Lead Author(s) Position within the Organisation Continence Service Manager

Transcription

1 Guidelines for Promotion of Urinary Continence in Females and of Lower Urinary Tract Symptoms (LUTS) in Males In adults from 16 years for use by Primary & Secondary Care Clinicians Document Description Document Type Guidelines Service Application Version 6.0 Ratification date May 2018 Review date May 2019 General Practitioners, Dudley Community Services (DCS) staff, contracted clinicians, secondary care clinicians. Lead Author(s) Name Position within the Organisation Gill Davey Continence Service Manager John Firth General Practitioner Judith Hesslewood Pharmaceutical Adviser (up to version 4.0) Jag Sangha Pharmaceutical Adviser (version 4.1 onwards) Aniruddha Chakravarti Consultant Urological Surgeon, Dudley Group of Hospitals NHS Trust (version 4.1 to 5.0) Presented for discussion, approval and ratification to Area Clinical Effectiveness Committee (ACE) May 2018 Change History Version Date Comments 1.0 Feb 2006 Audited Aug Feb 2008 Incorporates NICE CG 40 and Community Pharmacy. 2.1 April 2008 Minor changes to formatting and final ratified version. 2.2 Feb 2010 Updated. 2.3 Sept 2010 Formatting changes. 3.0 Dec 2012 Review. 4.0 Feb 2013 AMMC updated review date. 4.1 Sept 2014 Review/amendments. 5.0 April 2015 Incorporation of male (LUTS) pathway NICE CG97 May Approved pending minor amendment ACE meeting May April 2018 No changes. Consultation with Dr Abrar Malik (CCG Clinical lead and GP) and Gill Davey. Technical review completed. Extend 1 year pending full review. 6.0 May 2018 Approved at ACE subject to removal of Vesomni (Tamsulosin/Solifenacin) non-formulary. Reference to Vesomni removed from guidelines and minor formatting of document (including update of page numbers aligned to contents). 1

2 Link with Care Quality Commission Essential Standards of Quality & Safety Links with Trust Purpose and Values Statements Regulation 10, Outcome 16 - Assessing and monitoring the quality of service provision. Regulation 13, Outcome 9 - Management of medicines. We will work continuously to improve services We will value, support and develop all our staff 2

3 EXECUTIVE SUMMARY These Guidelines are intended to provide holistic patient care and ensure a consistent approach to the management of urinary incontinence across primary and secondary care. They refer to NICE Clinical Guidelines 40, 148, 171 (Females) and CG97 (Males) and local services. Healthcare Professionals are expected to take a patient centred, pro-active, team working approach, using their clinical judgement to assess each patient, referring patients directly to the Dudley Adult Continence Service after ruling out the need for urgent specialist referral. Guidance for female patients is encapsulated within the Model for Primary Care Team Approach chart (page 9) and Use of Drugs in Continence Management Algorithm (page 11). Pelvic Floor exercises and bladder training should always be first line treatment (NICE CG 40 CG 171). Pharmacotherapy should ideally only be trialled after a full assessment by the Continence Service and when physical therapies have proved unsuccessful or only partially successful. Support and provision of information at every stage is the consistent expectation to accompany treatment. In particular any prescribing of pharmacotherapy should be accompanied by oral and written information on the action, use, duration of treatment and expected side effects of the drugs prescribed. See Appendix 1. In addition patients can be directed to the NHS Choices website Health A-Z, search by alphabet letter I Incontinence, urinary. Available at: The continence service will also make and receive referrals to and from secondary care and maternity services (Incontinence following childbirth risk assessment tool). Patient self-referral and from community and public health initiatives is actively encouraged. Guidance for male patients is encapsulated within the Male Urinary Continence and LUTS (Integrated Pathway Dudley) Algorithm (page 10) and Drugs Used in Male Continence Management (Page 12) LUTS in men are best categorised into voiding, storage or post-micturition symptoms to help define the source of the problem. Voiding symptoms include weak or intermittent urinary stream, straining, hesitancy, terminal dribbling and incomplete emptying. Storage symptoms include urgency, frequency, urgency incontinence and nocturia. The major post-micturition symptom is post-micturition dribbling, which is common and bothersome. Although LUTS do not usually cause severe illness, they can considerably reduce men's quality of life, and may point to serious pathology of the urogenital tract. Pharmacotherapy should ideally only be trialled after a full assessment by the doctor. At initial assessment, offer men with LUTS an assessment of their general medical history to identify possible causes of LUTS, and associated co-morbidities. Review current medication, including herbal and over-the-counter medicines, to identify drugs that may be contributing to the problem. A physical examination guided by urological 3

