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The assessment and management of uterine fibroids in primary care

This guideline was developed by a multidisciplinary expert panel: Gray S et al with the support of a grant from Gedeon Richter (UK) Ltd. See bottom of page for full disclaimer.

Primary care pathway

  • See below for treatment algorithm

Presentation

  • Patients may present with:
    • heavy menstrual bleeding (HMB) (read code K59-2012):
      • defined as excessive menstrual blood loss that interferes with a woman's physical, social, emotional, and/or material quality of life
      • this can occur alone or in combination with other symptoms
    • pain
    • pressure effects:
      • pelvic pressure (sensation of something pressing down)
      • dyspareunia
      • bowel symptoms (e.g. bloating, constipation due to pressure on the bowel)
      • urinary symptoms (e.g. urinary retention)
  • Many asymptomatic fibroids are identified incidentally during investigations for other problems

Differential diagnosis

  • Keep an open mind about the cause of the problem if the examination or ultrasound findings do not correlate with the symptoms or severity
  • Fibroids are not the only cause of pelvic symptoms

Figure 1: Primary care pathway for uterine fibroids

Primary care pathway for uterine fibroids

Risk assessment

  • The assessment process should evaluate the potential risk of significant disease and trigger appropriate early referral. Low risk patients can be further evaluated and managed within primary care:
    • strong risk of gynaecological pathology—refer any of these:
      • intermenstrual bleeding, which is not cyclical
      • postcoital bleeding
      • postmenopausal bleeding
    • moderate risk factors for endometrial hyperplasia—consider number and strength of factors and refer if cumulative:
      • age >45 years with HMB
      • obesity
      • polycystic ovarian syndrome with few periods
      • diabetes
      • family history of ovarian/breast cancer with the presence of high-risk (e.g. BRCA) genes
      • tamoxifen use
      • nulliparity
    • alerts, which may alter management:
      • vaginal discharge
      • multiple sexual partners
      • not attending for cervical screening
      • recent uterine intervention/event, including termination and miscarriage
      • contraceptive method as this may explain the bleeding pattern (see CEU guidance)
      • anticoagulants (e.g. warfarin), which can increase bleeding

History

  • Explore presenting complaint, associated symptoms, and medical, family, and social history
  • Most women with fibroids present with pain/heavy bleeding during their menstrual cycle; the following five questions can help to assess the problem:
    • tell me about your periods
    • are your periods painful?
    • do you bleed between periods or after having sex?
    • do you have pain during or after having sex?
    • have you noticed any changes to your bladder and bowel?

Examination

  • Abdominal, bimanual, and speculum examination in primary care can help expedite diagnosis and treatment, and reduce the need for unnecessary investigation and referral

Initial investigations in primary care

  • A full blood count should be ordered in all women presenting with or identified as having HMB—iron deficiency should be treated in all women
  • Consider ordering tests for clotting disorders in women who have lifelong bleeding problems
  • Hormone (follicle-stimulating hormone, luteinising hormone, prolactin, and oestradiol) and thyroid tests are not needed unless there are other indications
  • Tests should be ordered to exclude sexually transmitted infections
  • Cervical cytology should be arranged if the woman's cervical screening is not up to date

Tentative diagnosis and early referral

  • Manage the patient in line with NICE CG44 if examination and relevant initial investigations are normal, the bleeding does not have any abnormal pattern, and the woman has no other risk factors
  • Early referral through the 2-week wait guideline should be made for:
    • postmenopausal women
    • women with persistent irregular and heavy menstrual bleeding
    • women with a palpable pelvic mass
    • women in whom cervical cancer is suspected
    • women with significant risk factors for other pathology (see Differential diagnosis)

