SOGC CLINICAL PRACTICE GUIDELINE
The Management of Uterine Leiomyomas

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Abstract

Objectives

The aim of this guideline is to provide clinicians with an understanding of the pathophysiology, prevalence, and clinical significance of myomata and the best evidence available on treatment modalities.

Options

The areas of clinical practice considered in formulating this guideline were assessment, medical treatments, conservative treatments of myolysis, selective uterine artery occlusion, and surgical alternatives including myomectomy and hysterectomy. The risk-to-benefit ratio must be examined individually by the woman and her health care provider.

Outcomes

Implementation of this guideline should optimize the decision-making process of women and their health care providers in proceeding with further investigation or therapy for uterine leiomyomas, having considered the disease process and available treatment options, and reviewed the risks and anticipated benefits.

Evidence

Published literature was retrieved through searches of PubMed, CINAHL, and Cochrane Systematic Reviews in February 2013, using appropriate controlled vocabulary (uterine fibroids, myoma, leiomyoma, myomectomy, myolysis, heavy menstrual bleeding, and menorrhagia) and key words (myoma, leiomyoma, fibroid, myomectomy, uterine artery embolization, hysterectomy, heavy menstrual bleeding, menorrhagia). The reference lists of articles identified were also searched for other relevant publications. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no date limits but results were limited to English or French language materials. Searches were updated on a regular basis and incorporated in the guideline to January 2014. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, and national and international medical specialty societies.

Benefits, Harms, and Costs

The majority of fibroids are asymptomatic and require no intervention or further investigations. For symptomatic fibroids such as those causing menstrual abnormalities (e.g. heavy, irregular, and prolonged uterine bleeding), iron defficiency anemia, or bulk symptoms (e.g., pelvic pressure/pain, obstructive symptoms), hysterectomy is a definitive solution. However, it is not the preferred solution for women who wish to preserve fertility and/or their uterus. The selected treatment should be directed towards an improvement in symptomatology and quality of life. The cost of the therapy to the health care system and to women with fibroids must be interpreted in the context of the cost of untreated disease conditions and the cost of ongoing or repeat investigative or treatment modalities.

Values

The quality of evidence in this document was rated using the criteria described in the Report of the Caadian Task Force on Preventive Health Care (Table 1).

Summary Statements

  • 1.

    Uterine fibroids are common, appearing in 70% of women by age 50; the 20% to 50% that are symptomatic have considerable social and economic impact in Canada. (II-3)

  • 2.

    The presence of uterine fibroids can lead to a variety of clinical challenges. (III)

  • 3.

    Concern about possible complications related to fibroids in pregnancy is not an indication for myomectomy except in women who have had a previous pregnancy with complications related to these fibroids. (III)

  • 4.

    Women who have fibroids detected in pregnancy may require additional maternal and fetal surveillance. (II-2)

  • 5.

    Effective medical treatments for women with abnormal uterine bleeding associated with uterine fibroids include the levonorgestrel intrauterine system, (I) gonadotropin-releasing hormone analogues, (I) selective progesterone receptor modulators, (I) oral contraceptives, (II-2) progestins, (II-2) and danazol. (II-2)

  • 6.

    Effective medical treatments for women with bulk symptoms associated with fibroids include selective progesterone receptor modulators and gonadotropin-releasing hormone analogues. (I)

  • 7.

    Hysterectomy is the most effective treatment for symptomatic uterine fibroids. (III)

  • 8.

    Myomectomy is an option for women who wish to preserve their uterus or enhance fertility, but carries the potential for further intervention. (II-2)

  • 9.

    Of the conservative interventional treatments currently available, uterine artery embolization has the longest track record and has been shown to be effective in properly selected patients. (II-3)

  • 10.

    Newer focused energy delivery methods are promising but lack long-term data. (III)

Recommendations

  • 1.

    Women with asymptomatic fibroids should be reassured that there is no evidence to substantiate major concern about malignancy and that hysterectomy is not indicated. (III-D)

  • 2.

    Treatment of women with uterine leiomyomas must be individualized based on symptomatology, size and location of fibroids, age, need and desire of the patient to preserve fertility or the uterus, the availability of therapy, and the experience of the therapist. (III-B)

  • 3.

    In women who do not wish to preserve fertility and/or their uterus and who have been counselled regarding the alternatives and risks, hysterectomy by the least invasive approach possible may be offered as the definitive treatment for symptomatic uterine fibroids and is associated with a high level of satisfaction. (II-2A)

  • 4.

    Hysteroscopic myomectomy should be considered first-line conservative surgical therapy for the management of symptomatic intracavitary fibroids. (II-3A)

  • 5.