4 symptoms and other medical conditions, an examination of the abdomen and external genitalia, and a digital rectal examination (DRE). CONTENTS Page No. Executive summary and contents 3 Development, consultation, monitoring and audit 4 Introduction, background and definitions, initial assessment. 5 6 Primary care interventions for continence management and treatment. 7 References 8 Glossary 9 Schematic representation of diagnosis, management and treatment Use of medicines in continence management - algorithms APPENDICES 1. Rationale for drug recommendations Example template of bladder diary Assessment & key questions Information Flow Continence Community Pharmacy Inclusion in Continence Pathway 21 DEVELOPMENT & CONSULTATION 1 1. Area Medicines Management Committee (AMMC) 14 th April Area Medicines Management Committee 9 th June Working Group 28 th July 05. First consultation re use of drugs flow chart PCT Prescribing Team and RHH Formulary Pharmacist. 4. Working Group 22 nd September 05. Second consultation. 5. Area Medicines Management Committee 13 th October Working Group Feb 2 nd, 23 rd, 2006 DEVELOPMENT & CONSULTATION 2 1. Ask about Medicines Continence Project Working Group 2. Continence Team 3. Area Medicines Management Committee 14 th December 2006 DEVELOPMENT & CONSULTATION 3 1. Area Medicines Management Committee 2. Working group REVIEW 2013 Area Medicines Management Committee REVIEW Working group 2. Area Clinical Effectiveness Committee (ACE) 4

5 REVIEW Working Group technical review (extension of 1 year) 2. Area Clinical Effectiveness Committee (ACE) AUDIT & MONITORING The Continence service regularly audits the outcome of its interventions, the results of which are available from Gill Davey. An audit was conducted in September 2007 by the Practice based Pharmacist Team to monitor the impact of the Guidelines and use of drugs. The action plan proposes a follow up audit together with a review of patients on long term antimuscarinic medication. Long term use of tolterodine in women was audited by the Practice based Pharmacist Team in Overall prescribing was found to be appropriate. Medication reviews were undertaken as highlighted by the audit and recommendations made to GPs. Prescribing data for duloxetine use in stress incontinence are monitored. Produced in 2005 by Area Medicines Management Committee (AMMC) working group comprising: Dr John Firth, GP Gill Davey, Continence Adviser Mr M FitzGibbon, Consultant Judith Hesslewood, Prescribing Adviser Lisa Marson, Clinical Governance Facilitator Reviewed in 2007 by Ask about Medicines Continence Project Working Group comprising Gill Davey, Continence Adviser Judith Hesslewood, Prescribing Adviser Janine Barnes, Practice-based Pharmacist Lyn Standley, Community Pharmacist Dr John Firth, GP Reviewed in 2010 by Gill Davey, Continence Adviser Judith Hesslewood, Prescribing Advisor. Liz Fisher, Commissioning Manager for SLK Cluster Dr Karen Hegarty, GP, Wychbury Medical Centre Reviewed in 2014 and 2015 by Gill Davey Continence Service Manager Dr J Firth GP Mr A Chakravarti Consultant Urologist, DGNFT Jag Sangha (Pharmaceutical Adviser Community Pharmacy and Public Health) INTRODUCTION The impact of incontinence on public health is very high with 1 in 4 women and 1 in 8 men experiencing episodes of urinary incontinence. Despite this condition affecting many people the subject is still rarely discussed in public and many people do not 5

