ACTIVITY DISCLAIMER. Urge Incontinence, Detrusor Instability, and Overactive Bladder: (OAB) DISCLOSURE. Learning Objectives

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1 Urge Incontinence, Detrusor Instability, and Overactive Bladder: (OAB) Benroe Blount, MD, MPH, FAAFP ACTIVITY DISCLAIMER The material presented here is being made available by the American Academy of Family Physicians for educational purposes only. This material is not intended to represent the only, nor necessarily best, methods or procedures appropriate for the medical situations discussed. Rather, it is intended to present an approach, view, statement, or opinion of the faculty, which may be helpful to others who face similar situations. The AAFP disclaims any and all liability for injury or other damages resulting to any individual using this material and for all claims that might arise out of the use of the techniques demonstrated therein by such individuals, whether these claims shall be asserted by a physician or any other person. Every effort has been made to ensure the accuracy of the data presented here. Physicians may care to check specific details such as drug doses and contraindications, etc., in standard sources prior to clinical application. This material might contain recommendations/guidelines developed by other organizations. Please note that although these guidelines might be included, this does not necessarily imply the endorsement by the AAFP. DISCLOSURE Benroe Blount, MD, MPH, FAAFP It is the policy of the AAFP that all individuals in a position to control content disclose any relationships with commercial interests upon nomination/invitation of participation. Disclosure documents are reviewed for potential conflict of interest (COI), and if identified, conflicts are resolved prior to confirmation of participation. Only those participants who had no conflict of interest or who agreed to an identified resolution process prior to their participation were involved in this CME activity. All individuals in a position to control content for this activity have indicated they have no relevant financial relationships to disclose. Medical Director, JenCare, Atlanta, Georgia; Adjunct Professor, Department of Family and Preventive Medicine, Emory University School of Medicine, Atlanta, Georgia. Dr. Blount is a graduate of the University of Miami Miller School of Medicine, Florida. He completed a faculty development fellowship at Madigan Army Medical Center, Tacoma, Washington, and earned a Master of Public Health degree from the University of Washington School of Public Health, Seattle. He has published numerous articles covering many areas of family medicine. Prior to his tenure at JenCare and Emory University School of Medicine, he was professor and chair of family medicine at the University of Tennessee Graduate School of Medicine, Knoxville The content of my material/presentation in this CME activity will not include discussion of unapproved or investigational uses of products or devices. Learning Objectives 1. Incorporate current guidelines for diagnosis in patients presenting with urinary problems. 2. Coordinate referral to an urologist or urogynecologist if initial diagnosis in unclear, or red flags such as hematuria, obstructive symptoms or recurrent urinary tract infections are present. 3. Counsel patients regarding first-line treatment options, including behavioral therapy and lifestyle modifications, emphasizing adherence and follow-up. 4. Prescribe second or third line treatment options if first-line therapies are unsuccessful, coordinating referral and follow-up care for surgical treatment as necessary. Audience Engagement System Step 1 Step 2 Step 3 1

2 Presentation Topics The approach to the incontinent patient The work-up of said patient The evidence-based, practical treatment of said patient The follow-up of such a patient Defining OAB The International Continence Society (2002) defines OAB as: Urgency, with or without urge incontinence, usually with frequency and nocturia Characterizes OAB as a syndrome that requires presence of 2+ symptoms This makes OAB a clinical Dx Polling Question 1 Which of the following is the most common symptom of OAB? A. Frequency A. Urgency B.Nocturia C.Urge Incontinence D.None of the above OAB Symptoms Frequency voiding too often during the day: Most Common Sx: 85% Urgency the complaint of a sudden, compelling desire to pass urine that is hard to defer: 2 nd most Common: 54% Urge Incontinence: 36% Nocturia voiding too often during the night. Types of Urinary Incontinence (UI) Urge Incontinence Type Urge (UUI) (OAB) Stress (SUI) Mixed (MUI) Symptom Involuntary leakage with urgency, frequency, Nocturia Involuntary leakage with exertion (sneezing, coughing) Combination of stress and urge symptoms Most Common Cause Detrusor overactivity Urethral hypermobility; intrinsic sphincter deficiency Combination Incontinence Clinic: Can you hold? 2

