Improving Diagnosis and Treatment of OAB Through Screening, Defining Goals and Customizing Treatment

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1 Improving Diagnosis and Treatment of OAB Through Screening, Defining Goals and Customizing Treatment Pamela Ellsworth, MD Professor of Urology UMassMemorial Medical Center/University of Massachusetts Medical School Disclosures PRIOR to November 2013 Advisory Board Member: Pfizer Allergan Astellas Speaker Pfizer Clinical Trials Pfizer CURRENTLY - none 1

Objectives Review OAB population and useful screening tools for OAB Evaluate treatment and patient goals to customize treatment Assess side effects of therapy and how to optimize outcomes Assess

2 Objectives Review OAB population and useful screening tools for OAB Evaluate treatment and patient goals to customize treatment Assess side effects of therapy and how to optimize outcomes Assess recommendations from guidelines on pharmacologic and non-pharmacologic treatment options Analyze information on new and emerging therapies 52 yr old female who complains of Frequency 12+ times per day Urgency - I barely get there in time UUI I wont go on a long car trip for fear I will have an accident Urine leakage with cough, laugh, sneeze DOES SALLY HAVE OAB? Sally s Trips to the Toilet I spend more time rushing to the bathroom 2

3 Symptoms Differential Diagnosis: OAB and Stress Incontinence Medical History and Physical Examination Symptom Assessment Overactive Bladder Stress Incontinence Urgency (strong, sudden desire to void) Yes No Frequency with urgency (> 8 times/24 h) Leaking during physical activity; eg, coughing, sneezing, lifting Amount of urinary leakage with each episode of incontinence Ability to reach the toilet in time following an urge to void Yes No Large (if present) Often no No Yes Small Yes Waking to pass urine at night Usually Seldom Abrams P, Wein AJ. The Overactive Bladder: A Widespread and Treatable Condition. Erik Sparre Medical AB; Urinary Incontinence Mixed Incontinence Overactive Bladder Stress Urge Incontinence Incontinence Frequency Urgency 37% Stewart WF, et al. World J Urol. 2003;20:

4 Is Sally at Risk for OAB? Risk Factors for OAB The most common risk factor for OAB is increasing age Other common risk factors include: Obesity White people are at greater risk Depression is associated with OAB Individuals on hormone replacement therapy Neurogenic OAB may be secondary to Multiple sclerosis Parkinson s disease Dementia Spinal cord injury CVA Diabetes (DuBeau CE. Urol Clin North Am Feb 1996; 23(1): 11-8) OAB V-8 Questionnaire A Simplified Screening Tool OAB V-8 comprises first 8 items of OAB-q Validated as a screening tool in primary care settings Patients rate how bothered they are by frequency, urgency, nocturia and UUI on scale of 0 to 5 (not at all; a very great deal) Linguistically validated in 40+ other languages Reliability, validity and responsiveness demonstrated in clinical trials OAB V-8 and other clinical research and patient management tools can be accessed for free at Coyne KS, et al. Urology 2006;68(Suppl 2A):

5 BUT THIS CAN BE FURTHER SIMPLIFIED.. First simply ask Is your bladder causing you any problems? Do you have trouble controlling your urine? Evaluating OAB AUA/SUFU Guideline Diagnostic process to document symptoms and signs that characterize OAB Exclude other disorders that could be the cause of the patient s symptoms Minimum requirement careful history, physical examination and urinalysis Gormley EA et al. Diagnosis and treatment of overactive bladder (non neurogenic) in adults: AUA/SUFU Guideline. 5

Evaluating OAB A Simplified Approach Initial Evaluation Focused history Exam focused physical Abdominal Pelvic Neurologic Urinalysis Degree of bother Supplemental Aids Bladder diary

6 Evaluating OAB A Simplified Approach Initial Evaluation Focused history Exam focused physical Abdominal Pelvic Neurologic Urinalysis Degree of bother Supplemental Aids Bladder diary Post void residual GOAL to rule out other conditions which may cause/mimic OAB Wein AJ. Urology. 2003;62 Suppl 2: Ouslander JG. N Engl J Med. 2004;350: Bladder Diary NIDDK 6