6 seek treatment. The involuntary leakage of urine is consistently associated with adverse effects on quality of life (Fonda et al 1995). In older women there is an association between urge incontinence and falls, increasing the risk of hip and wrist fractures (Brown et al 2000). Because they are too embarrassed or think nothing can be done many women wait up to 15 years before seeking professional help (Stanton S 1996). Healthcare Professionals must be encouraged to take any consultations mentioning symptoms of incontinence very seriously and use these guidelines to appropriately refer. The provision of a patient held diary sheet for completion whilst waiting confirmation of appointment date with Continence Service should reassure the patient that the matter is being taken seriously. BACKGROUND This well established commissioned service comprising of specialist nurses and physiotherapist as recommended by NICE 2006, 2012 and 2013 (clinical guideline 40, 148 and 171 respectively) have used the Dudley pathway since In the 1990 s there were numerous inappropriate referrals made to secondary care which resulted in long waiting lists and inconsistent patterns of treatment. This method was confusing for both the patient and healthcare professional. In 1995, the Dudley Adult Continence Service began to redesign the patient pathway. Assessment including investigations, physiotherapy and urodynamics could all be accessed and treated in Primary Care. If unsuccessful, appropriate referral would then be made to uro-gynaecologists and other specialists. The resulting pathway has been incorporated into these Guidelines. The Dudley Adult Continence Service is now well established across the borough with good links between primary and secondary care. It has the capacity and expertise to effectively treat stress, mixed and urge incontinence with a range of nonpharmacological treatments before recommending drug usage, while monitoring and reviewing the effect of treatment. In addition the service provides support and monitoring of long term neurological conditions associated with urinary incontinence e.g. Multiple Sclerosis (NICE, 2003 and NICE 2012 clinical guidance 148). A project to improve communication and knowledge about the actions, uses and side effects of the pharmacological interventions for health professionals and patients has extended the primary care team approach to include community pharmacy. Community pharmacy is ideally placed to sign post and refer patients directly to the Continence Service or GP. DEFINITIONS Urinary incontinence Relating to or exhibiting involuntary urination Overactive Bladder (Urgency) Syndrome formally known as Urge Incontinence Urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology. 6

7 Stress Incontinence The involuntary loss of urine when the intra-abdominal pressure exceeds the maximum urethral closure pressure in the absence of detrusor activity (Involuntary leakage on effort or exertion e.g. coughing, sneezing, laughing). Mixed Incontinence A combination of stress and urge incontinence. In addition, restriction of the urethral closure due to dry vaginal mucosa, particularly in post-menopausal women, should be considered. Initial assessment A patient presenting with incontinence or following a general enquiry by a health professional should have an initial assessment, which should include a clinical history, physical examination, review of medicines and structured questioning, see Appendix 3 Then, following the Primary Care A Team Approach pathway as illustrated on pages 9-12, will offer a consistent approach to management and treatment, most of which can be successfully managed in primary care. Primary Care Interventions for Incontinence NICE guidance indicates that there is good evidence that daily pelvic floor muscle training is a safe and effective treatment for stress and mixed urinary incontinence and that bladder training is an effective treatment for urge or mixed urinary incontinence, with fewer adverse effects and lower relapse rates than treatment with antimuscarinic drugs (NICE guidelines 2006, 2012). Nurse led intervention including assessment, need for drug treatment and pelvic exercise is effective (O Brien et al 1991). The effects of such treatment are beneficial in the long term, particularly when exercise is maintained (O Brien & Long 1995). 69% of women maintained improvement or improved further four weeks following initial intervention (O Brien & Long 1995). Pelvic floor muscle exercises are effective in treating both stress and mixed urinary incontinence in women (Hay-Smith et al 2004) and should be the first line treatment for these conditions. They also have a role in combination with bladder retraining (Wilson et al 2001) for over active bladder problems. Pharmacotherapy should ideally only be trialled after a full assessment by the Continence Service and when physical therapies have proved unsuccessful or only partially successful. Advice, information and reassurance provided for the patient during the consultation together with a continence diary (Appendix 2) to complete while awaiting appointment with a Continence Adviser may alleviate the perceived need to provide a prescription in order to end the consultation. At the GP practice, when information or a request for trial of pharmacotherapy is received from the Continence Adviser the practice should record and READ code the diagnosis, and link drug prescribed to problems on their computerised Clinical System. In addition the prescriber should document any counselling given relating to use of drug and side effects. Information and support throughout the referral and treatment pathway should be consistent and reinforced by all Healthcare Professionals involved in patients care. 7

