OAB Treatment Guidelines

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1 OAB Treatment Guidelines This Practice Aid has been provided as a quick reference to help learners apply the information to their daily practice and care of patients. It is part of the activity Overcoming the Barriers to Individualized Management of Overactive Bladder in the Primary Care Setting, which can be found in its entirety at. AUA/SUFU Guidelines in OAB: Diagnosis and Treatment Algorithm 1 History and Physical; Urinalysis Signs/symptoms of OAB, (-) urine microscopy Diagnosis unclear or additional information needed Consider urine culture, post-void residual, bladder diary, and/or symptom questionnaires Not OAB or complicated OAB; treat or refer Patient education: Normal urinary tract function Benefits/risks of treatment alternatives Agree on treatment goals Signs/symptoms of OAB Patient desires treatment, is willing to engage in treatment, and/or treatment is in patient s best interests Follow-up for efficacy and adverse events Behavioral Treatments Standard (consider adding pharmacologic management if partially effective) Treatment goals not met after appropriate duration a ; patient desires further treatment, is willing to engage in treatment, and/or further treatment in patient s best interests Treatment goals met In extremely rare cases, consider urinary diversion or augmentation cystoplasty Pharmacologic management Standard With active management of adverse events; consider dose modification or alternate medication if initial treatment is effective but adverse events or other considerations preclude continuation Treatment goals not met after appropriate duration a ; patient desires further treatment, is willing to engage in treatment, and/or further treatment in patient s best interests Reassess and/or refer; consider urine culture, post-void residual, bladder diary, symptom questionnaires, other diagnostic procedures as necessary for differentiation Signs/symptoms consistent with OAB diagnosis; treatment goals not met after appropriate duration a ; patient desires further treatment, is willing to engage in treatment, and/or further treatment in patient s best interests Consider in carefully-selected and thoroughly-counseled patients with moderate to severe symptoms Intradetrusor onabotulinumtoxina Standard (patients must be willing to perform CISC) OR Peripheral tibial nerve stimulation (PTNS) Recommendation (patients must be willing and able to make frequent office visits) OR Sacral neuromodulation (SNS) Recommendation a Appropriate duration is 8-12 weeks for behavioral therapies and 4-8 weeks for pharmacological therapies. AUA: American Urological Association; CISC: clean intermittent self-catheterization; OAB: overactive bladder; SUFU: Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction; UI: urinary incontinence. 1. Gormley EA et al. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline. Accessed November 1, Courtesy of Diane K. Newman, DNP, ANP-BC, FAAN Diane K. Newman UroToday Accessed November 1, 2016.

2 OAB Treatment Guidelines This Practice Aid has been provided as a quick reference to help learners apply the information to their daily practice and care of patients. It is part of the activity Overcoming the Barriers to Individualized Management of Overactive Bladder in the Primary Care Setting, which can be found in its entirety at. Urgency UI, Overactive Bladder, Mixed UI: Clinical Care Pathway 2 SYMPTOMS Urgency, frequency Urgency UI/overactive bladder/mixed UI LIFESTYLE MODIFICATIONS Diet modification, fluid management, BMI management, bowel regularity Depending on symptoms and bother, consider combining lifestyle modifications with drug therapy DRUG THERAPY Antimuscarinics (2-3) β 3 -adrenoceptor agonist Symptoms persist/patient choice/bother BEHAVIORAL TREATMENT Bladder training, urge-suppression techniques, biofeedbackassisted pelvic floor muscle training, knack/stress strategies Symptoms persist/patient choice/bother REFRACTORY overactive bladder Percutaneous tibial nerve stimulation (PTNS) Sacral Nerve Stimulation (SNS) OnabotulinumtoxinA a Appropriate duration is 8-12 weeks for behavioral therapies and 4-8 weeks for pharmacological therapies. AUA: American Urological Association; CISC: clean intermittent self-catheterization; OAB: overactive bladder; SUFU: Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction; UI: urinary incontinence. 1. Gormley EA et al. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline. Accessed November 1, Courtesy of Diane K. Newman, DNP, ANP-BC, FAAN Diane K. Newman UroToday Accessed November 1, 2016.

