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10.1576/toag.6.4.215.27018

Alternatives to hysterectomy for treatment of uterine fibroids Dattakumar Kunde, Yakoub Khalaf In recent years there has been a trend towards conservative treatment for symptomatic uterine fibroids. Historically, myomectomy has been the operation of choice. Over the past few years, however, new minimally invasive procedures have evolved. These include laparoscopic myomectomy, laparoscopic myolysis, uterine artery embolisation and, more recently, magnetic resonance-guided percutaneous laser ablation, interstitial laser photocoagulation and high-intensity focused ultrasound energy. Simultaneously, nonsurgical treatments including gonadotrophin-releasing hormone analogues and a levonorgestrel intrauterine system have been tried, with limited success. In this era of evidence-based medicine, a thorough assessment of available research data is necessary to determine the place of new therapies in clinical practice. This review discusses the various treatments and outlines a pragmatic approach to the management of fibroids in women wishing to preserve their uterus. This should enable clinicians to counsel women regarding the most appropriate treatment option based on the specific clinical situation. Introduction Fibroids are the most common benign tumours of the uterus to affect women of reproductive age. The symptoms caused by fibroids are often distressing and have a significant impact on women’s quality of life. The treatments required to improve or cure the symptoms also put a major strain on healthcare resources. Statistically, fibroids are the most common discharge diagnosis for hysterectomy in the USA.1 There has been a trend towards more conservative treatment of symptomatic fibroids, largely because of the changing attitudes of women towards childbearing and uterine conservation. This has been aided by the evolution of minimal access surgical and non-surgical techniques, both of which carry less morbidity than conventional surgery.

Incidence Fibroids are apparent clinically in up to 25% of women.2 A US study involving a random ultrasound examination of asymptomatic women without any previous diagnosis revealed fibroids in 51% women.3 Racial variation was observed and black women had a greater propensity to

fibroid growth compared with white women. The cumulative incidence was higher than 80% in black women compared with 70% in white women.

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Keywords fibroids, GnRH analogues, minimal access surgery, myomectomy, non-surgical treatment, uterine artery embolisation

Author details

Clinical features The symptoms produced by uterine fibroids are variable and a significant proportion of women are symptomless. The clinical symptoms are directly related to the size, site and number of fibroids present. Menstrual abnormalities occur in approximately 30% of women. Menorrhagia is the most common and occurs when the endometrial cavity surface area is increased by submucous fibroids. Excessive uterine bleeding does often happen, however, in the absence of submucous fibroids. This is believed to be because of congestion and dilatation of the endometrial venous plexuses, caused by obstruction of myometrial veins by fibroids, and results in profuse bleeding from the endometrium.4 A fibroid polyp growing into the uterine cavity may present with intermenstrual bleeding or postcoital bleeding if it is extruded through the cervical canal into the vagina.

© 2004 Royal College of Obstetricians and Gynaecologists

Dattakumar Kunde MRCOG, Senior Specialist Registrar, Department of Women’s Health, Guy’s & St Thomas’ Hospital, Lambeth Palace Road, London, SE1 7EH, UK. email: [email protected] (corresponding author)

Yakoub Khalaf MD MRCOG, Consultant Gynaecologist, Guy’s & St. Thomas’ Hospital, London, SE1 7EH, UK.

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Most women with abnormal uterine bleeding will have associated dysmenorrhoea. Pelvic pain and pressure effects are commonly reported in women with larger fibroids. Pressure symptoms depend on the area of growth. For example, urinary frequency or retention due to pressure on the bladder; constipation if a large fibroid growing into the pouch of Douglas compresses on the rectum, or oedema of lower extremity if there is vascular compression. Acute pain may result from the degeneration of an intramural fibroid or torsion of a pedunculated subserous fibroid.

Fibroids and reproductive dysfunction The association between uterine fibroids and subfertility remains controversial because of the lack of strong evidence to support the assumption that fibroids cause subfertility. Many published studies show improved pregnancy rates after myomectomy but the methodology used in most of these studies is open to criticism. For instance, many studies are retrospective and lack a control group.5 This leaves the following questions unanswered:

• • •

Do fibroids decrease a woman’s ability to conceive? Does fibroid location play any significant role in decreasing that ability? Does myomectomy improve fertility potential?