8 Area Clinical Effectiveness Committee (ACE, formerly AMMC) - approved drugs: See Use of Drugs in Continence and LUTS Management Algorithms. (Pages 12, 13) Patients should continue with Pelvic Floor Muscle Exercises whilst undergoing drug therapy. Urge, overactive bladder and mixed incontinence 1 st line - Initiate any drug treatment with oxybutynin (less than 65yrs) and titrate dosage to optimise treatment or MR oxybutynin if side effects are troublesome This is in line with NICE CG 40. Refer to NICE CG148 when prescribing for patients with neurological disease. If frail elderly over 65yrs to consider Tolterodine (immediate release). Mirabegron (see page 13 for more information) is an option if antimuscarinics are contraindicated (NICE TA 290 June 13). 2 nd line - MR Tolterodine, solifenacin or trospium, fesoterodine. Mirabegron (see page 13 for more information) can be considered if a patient suffers unacceptable side effects with antimuscarinics (NICE TA 290 June 13). Oxybutynin patches can be considered only in patients with swallowing difficulties who have shown benefit from use of antimuscarinic medication. Prescribing is restricted under the continence Service or secondary care supervision. Stress incontinence Duloxetine combined with pelvic floor muscle training for 2 to 4 weeks. Only under Continence Service supervision. Rationale behind drug use. See Appendix 1. References 1. Brown JS, Vittinghoff E, Wyman JF et al. Urinary incontinence: does it increase risk for falls and fractures? Study of Osteoporotic Fractures Research Group. J Am Geriatric Soc 2000; 48: Fonda D, Woodward M, D Astoli M, Chin WE. Sustained improvement of subjective quality of life in older community-dwelling people after treatment of urinary incontinence. Age Ageing 1995; 24: Hay-Smith J, Bo K, Berghmans LCM et al. Pelvic floor muscle training for urinary incontinence in women (Cochrane Review) In: The Cochrane Library, Issue 2, 2004, Chichester UK; John Wiley & Sons. 4. NICE Clinical Guideline 40. October NICE Clinical Guideline 148 August NICE Clinical Guideline 171 September O Brien J. et al. (1991) Urinary incontinence: prevalence, need for treatment and effectiveness of intervention by a nurse. BMJ303, O Brien J, Long H (1995). Urinary Incontinence; long term effectiveness of nursing intervention in primary care. BMJ 311, Stanton S (1996) British Journal of Nursing; Vol 5, No Wilson PD, Bo K, Hay-Smith J et al. Conservative treatment in women. In; Abrams P, Cardozo L, Hoary S, Wein A, eds. Incontinence: 2 nd international 8

9 Consultation on Incontinence, Paris, July 1-3, Plymouth: Health Publications. In addition these locally agreed guidelines have been based upon the following NSF for Older People Standard 2 Person Centred Care, states that by April 2004 all health and social care services should have established an integrated continence service. Agency for Health Care Policy and Research USA. Urinary Incontinence in Adults; clinical practice guidelines. (AHCPR Pub no Rockville MD 1992) Good Practice Guidelines for Management of Incontinence Royal College of Physicians Management of urinary incontinence in primary care SIGN Guideline 79 Dudley Area Medicines Management Committee (AMMC) - decisions. NICE Clinical Guideline 40, Urinary Incontinence, The management of urinary incontinence in women. October 2006 Essence of Care Patient Focused Bench marks for Clinical Governance, Benchmarks for Continence, Bladder & Bowel Care. NHS Modernisation Agency 2003 NICE, 2012 Clinical Guideline 148, Urinary incontinence in Neurological disease NICE, 2013 Clinical Guideline 171, Urinary Incontinence, The Management of urinary incontinence in women. Glossary Abbreviation AMMC ACE BNF MR MTRAC NHS NICE NSF OBD OBW SIGN SLK Cluster SI SPC Full Terminology Area Medicines Management Committee Area Clinical Effectiveness Committee (Formerly AMMC) British National Formulary Modified Release Midlands Therapeutic Review and Advisory Committee National Health Service National Institute of Clinical Excellence National Service Framework Overactive Bladder Dry Overactive Bladder Wet Scottish Intercollegiate Guidelines Network Stourbridge, Lye and Kingswinford GP Practice Cluster Stress Incontinence Summary of Product Characteristics 9