    Surgical planning for myomectomy should be based on mapping the location, size, and number of fibroids with the help of appropriate imaging. (III-A)

  • 6.

    When morcellation is necessary to remove the specimen, the patient should be informed about possible risks and complications, including the fact that in rare cases fibroid(s) may contain unexpected malignancy and that laparoscopic power morcellation may spread the cancer, potentially worsening their prognosis. (III-B)

  • 7.

    Anemia should be corrected prior to proceeding with elective surgery. (II-2A) Selective progesterone receptor modulators and gonadotropin-releasing hormone analogues are effective at correcting anemia and should be considered preoperatively in anemic patients. (I-A)

  • 8.

    Use of vasopressin, bupivacaine and epinephrine, misoprostol, peri-cervical tourniquet, or gelatin-thrombin matrix reduce blood loss at myomectomy and should be considered. (I-A)

  • 9.

    Uterine artery occlusion by embolization or surgical methods may be offered to selected women with symptomatic uterine fibroids who wish to preserve their uterus. Women choosing uterine artery occlusion for the treatment of fibroids should be counselled regarding possible risks, including the likelihood that fecundity and pregnancy may be impacted. (II-3A)

  • 10.

    In women who present with acute uterine bleeding associated with uterine fibroids, conservative management with estrogens, selective progesterone receptor modulators, antifibrinolytics, Foley catheter tamponade, and/or operative hysteroscopic intervention may be considered, but hysterectomy may become necessary in some cases. In centres where available, intervention by uterine artery embolization may be considered. (III-B)

Section snippets

Clinical Importance of Uterine Fibroids

The terms fibroid, myoma, and leiomyoma are synonymous and are the commonest gynaecological tumours, with a prevalence of 70% to 80% in women who have reached the age of 50.1 In 95 061 US nurses, aged 25 to 44 years, the incidence was 8.9/1000 for white women and 30.9/1000 for black women.2 The prevalence increases with age, peaking in women in their 40s. A hysterectomy study has found leiomyomas in 77% of uterine specimens.3

In many women, myomas may be asymptomatic and are diagnosed

MEDICAL MANAGEMENT

Until recently, medical management options for uterine leiomyomas have been of limited value because of their moderate efficacy and/or associated adverse effects. Novel therapies at the receptor and gene levels have emerged or are undergoing investigation and may eventually offer better long-term management options.58

Because estrogen upregulation of both ERs and PRs during the follicular phase is followed by progesterone-induced mitogenesis during the luteal phase, all hormonal therapies to

Hysterectomy

In women who have completed childbearing, hysterectomy is indicated as a permanent solution for symptomatic leiomyomas. The only indications for hysterectomy in a woman with completely asymptomatic fibroids are enlarging fibroids after menopause without HRT, which raises concerns of leiomyosarcoma, even though it remains very rare. 91., 92. Women with asymptomatic fibroids should be reassured that there is no evidence to substantiate concern about malignancy, and that hysterectomy is not

Uterine Artery Embolization

An SOGC clinical practice guideline on UAE has been published,178 and an up-to-date-review of UAE to treat uterine fibroids is included in the upcoming SOGC guideline.19 UAE is a procedure carried out by interventional radiologists and consists of injecting an occluding agent into one or both uterine arteries. First described in 1995, it has become one of the most common alternative conservative therapies offered to women with sympotomatic uterine fibroids. The procedure is minimally invasive

Acute Uterine Bleeding

Acute uterine bleeding unrelated to pregnancy has been defined as that which is sufficient in volume, in the opinion of the treating clinician, to require urgent or emergent intervention.190 Women with fibroids may present with acute intraperitoneal or vaginal hemorrhage, which can become life-threatening on rare occasions. Since acute uterine bleeding may or may not be associated with leiomyomas, the approach to investigation and treatment should be the same.45

Endometrial biopsy and

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    This clinical practice guideline has been prepared by the Uterine Leiomyomas Working Group, reviewed by the Clinical Practice Gynaecology, Reproductive Endocrinology & Infertility, and Family Physician Advisory Committees, and approved by the Executive and Board of the Society of Obstetricians and Gynaecologists of Canada.

    Disclosure statements have been received from all contributors.

    The literature searches and bibliographic support for this guideline were undertaken by Becky Skidmore, Medical Reserch Analyst, Society of Obstetricians and Gynaecologists of Canada.

    This document reflects emerging clinical and scientific advances on the date issued and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed. Local institutions can dictate amendments to these opinions. They should be well documented if modified at the local level. None of these contents may be reproduced in any form without prior written permission of the SOGC.

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