Abnormal uterine bleeding:

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1 Primary Care Women s Health Forum 16th June 2010 Abnormal uterine bleeding: The University Of Birmingham T Justin Clark MD (Hons), MRCOG Consultant Obstetrician and Gynaecologist Birmingham Women s Hospital United Kingdom

2 Overview Modern management of abnormal uterine bleeding ( AUB ) Medical Management Hysteroscopic surgery and fibroid management

3 Primary Care Women s Health Forum 16th June 2010 Modern management of AUB The University Of Birmingham T Justin Clark MD (Hons), MRCOG Consultant Obstetrician and Gynaecologist Birmingham Women s Hospital United Kingdom

4 What is modern management? Key features: Efficient, structured and office based Patient-care pathways Interface between primary and secondary care Diagnosis ultrasound Treatment Woman-centred; choice; minimally invasive

5 Outpatient or office procedure: Definition Outpatient procedures are performed in an appropriate clinic setting, but without the need for formal operating theatre facilities or general anaesthesia. These clinics are usually within a hospital outpatient department (an outpatient hysteroscopy clinic ), but specific minor operative rooms, other multi-purpose facilities or primary care centres. True outpatient procedures will be discharged unaccompanied within the allocated clinic time and do not require a formal recovery period in a hospital bed.

6 Primary care setting? Hospital based (secondary care) Inpatient Day case Day case Office This new paradigm has been driven by health technologies and enthusiasts Primary care: Office Primary care (Office High street) These concepts can be driven by infrastructure, government and enthusiasts

7 Pelvic ultrasound

8 Miniaturisation of endoscopes COPYRIGHT PRIMARY CARE WOMEN S HEALTH FORUM Justin Clark REPRODUCTION/DISTRIBUTION MD (Hons) MRCOG, Birmingham Women s PROHIBITED Hospital

9 Mirena (LNG-IUS)

10 Endometrial ablation Various devices Two that I use in both the inpatient and outpatient setting Justin Clark MD (Hons) MRCOG Birmingham Women s Hospital

11 Enthusiasts...

13 Primary care setting? Hospital based (secondary care) Inpatient Day case Day case Office This new paradigm has been driven by health technologies and enthusiasts Primary care: Office Primary care (Office High street) These concepts can be driven by infrastructure, government and enthusiasts

14 Change of outpatient treatment setting: Secondary to primary care???

15 Change in philosophy NHS Operational strategy Diagnosis & Treatment Centres

16 High Street Gynaecology??

17 Responding to DoH- Care Closer to home The Our health, our care, our say White Paper sets out a vision to provide people with good quality social care and NHS services in the communities where they live. NHS services are half way through a 10 year plan to become more responsive to patient needs....and prevent ill health by the promotion of healthy lifestyles. Give service users more independence, choice and control.

Responding to DoH- Care Closer to home http://www.dh.gov.

18 Responding to DoH- Care Closer to home The Our health, our care, our say White Paper sets out a vision to provide people with good quality social care and NHS services in the communities where they live. NHS services are half way through a 10 year plan to become more responsive to patient needs....and prevent ill health by the promotion of healthy lifestyles. Give service users more independence, choice and control.

19 Responding to DoH- the Darzi review of the NHS To set us on the path to the next stage of the transformation of the NHS, the Prime Minister and I have asked Professor Sir Ara Darzi one of the world s leading surgeons - to carry out a wide-ranging review of the NHS. This is a once in a generation opportunity to ensure that a properly resourced NHS is clinically led, patient-centred and locally accountable.

20 What is modern management? Key features: Efficient, structured and office based Patient-care pathways Interface between primary and secondary care Diagnosis ultrasound Treatment Woman-centred; choice; minimally invasive

21 Uniformly optimsing care Clear, evidence-based pathways Standardised referral criteria Requires: Audit compliance and patient outcomes Specialists within primary care GPSIs / PCWHF Nurse practitioners Lead clinician in secondary care

22 What is modern management? Key features: Efficient, structured and office based Patient-care pathways Interface between primary and secondary care Diagnosis ultrasound Treatment Woman-centred; choice; minimally invasive

23 Conclusions Office-based diagnosis and treatment Standardised, evidence based care pathways between primary & secondary care Utilisation of latest medical and surgical health technologies where evidence supports