10 PRIMARY CARE A TEAM APPROACH TO CONTINENCE Presenting symptoms of INCONTINENCE OPPORTUNISTIC General inquiry to patient by healthcare professional Take the history Review Physical Examination Urinalysis/MSU Provisional Pelvic Floor assessment Refer to Urologist YES Haematuria without infection NO Specialist referral UTI, constipation, diarrhoea, vaginitis, lifestyle, caffeine etc YES TREAT & REFER? Abnormal examination e.g. mass fistula, recurrent incontinence Failed previous surgery Neurological Signs Symptomatic prolapsed with incontinence Retention Reduced fixed volume Bladder pain YES NO Any criteria for specialist referral? NO REFERRAL TO CONTINENCE SERVICE FROM GP/COMMUNITY SERVICE OR SELF-REFERRAL Continence Adviser Assessment Is further investigation required to determine diagnosis? Physio assessment made, Urodynamics Public Health Lifestyle Intervention Programmes Diagnosis Made? Specialist referral e.g. Physio, OT, Social Services, carers YES Is help required? Drug management advised see charts Report back to GP with Advice Overactive Bladder Wet (OBW), Overactive Bladder Dry (OBD) (Urge) Overflow incontinence, mental state, Stress Incontinence (SI), Mixed Specialist referral If NO Better in 3 months Planned review of progress CONTINENT Treated patients to be encouraged to attend for six monthly review or self-referral if symptoms return Acknowledgements to Dr John Firth GP, Continence Service Dudley, to be reproduced without prior permission ,

11 Male Urinary Continence & LUTS (Integrated Pathway Dudley) Presenting symptoms of LUTS to GP Opportunistic General Enquiry to patient by health professional Indications For secondary Care Referral Haematuria raised PSA/prostate feels abnormal renal impairment urinary retention>200ml Persistent bladder/urethral pain Suspected neurological diseases-refer as appropriate nocturnal enuresis stress incontinence unless post prostatectomy History including urinary symptoms, back problems, diabetes, constipation etc Yes Physical examinations; abdominal, rectal, genital and dipstick Urinalysis consider sending MSU, PSA and UE, USS or bladder scan depending on symptoms, IPSS, Prostate size fluid/volume chart Pathology found No Treat as appropriate UTI, constipation BPH Advise on fluid and caffeine Review at 6 weeks If MSU is positive delay PSA testing by 6 weeks If Confident Treat See Therapy Guide* If unsuccessful refer to Continence Service Referral to Continence Service (Advisers) from GP/Community Service or Patient Self-Referral etc Continence Assessment History/Examination MSU/Bladder scan if appropriate (Note Rectal examination is important and should be done by GP before referral) Further investigation required to determine diagnosis or specialist referral if required (See list) Over Active Bladder (OAB) Bladder Scan Pre and post voiding Advice on fluid intake Supervised bladder training: If unsuccessful after 6 weeks Trial of Antimuscarinic for at least 4 weeks (GP to prescribe, see over* reassess at 6 months) Void Dysfunction Determine causes e.g. Stricture BPH Constipation Drug side effects, neuropathic Actions-Bladder scan Voiding education-if indicated Consider intermittent self Catheterisation For post micturition dribble Trial up to 2 Classes of Drug See Therapy Guide* (4-6 weeks to take effect) prior to secondary care referral All patients to receive advice on lifestyle modification as per NICE guidelines 2010 Report back GP with advice and treatment plan Drug management advised refer to drugs management algorithm* Refer to Secondary Care urology No Patient improved in 3/12 Yes Planned progress review at 6 months Better discharge No better refer to Secondary Care Male Urinary Continence & LUTS (Integrated Pathway Dudley) Dudley CCG Dudley Wes Midlands NHS

