sonata

Currently Sonata is not offered to women wishing to conceive. However, there is limited data of successful pregnancies without complications in people who had Sonata treatment.

For further advice

• Contact your GP