24 Primary Care Women s Health Forum 16th June 2010 Medical management of AUB The University Of Birmingham T Justin Clark MD (Hons), MRCOG Consultant Obstetrician and Gynaecologist Birmingham Women s Hospital United Kingdom

25 Up to date guidance Justin Clark MD (Hons) MRCOG

26 Investigations

28 Pelvic ultrasound

29 What investigations should I arrange in primary care? Abnormal Uterine Bleeding Menorrhagia FBC (Pelvic USS DEPENDS UPON EXAMINATION FINDINGS) IMB (Pelvic USS DEPENDS UPON EXAMINATION FINDINGS) (Genital tract swabs) PMB/HRT bleed Pelvic USS

30 Medical Management

31 Incidence and prevalence of menorrhagia Affects approximately 880,000 women in England Annual rate of women with heavy menstrual bleeding presenting to services 6.00% 5.40% Rate of presentation 5.00% 4.00% 3.00% 2.00% 1.00% 0.67% 2.58% 1.94% 1.73% 2.10% 2.96% 4.47% 4.64% 0.00% 12 to to to to to to to to to 51 Age range

32 Likely causes of heavy menstrual bleeding Common Less common Rare Dysfunctional Uterine Bleeding Gynaecological disease Gynaecological cancer Ovular Endometriosis Uterus Anovular (endometrial Adenomyosis Ovary (theca and granulosa cell tumours) hyperplasia) Diffuse myometrial hypertrophy Pelvic inflammatory disease Intrauterine polyps Fibroids Pregnancy related Endocrine Submucous Retained products of conception Thyroid dysfunction Intramural Iatrogenic Haematological Intrauterine contraceptive devices von Willebrand s disease Exogenous sex hormones Idiopathic thrombocytopenia Anticoagulants

Common presentations: HEAVY REGULAR PERIODS Likely diagnosis = dysfunctional uterine bleeding Treatment First-line Non-hormonal TXA, MFA, (Iron) Hormonal COC Mirena Second-line

33 Common presentations: HEAVY REGULAR PERIODS Likely diagnosis = dysfunctional uterine bleeding Treatment First-line Non-hormonal TXA, MFA, (Iron) Hormonal COC Mirena Second-line Endometrial Ablation Hysterectomy Take home message = Regular menstruation is not associated with significant pathology but treatment is indicated on the impact symptoms have on HRQL

34 Common presentations: HEAVY REGULAR PERIODS + FIBROIDS In the presence of fibroids pharmacological treatments more likely to fail earlier referral to secondary care for... Myomectomy Hysteroscopic Open Radiological Uterine Artery Embolisation Hysterectomy Laparoscopic / Vaginal Open Take home message = Fibroids are common; symptoms more resistant to standard pharmacological treatments and endometrial ablation

Common presentations: HEAVY IRREGULAR PERIODS Likely diagnosis Dysfunctional uterine bleeding Anovulation Endometrial hyperplasia Treatment First-line Hormonal COC Mirena Cyclical systemic progestins

35 Common presentations: HEAVY IRREGULAR PERIODS Likely diagnosis Dysfunctional uterine bleeding Anovulation Endometrial hyperplasia Treatment First-line Hormonal COC Mirena Cyclical systemic progestins Second-line Endometrial Ablation Hysterectomy Take home message = Erratic menstruation requires hormonal or surgical management; further endometrial assessment (biopsy +/- hysteroscopy) is required if >45 years or obese

36 Common presentations: HEAVY PERIODS IN TEENAGERS / YOUNG Likely diagnosis Dysfunctional uterine bleeding Anovulation BUT CONSIDER HAEMATOLOGICAL PROBLEM Von Willebrand s disease Platelet disorder Treatment First-line Hormonal COC +/- TXA/MFA (Mirena) (Cyclical systemic progestins) Second-line Haematologist / Desmopressin (Octim nasal spray) Endometrial Ablation Hysterectomy Take home message = Consider clotting disorders in young women (bleeding history) COPYRIGHT PRIMARY CARE WOMEN S HEALTH FORUM REPRODUCTION/DISTRIBUTION Justin Clark MD (Hons) MRCOG, Birmingham PROHIBITED Women s Hospital