Direct-access investigations

  • Arrange imaging to detect structural anomalies in women with symptoms of pelvic pressure, a bulky uterus, or a pelvic mass. A combination of transabdominal and transvaginal ultrasound (TVUS) is often performed:
    • magnetic resonance imaging is not recommended as first-line imaging
  • If the sonographer returns a purely technical report without guidance on clinical significance and recommendations for next steps, contact them to seek further guidance
  • Women with endometrial anomalies or suspicious findings on ultrasound should be referred for further endometrial assessment (e.g. endometrial biopsy [not dilatation and curettage]), hysteroscopy, and/or saline infusion sonography)
  • Women whose endometrial biopsy shows hyperplasia or atypia should be referred

Management

  • If HMB is identified as a component of the presentation, interim mitigating management should be offered while the condition is further evaluated. Either, or both, a non‑steroidal anti-inflammatory drug (NSAID) or tranexamic acid can be offered
  • If, after evaluation, medical management is appropriate the options available should be discussed with the patient. She should be offered a review and the option to change treatment at 3 months. Listed below are some points provided by the working party group to assist clinical decision making. For more information refer to Table 1 (below), the British National Formulary, and the individual Summary of Product Characteristics
  • Non-hormonal interim management and treatment options:
    • NSAID:
      • moderate effect on bleeding—may be enough
      • will help pain and is often useful in young women soon after menarche
      • can be used if trying to conceive as started at onset of bleeding
    • tranexamic acid:
      • moderate effect on bleeding—may be enough
      • does not help pain but may be useful in anovulatory bleeding close to menopause
      • can be used if trying to conceive as started at onset of bleeding
  • Hormonal treatment options:
    • levonorgestrel 20 mcg IUS:
      • highly effective at reducing blood loss and usually pain associated with bleeding
      • change is progressive over about 6 months
      • can be offered to women of all ages, regardless of parity
      • minimal systemic progestogenic side-effects
    • combined hormonal contraception (only Qlaira® [estradiol/dienogest] is licensed for HMB):
      • moderately to highly effective (this may vary with the regimen used) at reducing blood loss and usually pain associated with bleeding
      • will provide cycle control and predictability of bleeding
      • cardiovascular risk profile should be evaluated and additional risks associated with use of oestrogen considered
    • high-dose cyclical progestogen for 3 weeks:
      • moderately effective at reducing blood loss and usually pain associated with bleeding
      • will provide cycle control and predictability of bleeding
      • limited by progestogenic side-effects so not suitable for long-term use but may be useful in anovulatory bleeding close to menopause
      • cardiovascular risk profile should be evaluated and additional risks associated with use considered
      • luteal phase use is ineffective and should not be offered
    • high-dose injectable progestogen (recommended by NICE CG44, but not licensed):
      • highly effective at reducing blood loss and usually pain associated with bleeding
      • will ablate cycle and residual bleeding may be unpredictable
      • may be limited by progestogenic side-effects
      • potential effect on bone metabolism should be considered
    • ulipristal acetate (selective progesterone receptor modulator):
      • treatment option where fibroids identified (local formulary may state GP or specialist initiated)
      • 3-month course, which may be repeated once rapidly and highly effective at reducing blood loss and pain associated with fibroids
      • highly effective in reducing volume of fibroids and pressure effect
      • few associated menopausal symptoms
    • gonadotrophin-releasing hormone agonist:
      • treatment option where fibroids identified (specialist initiated)
      • usually use limited to 6 months due to effects on bone metabolism—add back hormone replacement therapy may be considered
      • progressively effective over about 3 months at reducing blood loss and pain associated with fibroids
      • progressively effective in reducing volume of fibroids and pressure symptoms
      • significant associated menopausal symptoms
Table 1: Features of drugs available to primary care for the treatment of fibroids
TreatmentEffect on bleedingSpecial consideration
NSAID
  • Reduction shown in HMB
  • Gastric irritation
  • Patients with asthma
  • Start at onset of bleeding
  • Mefenamic acid is the only NSAID with a licence for HMB but other NSAIDs may have a class effect
Tranexamic acid
  • Reduction shown in HMB
  • Maximum daily dose of 4 g best given as 1 g four times daily
  • Start at onset of bleeding and use for up to 4 days
  • Available over the counter
  • Thromboembolic events are rare
LNG-IUS
  • Significant reduction but may take 6 months
  • Not contraindicated in nulliparous women
  • Clinicians who fit intrauterine devices should be
    appropriately trained and attend regular updates to maintain their competence
  • Progestogenic side-effects tend to be minimal and
    usually settle after 6 months
CHC
  • Reduction shown in HMB
  • Helped by extended use (tricycling or continuous)
  • Commonly used in clinical practice, although oestradiol valerate/dienogest combination is only product licensed in women with HMB, with evidence of 88% reduction in menstrual blood loss
  • Assess risk of ATE and VTE
  • Refer to UK Medical Eligibility Criteria
High-dose oral progestogen
  • Reduction shown in HMB if used on days 5–26 of each cycle (15 mg norethisterone or 20–30 mg/day medroxyprogesterone acetate
  • Progestogenic side-effects significant and limit long-term continuation
  • May be helpful at menopause
  • Avoid norethisterone if BMI >30 kg/m2 due to risk of VTE
  • Use in luteal phase only (i.e. day 19–26) is not effective
High-dose injected progestogen
  • Reduction, with high incidence of amenorrhoea with continuous use
  • Variable weight gain
  • Caution in women with high risk of osteoporosis or cardiovascular disease due to hypooestrogenic effects
Ulipristal acetate (5 mg)
  • Rapid reduction in bleeding, with many achieving amenorrhoea within 7–10 days
  • Licensed for women with fibroids suitable for surgery to relieve symptoms
  • 3-month course can be repeated once; second 3-month course is licensed
  • Benefit on fibroid volume when stopping may persist for 3–6 months
GnRH analogues
  • Gradual reduction up to 30 days to achieve amenorrhoea
  • Specialist initiated; for shared care, see local guidelines
  • Menopausal symptoms usual
  • Consider add-back HRT (continuous combined or tibolone) if young (<45 years), high osteoporotic risk, or intractable menopausal symptoms develop
  • Limited use because of osteoporosis risk
NSAID=non-steroidal anti-inflammatory drug; HMB=heavy menstrual bleeding; LNG-IUS=levonorgestrel intrauterine system; CHC=combined hormonal contraception; ATE=arterial thromboembolism; VTE=venous thromboembolism; BMI=body mass index; GnRH=gonadotrophin-releasing hormone; HRT=hormone replacement therapy.