7 Sally PMH/SH: hypertension, elevated cholesterol, obesity Med: diuretic, beta-blocker, cholesterol lowering agent ROS: SUI: not bothersome I can control that with a Kegel and a pad bowels regular PE: normal Lab evaluation: urinalysis - normal Further Evaluation? Urodynamics, cystoscopy, US not indicated in initial eval of uncomplicated pt. Post void residual Not necessary if being treated with first-line behavioral interventions or uncomplicated patients Necessary - obstructive sx, hx of incontinence or prostatic surgery, neurologic dz and in men with sx prior to starting antimuscarinic therapy (Gormley EA et al. Diagnosis and Treatment of Overactive Bladder (Non-neurogenic) in Adults: AUA/SUFU Guideline. 7

Red Flags on Evaluation Frequent UTIs Sensation of Incomplete emptying, straining to void Significant pelvic organ prolapse Prior pelvic surgery or radiation therapy Hematuria Neurologic conditions

8 Red Flags on Evaluation Frequent UTIs Sensation of Incomplete emptying, straining to void Significant pelvic organ prolapse Prior pelvic surgery or radiation therapy Hematuria Neurologic conditions which may affect bladder function Is NOT a disease Overactive Bladder It is a SYMPTOM COMPLEX Urgency -sudden compelling desire to void that is difficult to defer Frequency ( 8 or more micturitions in 24 hrs) Urgency Urinary Incontinence +/- nocturia 8

9 Prevalence of OAB Symptoms 1 in 3 US adults 40 years of age reported symptoms of OAB at least sometimes Respondents (%) Age (years) Coyne S, et al. Urology. 2011;77:

10 Coping with OAB OAB is more than Urinary Frequency, Urgency and Urgency Urinary Incontinence 10

OAB Has a Considerable Impact on QoL 90 80 SF-36 Score 70 60 50 40 10 0 Healthy Diabetes

intimacy Occupational Absence from work Decreased productivity Physical Limitations or

self-esteem Fear of Being a burden Lack of bladder control Urine odor Social Reduction in

11 OAB Has a Considerable Impact on QoL SF-36 Score Healthy Diabetes Depression OAB Kobelt G, et al. BJU Int 1999;83: Komaroff AL, et al. Am J Med 1996;101: Impact of Overactive Bladder on Quality of Life Sexual Avoidance of sexual contact and intimacy Occupational Absence from work Decreased productivity Physical Limitations or cessation of physical activities Quality of Life Psychological Guilt/depression Loss of self-esteem Fear of Being a burden Lack of bladder control Urine odor Social Reduction in social interaction Limit and plan travel around toilet accessibility Domestic Require specialized underwear, bedding Special precautions with clothing Tubaro A. Urology. 2004;64(6 suppl 1):

12 The Economic Impact 2007 annual per capita cost of OAB estimated to be $1925 (75% direct medical costs, 22% lost productivity, 4% direct nonmedical costs) = $ 65.9 billion for estimated 34 million with OAB in US projected per capita cost of OAB $1970 (direct medical costs 77%) = $76.2 billion in 2015 and $82.6 billion in Patient-based studies in US 528 F (mean age 58yr) mean wkly direct cost of routine care/pt in 2005 was $6.02 for UUI, $3.91 for SUI, and $6.35 for MUI women reporting any UUI-assoc costs, mean cost of routine care $10.59/wk 3 1 Ganz ML et al. Urology 2010; 2 Subak L et al. Am J Obstet Gynecol 2007; 3 Subak L et at. Obstet Gynecol 2006 Treatment of OAB Education Management Strategies Behavioral Modification OAB Treatment Medications Surgical Procedures Borello-France D, Burgio KL. Clin Obstet Gynecol. 2004;47: Gross M, et al. Curr Urol Rep. 2002;5: Rovner ES, et al. Women s Health in Primary Care. 2000;3: Sahai A, et al. Neurourol Urodyn. 2005;1: Accessed April 6,