12 USE OF MEDICINES IN FEMALE CONTINENCE MANAGEMENT Stress Incontinence REFER TO CONTINENCE SERVICE Give Bladder DIARY to complete until appointment Mixed Problem (Stress + urge) Urge Incontinence Overactive Bladder Wet Overactive Bladder Dry Dry REFER TO CONTINENCE SERVICE Give Bladder DIARY to complete until appointment Assessment Agreed Holistic Treatment Plan Effective Pelvic Floor Muscle Training Duloxetine, 40mg twice a day, with pelvic floor exercises 2-4 weeks then re - assess (reduce to 20mg Twice a day if side effects) Maximum 3 months duration ONLY UNDER CONTINENCE SERVICE SUPERVISION NO O For under 65yrs Oxybutynin 2.5mgs-5mgs twice a day follow holistic approach and treatment plan Review after 4 weeks If effective increase to 5mg 4 times per day (max 20mg daily) Over 65yrs consider Tolterodine 1-2mg twice a day / Tolterodine MR 4mg once a day If anti-muscarinics contra indicated consider Mirabegron (i.e. myasthenia gravis/ closed angle glaucoma) Effective and tolerated review in 4 weeks review NO Look at 2 nd line treatment YES YES Effective BUT NOT tolerated- go to Mirabegron 50 mg (25mg daily in hepatic/renal impairment/concomitant Cytochrome P450 medicines) daily. Review in 4 weeks If effective and tolerated maintain. Maintain Current dosage 3 months review. 6mth review MONITOR Oxybutynin patches 1 patch applied twice weekly to clean dry skin as per SPC. Restricted use dysphagia and only under supervision of continence service or secondary care. Fesoterodine 4mg start dose review in 4weeks option to increase to 8mg Solifenacin 5mg daily increasing to 10mg daily if appropriate. Trospium 20mg twice a day (bd) before food. Trospium MR 60mg daily (OD) If not tolerated/or effective consider Mirabegron 50 mg daily (25mg daily in hepatic/renal impairment/concomitant Cytochrome P450 medicines) Yes Acknowledgements to Continence Service Dudley Not to be reproduced without prior permission, , AUG2014

13 Alpha-blocker e.g. Tamsulosin 400mcg daily USE OF MEDICINES IN MALE CONTINENCE MANAGEMENT Less than 7 IPSS Greater than 7 Less than 30gram Prostate Volume Greater than 30gram Less than 1.4 PSA Greater than 1.4 Alpha-blocker plus 5α-reductase inhibitor Storage Problem Drug therapy for overactive bladder (OAB-adapted from NICE CG171) (In addition to lifestyle and conservative treatments) First line Antimuscarinics Tamsulosin 400microg + Finasteride 5mg If not effective after 3 months (12 weeks) Consider Combodart (Tamsulosin + Dutasteride) 1 daily Dosages (consider reduced dosage in renal impairment egfr <30 or concomitant Cytochrome P450 medication) Under 65 If contraindicated consider Mirabegron Over 65 Oxybutynin Immediate release (i.e. Myasthenia Gravis/closed angle Glaucoma) Tolterodine immediate release Tolterodine immediate release Offer transdermal medication if unable to tolerate oral Oxybutynin 2.5mg 5mgs Increasing up to 5mgs 4 times per day (max) Tolterodine 1 2mg bd 4mg MR one daily Solifenacin 5mg daily Increasing to 10 mg daily Fesoterodine 4mg daily Increasing to 8mg daily 4 week review Success Ineffective or not tolerated Effective but not tolerated - go to Mirabegron Under 65 Over 65 Solifenacin Trospium Chloride (immediate and prolonged release) Fesoterodine Annual review (6 monthly if >75 years old Trospium 20mg bd Mirabegron 50mg daily (25mg daily in hepatic/renal impairment) Acknowledgements to Continence Service Dudley Not to be reproduced without prior permission, , week review Success Ineffective or not tolerated Consider Dose adjustment or different antimuscarinic, first or second line Mirabegron Offer referral to secondary care Combination Voiding & Storage (large prostate and OAB) Tamsulosin + Oxybutynin if tolerated or age appropriate Tamsulosin + solifenacin second line 13 4 week review Success

14 Appendix 1 Rationale behind medicine use, warnings, contra indications, interactions Antimuscarinic These drugs counteract the effects of acetylcholine, which is largely responsible for contraction of the smooth detrusor muscle of the bladder. They therefore tend to reduce these contractions and increase bladder capacity. However the side effect profile of antimuscarinic drugs, due to their non-selective action on other antimuscarinic receptors, means they must be used with caution and risk/benefit effect monitored and there is a continuing need for regular review. Side effects Common side effects include dry mouth, blurred vision, dry eyes, dizziness, gastro-intestinal disturbances (including constipation), drowsiness, and difficulties in micturition and skin reactions. (See BNF & SPC of recommended drugs for full information). All antimuscarinic drugs should be used with caution in the elderly, especially if frail. (Note the change on the pathway according to age). Mirabegron Mirabegron is a novel selective beta3 adrenoceptor agonist, which activates beta-3- adrenoceptors causing the bladder to relax, which helps it to fill and also to store urine. It is administered orally. Mirabegron is available as 25 mg and 50 mg tablets, with the recommended dose being 50 mg daily, and 25 mg if there is renal or hepatic impairment. Prescribers are advised to consult product literature for more information. Mirabegron is recommended as an option for treating the symptoms of overactive bladder only for people in whom antimuscarinic drugs are contraindicated or clinically ineffective, or have unacceptable side effects (NICE TA290, June 2013). Common side effects as listed within the summary of product characteristics for Mirabegron include urinary tract infection and tachycardia. For full details of adverse reactions and contraindications, prescribers are advised to consult the summary of product characteristics for Mirabegron. This can be found at The dose of Mirabegron should be restricted to 25mg daily in the presence of concomitant prescribing of strong cytochrome P450 inhibitors (increased drug accumulation likely) such as itraconazole, ketoconazole, ritonavir and clarithromycin. Further details can be found by consulting the summary of product characteristics for Mirabegron. Mirabegron is contra-indicated in severe hypertension.. 14

