Uterine fibroids are the most common tumour of the reproductive tract in women
of reproductive age. Although they are benign tumours that are often
asymptomatic, they may cause debilitating symptoms in many women, such as
abnormal uterine bleeding, abdominal pain, increased abdominal girth, urinary
frequency, constipation, pregnancy loss, dyspareunia, and in some cases
infertility.
Several approaches are available for the treatment of uterine fibroids. These
include pharmacologic options, such as hormonal therapies and gonadotropinreleasing
hormone agonists; surgical approaches, such as hysterectomy,
myomectomy; myolysis, laparoscopic uterine artery occlusion, uterine artery
embolisation and magnetic resonance imaging-guided focused ultrasound surgery.
The choice of approach may be dictated by factors such as the patient’s desire to
become pregnant in the future, the importance of uterine preservation, symptom
severity, and tumour characteristics. There is however, no widely agreed
therapeutic strategy. There is a widespread view that hysterectomy is overused in
the UK; the Chief Medical Officer in his annual report ‘On the state of public
health’ in 2005, highlighted that hysterectomy in younger women is associated
with complications, hospital stays, procedure-related interference with normal life
and is costly. In addition he outlined the need to reduce the number of
hysterectomies. This, along with the change in cultural attitudes amongst patients,
who are becoming increasingly reluctant to undergo these conventional invasive
procedures, has increased the need for new treatment options.
Ideally new treatment options for uterine fibroids would be minimally invasive,
have long-term data demonstrating efficacy and safety, have minimal or no
incidence of fibroid recurrence, be easy to perform, preserve fertility, and be cost
effective. New treatment approaches are under investigation, with the goals of
being effective, safe, and less invasive.
MRgFUS is a non-invasive thermo-ablative hybrid technique which uses both MR
and ultrasound to destroy tumours. It is an outpatient procedure, which avoids the
need for an anaesthetic, has a short recovery period, and is uterine sparing.
The main objective of this work was to set out the rationale for using Magnetic
Resonance guided Focused Ultrasound Surgery (MRgFUS) for the treatment of
uterine fibroids. In order to achieve this aim, four main bodies of work are
necessary;
1) Identifying patient selection criteria and investigating mitigating
techniques to increase the pool of women for whom this treatment can be
offered.
2) Investigating a method designed to overcome the problem of safely
treating women with abdominal scars for whom this treatment can cause
potential morbidity.
3) Investigating the potentiality of using MRgFUS to prolong the tumour
shrinkage effect of GnRH analogue injections.
4) Investigating the safety of MRgFUS in treating symptomatic women who
wish to preserve fertility.
Results: the first aim of this project was to identify patient selection criteria and to
investigate methods to widen the selection criteria. In our retrospective review it
was found that 74% of women presenting were deemed technically suitable to
proceed with treatment and several mitigating techniques that solved current
technical difficulties were identified and allowed for less restrictive MRgFUS
selection criteria for treatment of symptomatic uterine fibroids. These less
restrictive criteria are expected to expand the pool of patients for whom MRgFUS
is a viable treatment option for uterine fibroid symptoms.
The second aim was to identify a method of overcoming the problem of treating
women with previous abdominal scars safely. We identified a unique method of
highlighting the scar by painting it with a paramagnetic iron oxide material which
clearly outlined the scar on MR scanning allowing complete avoidance of the scar
using MR guidance. In this small pilot study, all women were treated safely with
no skin burns.
The third aim of this project looked at the potentiality of prolonging the shrinkage
effect of GnRH analogues by following a course of 3 injections with MRgFUS
treatment. In this prospective study of fifty women, there was a 50% reduction in
the mean symptoms severity score at 6 months which was maintained for 24
months post treatment. There was an average reduction in target fibroid volume
which was maintained for 24 months.
The final aim of the project was to investigate the safety of using MRgFUS as a
treatment option for those women who wished to preserve their fertility. In this
multicentre international study, One hundred and sixteen women were recruited
from five centres. There were sixty four reported pregnancies in Sixty one
women, with 30 completed deliveries. There were no reported cases of uterine
rupture, premature labour, abnormal placentation or placental abruption.
Conclusion: There is a growing body of data from clinical trials and more than
four years of clinical experience to validate the safety and efficacy of MRgFUS
for the treatment of uterine fibroids. MRgFUS is a totally non-invasive outpatient
procedure that is not associated with the typical surgical risks of bleeding,
infection and has minimal recovery time. Additionally, the procedure allows
women to address their symptoms whilst preserving the uterus. Consequently,
MRgFUS is an alternative treatment option for suitable patients who have refused
other interventions due to concerns about lost productivity, risks of surgical
complications or future fertility