It is not unusual to see women with fibroids becoming pregnant without any difficulty. The majority of pregnancies have a favourable outcome despite the risks of miscarriage and antenatal, intrapartum and postpartum complications. The first question, therefore, remains the most controversial and, as yet, there is no evidence from prospectively controlled studies from which to draw firm conclusions. The direct impact of myomas on the implantation of embryos can be best studied using in vitro fertilisation (IVF) as a model with standard quality embryos (having excluded other causes of subfertility such as tubal, ovarian and male factors). A comparison of the results of IVF in women with untreated myomas against those without myomas demonstrated low pregnancy rates when the uterine cavity was distorted by fibroids.The presence of fibroids without distortion of the cavity did not impair implantation.6 Eldar-Geva et al.7 disputed this observation, concluding that pregnancy rates are affected by the presence of intramural fibroids even when there is no distortion of the cavity. 216

In a prospective case–control study to evaluate the impact of small intramural fibroids (mean size 2.3 cm) on the outcome of IVF or intracytoplasmic sperm injection (ICSI) treatment, Hart et al.8 showed that an intramural fibroid halves the chances of continuing pregnancy after assisted conception. A matched-control retrospective study9 compared the outcome of IVF/ICSI treatment in women with subserosal and intramural fibroids not encroaching on the uterine cavity with the treatment outcome of women without fibroids. There was no difference when fibroid size was less than 4 cm. Women with intramural fibroids greater than 4 cm in size, however, had lower pregnancy rates than those whose intramural fibroids were less than or equal to 4 cm.Thus, the location and size of fibroids adds a new dimension to the debate on the influence of fibroids on fertility outcome. It should be stressed, though, that no study has addressed the risk–benefit balance of performing a myomectomy for small intramural fibroids that are not distorting the uterine cavity.The consensus regarding the treatment of fibroids in women who are subfertile suggests that the fibroids not distorting the uterine cavity do not cause any appreciable reduction in the chance of pregnancy and myomectomy is not indicated. Fibroids distorting the uterine cavity appear to be associated with a reduced chance of pregnancy and should be removed.10

Diagnosis Clinical diagnosis of fibroids is based on abdominal and/or bimanual pelvic examination and is usually followed by an imaging test to confirm the diagnosis. Ultrasonography is traditionally used for this purpose and, depending on the uterine size, a transabdominal or transvaginal scan (or both) will assess the location, number and size of fibroids. Use of saline as a contrast medium has improved the accuracy of assessment of the endometrium and uterine cavity, making it a sensitive test for diagnosing submucous fibroids.11 Three-dimensional ultrasonography is evolving as a useful diagnostic tool that can locate fibroids accurately. This information can help in planning appropriate treatment and determining which fibroids would be most responsive if uterine artery embolisation (UAE) is performed.12 The exact location and size of fibroids are even more significant for cases in which one of the newer treatments such as magnetic resonanceguided percutaneous laser ablation or the use of high-intensity focused ultrasound (HIFU) energy is contemplated. In such cases, the magnetic resonance imaging (MRI) scan provides invaluable

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information for the interventional radiologist and is superior to conventional ultrasound.13

Expectant management The dictum ‘primum non nocere’ (first, do no harm) is an important concept in medicine and holds true for the management of uterine fibroids. Women who are asymptomatic or whose symptoms do not have any influence on their general health and lifestyle can be kept under surveillance. Periodic follow-up and ultrasound scans can be arranged to detect any deterioration in symptoms or increase in fibroid volume so that appropriate treatment can be offered.

Myomectomy Myomectomy has traditionally been offered for the treatment of symptomatic fibroids in women who wish to retain their uterus. It gained popularity in the UK in the early 20th century when Victor Bonney pioneered various techniques to remove fibroids without sacrificing the uterus, giving childless women the opportunity to retain their reproductive function.14 The surgical principles described by Bonney are still applied in clinical practice today. Haemorrhage and infection remain the most common complications but, with better access to blood transfusion facilities and the use of prophylactic antibiotics, the overall morbidity is comparable to that of hysterectomy.15 With the technical advances in minimal access surgery, myomectomy can now be performed laparoscopically for intramural and subserous fibroids16 and hysteroscopically for submucous fibroids.17 Although laparoscopic myomectomy is technically difficult (it prolongs the operating time and has a longer operator learning curve), it offers significant benefits in terms of lower postoperative pain and shorter recovery time in comparison with open myomecotmy.18 In expert hands, the conversion rate to open myomectomy is reported to be 11.3%. The probability of conversion to laparotomy is determined by the following factors:

