Fibroids (Leiomyomas) Guideline GL1095

Author: B Chohan Date: November 2019 Job Title: Consultant O&G Review Date: November 2021 Policy Lead: Group Director Urgent Care Version: V2.0 ratified 15/11/19 Location: Policy hub/Clinical/Gynaecology/GL1095 This document is valid only on date printed of 15

Fibroids (Leiomyomas) Guideline GL1095

Approval

Approval Group Job Title, Chair of Committee Date Gynaecology Clinical Governance

Chair, Gynaecology Clinical Governance

15th November 2019

Change History

Version Date Author, job title Reason 1

October 2017 Gbemisola David-West, Ayo Olumbori, Registrars O&G Dalia Sikafi O&G, Consultant

Benign Gynaecology Requirement

2.0 October 2019 B Chohan, O&G Consultant Reviewed, minor changes pg 8/9 re: degenerating fibroids


Fibroids (Leiomyomas) GL1095 November 2019

Contents 1. Purpose .......................................................................................................................... 3

2. Scope ............................................................................................................................. 3

3. Roles and Responsibilities ............................................................................................. 3

4. Definitions ....................................................................................................................... 3

5. Document content .......................................................................................................... 3

5.1. Introduction .................................................................................................................. 3

5.2. Diagnosis: .................................................................................................................... 4

6. Consultation Undertaken ................................................................................................ 9

7. Dissemination/Circulation/Archiving ............................................................................. 10

8. Implementation ............................................................................................................. 10

9. Training ........................................................................................................................ 10

10. Monitoring of Compliance .......................................................................................... 10

11. Supporting Documentation and References: ............................................................. 10

12. Equality Impact Assessment ........................................ Error! Bookmark not defined. Flow chart 1: Medical Management Guideline of fibroids. ................................................... 13

Flow chart 2: Surgical Management Guideline of fibroids. .................................................. 14

Table 1: Medical management ............................................................................................ 15



1.0 Purpose

1.1. To aid all clinical staff in the management of fibroids in accordance to NICE recommendations.

1.2. The aim of this guideline is to provide evidence based up to date information on the treatment of uterine fibroids

2.0 Scope

• Gynaecology Clinics

• Gynaecology Clinic Staff

3.0 Roles and Responsibilities

All medical staff who review patients with fibroids in the gynaecology clinic and on Sonning ward.

4.0 Definitions

Leiomyomas or uterine fibroids are common benign uterine smooth muscle tumours. Their growth is hormone dependant, affected by both oestrogen and progesterone.

5.0 Document content

5.1. Introduction

Uterine fibroids are the most common solid tumour of the female pelvis, occurring in up to 30% of women after 30 years of age with a higher incidence in women of Afro-Caribbean origin. The majority of fibroids are asymptomatic and will not require therapy. However, they may cause symptoms of menorrhagia, pressure, pain and reproductive problems.

Fibroids can be single or multiple and can vary in size, location, and perfusion. Fibroids can be classified based on their location: subserosal (projecting outside the uterus), intramural (within the myometrium), and submucosal (projecting into the cavity of the uterus) 2.

A newer, more detailed classification system has been devised and advocated by FIGO2



5.2. Diagnosis:

In many women, fibroids may be asymptomatic and are diagnosed incidentally on clinical examination or imaging. Fibroids can cause significant morbidity including menstrual abnormalities (e.g. heavy, irregular, and prolonged uterine bleeding), iron deficiency anaemia, bulk symptoms (e.g. pelvic pressure/pain, obstructive symptoms), and fertility issues3. Symptomatic fibroids have a considerable impact on women’s quality of life as well as their productivity.

5.3. Assessment:

5.3.1 History If fibroids are suspected, take a full medical and gynaecological history. This should include her cervical screening history, risk factors (including family history of fibroids), history of fertility problems and whether their family is complete.

Ask about symptoms such as heavy bleeding, pelvic pain, abdominal distension, pressure symptoms and urinary or bowel symptoms

5.3.2 Clinical assessment Conduct an abdominal and bimanual pelvic examination to assess for the presence of a mass.

On physical examination, an enlarged, mobile uterus (correlating to a weight of approximately 300 g or 12 weeks of pregnancy) with irregular contour is consistent with fibroids.