37 Heavy Menstrual Bleeding: When is referral to secondary care warranted? Symptoms refractory to medical treatment Abnormal clinical examination Abnormal cervix Significant tenderness Pelvic mass not thought to be fibroids Significant fibroid uterus (palpable abdominally) Lower threshold for referral if: Risk factors for endometrial hyperplasia Irregular periods, obesity, family history, >40 years Substantial impact on health related quality of life Associated iron deficiency anaemia

Progestogen insufficiency Endometrial polyp Cervix Cervical cancer rare (especially in women with normal smear history) Cervical

38 Common presentations: INTERMENSTRUAL BLEEDING Likely diagnosis Endometrium Physiological (hormonal) Dysfunctional uterine bleeding Endometrial instability -? Progestogen insufficiency Endometrial polyp Cervix Cervical cancer rare (especially in women with normal smear history) Cervical polyp Lower genital tract infection Treatment Reassurance COC (Antibiotics) (Cervical cautery) Take home message = Examine cervix, check smear history, consider triple swabs & arrange a pelvic USS; Distinguish from irregular periods

39 Intermenstrual Bleeding: When is referral to secondary care warranted? Normal examination Persistent symptoms (Anxiety) Abnormal clinical examination Abnormal cervix Significant tenderness Pelvic mass not thought to be fibroids

Common presentations: POSTMENOPAUSAL BLEEDING Likely diagnosis 5-15% = Endometrial cancer / pre-cancer (atypical endometrial hyperplasia) 85-95%= Benign pathology Atrophic changes to lower genital

40 Common presentations: POSTMENOPAUSAL BLEEDING Likely diagnosis 5-15% = Endometrial cancer / pre-cancer (atypical endometrial hyperplasia) 85-95%= Benign pathology Atrophic changes to lower genital tract Endometrial polyps Investigation Pelvic examination Pelvic ultrasound (endometrial thickness) Outpatient endometrial biopsy +/- outpatient hysteroscopy Management Reassurance (50% +) Benign pathology Outpatient hysteroscopy clinic hysteroscopic polypectomy / myomectomy) Local / systemic oestrogen Malignant pathology Oncology (hysterectomy/radiotherapy/chemotherapy) Take home message = Arrange urgent referral via PMB pathway for rapid pelvic ultrasound

41 Post-menopausal Bleeding: When is referral to secondary care warranted? Mandatory urgent referral

42 Common presentations: HRT RELATED BLEEDING Likely diagnosis Absorption compliance / malabsorption Cervical/Endometrial/Ovarian pathology Common Endogenous ovarian activity (i.e perimenopause ) Endometrial pathology - Hyperplasia, Polyps, Unstable atrophic endometrium Investigation Pelvic examination Pelvic ultrasound (endometrial thickness) Outpatient endometrial biopsy +/- outpatient hysteroscopy Management Pathology Polypectomy; systemic / local progestins (Mirena TM for hyperplasia) No pathology Review need for HRT Change HRT preparation: Sequential sequential; Sequential continuous combined ( no bleed ) or vice-versa; ERT +Mirena Take home message = Exclude gynaecological pathology (pelvic exam + arrange pelvic ultrasound) and review need for and type of HRT

43 HRT Bleeding: When is referral to secondary care warranted? Persistent symptoms Definition? Abnormal clinical examination Abnormal cervix Significant tenderness Pelvic mass Abnormal ultrasound scan Endometrial thickness >4mm Lower threshold for referral if: Risk factors for endometrial hyperplasia / cancer Obesity Family history Substantial impact on health related quality of life COPYRIGHT PRIMARY CARE WOMEN S HEALTH FORUM REPRODUCTION/DISTRIBUTION Justin Clark MD (Hons) MRCOG, Birmingham PROHIBITED Women s Hospital

44 Further Information Diagnosis and Management of common gynae conditions PMB HRT & menopause Menorrhagia Outpatient hysteroscopic surgery - polyps, fibroids Mirena Essure sterilisation Outpatient endometrial ablation

45 Conclusions NICE guidance for HMB Tranexamic acid, mefanamic acid, COC and MIRENA PMB pathways based upon USS and locally organised Uniformity of approach needed Audit of referral rates, treatments, hysterectomy rates, outcomes, patient satisfaction