13 Management Strategies and Patient Education Education regarding normal bladder function OAB is a symptom complex with variable and chronic course Identify treatment goals what you as the provider thinks is important may not be the patient s goal Setting patient expectations Getting better versus getting cured Often task oriented for patient instead of number (ie watch a movie without interruption) Borello-France D, Burgio KL. Clin Obstet Gynecol. 2004;47: Gross M, et al. Curr Urol Rep. 2002;5: Rovner ES, et al. Women s Health in Primary Care. 2000;3: Sahai A, et al. Neurourol Urodyn. 2005;1: Accessed April 6, Sally s Goals She is aware that treatment of her SUI would require surgery as she is no better with pelvic floor muscle exercises I am always going to need to wear a pad so the incontinence is not a significant bother I want to be able to go someplace without having to stop several times on the way and worry about where the restrooms are MUI - Identify which is more bothersome SUI or UUI and treat that first 13

14 Education Diet Modifying bladder function by changing voiding habits Timed voiding Delayed voiding Behavioral training First- Line Treatments: Behavioral Therapies Pelvic floor muscle therapy Biofeedback Burgio KL, et al. JAMA. 2002;288: Borello-France D, Burgio KL. Clin Obstet Gynecol. 2004;47:70-82.; Gormley EA et al. Diagnosis and Treatment of Overactivbe Bladder (non-neurogenic in adults: AUA/SUFU Guideline. Fluids Dietary Regulation Alcoholic beverages Carbonated beverages Soda caffeine Milk milk products Coffee even decaffeinated Tea Citrus juice Fluid restriction WATER IS THE BEST Foods Citrus fruits Tomatoes Tomato-based products Highly spiced foods Sugar Honey Chocolate Corn syrup Artificial sweeteners 14

15 Impact of Behavioral Modifications 8% weight loss in obese women reduced incontinence episodes per week by 47% (28% in control group), decreased UUI episodes by 42% (26% in controls) 25% reduction in fluid intake reduced frequency and urgency Reducing caffeine intake decreases voiding frequency (Subak LL et al. NEJM 2009; 360: 481; Hashim H, Abrams P. BJU Intl 2008, 102: 62; Bryant CM et al. Br J Nurs 2002; 11: 560) Behavioral Therapies Generally equivalent to or superior to medications in reducing incontinence episodes, improving voiding parameters and QoL (Jarvis GJ. BJU 1981; 53: 565; Burgio KL et al. J Am Geriatr Soc 2011; 59: 2209; Goode PS et al. J Am Geriatr Soc 2002; 50: 808; Kaya S et al. Clin Rehabil 2011; 25: 327;Arruda RM et al. Int Urogynecol J Pelvic Floor Dysfunct 2008; 19: 1055; Colombo M et al. Int Urogynecol J 1995; 6: 63; Burgio KL et al. JAMA 1998; 280: 1995; Song C et al. J Korean Med Sci 2006; 21: 1060; Kafri R et al. Int Urogynecol J Pelvic Floor Dysfunct 2007; 18: 407; Johnson TM et al. J Am Geriatr Soc 2005; 53: 846; Gormely EA et al. Diagnosis and Treatment of Overactive Bladder (non-neurogenic) in Adults: AUA/SUFU Guideline. 15

Second Line Therapy Pharmacotherapy Muscarinic Receptor-Mediated Effects In the Detrusor In the detrusor, the postjunctional M 3 receptor is the predominant subtype mediating contraction Role of M 2

16 Second Line Therapy Pharmacotherapy Muscarinic Receptor-Mediated Effects In the Detrusor In the detrusor, the postjunctional M 3 receptor is the predominant subtype mediating contraction Role of M 2 not fully understood M 3 receptor antagonism Stabilizes bladder (detrusor) muscle Increases bladder capacity Diminishes frequency of involuntary bladder contractions Delays initial urge to void Andersson KE, Yoshida M. Eur Urol. 2003;43:

Not All Antimuscarinic Agents Are the Same All antimuscarinics are effective for treatment of OAB symptoms Individual differences exist in the

exist in the route of administration topical and oral Chapple C et al. Eur Urol. 2005;48(1):5-26. Staskin DR. Drug Aging. 2005;22:1013-1028.