3 OAB Treatment Guidelines This Practice Aid has been provided as a quick reference to help learners apply the information to their daily practice and care of patients. It is part of the activity Overcoming the Barriers to Individualized Management of Overactive Bladder in the Primary Care Setting, which can be found in its entirety at. AUA/SUFU OAB Treatment Guidelines 3 1 st Line Behavioral therapies for all patients May be combined with antimuscarinics 2 nd Line Oral antimuscarinics or β 3 -agonist Transdermal oxybutynin may be offered Dose modification or switch to different antimuscarinic or β 3 -agonist if inadequate efficacy or poor tolerability with an antimuscarinic 3 rd Line Sacral nerve stimulation Peripheral tibial nerve stimulation Intradetrusor onabotulinumtoxina a Appropriate duration is 8-12 weeks for behavioral therapies and 4-8 weeks for pharmacological therapies. AUA: American Urological Association; CISC: clean intermittent self-catheterization; OAB: overactive bladder; SUFU: Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction; UI: urinary incontinence. 1. Gormley EA et al. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline. Accessed November 1, Courtesy of Diane K. Newman, DNP, ANP-BC, FAAN Diane K. Newman UroToday Accessed November 1, 2016.

4 Approved Therapies for OAB This Practice Aid has been provided as a quick reference to help learners apply the information to their daily practice and care of patients. It is part of the activity Overcoming the Barriers to Individualized Management of Overactive Bladder in the Primary Care Setting, which can be found in its entirety at. First-Line Treatment: Lifestyle Changes and Behavioral Therapy 1-5 Supported by national and international urology and urogynecology medical societies Education reinforcement Bladder training Diaries Behavioral therapy for OAB Pelvic floor exercises Biofeedback Fluid/dietary management Timed voiding No matter what the treatment course, behavioral modification should be offered to every patient

5 Approved Therapies for OAB Pharmacologic Therapies for OAB: Dosage and Side Effects 6-8 Agent Dosage Hepatic/Renal Adjustment Common Side Effects Oxybutynin ER 5-30 mg QD No Dry mouth, constipation, dry eyes, dyspepsia, dizziness Oxybutynin IR 5 mg BID-5 mg TID (geriatric: 2.5 mg BID-5 mg TID), not to exceed 20 mg/day No Dry mouth, constipation, dyspepsia, dizziness Oxybutynin patch 3.9 mg/day twice weekly No Dry mouth Tolterodine ER 2-4 mg QD CrCl ml/min: 2 mg daily; Not recommended for CrCl <10 ml/min or Child-Pugh Class C Dry mouth, constipation Fesoterodine 4-8 mg QD CrCl <30 ml/min: 4 mg daily; Not recommended for Child-Pugh Class C Dry mouth, constipation Solifenacin 5-10 mg QD CrCl <30 ml/min: 4 mg daily; Not recommended for Child-Pugh Class C Dry mouth, constipation Darifenacin mg QD 7.5 mg daily for Child-Pugh Class B Dry mouth, constipation Trospium Cl 20 mg BID CrCl <30 ml/min: 20 mg daily; Not recommended for Child-Pugh Class C Dry mouth, constipation Mirabegron mg QD CrCl ml/min or Child-Pugh Class B: 25 mg daily; Not recommended for Child-Pugh Class C or ESRD Hypertension

6 Approved Therapies for OAB Third-Line Therapies 9 PTNS SNS OnabotulinumtoxinA Primary location of service Clinic OR/ASC Clinic/OR/ASC AUA/SUFU guideline (recommendation or standard) Adverse events Reported AEs are minor Painful sensation during stimulation that did not interfere with treatment Minor bleeding at insertion site Pain at stimulator site Pain at lead site Lead migration Infection/irritation Electric shock Need for revision UTI Urinary retention Elevated post-void residual Need for self-catheterization Gross hematuria Provider driven Physician or nurse Physician Physician Provider performed Nurse Physician Physician ASC: ambulatory surgery center; AUA: American Urological Association; BID: twice daily; Cl: chloride; CrCl: creatinine clearance; ER: extended release; ESRD: end-stage renal disease; IR: immediate release; OAB: overactive bladder; OR: operating room; PTNS: percutaneous tibial nerve stimulation; QD: once daily; SNS: sacral nerve stimulation; SUFU: Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction; TID: three times daily Accessed November 1, Qaseem A et al. Ann Int Med. 2014;161: Tse V et al. BJU Int. 2016;117: Moore K et al. Incontinence: Proceedings From the 5th International Consultation on Incontinence. Plymouth UK: Health Publications;2013: Newman and Burgio. In: Campbell-Walsh Urology. 11th ed. 2016;80: Gomelsky A, Dmochowski RR. Open Access J Urol. 2010;3: Hesch K. Proc (Bayl Univ Med Cent). 2007;20: Lacy CF et al. Drug Information Handbook. 14th ed. Hudson, OH: Lexi-Comp Inc.; Gormley EA et al. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline. Accessed November 1, 2016.