46 Future developments: Abnormal uterine bleeding, fibroids, chronic pelvic pain & endometriosis

47 Future developments: Abnormal uterine bleeding, fibroids, chronic pelvic pain & endometriosis

48 Future developments: Abnormal uterine bleeding, fibroids, chronic pelvic pain & endometriosis

49 Primary Care Women s Health Forum 16th June 2010 Hysteroscopic surgery and fibroid mangement The University Of Birmingham T Justin Clark MD (Hons), MRCOG Consultant Obstetrician and Gynaecologist Birmingham Women s Hospital United Kingdom

50 Routine hysterectomy?

51 Examples: Old vs. New Approaches Uterine polyp INPATIENT OFFICE Abnormal Uterine bleeding Abnormal Uterine bleeding Hysteroscopy / D&C under GA Pelvic Ultrasound Outpatient hysteroscopic polypectomy

52 Examples: Old vs. New Approaches Submucous fibroid INPATIENT Abnormal Uterine bleeding OFFICE Abnormal Uterine bleeding Hysteroscopy / D&C under GA Pelvic Ultrasound Reschedule for hysteroscopic resection under GA OR Hysterectomy Outpatient hysteroscopic resection of fibroid OR scheduling for GA procedure (hysteroscopic resection OR hysterectomy)

53 Fibroids: Management Medical TXA, MFA, progestogens, GnRH-a Mirena TM Surgical Endometrial ablation Sound length<12cm Regular cavity (no distorting SMFs) Myomectomy Hysteroscopic (+/- Mirena TM or endometrial ablation) Laparoscopic Open Hysterectomy Radiological Uterine Artery Embolisation Other (under evaulation) MRI cryoablation; myolysis; USS guided injection; uterine arterial mechanical occlusion)

Fibroids: Management Medical TXA, MFA, progestogens, GnRH-a Mirena TM Surgical Endometrial ablation Sound length<12cm Regular cavity (no distorting SMFs) Myomectomy Hysteroscopic (+/- Mirena TM or

54 Fibroids: Management Medical TXA, MFA, progestogens, GnRH-a Mirena TM Surgical Endometrial ablation Sound length<12cm Regular cavity (no distorting SMFs) Myomectomy Hysteroscopic (+/- Mirena TM or endometrial ablation) Laparoscopic Open Hysterectomy Radiological Uterine Artery Embolisation Other (under evaulation) MRI cryoablation; myolysis; USS guided injection; uterine arterial mechanical occlusion)

55 Examples: Old vs. New Approaches Endometrial Ablation INPATIENT OFFICE Abnormal Uterine bleeding Abnormal Uterine bleeding Hysteroscopy / D&C / Endometrial Ablation under GA (if suitable) Pelvic Ultrasound + Outpatient Biopsy Outpatient hysteroscopy with endometrial ablation

56 Evidence for Office procedures Outpatient hysteroscopic sterilisation:

EFFECTIVENESS OF OUTPATIENT ENDOMETRIAL ABLATION TECHNIQUES

57 Evidence for Office procedures Outpatient endometrial ablation: COAT Trial THE COAT TRIAL A RANDOMISED CONTROLLED TRIAL TO COMPARE THE EFFECTIVENESS OF OUTPATIENT ENDOMETRIAL ABLATION TECHNIQUES (NOVASURE TM VERSUS THERMACHOICE TM III) IN THE TREATMENT OF MENORRHAGIA versus

58 Evidence for Office Procedures OUTPATIENT POLYP TREATMENT OPT TRIAL RCT comparing outpatient versus inpatient uterine polypectomy Outcomes: Effectiveness Acceptability Costs Multi-centre trial funded by the DoH Health Technology Assessment Programme ( 1.1million) Contact: Mr Justin Clark at Birmingham Women s Hospital for further information Phone: justin.clark@bwhct.nhs.uk Collaborating centres welcome Joint authorship as part of collaborating group Biannual collaborators meetings Per patient payments Outpatient operative training

59 Conclusions Office or ambulatory hysteroscopic surgery has allowed an efficient, one stop approach to managing intrauterine pathologies and dysfunctional uterine bleeding avoiding hospital admission Fibroids are common and adversely impact upon the effectiveness of standard medical and minimally invasive treatments for AUB. Referral to secondary care is more likely to be required.

60 Thank you for your attention Any Questions?

Investigating HMB- an evidence based approach

BSGE Meeting: Contemporary management of heavy menstrual bleeding (HMB) in primary and secondary care: (7 th December 2018, RCOG) Investigating HMB- an evidence based approach T. Justin Clark MB ChB, MD(Hons),