3 Epidemiology of OAB Affects approximately 33 million US adults (17% of women; 16% of men) 1 Second most common chronic condition (behind arthritis) Managing OAB in the Primary Care Setting: Diagnosis Symptom prevalence increases with age and is higher in nursing-home and homebound populations Shhhh! Urinary Incontinence: A Silent Issue Majority of community-dwelling older adults fail to report UI to provider UI may not be perceived as important or may be seen as part of aging process Men may ascribe UI to enlarged prostate; women to menopause Patients may privately associate UI with gradual loss of bodily control Shhhh! Reasons For Not Seeking Help Considered minor problem Accepted as normal part of aging or being female Denial of problem Embarrassment Fear that doctor will think problem is trivial Hope for improvement without intervention Unaware of treatment availability Low expectations from treatment Too busy Cost 1 The First Step: Ask About It! Begin with open-ended query: Do you have any problems with urination? If no, become more specific: How many times do you urinate during the day or night? What s normal? 5-6 X/day Do you ever feel that you cannot empty your bladder? 1 2 The Second Step: Get Details Get the usual 7 characteristics of every symptom : L ocation O nset C haracrter A lleviating factors T iming E xaccerbating factors S everity 2 3

4 3 3rd Step: The Voiding Diary: Encourage patient to keep voiding diary by recording: Voiding patterns Precursor symptoms Relationships between leaking and activity Presence of urge Fluid and caffeine intake..education on Urinary Incontinence and Women s Health, available at 3 Polling Question 2 Which of the following is/are a reversible cause of Urinary Incontinence? A. Delerium B. Infection C. Stool Impaction D. Psychological Problems E. All of the above 4 4 th Step: Exclude Reversible Causes D elirium I nfection A trophic vaginitis P harmaceuticals P sychological problems E xcessive Urination R estricted mobility S tool impaction 4 Medicines that May Influence Bladder Function Complicating Factors (Need Referral) Diuretics Antidepressants Antihypertensives Hypnotics Analgesics Narcotics Sedatives Over-the-counter sleep aids and cold remedies Prior incontinence surgery Prior radical pelvic surgery Prior pelvic radiation Gross pelvic prolapse Recent onset overactive symptoms Hematuria (w/o infection) 4

5 5 The 5th Step: Establishing Diagnosis of OAB Step 5a: The Physical Exam Focused Neurological 5 Initial Workup a. Physical Exam b. Urinalysis c. Post void Residual Mental Status Weight Abdominal (looking for masses) Genitalia & pelvic (Check pelvic floor, for cystocele, S.U.I., & masses) Rectal Overactive Bladder Evaluation Step 5b: Urinalysis Dipstick for: Proteinuria Glycosuria Hematuria Bacteruria Pyuria Step 5c: Exclude Overflow Measure Post-Void Residual Urine Patient empties bladder Catheter or sono to measure PVR 0-50 cc NORMAL cc EQUIVOCAL >200 cc HIGH Patients w/overflow need urodynamic testing and catheter drainage; i.e. referral Referral/Consultation Criteria Uncertain diagnosis; pelvic organ prolapse Uncertain treatment plan; prior pelvic surgery Failure to respond to therapy Consultation regarding surgery Hematuria; recurrent U.T.I. Recurrent urinary tract infections Abnormal PVR (postvoid residual) Neurogenic bladder 5