17 Not All Antimuscarinic Agents Are the Same All antimuscarinics are effective for treatment of OAB symptoms Individual differences exist in the profiles of antimuscarinics There is some evidence of differences among AE profiles There are differences in tolerability profiles Differences exist in the route of administration topical and oral Chapple C et al. Eur Urol. 2005;48(1):5-26. Staskin DR. Drug Aging. 2005;22: Antimuscarinic Agents - Efficacy asad 1) Gormley EA et al. Diagnosis and Treatment of Overactive Bladder (Non-neurogenic) in Adults: AUA/SUFU Guideline. 17

Additive Effect of Combining Behavioral And Drug Therapies 0 Behavioral Therapy Combined Therapy Drug Therapy Combined Therapy Mean Reduction in UI, % 20 40 60 80 57.5% 88.5% 72.7% 84.3% 100 P <.

18 Additive Effect of Combining Behavioral And Drug Therapies 0 Behavioral Therapy Combined Therapy Drug Therapy Combined Therapy Mean Reduction in UI, % % 88.5% 72.7% 84.3% 100 P <.05 P =.001 Burgio KL, et al. J Am Geriatr Soc. 2000;48: Selective beta-3 adrenoceptor agonist Activates beta-3 adrenoceptor on the detrusor muscle of bladder to facilitate filling of bladder and storage Does not affect detrusor contractility Mirabegron 18

19 Mirabegron Prescribing Information Starting dose 25mg with or without food Effective within 8 wks, may increase to 50mg Do not cut, crush or chew Max dose 25mg with severe renal impairment or moderate hepatic impairment ESRD and severe hepatic impairment not recommended Mirabegron is a CYP2D6 inhibitor May increase BP BP checks rec don t use in severe uncontrolled HTN (prescribing information Mirabegron (Myrbetriq), Astellas) 1329 pts were randomized 1:1:1 to placebo, Mirabegron 50mg, and Mirabegron 100mg Mean reduction of incontinent episodes per 24hrs Efficacy data -> patient diaries and QoL assessments Mean reduction number of micturitions per 24hrs Incidence of HTN, UTI, headache & nasopharyngitis was similar in all groups 19

Mirabegron Adverse Events Phase III trials No significant CV events in the mirabegron groups Overall incidence HTN similar across groups No effect on QT interval Dry mouth,

20 Mirabegron Adverse Events Phase III trials No significant CV events in the mirabegron groups Overall incidence HTN similar across groups No effect on QT interval Dry mouth, sim to PBO 3%, tolt 10% Overall, treatment-emergent AEs similar btn PBO, mirabegron (50 and 100mg) and tolt ( EAU 26th Annual Congress: Posters 885 and 886. March 21, 2011) 20

Case 2: Sylvia 78 yr old female with multiple medical problems and OAB Meds hctz, amlodipine, sertraline, calcium, vitamin D, laxative prn Lives alone depends on daughter I worry about being a burden

21 Case 2: Sylvia 78 yr old female with multiple medical problems and OAB Meds hctz, amlodipine, sertraline, calcium, vitamin D, laxative prn Lives alone depends on daughter I worry about being a burden to my daughter, she has enough to do Daughter worries about her falling during her rush to bathroom particularly at night Her OAB is bothersome and pads/diapers are expensive Tried oxybutynin 5mg BID not effective enough and intolerable dry mouth and constipation I take enough medications Can something else be done? I don t drink much fluids during the day why do I still have to go so frequently? Sylvia Fluid intake One cup of caffeinated coffee in am One cup of tea in the afternoon One glass of milk with dinner Bowel history Moves her bowels 2 times per week Takes a stool softener and laxative prn 21

22 AUA/SUFU Guidelines Clinicians should manage constipation and dry mouth before abandoning effective antimuscarinic therapy Minimizing AEs in Patients on Anticholinergics for OAB Baseline bowel function Ask about bowel frequency and stools Many pts fluid restrict in hopes of decreasing frequency, incontinence If infrequent stools/constipation Increase fluid intake Increase dietary fiber Osmotic laxative No improve consider GI evaluation (Toney, Agrawal. Practical Gastroenterology, May 2008) 22

Don t Just Ask Are You Constipated? Character and Frequency Minimizing AEs in Patients on Anticholinergics for OAB- Xerostomia www.essology.