7 Beers Criteria for Potentially Inappropriate Medication Use in Older Adults: Implications for Urologic Care 1 This Practice Aid has been provided as a quick reference to help learners apply the information to their daily practice and care of patients. It is part of the activity Overcoming the Barriers to Individualized Management of Overactive Bladder in the Primary Care Setting, which can be found in its entirety at. Disease/Syndrome Drug Recommendation Rationale Delirium All TCAs Anticholinergics Benzodiazepines Chlorpromazine Corticosteroids H 2 -receptor antagonists Meperidine Seda Thioridazine Avoid Avoid in older adults with or at high risk of delirium to prevent inducing or worsening delirium; if discontinuing drugs used chronically, taper to avoid withdrawal symptoms Dementia and cognitive impairment Anticholinergics Benzodiazepines H 2 -receptor antagonists Zolpidem Antipsychotics, chronic and as-needed use Avoid Avoid because of adverse CNS effects; avoid antipsychotics for behavioral problems of dementia unless nonpharmacological options have failed and patient is a threat to themselves or others; antipsychotics are associated with increased risk of stroke and mortality in patients with dementia Chronic constipation Oral antimuscarinics for UI a Darifenacin Fesoterodine Oxybutynin (oral) Solifenacin Tolterodine Trospium Avoid unless no other alternatives Can worsen constipation; antimuscarinics differ in incidence of constipation; response variable; consider alternative agent if constipation develops UI (all types in women) Estrogen oral and TD (excludes intravaginal estrogen) Avoid in women Aggravation of incontinence LUTS benign prostatic hyperplasia Inhaled anticholinergic agents; strongly anticholinergic drugs, except antimuscarinics for UI Avoid in men May decrease urinary flow and cause urinary retention Stress or mixed UI Alpha blockers Doxazosin Prazosin Terazosin Avoid in women Aggravation of incontinence a Only medications prescribed by urologists are listed as examples. LUTS: lower urinary tract symptom; TCA: tricyclic antidepressant; TD: transdermal; UI: urinary incontinence. 1. American Urological Association Education and Research, Inc. AUA White Paper on the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults made or implied by coverage of these products or uses in this activity. No responsibility is taken for errors or omissions. The information presented is solely intended for general education purposes, and it is not intended to discuss any specific product.

8 Assessment of OAB This Practice Aid has been provided as a quick reference to help learners apply the information to their daily practice and care of patients. It is part of the activity Overcoming the Barriers to Individualized Management of Overactive Bladder in the Primary Care Setting, which can be found in its entirety at. Helpful Screening Questions to Evaluate for OAB and Incontinence 1 Question Do you get sudden urges to go to the bathroom that can t be ignored? How often do you go to the bathroom? More than 8 times per day? Do you have uncontrolled urges to urinate that sometimes result in wetting accidents? Do you leak urine on the way to the bathroom? Do you frequently get up 2 or more times during the night to go to the bathroom? Do you avoid places you think won t have a nearby restroom? When you are in an unfamiliar place, do you make sure to find out where the restroom is? Do you leak urine when you laugh, cough, or sneeze? Do you use absorbent pads to keep from wetting your clothes? Possible Condition OAB OAB UUI UUI OAB OAB or UUI OAB or UUI SUI SUI or UUI Defining LUTS 2-5 Frequency Nocturia Urgency UUI OAB Wet OAB Dry Warning Time Patient considers that he/she voids too often by day Normal is <8 times per 24 hours Waking at night to void Likely clinically meaningful if frequency is greater than twice a night Sudden compelling desire to pass urine that is difficult to defer Involuntary leakage accompanied by, or immediately preceded by, urgency OAB with UUI OAB without UUI Time from first sensation of urgency to voiding