6 Mid-Summary Diagnostic Plan for UI/OAB??QUESTIONS?? Diagnose with history, physical, U/A Exclude reversible causes and complicating factors Exclude overflow Use history to decide on urge vs. stress Treat: 6 th Step 6 6 th Step: Managing OAB in the Primary Care Setting: 6 General Considerations for OAB Management Focus on meeting reasonable expectations (e.g., < 100% dryness) - Decrease incontinent episodes; frequency of bathroom; & improve control Discuss options with the patient Tailor therapy to the patient s needs Use behavioral and pharmacologic interventions in combination Recognize that regimens may need to be altered over time Behavioral Interventions Behavioral Intervention Lifestyle Interventions Bladder Retraining Pelvic Floor Muscle Rehabilitation 6

7 Polling Question 3 Which of the following has A level evidence as effective in decreasing OAB? A.Weight reduction B. Smoking cessation C.Caffeine reduction D.All of the above E.Only B & C Lifestyle Interventions Conservative management strategies that apply or remove a particular behavior Weight reduction : A Rec Smoking cessation : C or B Constipation prevention C Dietary modifications: C Caffeine reduction : C (<400mg/d) Lifestyle Interventions: Weight Reduction Obesity is an independent risk factor for UI Each unit increase in BMI increases risk of UI by 5 percent Weight reduction associated with improved UI in moderately obese women Polling Question 4 Patients with urinary incontinence should be advised to decrease their fluid intake. True False What About Fluid Intake? Fluid reduction is not recommended as a treatment strategy for incontinence Role of fluid intake on UI is unclear Fluid reduction may promote dehydration, constipation, and urinary tract infections To help alleviate nocturia, fluid intake may be rescheduled to reduce intake 3-4 hours preceding bedtime Bladder Retraining:Overview The Main behavioral intervention Management strategy that combines Education Scheduled voiding Urge suppression behaviors Reinforcement May be used alone or in conjunction with lifestyle interventions or pharmacotherapy Regimen design should consider patient s physical capabilities and motivational level 7

8 Bladder Retraining: Efficacy In older women with UI (n=123), bladder retraining reduced incontinence episodes by 57 percent vs control (P < ) 1 Bladder training plus caffeine reduction (in patients with intake > 100 g/day) significantly decreased the number of voids/24 hours and urgency episodes when compared to bladder training alone 2 After 24 weeks of treatment, bladder training plus tolterodine significantly decreased voiding frequency and voided volume vs tolterodine alone (P < 0.001) 3 More effective than anticholinergics Bladder Retraining Strategies: Scheduled Voiding Establishes a fixed voiding schedule that may vary from hours, depending on results from the patient s voiding diary Is an essential adjunct to pharmacotherapy Can be used to retrain the habits of patients with mild-to-moderate mobility or cognitive defects Bladder Retraining Strategies: Suppressing the Urge Behavioral Intervention Recognize that the best time to void is when calm Squeeze pelvic floor muscles (2-4 seconds then relax 2-4 seconds; repeat 3-5 times) Breathe slowly and deeply Use simple distraction (counting backwards from 10, or success reinforcement methods (repeating I am in control )) Wait until the urge subsides Walk to the bathroom at a normal pace Practice Recommendation Pelvic Floor Muscle Rehabilitation Bladder education (normalizing the micturition interval) should be recommended to patients with mild urge urinary incontinence. This statement is supported by evidence of Grade B (Moderate research-based evidence), indicating at least one relevant, high-quality study or multiple adequate studies. EBM Source: National Guideline Clearinghouse. Finnish Medical Society Duodecim. Urinary incontinence in women. In: EBM Guidelines. Evidence-Based Medicine. Helsinki, Finland: Duodecim Medical Publications Ltd.; 2005 Aug ctive+and+bladder#s24 Element Muscle Training (12-16 weeks) Biofeedback Neuromuscular Education Purpose Improve function, tone, strength, endurance Teach muscle isolation and identification Promote continence, urge relief, and complete bladder evacuation during micturition 8