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the presence of fibroids over 5 cm in size preoperative use of gonadotrophin-releasing hormone (GnRH) analogues intramural or anterior location of fibroids.19

There have been concerns that the scar resulting from repair of the uterus after laparoscopic myomectomy may be weak and may rupture during pregnancy or labour.20 The underlying cause appears to be the use of diathermy energy,

resulting in extensive collateral damage and weakening of the myometrium.16 Ultrasonically activated shears and blades use high frequency sound energy and are more appropriate for this type of surgery because of the reduced collateral damage produced during their use.21

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Recurrence of fibroids after laparoscopic myomectomy remains a concern. A cumulative rate of 51% at 5 years is reported.22 This is much higher than the rate of 10% reported after abdominal myomectomy.23 Myomectomy is also associated with a high risk of postoperative adhesion formation and adhesion prevention measures should be employed. These include good surgical technique as well as the use of anti-adhesion products.24 Hysteroscopic resection of submucous fibroid is indicated in symptomatic women presenting with heavy bleeding or reproductive failure.The procedure can be performed as a day case and the risk of complications is small. The majority of women are satisfied with the treatment and the long-term follow up results are promising.25

Uterine artery embolisation The first report of embolisation for symptomatic fibroids was published in 1995.26 In this series of 16 women, the main indication for treatment was menorrhagia (n  14). Nine women reported complete resolution of their menorrhagia and three reported an improvement. Since then, this technique has been widely employed by gynaecologists and published data indicate that it is effective in controlling symptoms caused by fibroids.27,28 The procedure is performed under sedation and involves percutaneous insertion of an angiography catheter via a femoral artery into the ipsilateral or the contralateral uterine artery. Polyvinyl alcohol particles 300–500 m in size are injected into the vessel until blood flow ceases. Although UAE can be performed as a day procedure, overnight admission may be necessary. In one large multicentre trial,29 18% stayed longer than one night and 5% stayed longer than two nights. The indicator of recovery is the number of days to return to normal activity or work. One study reported this as 13.6 days and 16.6 days, respectively.28 Many women undergoing this treatment present with bulk symptoms and achieve a significant reduction (40–69%) in uterine volume post-treatment. Although successful pregnancies following this treatment have been reported, embolisation may affect myometrial integrity. This could lead to uterine rupture during pregnancy. The Royal College of Obstetricians and

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Gynaecologists30 and the American College of Obstetricians and Gynecologists31 recommended that this procedure should not be offered to women wishing to retain their fertility. Although UAE provides good short-term relief of bulk symptoms and menorrhagia caused by fibroids, the procedure is not without complications. Women should therefore be adequately counselled to ensure appropriateness of the therapy, with particular emphasis on her reproductive wishes. The National Institute for Clinical Excellence (NICE) has also made the following recommendations for clinicians who wish to undertake this procedure:32

• • • • •

inform the clinical governance leads in their trusts ensure that women offered the procedure understand the uncertainty about its safety and efficacy, and provide them with clear written information ensure that appropriate arrangements are in place for clinical audit and research involve a gynaecologist and an interventional radiologist in a team approach to patient selection and management submit data to the British Society of Interventional Radiology registry.

Complications of UAE Immediate complications Almost all women experience abdominal cramps that respond to oral analgesics. Pain intensity can vary, however, and a well-defined pain management protocol must be in place to provide effective relief. Nausea is common and may lead to vomiting but this can be prevented by routine administration of antiemetics following the procedure. Postprocedural vaginal discharge (21%), spotting (22%) and bleeding (32%) are commonly reported. In some cases, haematoma formation at the site of catheterisation can occur and damage to the femoral artery has been reported. Persistent pain, malaise, dysuria and pyrexia may necessitate readmission to hospital.29

Intermediate and delayed complications Up to 30% of women reported hot flushes, and mood swings can also occur.29 Fibroid expulsion occurs in up to 10% and can cause intense abdominal discomfort, particularly if larger fibroids are causing an obstruction in the cervix. When the fibroid protrudes through the cervix a vaginal myomectomy can be performed with little blood loss. Another serious, albeit rare, complication is a necrotic fibroid infection, which can happen several months after emboli218

sation. Amenorrhoea may follow 1% of procedures and can be either transient or permanent.30 Ahmed et al.33 demonstrated that, in younger women (less than 40 years), ovarian function would not be compromised by UAE, whereas older women (over 45 years) are at higher risk of ovarian failure. Although rare, death from sepsis has also been reported.34 UAE has gained popularity as an alternative treatment to myomectomy and hysterectomy. It has been shown to be safe and effective compared with hysterectomy, has fewer major complications and a shorter hospital stay.35

