Earlier this year saw the introduction into the UK of a new, revolutionary technology for the treatment of uterine fibroids. The Sonata System is a clinically proven, minimally invasive day-case solution for uterine fibroids, a common condition that affects up to 1 in 3 women in the UK .
Used predominantly in an outpatient environment, hospitals are showing interest in what the Sonata System offers in terms of efficacy and cost efficiency. We spoke with consultant gynaecologist Mr Bruce Ramsay, pictured, who has been offering the Sonata treatment to patients at Peterborough City Hospital since January 2019. He gave his expert opinion to OGMN on treating patients with what can prove to be a life-debilitating condition.
Q: Historically, what treatments options have you been able to offer patients for uterine fibroids?
A: I have offered numerous treatments to patients during my career, ranging from the more invasive options such as hysterectomy and myomectomy, to techniques such as fibroid embolisation and drug treatments. Most recently, I have been able to offer the Sonata System.
Q: How does the Sonata System compare to other treatments?
A: The Sonata System has many advantages – it is a much more straightforward treatment than more invasive options, such as a hysterectomy or myomectomy. It is incisionless and minimally invasive, so it is less risky, and the recovery time is speedier. As it can be performed under local anaesthetic in an outpatient setting, there are advantages for both the patient and the hospital. Patients are able to return home after the procedure and the operating theatre is freed up for other operations – representing a saving in terms of both staff and beds – most hysterectomy and myomectomy patients tending to need to stay in for a good couple of days.
Compared to other treatments like fibroid embolisation, Sonata has a similar effect on the fibroids in that it causes them to shrink, leading to clinical improvement that can be long-lasting. Unlike embolisation, which can impair ovarian function and has been associated with scar tissue within the uterus, Sonata seems less likely to impact fertility. That said, it is important to state that while there have been normal pregnancy outcomes, including vaginal deliveries, after treatment with Sonata, the appropriateness of this treatment in women regarding fertility and delivery has not been established. In terms of other fibroid treatments, drug treatments tend to be temporary, often do not work at all, and have side effects, so Sonata really is an excellent treatment option in comparison to alternatives.
Q: For how long have you been using the Sonata System?
A: I have been using Sonata for about 18 months. I received company training from Gynesonics, where I was given a full training program and was taught how to use the Sonata System and was given initial case guidance by a Gynesonics clinical specialist as well as their medical director. The implementation of the Sonata System into Peterborough City Hospital has taken slightly longer due to COVID-19, but the long-term savings of using Sonata will be hugely beneficial to the hospital.
Q: How does the technology work?
A: A patient will initially have an examination to look at the cervix, similar to a Pap smear. We then put some local anaesthetic into the cervix and widen the cervix to admit the ultrasound probe into the uterus. We can then identify the fibroid or fibroids that we want to treat, position the electrodes into the fibroids, all the time looking at it on the ultrasound, so we know exactly where the electrodes should be inserted. We then activate the radiofrequency (RF) energy for a pre-determined length of time, which is calculated by the machine based on how big the fibroid is. The Sonata device delivers RF energy to shrink the fibroid and the device can then be repositioned to treat additional fibroids or removed from the patient’s uterus.
Q: How effective is Sonata?
A: I have treated around ten patients so far, and nine out of 10 were happy with the outcome in terms of what they wanted to achieve, whether that was to reduce bleeding, or to shrink fibroids in the womb. Sonata is hugely beneficial for women who are interested in conserving their uterus. With a hysterectomy, the womb is removed. With a myomectomy, the uterus is preserved but there is a much longer recovery time. Sonata offers a treatment for women who want to conserve their uteri, with a mean return to normal activity of 2.2 days. After rescanning people two to three months after the procedure, I found my patients had a 50% reduction in the fibroid volume which compares very favourably to alternative options, such as drug treatment. In terms of recovery, the majority of my patients returned to regular activity the following day.
Q: Are there any implications with regards the COVID-19 pandemic?
A: The COVID-19 pandemic has meant that there is a huge waiting list for procedures to be carried out in theatres and processes are much slower than they were beforehand. Apart from its efficacy in treating uterine fibroids, the major advantage of the Sonata System is that it is an outpatient procedure, meaning beds are not taken up. Also, being minimally invasive and incisionless, there appear to be lower infection risks, resulting in reduced reinterventions and patients are in and out of the hospital within the day.
For further information, please visit www.treatsmarterwithsonata.co.uk
The Sonata System is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding. For Indication and Safety Information, or to learn more about the Sonata System, visit gynesonics.com/sonata-system. Gynesonics, Sonata, and the logo are trademarks and registered trademarks of Gynesonics, Inc. All other trademarks are properties of their respective owners. Gynesonics products are covered by US and foreign patents. See www.gynesonics.com/us/patents. ©2020 Gynesonics, Inc.