5.3.3 Investigations

FBC To assess for iron deficiency anaemia



Ultrasound Scan (trans-abdominal and trans-vaginal) Ultrasound is the most widely used modality because of its availability, ease of use, and cost-effectiveness. It is particularly helpful to assess fibroid growth and the adnexae if these cannot be palpated separately with confidence4.

MRI An MRI of the pelvis may provide further information regarding location and size of fibroids. It is a prerequisite before consideration of uterine artery embolisation. It is also recommended prior to performing a myomectomy procedure.

Any rapid growth in the size of the fibroids needs urgent investigation to exclude sarcomatous change. Abnormal uterine bleeding i.e. intermenstrual, heavy >45 years, postcoital or post menopausal bleeding necessitates further investigation to exclude pathology.

5.4. Management (Flow chart 1 and 2):

Management of fibroids depends mainly on patient’s symptoms. Appropriate treatment should be planned with the woman, based on symptoms, fertility wishes, age and fibroid characteristics – site, size and location.

5.5. Expectant management

Expectant management is acceptable in those who are asymptomatic. Consider annual follow up to monitor size and growth (NICE recommendation).

5.6. Medical Management for Symptomatic Patients: 5.6.1 Medical management (fibroid <3 cm)

If the fibroids are less than 3 cm and the uterine cavity is not distorted, consider treatments in the following order: (NICE recommendation)

Levonorgestrel-releasing intrauterine system (LNG-IUS) for at least 12 months LNG-IUS has been widely accepted as an effective treatment for heavy menstrual bleeding. Observational studies have shown a reduction in uterine volume, bleeding, and an increase in haematocrit5. Progesterone also induces endometrial atrophy. Another advantage is that it provides contraception.

A randomised controlled trial showed that the LNG-IUS was more effective than the COCP in reducing menstrual loss and improving haemoglobin levels6.

The LNG-IUS can be inserted by the GP/family planning clinic or booked into minor ops clinic at the RBH Hospital. Please ensure patients are given the information leaflet.



Tranexamic acid (antifibrinolytic agent) Approved for treatment of heavy menstrual bleeding.

Non-steroidal anti-inflammatory drugs (NSAIDs) NSAIDs are used to reduce menstrual blood loss and dysmenorrhoea. They are prostaglandin antagonists which prevent the uterus contracting, leading to pain.

Combined oral contraceptive pill (COCP) Approved for treatment of heavy menstrual bleeding. Mechanism of action is endometrial atrophy. Associated with decreased risk of fibroids and reduced symptoms from other gynaecological conditions.

Norethisterone/ Long-acting progesterone-only injectables This form of treatment is thought to induce endometrial atrophy thus licensing it for the treatment of heavy menustrual bleeding.

5.6.2 Medical Management (Fibroids > 3cm) If fibroids are 3cm or more in diameter and the women has heavy menstrual bleeding or medical treatment is required pre- operatively to reduce size and vascularity of the fibroids consider the following: (NICE recommendation)

Ulipristal acetate (Esmya) A selective progesterone receptor modulator. It works by blocking progesterone receptors which prevent the growth of fibroids. It also reduces menstrual bleeding and dysmenorrhoea. It is indicated for pre-operative or intermittent treatment of moderate to

severe symptoms of uterine fibroids in adult women of reproductive age. The treatment consists of one tablet of 5 mg to be taken orally once daily for 3 months (one course) followed by a 1 month break for the lining of the endometrium to shed. Treatments should only be initiated when menstruation has occurred. The first treatment course should start during the first week of menstruation. If a patient misses a dose, the patient should take ulipristal acetate as soon as possible. If the dose is missed by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. Treatment can be used indefinitely in women who have a good response.

Contraindications:

Pregnancy and breastfeeding.

Genital bleeding of unknown aetiology or for reasons other than uterine fibroids.

Uterine, cervical, ovarian or breast cancer.



Gonadotrophin-releasing hormone (GnRH) agonist (Zoladex) +/- add-back HRT limit use to 6 months GnRH agonists reduce hormonal stimulation of fibroids and can reduce fibroids to approximately 25-50% of their size within 3 months, but the fibroids can return to their former size within 3-6 months of stopping treatment. GnRH agonists also cause amenorrhoea, menopausal symptoms and bone loss.