Laparoscopic myolysis Myolysis was proposed as a treatment for fibroids in women who did not wish to have children. The technique involves laparoscopic use of the neodymium:yttrium–aluminium–garnet (Nd:YAG) laser to coagulate the myoma. Alternative energy sources have subsequently been used, such as diathermy, and a cryoprobe has been used to carry out myolysis.36 Laparoscopic myolysis causes marked devascularisation and significant shrinkage of fibroids, and fibroids up to 8 cm have been treated this way. It can be proposed as a minimally invasive alternative treatment to myomectomy in women with large symptomatic fibroids. It should not, however, be offered to women who desire future pregnancies because there is a risk of uterine rupture caused by devascularisation of the myometrium.37 Second-look laparoscopy has shown the presence of dense adhesions in 10–50% of cases and there is concern that adhesion formation between the uterus and bowel may result in bowel obstruction.

High-intensity focused ultrasound There has been great interest in this novel treatment because of its noninvasive approach. It was developed following in vitro experiments with a prototype device that used a commercially available abdominal ultrasound image probe aligned to a vaginal HIFU transducer. This focused the HIFU in the image plane. HIFU was generated using a 3.5 MHz PZT-8 crystal (PZT  piezoelectric transducer), with a diameter of 25.4 mm, bonded to an aluminium lens. The ultrasound beam was fixed at a focal depth of 40 mm using computer simulations. A water-filled latex condom surrounding the transducer provided acoustic coupling and allowed water circulation for transducer cooling. It was possible to demonstrate ultrasound-guided tissue necrosis caused

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by HIFU-induced thermal and cavitational effects in animal tissues. The treatment site appeared as a hyperechoic spot on the ultrasound image at intensities above 1250 W/cm.38 The safety and efficacy of this technique was further evaluated in a multicentre trial involving 55 women with symptomatic fibroids.39 Under MRI guidance, an ultrasound beam of approximately 1.0–1.5 MHz delivered the energy directly to the targeted tissue for fibroid ablation. The post- treatment effect in those who underwent planned hysterectomy after treatment was assessed using either MRI or pathological examination. This study has shown that HIFU has an excellent safety profile. In contrast to the more diffuse necrosis caused by UAE, the targeting ability of HIFU produces few adverse effects. Further studies are needed, however, to establish the long-term benefits that could be achieved in terms of fibroid shrinkage and resolution of menorrhagia.

Magnetic resonance-guided percutaneous laser ablation This is a promising treatment that may provide an alternative minimally invasive therapy.40 It is carried out under a local anaesthetic. Four magnetic resonance-compatible, 18-gauge needles are placed within the target fibroid under MRI guidance. Laser fibres are threaded in to the outer needle sheath until the laser tips are within the substance of the fibroid. An infra-red diode laser is used for thermal ablation of the fibroid and tissue changes are monitored with real-time image processing software. Post-treatment follow-up at 12 months showed a 41% reduction in mean fibroid volume. Quality of life and satisfaction scores were similar to those seen in women after hysterectomy.41

Interstitial laser photocoagulation The principle here is the same as for magnetic resonance-guided percutaneous laser ablation but the laser fibres are placed in the fibroids under laparoscopic guidance.42 The advantage of this technique is that it can be performed by any gynaecologist trained in laparoscopic surgery without the need for expensive equipment to monitor thermal changes. This gives it the potential for wider use in clinical practice.

Levonorgestrel-releasing intrauterine system The levonorgestrel-releasing intrauterine system was originally licensed for contraceptive use but it has also been used in the conservative treat-

ment of menorrhagia, with considerable success. This has inspired clinicians to use it for carefully selected women with menorrhagia caused by fibroids.43 It should only be offered to women whose uterus does not exceed 12 weeks in size and where there is no distortion of the cavity. The results from observational studies appear to be promising, showing a reduction in blood loss as well as fibroid shrinkage (possibly due to growth factor inhibition).44,45

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GnRH analogues GnRH analogues are often used to control menorrhagia caused by fibroids.When used preoperatively they reduce fibroid volume and control excessive bleeding. Use is normally restricted to a maximum of 6 months because long-term use is associated with menopausal adverse effects and bone density loss. Lethaby et al.46 carried out a systematic review of randomised trials to test the hypothesis that treatment with GnRH analogues is superior to placebo, no treatment or other medical therapy prior to surgery. They evaluated the benefits of GnRH analogues before, during and after myomectomy.