Review

  • Review with the patient after 3 months to determine whether treatment has led to a satisfactory improvement in symptoms (as judged by the woman). This will allow change to or addition of a further medical option
  • If the decision is to refer to secondary care, discuss specialist management options in outline prior to referral so that the woman can express a preference and be referred appropriately

Working with secondary care

  • Ahead of referral, as a minimum, primary care should examine the patient, initiate medical treatment, and request an ultrasound scan
  • If secondary care request primary care to undertake follow-on prescribing ensure that the patient has been appropriately counselled by them and that you have sufficient understanding of the treatment to take prescribing responsibility. The dose and frequency should be specified, especially if the drug is being used off-licence. Contact the initiator to clarify if these are not explicit
about this working party guideline…
sponsor—

This guideline has been developed by MGP Ltd, the publishers of Guidelines, and the Working Party was convened by them. Gedeon Richter (UK) Ltd was able to recommend experts for the working party group and comment on the scope and title, with final decisions resting with the Chair. Gedeon Richter (UK) Ltd had the opportunity to comment on the technical accuracy of this guideline but the content is independent of and not influenced by Gedeon Richter (UK) Ltd

working party members—

Sarah Gray (Chair, GP specialist women's health) Anne Connolly (GPwSI gynaecology, Clinical speciality lead for maternity, women's, and sexual health), Richard Ma (GP partner), Erika Manzo (Consultant obstetrician and gynaecologist) and Diane Webb (Ultrasound advanced practitioner)

further information—
call MGP Ltd (01442 876100)