NICE guidance recommends that GnRH agonists can be used pre-operatively for 3-4 months prior to a hysterectomy or myomectomy when fibroids are causing an enlarged or distorted uterus6. GnRH agonists are licensed for the reduction of uterine fibroids in women with heavy bleeding for up to 6 months.

Side effects of GnRH agonists can be minimised by giving add-back hormone replacement therapy with low dose oestrogen-progesterone such as tibolone.

5.7. Interventional radiology

Uterine Artery Embolisation (UAE) UAE can be offered as a treatment for symptomatic large (>3cm) or multiple fibroids. UAE is not a recommended treatment option for a degenerating fibroid. This procedure is performed by the interventional radiologists under local anaesthetic. This involves the occlusion of the uterine arteries with tiny microembolic particles which causes the fibroid to shrink. The resulting ischaemia is not permanent. NICE has reviewed the evidence and found that it is associated with a reduction in fibroid volume of 40-70%, however the re-intervention rate at two years is 14%.Improvement in symptoms were reported between 62-95% of women.

UAE is associated with a 3% rate of major complications which include septicaemia and hysterectomy.

5.7.1 Contraindications



Absolute: Any evidence of current or recent infection in the genital region

Asymptomatic fibroids

Pregnancy

Where a patient would refuse a hysterectomy under any circumstance for social or cultural reasons

Degenerating fibroid(s)

Relative: Pedunculated submucousal and subserosal fibroids

Desire to preserve fertility in women of child -bearing age

5.7.2 Pre-procedure review/counselling Review patient in GOPD and provide description of procedure including full

information on the advantages and disadvantages in verbal and written form.

Fertility and pregnancy desire of the patient must be determined and patient should be told of the uncertain effects of UAE on fertility and pregnancy.

Patient must be informed of the possible need of further treatment for recurrent symptoms; the younger the patient, the more likely this is.

MRI to further evaluate fibroid characteristics.

Arrange to remove IUCD, if present, prior to the procedure.

Stop GnRH analogues once patient is referred (NICE recommendation).

For referral dictate a letter to Dr Archie Speirs, consultant interventional radiologist.

An individual funding request form must be filled and sent to the Commissioning Support Unit.

5.8. Surgical management Surgery is indicated if medical therapies are unsuitable or have failed. The type of surgery depends on the site and size of the fibroid(s).

5.8.1 Endometrial ablation This procedure involves the destruction of the endometrial lining for the relief of heavy menstrual bleeding. It is performed in this trust under a general anaesthetic. Fibroids with a diameter less than 3cm are not a contraindication. A study showed that the combination of a hysteroscopic fibroid resection plus endometrial ablation provided 90% percent of women with reduced menstrual loss at one year7. Up to 30 percent need further treatment at two years8.



Women must be advised to avoid subsequent pregnancy and to use effective contraception following the procedure.

5.8.2 Transcervical resection of fibroids Minimally invasive approaches of surgically treating submucosal fibroids have evolved and TCRF can be employed to treat symptomatic fibroids. The most common indications for this procedure are abnormal uterine bleeding, recurrent pregnancy loss and infertility.

In general, submucosal fibroids (types 0,I and II) up to 4-5 cm in diameter can be removed hysteroscopically by experienced surgeons. Type II myomas are more likely to require a 2 staged procedure than types 0 and I because of the risk of excessive fluid absorption and uterine perforation9.

Consent and counseling for the procedure should be undertaken by a doctor conversant with the risks and benefits.

5.8.3 Myomectomy This procedure is an option for women who wish to preserve their uterus or retain their fertility. It can be performed by the laparoscopic route or by open surgery for intramural and subserosal fibroids. Myomectomy reduces the need for further treatment as compared with UAE10.

Women undergoing surgery need to sign a consent form acknowledging the risk of a haemorrhage leading to a hysterectomy (rare). Those who undergo laparoscopic morcellation of the fibroids need to be aware of the dissemination of cancer if fibroids have undergone sarcomatous change9.

5.8.4 Hysterectomy This is a definitive treatment for women who have completed their families and in whom other therapeutic modalities have failed. This procedure can be performed by abdominal, laparoscopic or vaginal route.

Prior approval needs to be obtained from the Commissioning Support Unit. Women should be informed of the risk of serious complications (such as intraoperative haemorrhage or damage to other abdominal organs).