9 Pelvic Floor Muscle Training: Kegel Exercises Pelvic Floor Muscle (Kegel) Exercises Strong, fast, and well-timed pelvic muscle contractions can prevent leakage resulting from a sudden increase in intra-abdominal pressure (e.g., coughing) by: Closing the urethra Increasing urethral pressure Pressing the urethra against the pubic symphysis Preventing urethral descent Repeat in sets of up to 10 each 3 times/day Locate pelvic muscles Relax completely after each contraction Two types of contractions: Quick (2 sec) Long (up to 10 sec) Practice Recommendation Pelvic-floor muscle training should be included in the first-line management of women with stress, urge, or mixed urinary incontinence. The evidence supporting this recommendation is based on the meta-analysis of 6 randomized/quasi-randomized clinical trials (n=403) in women with stress, urge, or mixed urinary incontinence in which pelvic floor muscle training was compared with no treatment, placebo, sham, or another inactive control treatment. Grade B EBM Source: Hay-Smith EJC, Dumoulin C. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev 2006, Issue 1. Art. No.: CD ml. Getting The Knack : An Acute Method of Control A fast and strong pelvic muscle contraction used before and during an activity that causes leakage Temporarily closes the urethra and increases urethral pressure Useful once a patient has learned to identify and quickly contract pelvic floor muscles Unlike pelvic floor muscle exercise, the Knack provides an acute method to control leakage Does not improve muscle tone over the long term Using Behavioral Approaches in Practice Biofeedback-assisted behavioral treatment reduces OAB episodes in women Combining behavioral and pharmacotherapies in a stepped program increases reduction in incontinence compared to either single modality alone Behavioral training can be efficacious when selfadministered In women with UUI or MUI (n=222), no statistically significant difference in incontinence episodes (P=0.23) between behavioral training regimens that employed biofeedback, verbal feedback, or a self-help booklet Using Devices in OAB Most devices are for S.U.I.; BUT Pessaries can decrease incontinence is some women with strict OAB and in many women with mixed OAB Caveats to pessary use: Estrogen enough to have moist vagina No active pelvic infection No allergy to latex or silicone Experienced fitter 9

10 Antimuscarinic Agents Managing OAB in the Primary Care Setting: Pharmacotherapy Anticholinergic agents that operate on muscarinic acetylcholine receptors Well-established as a class Should be used only in context of coordinated treatment plan that includes behavioral interventions Common side-effects include constipation, dry eyes, and dry mouth Antimuscarinic Agents Polling Question 5 Agent Oxybutynin Oxybutynin ER Oxybutynin TDS Tolterodine Tolterodine ER Darifenacin Flavoxate Hyoscyamine sulfate Trospium Darifenacin Solifenacin Fesoterodine Ditropan Ditropan XL Oxytrol Detrol Detrol LA Enablex Urispas Levsin Sanctura Enablex VESIcare Toviaz Trade Name Which of the following is/are correct about using antimuscarinic agents for OAB? A. They are all clinically equally effective B. They all have equal side effects C. Use an antimuscarinic agent for at least 2 weeks before assessing efficacy D. All of the above E. Only A & C Agent Selection Considerations Treatment Effect Rates Clinical efficacy Safety Possible CNS side effects (cognitive impairment, sleep disturbance, photophobia) Drug-drug interactions Cost Convenience All are effective Drug # women/1000 resolved Fesoterodine 130 Oxybutynin 114 Trospium 114 Solifenacin 107 Tolterodine 85 10