15 Combination Voiding and Storage Tamsulosin 400 micrograms daily (alpha adrenoreceptor antagonist) and Solifenacin (prescribed individually) may be considered second line. This option may be considered after an initial trial of tamsulosin and oxybutynin (if treatment ineffective and/or not tolerated) providing there are no contraindications to its use (see antimuscarinic rationale above). Urge (overactive bladder) and mixed incontinence. See Algorithm page 12. Pelvic floor muscle exercise should be continued during any trial of drug treatment. First line drug For less than 65 year olds, initiate drug treatment with oxybutynin and titrate to optimise treatment. In accordance with NICE 2013 tolterodine modified release (MR) for frail elderly over 65yrs. Mirabegron can be considered if antimuscarinics are contraindicated i.e. closed angle glaucoma, myasthenia gravis etc (NICE TA 290 June 13). Second line drugs Tolterodine and/or MR Oxybutynin could be considered if side effects are troublesome with 1 st line antimuscarinic. Solifenacin can be considered if tolterodine is not tolerated &/or ineffective. Solifenacin is a newer antimuscarinic drug which competitively inhibits the M3 subtype receptors (MTRAC 2003) on the detrusor smooth muscle, suggesting relative selectivity for the bladder over the salivary gland (thus theoretically lower likelihood of dry mouth as a side effect). The starting dose is 5mg daily and this can be increased to a maximum of 10mg daily as needed. Fesoterodine 4mg can be used if other antimuscarinic have not been tolerated with review in 4 weeks. If symptoms remain troublesome and the 4mg dose tolerated by the patient increase to 8mg Trospium can be considered if pharmacotherapy is needed and oxybutynin or tolterodine are not tolerated. Central nervous system side effects are unlikely, as the drug hardly penetrates the blood-brain barrier due to its low lipophilicity (Fusgen et al 2000). This is an important consideration in use in the elderly over 65yrs and the prevention of falls. Mirabegron can be used if unacceptable side effects with antimuscarinic medicines (NICE TA 290 June 13). Oxybutynin patches restricted use for patients with swallowing difficulties who would benefit from antimuscarinic therapy. Effectiveness to be monitored regularly with guidance from the Continence service. 15