Preoperative outcomes

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Significant rise in haemoglobin and haematocrit with preoperative use of analogues compared with no treatment or placebo treatment. Uterine volume was significantly reduced in the GnRH group compared with the no treatment or placebo groups. Uterine gestational size and fibroid volume were significantly reduced in no treatment trials with GnRH analogues. Average reduction in uterine volume was 159 ml (this may be greater in women with a larger uterus). All trials comparing the use of analogues with no treatment or placebo treatment reported a significant improvement of pelvic symptoms attributable to fibroids. A significantly higher proportion of women in the treatment group reported adverse effects such as hot flushes, vaginitis, sweating and change in breast size.

Intraoperative outcomes

•

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It has been suggested that blood loss may be reduced with the use of GnRH analogues. There was no significant difference in 219

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• • •

intraoperative blood loss in one placebo controlled trial but there was significant reduction in the GnRH analogue treated group in the no treatment trial. The rate of blood transfusion did not differ. Use of analogues made no difference to the duration of surgery or duration of hospital stay following myomectomy. There was a significant reduction in the rate of vertical incisions (as opposed to transverse incisions) in the GnRH analogue group because of a reduced preoperative uterine volume. Combining data from trials of no treatment shows that intraoperative blood loss is reduced at myomectomy. No significant benefit in terms of reduced transfusion requirements with the placebo controlled trials because of the small size of these studies. No reduction has been demonstrated in operative time for myomectomy with the use of GnRH analogues. The trials have not answered the important question of whether the use of GnRH analogues makes myomectomy (‘shelling out’ a fibroid) difficult.

benefit women with severe menorrhagia and anaemia. In conclusion, there is evidence from this review that GnRH analogues reduce uterine volume because of the reduction in size of the uterus. Blood indices are improved and there may be a reduction in intraoperative blood loss and operative time. A randomised controlled trial by Vercellini et al.,47 however, failed to show any significant effect on intraoperative blood loss with GnRH analogue treatment before myomectomy. The current evidence does not support routine use of GnRH analogues for all women undergoing myomectomy. They should be recommended for women with a greatly enlarged uterus, preoperative anaemia and when a transverse incision is planned. A cost-effectiveness analysis of preoperative GnRH analogues found that the benefits do not justify the costs and therefore selective, rather than routine, use of GnRH analogues prior to myomectomy is recommended.48 Future randomised trials should try to address whether fibroid recurrence increases after the use of GnRH analogues and whether subsequent fertility outcomes improve.

Postoperative outcomes

• • •

•

•

The rate of postoperative complications did not vary between the two groups after myomectomy. Postoperative haemoglobin was significantly higher after myomectomy in one trial. Recurrence of fibroids 6 months after myomectomy was more likely than in the no treatment group but this difference was not found in one small placebo trial (combined trials, OR 4.0, 95% CI 1.1–14.7). The question of whether GnRH analogues improve postoperative fertility potential remains unanswered.There are presently insufficient data to answer this and future trials should address this issue. The odds of pregnancy in infertile women undergoing myomectomy in one small trial did not vary between the two groups.

The review shows the combined results of both placebo-controlled and no treatment trials strongly suggest that the use of GnRH analogue is associated with an increase in preoperative haemoglobin and haematocrit. This may

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Conclusion Symptomatic fibroids are common in women of reproductive age and the demand for conservative treatment is increasing.Women often face the dilemma of choosing the right treatment from various available options.The review of available evidence indicates that, in current practice, myomectomy is the most common procedure offered to women seeking to retain their uterus. When performed by an experienced surgeon the procedure is safe and the morbidity is no greater than that of a hysterectomy. Published studies on UAE show that it results in a significant improvement in symptom status. Large randomised trials comparing embolisation to other therapies will be necessary, however, in order to define the differences in safety and efficacy. Despite the availability of a number of new therapies they have yet to be validated because the existing studies evaluating these techniques are small and of poor quality. Robust research trials are therefore needed in order to determine the place of various new treatments in the conservative management of uterine fibroids. ■

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