6.0 Consultation Undertaken

Gynaecology Clinical Governance Committee – This includes: a patient representative, Gynaecology Operations Managers, Gynaecology consultants, Junior and middle grade medical staff.

A copy of the protocol was circulated to all stakeholders for amendments prior to a scheduled clinical governance meeting.



7.0 Dissemination/Circulation/Archiving

A hard copy will be kept in the Emergency Gynaecology clinic and on Sonning Ward.

A hard copy will be given to all junior medical staff at induction.

Copy will be e-mailed all medical staff.

Protocol will be available on the Trust intranet (Gynaecology section) and external website.

The Maternity & Gynae Information Officer will be responsible for archiving old versions of this document.

8.0 Implementation

Medical and nursing staff will be reminded of protocol by the Gynaecology Sister and Gynaecology consultants.

9.0 Training

There is no mandatory training associated with this procedure. If staff have queries about its operation, they should contact their line manager in the first instance.

10.0 Monitoring of Compliance Aspect of compliance or effectiveness being monitored

Monitoring method

Individual or dept. responsible for the monitoring

Frequency of the monitoring activity

Group/committee which will receive the findings/ monitoring report

Committee/ individual responsible for ensuring that the actions are completed

Ensuring protocol for management of fibroids being followed by all staff.

Oversight of Juniors & Complaint

reviews

Gynaecology Monthly Gynaecology MDT/Governance

D Sikafi/ A Swanton

The Trust reserves the right to amend its monitoring requirements in order to meet the changing needs of the organisation.

11.0 Supporting Documentation and References: 1. Bulun SE. Uterine fibroids. N Engl J Med 2013; 369:1344–55. 2. Munro MG, Critchley HO, Broder MS, Fraser IS. The FIGO Classification System

(“PALM-COEIN”) for causes of abnormal uterine bleeding in non-gravid women in the reproductive years, including guidelines for clinical investigation. Int J Gynaecol Obstet 2011;113:3–13.

3. Zimmermann A, Bernuit D, Gerlinger C, Schaefers M, Geppert K. Prevalence,



symptoms and management of uterine fibroids: an international internet-based survey of 21,746 women. BMC Womens Health 2012;12:6 (26 March 2012). Available at: http://www.biomedcentral.com/1472-6874/12/6. Accessed on November 10, 2014.

4. Maruo T, Ohara N, Yoshida S, Nakabayashi K, Sasaki H, Xu Q, et al. Translational research with progesterone receptor modulator motivated by the use of levonorgestrel-releasing intrauterine system. Contraception 2010;82:435–41.

5. Englund K, Blanck A, Gustavsson I, Lundkvist U, Sjöblom P, Norgren A, et al. Sex steroid receptors in human myometrium and fibroids: changes during the menstrual cycle and gonadotropin-releasing hormone treatment. J Clin Endocrinol Metab 1998 11;83:4092–6.

6. Sayed GH, Zakherah MS, El-Nashar SA, Shaaban MM. A randomized clinical trial of levonorgestel-releasing intrauterine system and low dose combined oral contraceptive for fibroid-related menorhhagia. Int J Gynaecol Obstet 2011; 112;126-30

7. Sabbah R, Desaulniers G. use of novasure impedence controlled endometrial ablation system in patients with intracavitary disease: 12 month follow-up results of a prospective, single-arm clinical study. J Minim invasive Gynecol 2006;13:467-71

8. Fergusson RJ, et al. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013; issue 11:CD000329.

9. Vilos GA, et al. The management of Uterine Leiomyomas. J Obstet Gynaecol Can 2015:37(2):157-178

10. Manyonda I, et al. Uterine artery embolization versus myomectomy: impact on quality of life – results of the FUME (Fibroids of the Uterus: Myomectomy versus Embolization) Trial. Cardiovasc Intervent Radiol 2012;35(3):530–6.

11. Heavy Menstrual Bleeding; assessment and management. NICE guideline CG44 12. Cantuaria GH, Anglioli R, Frost L, Duncan R, Penalver MA. Comparison of bimanual

examination with ultrasound before hysterectomy for uterine leiomyoma. Obstet Gynecol 1998;92:109–12

13. Lumsden MA, Wallace EM. Clinical presentation of uterine fibroids. Baillieres Clin Obstet Gynaecol 1998;12:177–95.

14. Schwartz LB, Diamond MP, Schwartz PE. Leiomyosarcomas: clinical presentation. Am J Obstet Gynecol 1993;168(1 Pt 1):180–3.

