The latest recommendations, jointly issued by the Royal College of Obstetricians and Gynaecologists (RCOG) and the Royal College of Radiologists (RCR), has recently been published and are intended both for the National Health Service and the private sector.
The recommendations state that the early and medium term (to five years) results of uterine artery embolization (UAE) are good. It is as effective as surgery for symptom control, with the caveat that about a third of women will require a second intervention by five years, it finds. For women with symptomatic fibroids, UAE should be considered as one of the treatment options alongside surgical treatments (such as myomectomy and hysterectomy), endometrial ablation, medical management and conservative measures, the authors write.
However, one of the important points of the recommendations, published on 23 December 2013, is that the evidence for fertility and pregnancy outcomes after embolization and after myomectomy is poor. “Similarly there is no robust evidence comparing embolization or myomectomy for these outcomes,” the report says.
The document pinpoints that it is currently impossible to make an evidence-based recommendation about treatment (UAE or myomectomy) for women with fibroids who wish to maintain their fertility. Treatments for fibroids in women of child-bearing age who wish, or might wish, to become pregnant in the future should be offered only after fully informed discussion.
In the light of this, the investigators of the UK FEMME trial hope to spur enrolment in the National Institute for Health Research (NIHR)-funded clinical trial which is designed to measure the changes in the quality of life women experience when their fibroids are treated by either myomectomy or uterine artery embolization. (For more information, please email [email protected] or call +44(0)1214148335.)
The FEMME triallists have explained the background to the trial as: “With both myomectomy and UAE having their own risks and potential side effects, many health care professionals are uncertain which is the best treatment to offer to women who wish to retain their wombs and this is why the research arm of the NHS have funded the FEMME trial.
FEMME will follow the progress of 216 women over four years. Half of the women will be randomly allocated to have a myomectomy and the other half will receive a UAE. Using questionnaires that reflect how well women feel, FEMME will record the quality of life women say they have after they have undergone a myomectomy and this will be compared with the quality of life women report after having UAE. The trial is also going to measure how each procedure changes how much blood is lost as well examining if UAE and myomectomy change the level of ovarian hormones associated with fertility. The triallists explain that they are well on the way to meeting the target of 216 patients and need recruit less than eighty more women to reach it. They also clarify that ideally, they would like to randomise as many women as possible to FEMME to ensure that any conclusion reached is as robust and reliable as possible.
The joint report from the RCOG and RCR also recommends that UAE is contraindicated in women who have evidence of current or recent pelvic infection, who are pregnant, who are not prepared to accept the small risk of the requirement for hysterectomy in the event of complication or in whom there is significant doubt about the diagnosis of benign pathology.
Other recommendations from the report:
Patients for UAE should be selected and assessed by a multidisciplinary team including a gynaecologist and an interventional radiologist. Direct referral from primary care to an interventional radiologist is acceptable though local governance arrangements should ensure gynaecology input into the management of patients referred in this manner. Accurate pretreatment diagnosis with MRI is recommended.
- The procedure should only be undertaken by radiologists with established competence in embolisation techniques who have undergone appropriate training
- The responsibilities of both gynaecologist and radiologist for the care of the patient should be established prior to treatment and be set out in a relevant hospital protocol. The patient must be under a named responsible consultant at all times – this could be a radiologist or a gynaecologist (or both). Comprehensive follow-up protocols should be established. This should include contact telephone numbers for advice after discharge from hospital.