23 Don t Just Ask Are You Constipated? Character and Frequency Minimizing AEs in Patients on Anticholinergics for OAB- Xerostomia has a 23 page list of medications that can cause xerostomia Tips for treating dry mouth Sips cool water throughout the day Drink milk lubricates oral mucosa Restrict caffeine and alcohol intake both cause dry mouth Use of sugar-free gum stimulates saliva flow Saliva sure tables, oral balance, biotene toothpaste, recaldent 23

Xerostomia Therapies Managing OAB in Sylvia

Many commonly prescribed drugs have anticholinergic

anticholinergic toxicity are likely to be

anticholinergic burden No clinically available

24 Xerostomia Therapies Managing OAB in Sylvia Concerns regarding anticholinergic use in elderly Many commonly prescribed drugs have anticholinergic properties Clinical manifestations of anticholinergic toxicity are likely to be nonspecific and reflect the effects of cumulative anticholinergic burden No clinically available laboratory test to assess anticholinergic levels ( 24

25 Drugs With Strong Anticholinergic Properties Antihistamines Antiparkinson agents Skeletal Muscle Relaxants Antidepressants Antipsychotics Antimuscarinics (urinary incontinence) Darifenacin Fesoterodine Flavoxate Oxybutynin Solifenacin Tolterodine Trospium Antispasmodics (AGS Beers Criteria) Third Line Therapies 25

Surgical Procedures: Sacral Nerve Stimulation (Neuromodulation) 2-step process Initial test

sacral nerve FDA approval 1997: Urge incontinence 1999: Urinary retention and urgency/frequency

Curr Urol Rep. 2002;5:388-395. Rovner ES, et al. Women s Health in Primary Care. 2000;3:179-186.

26 Surgical Procedures: Sacral Nerve Stimulation (Neuromodulation) 2-step process Initial test stimulation If good response, permanent stimulator implanted Small doses of electric current sent to sacral nerve FDA approval 1997: Urge incontinence 1999: Urinary retention and urgency/frequency symptoms Borello-France D, Burgio KL. Clin Obstet Gynecol. 2004;47: Gross M, et al. Curr Urol Rep. 2002;5: Rovner ES, et al. Women s Health in Primary Care. 2000;3: Accessed April 6, Image reprinted with permission of Medtronic, Inc. Interstim 26

Interstim Sacral Nerve Stimulation Systematic review - 1996-2003 4 RCTS -80% achieved continence or > 50% improvement in main

after implantation Reoperation rate in implanted cases 33% Relocation of generator due to pain or infection (Brazzelli M et al.

27 Interstim Sacral Nerve Stimulation Systematic review RCTS -80% achieved continence or > 50% improvement in main incontinence sxs after SNS vs 3% of ctrls 30 Case series - 67% patients dry of > 50% improvement in sx Benefits persisted 3-5 yrs after implantation Reoperation rate in implanted cases 33% Relocation of generator due to pain or infection (Brazzelli M et al. J Urol 2006; 175(3 pt 1): Sustained long-term benefit through average of 30.8 months (Janknegt RA et al. Eur urol 2001; 39(1): 101-6) 27

PTNS Advantages Minimally invasive No foreign body Minimal side effects Disadvantage Requires trips to office for rx Percutaneous Tibial Nerve

rx cont for 1 yr and were able to sustain improvement with rx Q 21 days (MacDiarmid SA et al.

28 PTNS Advantages Minimally invasive No foreign body Minimal side effects Disadvantage Requires trips to office for rx Percutaneous Tibial Nerve Stimulation (PTNS) RX protocol once/wk for 12 wks, 30 min/session Pts who respond may require occ rxs to sustain OrBIT Trial 73% pts who responded to rx cont for 1 yr and were able to sustain improvement with rx Q 21 days (MacDiarmid SA et al. J Urol 2010; 183: ) STEP Study statistically significant improvements in OAB sx and QoL at 3 years of treatment compared to baseline. (Peters K J Urol 2013; 189(6): ) Urgent PC Neuromodulation System 28

Onabotulinum Toxin A Onabotulinum Toxin A for OAB and UUI Nitti VW

J Urol 2013; 189(6): 2186-93 Results of phase 3 RCT Significant

001) 22.9% treated with botox became dry vs 6.5% PBO 60.