11 Agent Selection Considerations ER formulations associated with less dry mouth than corresponding IR formulations With the exception of trospium, most agents easily pass the blood-brain barrier Differences in tolerability & safety profiles Clinical Considerations for Antimuscarinic Agents Use agent at least 1 month before assessing efficacy Titrate to achieve balance between benefits and side effects Switch agent if it becomes less effective after longterm use; or if A.E.s are intolerable Use with caution in elderly because of possible CNS side effects and CV risk associated with anticholinergic agents Head-to-head trials have not shown clinically significant differences in effectiveness Clinical Considerations for Antimuscarinic Agents More women stop Rx with fesoterodine & oxybutynin 5 mg solifenacin has lowest discontinuation rate. Adverse effects more common in pts already taking > 7 other meds Because of least CNS action, trospium MAY cause the least somnolence, dizziness, cognitive impairment, & insomnia Most are metabolized by the CYP450 system, except Trospium No Effect on the QT interval: Darifenacin, fesoterodine, & trospium Considerations for Adverse Effects Dry mouth is most common A.E. Discontinuation Rates/1000 women (in studies) Drug # Discontinued Rx Oxybutynin 63 Fesoterodine 31 Trospium 18 Solifenacin 13 Real world Discontinuation can be 70-90%. Avg. length of adherence = 3 months Efficacy Less frequency Less UUI Increased voided volume Anticholinergics: A Delicate Balance Adverse effects Dry mouth Constipation CNS Counsel Pt.s they will have 1-4 wks delay for max Sx relief, but can see a response in 1 wk. Practice Recommendation Clinicians should consider an anticholinergic agent for adults with OAB, as use of these agents results in statistically significant improvement in symptoms compared to placebo. The evidence supporting this recommendation is based on the meta-analysis of 61 randomized/quasi-randomized clinical trials (n=11,956) in adults with overactive bladder in which an anticholinergic agent was compared with placebo or no treatment. Grade A EBM Source: Nabi G, et.al. Anticholinergic drugs versus placebo for overactive bladder syndrome in adults. Cochrane Database Syst Rev 2006, Issue 4. Art. No.: CD

12 Practice Recommendation Clinicians should consider an anticholinergic agent in combination with bladder training for adults with OAB, as the combination improves symptoms compared to each modality alone. Practice Recommendation Bladder education (normalizing the micturition interval) should be recommended to patients with mild urge urinary incontinence. The evidence supporting this recommendation is based on the meta-analysis of 13 randomized/quasi-randomized clinical trials (n=1170) in adults with OAB or UUI in which at least one management arm involved a non-drug new therapy. Grade A EBM Source: Alhasso AA, et.al. Anticholinergic drugs versus non-drug active therapies for overactive bladder syndrome in adults. Cochrane Database Syst Rev 2006, Issue 4. Art. No.: CD Practice Recommendation Pelvic-floor muscle training should be included in the first-line management of women with stress, urge, or mixed urinary incontinence. Future RX of OAB Posterior Tibial nerve stimulator (same nerve root as bladder control) BoTox (effective, even beyond 2 yrs with repeated injections at least 12 wks apart) Sacral Neuromodulation For patients who fail standard therapy Success At age 4 success is...not peeing in your pants At age 12 success is...having friends At age 16 success is...having a driver s license At age 20 success is...having sex Age age 35 success is...having money Success At age 50 success is... having money At age 60 success is... having sex At age 70 success is... having a driver s license At age 75 success is...having friends At age 80 success is...not peeing in your pants 12

13 Websites for Additional Information on OAB National Kidney and Urologic Diseases Information Clearinghouse (NKUDIC): kidney.niddk.nih.gov/kudiseases/pubs/uiwomen/index.htm National Association for Continence: References National Kidney and Urologic Diseases Information Clearinghouse (NKUDIC): kidney.niddk.nih.gov/kudiseases/pubs/uiwomen/index.htm Frequently asked questions in the evaluation & management of overactive bladder. Supplement to The Journal of Family Practice. Oct. 2009;58:S1-S Chapple CR, et al. The effects of antimuscarinic treatments in OAB. Eurpoean Urology. 2008;54: Muscarinic Receptor Distribution Iris/ciliary body CNS Blurred vision Lacrimal gland Dry eyes EXTRAS Dizziness Somnolence Salivary glands Dry mouth Impaired memory and cognition Heart Tachycardia Stomach and esophagus Dyspepsia Colon Constipation Bladder (detrusor muscle) Efficacy of Antimuscarinic Agents Meta-analyses indicate that use of antimuscarinic agents in adults: Results in statistically significant improvement in OAB symptoms compared to placebo In combination with bladder training, results in increased OAB symptom improvement during initial treatment as compared to each modality alone Impact of OAB on the Patient Poses significant quality-of-life issues 1 May affect: Physical function Daily activities Social interactions Most OAB sufferers use coping strategies: Planned voiding Travel restriction Fluid restriction Seeking bathroom locations 13