16 Selective serotonin (5HT) and noradrenaline reuptake inhibitor (SNRI). Duloxetine Stress incontinence Symptoms of stress incontinence usually respond well to pelvic floor muscle training. Duloxetine (Yentreve 20 & 40mg) is the only drug licensed for treatment of moderate to severe stress incontinence in women. Research in animals has shown that serotonin and noradrenaline stimulate the pudendal nerve. This causes the external sphincter to contract, thus inhibiting the flow of urine. By inhibiting the reuptake of these neurotransmitters it is postulated that duloxetine increases receptor stimulation and potentiates this effect (Fraser & Chancellor 2003). NICE CG171 (Urinary Incontinence The management of urinary incontinence in women, Sept 2013) recommends the following: o Do not use duloxetine as a first-line treatment for women with predominant stress urinary incontinence (UI). Do not routinely offer duloxetine as a second-line treatment for women with stress UI, although it may be offered as second-line therapy if women prefer pharmacological to surgical treatment or are not suitable for surgical treatment. If duloxetine is prescribed, counsel women about its adverse effects. Therefore, duloxetine should only be used as part of an overall management strategy. The Continence Service can advise the use of duloxetine combined with pelvic floor muscle training for 2 to 4 weeks followed by a re-assessment. There is not yet any evidence of its use long term. The Area Medicines Management Committee approved the use of duloxetine only under the supervision of the Continence Service, with a maximum duration of treatment of 3 months. Commonly reported adverse effects of duloxetine are nausea, dry mouth, fatigue, insomnia and constipation. When discontinuing duloxetine the dose should be tapered over a two week period and not stopped abruptly. Cautions and contra-indications See BNF & SPC for complete information. All antimuscarinic drugs Use with caution in the frail elderly and those with autonomic neuropathy. Use with caution in hiatus hernia with reflux oesophagitis, and in renal and hepatic impairment and patients with coeliac disease May worsen hyperthyroidism, coronary artery disease, congestive heart failure, hypertension, prostatic hypertrophy, arrhythmias and tachycardia. Do not use in patients with myasthenia gravis, angle closure glaucoma, urinary retention, tachyarrhythmia, severe ulcerative colitis or gastro intestinal obstruction. Use in pregnancy and breast feeding is not recommended. Many drugs have antimuscarinic effects. Concomitant use of two or more such drugs can increase side effects such as dry mouth, and lead to confusion particularly in the elderly. Refer to BNF and/or SPC for full information. 16

17 Duloxetine Use in pregnancy and breast feeding is not recommended. Avoid in liver disease resulting in hepatic impairment. Use with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures. Use with caution in patients with increased intra-ocular pressure or risk of acute narrow-angle glaucoma. Use with caution if treated with anti-depressants and other CNS acting drugs. Should not be used in combination with monoamine oxidase inhibitors, fluvoxamine or ciprofloxacin. Refer to BNF and/or SPC for full information. Mirabegron See page 14 above. Refer to BNF and/or SPC for full information. REFERENCES 1. MTRAC Verdict Nov Fusgen I, Hauri D. Trospium chloride: an effective option for medical treatment of bladder overactivity. Int J Clin Pharmacol Ther 2000; 28: Fraser MO, Chancellor MB. Neural control of the urethra and development of pharmacotherapy for stress urinary incontinence. BJU International 2003; 91: In addition the following sources of information: AMMC decisions 2005, 07,08,09,10 BNF section Drugs for urinary frequency, enuresis and incontinence Summary of Product Characteristics Trospium, Solifenacin, Tolterodine Oxybutynin, Duloxetine, Fesoterodine 17

18 Appendix 2 Your 24-hour bladder Diary Time Drinks Urine Accidental Leaks Type Quantity How many times? Did you leak before you went to the toilet? Quantity (circle one) Did you feel a strong Urge to go? (circle one) What were you doing At the time? (Sleeping, exercising, having sex, lifting, riding in a car, etc.) Example Coffee 2 cups yes no small + medium ++ large +++ yes no running yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no 18

19 Appendix 3 Assessment and key questions Patient Assessment: 1. Medical history 2. Mobility/Dexterity 3. Environment 4. Psychological State 5. Medication Key Questions: 1. Does leakage occur? 2. Does the bladder feel empty after passing urine? 3. Urinary incontinence? 4. Bowel habit 5. Fluid intake 6. Physical examination 19

20 Patient Information Flow Continence Service Appendix 4 Community Pharmacy Brief intervention > MUR At Referral Continence Service Address Card Pharmacy Continence Leaflet GP Practice At Referral Bladder Chart Continence Service Leaflet Community Nurse At Referral Service leaflet/bladder chart Bladder Maternity Service Service leaflet/own exercise leaflet Secondary Care Urology > Referrals Gynaecology Community Pharmacy Prescription for medicine dispensed. Prescription for information followed up. 10-minute conversation Product insert Additional information Pelvic Floor Leaflet Continence Advisers Information personalised to each client Continence Service Advice to initiate prescription Request to GP Information to patient GP Practice Prescription generated Consultation with GP + Information prescription? Continence Service Referral to secondary care Urodynamics/leaflet Physiotherapist Service leaflet/information prescription Exercise leaflet/information leaflet 20

21 Appendix 5 PATIENT Community Pharmacy Inclusion In Continence Care Pathway. 1 CONTINENCE SERVICE 1 PATIENT DIARY 1 1 PHYSIO TABLETS 1 2 PHARMACY GP 2 3 HOSPITAL 21