9 Assessment of OAB Polypharmacology: Who Is at Risk? 6-8 Sedatives, psychotropic drugs Alcohol, caffeine, diuretics Anticholinergics α-agonists ß-blockers Calcium-channel blockers ACE inhibitors First-generation antihistamines Cholinesterase inhibitors Opioids SSRIs Gabapentin, glitazones, NSAIDs Confusion, secondary incontinence Diuresis Impair contractility, voiding difficulty, overflow incontinence Increased outlet resistance, voiding difficulty Decreased urethral closure, stress incontinence Reduce bladder smooth muscle contractility, constipation, retention, edema Induce cough, increase contractility, stress urinary incontinence Increase outlet resistance Precipitate urge incontinence Indirect effect, retention, constipation, confusion, immobility Urinary incontinence Edema, nocturia Disease/Conditions: Who Is at Risk? T2DM 9,10 Heart failure 10,11 Nocturia 12 Sleep apnea 10 Neurological disease 10 Stroke Parkinson s disease NPH Psychiatric conditions 10 Depression Dementia Multi-infarct/vascular Frontotemporal Parkinson s dementia Dementia with Lewy bodies Alzheimer s ACE: angiotensin converting enzyme; LUTS: lower urinary tract symptom; NPH: normal pressure hydrocephalus; OAB: overactive bladder; SSRI: selective serotonin reuptake inhibitor; SUI: stress urinary incontinence; T2DM: type 2 diabetes mellitus; UUI: urge urinary incontinence. 1. Rosenberg MT et al. Can J Urol. 2014;21(Suppl 2): Abrams P et al. Neurourol Urodyn. 2002;21: Wein A et al. J Urol. 2006;175:S5-S Zinner N et al. Int J Clin Pract. 2006;60: Wein AJ. Am J Manag Care. 2000;6:S559-S Accessed November 1, Wyman J et al. Int J Clin Pract. 2009;63: Newman DK. Nurse Pract. 2009;34: Devore EE et al. J Urol. 2012;188: Accessed November 1, Palmer MH, Busby-Whitehead J. Curr Bladder Dysfunct Rep. 2010;5: Parthasarathy S et al. PLoS One. 2012;7:e Accessed November 1, Neef D, Walling AD. Am Fam Physician. 2006;73: Ransmayr GN et al. Neurology. 2008;70: Sakakibara R et al. J Neurol Neurosurg Psychiatry. 2005;76: Averbeck MA et al. Neurourol Urodyn [Epub ahead of print].

10 Mechanism of Action of Mirabegron and Its Role in OAB Therapy This Practice Aid has been provided as a quick reference to help learners apply the information to their daily practice and care of patients. It is part of the activity Overcoming the Barriers to Individualized Management of Overactive Bladder in the Primary Care Setting, which can be found in its entirety at. Mechanism of Action Mirabegron relaxes the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle by activation of β 3 adrenergic receptor and increases bladder capacity. Detrusor smooth muscle (Relaxation) NE β 3 -agonist Norepinephrine β 3 -AR Prescribing Information 1,2 Starting dose: 25 mg with or without food Effective within 8 weeks; may increase to 50 mg Do not cut, crush, or chew Max dose 25 mg with severe renal impairment or moderate hepatic impairment ESRD and severe hepatic impairment not recommended Mirabegron is a CYP2D6 inhibitor May increase BP; periodically monitor BP if hypertensive; don t use in severe uncontrolled HTN

11 Mechanism of Action of Mirabegron and Its Role in OAB Therapy Where Does This Fit in Therapy? 2 Potential for use in first-line therapy Use in patients who Cannot tolerate an antimuscarinic OAB drug Have contraindications to or could be harmed by drugs with anticholinergic properties β 3 -AR: β 3 adrenergic receptor; ESRD: end-stage renal disease; HTN: hypertension; NE: norepinephrine; OAB: overactive bladder. 1. Myrbetriq (mirabegron). Accessed November 1, Accessed November 1, 2016.

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