29 Onabotulinum Toxin A Onabotulinum Toxin A for OAB and UUI Nitti VW et al. J Urol 2013; 189(6): Results of phase 3 RCT Significant decrease in frequency of UUIs/day vs PBO (-2.65 vs -0.87, p<0.001) 22.9% treated with botox became dry vs 6.5% PBO 60.8% treated with botox reported (+) response on treatment benefit scale vs 29.2% PBO, p<0.001 Most common AE UTI 5.4% rate of urinary retention 29

5.4% Required CIC CIC for 6-12 weeks No CIC Repeat injections Median Time Between Injections 1 to 2 = 377 days 2

Re-injection timing not well studied Frequency UDI-6 QOL Urgency Episodes UUI Episodes 1) Sahai A, Dowson C, Khan

2) Gamé X, Khan S, Panicker JN et al: Comparison of the impact on health-related quality of life of repeated

30 5.4% Required CIC CIC for 6-12 weeks No CIC Repeat injections Median Time Between Injections 1 to 2 = 377 days 2 to 3 = 378 days 3 to 4 = 256 days Equivalent Efficacy Frequency Urgency Episodes UUI Episodes QOL Improvement Re-injection timing not well studied Frequency UDI-6 QOL Urgency Episodes UUI Episodes 1) Sahai A, Dowson C, Khan MS et al: Repeated injections of botulinum toxin-a for idiopathic detrusor overactivity. Urology 2010; 75: ) Gamé X, Khan S, Panicker JN et al: Comparison of the impact on health-related quality of life of repeated detrusor injections of botulinum toxin in patients with idiopathic or neurogenic detrusor overactivity. BJU Int 2010; 107:

31 Male LUTS: The Prostate, The Bladder or Both Does OAB exist in men? Can one safely treat OAB in men? Male LUTS George is a 62 yr old male who presents c/o Decreased force of stream, straining to void Frequency, urgency and nocturia Feeling of incomplete emptying DRE enlarged prostate w/out nodules, tenderness UA negative PSA

32 George Started on alpha-blocker Returns to clinic 6 wks later and notes Improved force of stream Doesn t feel the need to strain to void Not sure if he is emptying his bladder because he still notes urinary frequency and nocturia Urgency still present How should George be treated next? Lower Urinary Tract Symptoms (LUTS) Storage Symptoms Urinary frequency Urgency Urge urinary incontinence Voiding Symptoms Slow Stream Intermittency Hesitancy Straining Post Micturition Symptoms Sensation of incomplete emptying Post void dribble 32

33 LUTS in Men Prostate, Bladder or Both? Detrusor overactivity occurs in about 50% of men with bladder outlet obstruction 1 Etiologies BOO leads to cholinergic denervation of detrusor muscle fibers and supersensitivity of muscarinic receptors to acetycholine 2 BOO results in ischemia, increased detrusor collagen content, changes in electrical properties of detrusor smooth muscle and reorganization of spinal micturition reflex 3,4 1 Abrams P et al. Urology 2003; 61: 37-49; 2 Sibley GN. BJU 1987; 60: 332-6; 3 Chapple CR, Roehrborn CG. Eur Urol 2006; 49: 651-8; 4 Steers WD. Rev Urol 2002; 4 suppl 4: S7-S18 BOO is not a prerequisite for OAB in Men Chapple and Roehrborn 2006 concluded: OAB symptoms are highly prevalent in men Prostatic pathology and coexisting OAB symptoms are not always causally related Many men with OAB symptoms do not have BOO (Chapple CR, Roehrborn CG. Eur Urol 2006; 49: 651-8) 33