15. Vercellini P, Crosignani PG, Mangioni C, Imparato E, Ferrari A, De Giorgi O. Treatment with a gonadotrophin releasing hormone agonist before hysterectomy for leiomyomas: results of a multicentre, randomized controlled trial. Br J Obstet Gynaecol 1998;105:1148–54.

16. NICE CKS Fibroids management. https://cks.nice.org.uk/fibroids#!scenario 17. Clinical recommendation on the use of uterine artery embolization (UAE) in the

management of fibroids 3rd edition; RCOG and RCR

http://www.biomedcentral.com/1472-6874/12/6

https://cks.nice.org.uk/fibroids#!scenario



Flow chart 1: Medical Management Guideline of fibroids.

Bimanual examination / FBC / Ultrasound

Asymptomatic

Expectant management

Abnormal uterine bleeding (AUB)

(Fibroid <3cm)

Abnormal uterine bleeding (AUB) +/- pressure symptoms

(Fibroid ≥3cm)

• Levonorgestrel-releasing intrauterine system (LNG-IUS)

• Tranexamic acid / NSAIDs / COCP

• Norethisterone - 15mg daily from day 5-26 of menstrual cycle

• Long-acting progesterone-only injectables

• Tranexamic acid / NSAIDs / COCP

• Norethisterone - 15mg daily from day 5-26 of menstrual cycle

• Long-acting progesterone-only injectables

• Ulipristal acetate (Esmya) - 5mg daily (initially up 4 courses – can be used indefinitely if good response

• Gonadotrophin-releasing hormone (GnRH) agonist (Zoladex) +/- add-back HRT – limit use to 6 months



Flow chart 2: Surgical Management Guideline of fibroids.

Bimanual examination / FBC / Ultrasound

Preserving fertility Family complete

• Submucosal – transcervical resection of fibroid (TCRF)

• Subserosal/intramural – myomectomy

• Endometrial ablation – for HMB and

submucosal fibroids < 3cm

• Submucosal – transcervical resection of fibroid (TCRF)

• Subserosal/intramural – myomectomy

• Uterine artery embolization (UAE) – must perform MRI and refer to Dr A Speirs (Radiologist)

• Hysterectomy (vaginal, abdominal or laparoscopic) +/- preservation of cervix/tubes/ovaries



Table 1: Medical management Treatment Indication Dosage Route Notes Levonorgestrel-releasing intrauterine system (LNG-IUS)

Heavy menstrual bleeding

Single device inserted following menses for at least 12 months.

Intrauterine May be difficult to site if submucosal fibroids present. Irregular bleeding for up to 6 months. 37% amenorrhoeic by one year.

Tranexamic acid Heavy menstrual bleeding

1 gram three times daily until cessation of period.

Oral Non-hormonal

GI side effects

May be taken alongside NSAIDs

Non-steroidal anti-inflammatory (NSAIDs) – Mefanamic acid

Painful and heavy menstrual bleeding

250-500mg three times daily as required

Oral Non-hormonal

Upper GI side effect

Worsening of asthma

Combined oral contraceptive pill (COCP)


One tablet to be taken for 21 days in a 28 day cycle

Oral Well tolerated

UKMEC regarding contraindications of use.

Oral progesterone

Norethisterone


5mg three times daily from day 5-26 of menstrual cycle

Oral Weight gain and bloating side effects.

Long-acting progesterone-only injectables

Depo-provera/ Noristerat


Single im injection every 8-12 weeks depending on type

Intramuscular May take up to one year for fertility to return to normal.

Ulipristal acetate (Esmya)

Heavy menstrual bleeding and fibroid size reduction.

5mg daily for 3 months (one course) with a 1 month break for withdrawal bleed.

Oral Initially to be used for up to four courses. Can be used indefinitely if good response.

Gonadotrophin-releasing hormone analogue (GnRH) – Zoladex (Goserelin)

Heavy menstrual bleeding and fibroid size reduction.

Single sc depot injection every 28 days

Subcutaneous Limit use up to 6 months.

Prescribe add-back therapy for menopausal symptoms.

Fibroids (Leiomyomas) Guideline GL1095

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