14 Comorbidities Associated with OAB Risk Factors for OAB Depression Sleep deprivation Urinary tract infections Skin breakdown Orthopedic injuries (from falls related to urgency and nocturia) Obesity Age Trauma Cognitive Impairment Prolapse Parity Surgery OSA Neurologic disease/injury Stress and Urge Incontinence Screening Questions During the last week, how many times did you accidentally leak urine with A physical activity like coughing, sneezing, lifting, or exercising? A feeling of strong, sudden need to pass your urine that did not allow you to get to the toilet fast enough? Primary Underlying Causes of Incontinence Urge Incontinence Detrusor instability Stress Incontinence Diminished urethral sphincter function and/or Urethra hypermobility Urge Stress UI Occurs When Bladder Pressure > Urethral Pressure Any factor that pushes the equation towards a positive urethral pressure gradient has the potential to be effective Cough Control, Weight Loss Surgery Exercises, Medication Pathophysiology Enhanced Rxn to wall tension & stretching of detrusor muscle Leads to increased afferent signaling Increased Ach release Increased sensitivity of detrusor to neurotransmitters More detrusor activity 14

15 Epidemiology of OAB One-third of US adults with OAB experience UUI 1 UUI affects as many as 20% of US women aged 75 and older 1 Total cost of UUI in 2000 estimated at $32 billion 2 Behavioral Interventions: General Considerations Safe, inexpensive, comfortable for patient Efficacy influenced by patient: Motivation and commitment Time constraints Ability to identify and contract pelvic muscles Condition of pelvic muscles (e.g., age-associated atrophy, denervation) Lifestyle Interventions: Decreasing Caffeine Intake No association shown between UI and consumption of coffee or alcohol 1 Caffeine intake > 400 mg/day has been associated with detrusor instability 2 Reducing or restricting caffeine intake may help reduce UI, especially in patients with high intakes (> 5 drinks/day) Caffeine intake should be tapered slowly to avoid the onset of migraine-type headaches All antimuscarinic agents Increase volume to 1 st contraction Increase time between voids Decrease contraction magnitude Do not eliminate contractions Do not increase warning time Oxy Patch Muscarinic blockade: Non-selective Name : Oxytrol Dosing: 3.9 mg patch 2X/week Dry Mouth: 5-10% Blood Brain barrier: Crosses Also comes in immediate release, & extended release PO Tolteradine ER Muscarinic blockade: Non-selective Name : Detrol LA Dosing: 4 mg Q Day Dry Mouth: 7-25% Blood Brain barrier: Crosses Also comes in immediate release 15

16 Trospium Muscarinic blockade: Selective Name : Sanctura Dosing: 20 mg BID or 60 mg Q Day Dry Mouth: 20% Blood Brain barrier: Minimal Darifenacin IR Muscarinic blockade: Selective Name : Enablex Dosing: mg Q Day Dry Mouth: 20-35% Blood Brain barrier: Minimal Fesoterodine Muscarinic blockade: Non-selective Name : Toviaz Dosing: 4-8 mg Q Day Dry Mouth: 7-25% Blood Brain barrier: Crosses Active metabolite is tolteradine Solifenacin Muscarinic blockade: Selective Name : Vesicare Dosing: 5-10 mg Q Day Dry Mouth: 11-28% Blood Brain barrier: Minimal??QUESTIONS?? Contact Info Benroe.blount@jencaremed.com bwbloun@emory.edu , if you are looking for a job 16