34 Traditional Treatment of Male LUTS Alpha blockers and 5-alpha reductase inhibitors widely used for treatment of BOO However, many men have persistent storage symptoms What is the role of antimuscarinic agents in male LUTS? What is the role of mirabegron in male LUTS? Use of Antimuscarinic Agents in Males with LUTs Monotherapy few studies available it seems likely that pts with mild obstruction, smaller prostates, low PSA levels, and OAB sx are most likely to benefit from monotherapy with antimuscarinics (Chung DE, Kaplan SA. Arch Esp Urol 2010; Athanasopoulos A et al. Eur Urol 2011) Combination Therapy more frequently studied - Sequential use first treat with alpha-blocker and those with continuing OAB sx add antimuscarinic appears to be most pragmatic decreases poss # meds and unnecessary AEs. (Athanasopoulos A et al. Eur Urol 2011) 34

35 Reference # pts Rx Study type f/up (wk) Efficacy Endpt Kaplan et al 225 Tolterodine + Tamsulosin MacDiamird et al 203 Oxy + Tamsulosin Chapple et al 283 Tolterodine + alpha-blocker Kaplan et al 398 Solifenacin + Tamsulosin Athansasopoul os et al 25 Tolterodine + Tamsulosin Lee et al 68 Tolterodine + Doxazosin Yang et al 33 Tolterodine + Terazosin Mohanty et al 38 Tolterodine + Tamsulosin Wiedemann et al 4382 Tolterodine + alpha-blocker Prospective, RCT, dble-blind Prospective, RCT, dble-blind Prospective, pbo-ctrlled, dble-blind Prospective, pbo-ctrlled, dble-blind Prospective, randomised, Prospective, observational Prospective, randomised Prospective, randomised Prospective, multicentre, open, nonintervention, 12 PPTB (+) B diary(+) IPSS (+total) 12 IPPS (+storage) QoL (+) Uroflow & PVR 12 IPSS (+) Sx bother (+) B diary (+) Uroflow & PVR 12 Bladder diary (+) IPSS (total) Uroflw & PVR 12 UDS (+storage) PFS QoL (+) # cases of retention 2 1b 0 1b 0 1b 7 1b 0 2b 12 IPSS (+) 2 2b 6 IPSS (+storage) Uroflow & PVR 12 UDS (+) PFS Qol (+) B diary(+) IPSS (total) 4 IPSS (+) QoL (+) B diary (+) Pads use (+) 0 2b 0 2b Aldemir et al 45 Tolterodine + Prospective, 12 IPSS (total) 0 3b N/A Level of evidence 3b Role of Mirabegron in Males Otsuki et al 1 eval mirabegron 50mg in OAB unresponsive to antimuscarinics or related to BPH Mirabegron significantly decreased total OAB sx score, day & nite frequency, urinary urgency, urgency incontinence score and IPSS-QoL in pts with newly dxd OAB PVR did not change significantly throughout study Ogura et al 2 eval benefit as add-on rx in men with OAB sx on alpha-blocker End of 4 wk rx, total IPSS and QoL scores significantly improved No significant improvement in total OAB sx scores Nitti et al 3 phase II -eval urodynamic safety in males with LUTS & BOO No negative effect on Qmax and PdetQmax for mirabegron 50 and 100mg compared to PBO 1 patient in PBO and 1 pt on mirabegron 100mg developed acute urinary retention 1 Otsuki H et al. Int Urol Nephrol 2013; 45: 53-60; 2 Ogura K et al. Eur Urol Suppl 2013; 12: e1091; 3 Nitti V et al. J Urol 2013; 190:

36 Conclusion OAB is common Simplified evaluation 3 tiers of therapy First line behavioral Second line pharmacologic Anticholinergic agents Beta3 agonists Third line Onabotulinum toxin A intradetrusor injections Neuromodulation Sacral nerve stimulation Percutaneous tibial nerve stimulation Conclusions Setting appropriate goals and treatment expectations are important Managing side effects is critical No single therapy is ideal for all More than one pharmacologic and third line therapy is available Men with LUTs should be evaluated for BOO and OAB sx treat BOO sx first and if OAB sx persist then treat OAB sx 36

37 Questions? 37

Various Types. Ralph Boling, DO, FACOG

Various Types. Ralph Boling, DO, FACOG Various Types Ralph Boling, DO, FACOG The goal of this lecture is to increase assessment and treatment abilities for physicians managing urinary incontinence (UI) patients. 1. Effectively communicate with