Overactive Bladder. Jennifer Mosher, WHNP-BC, CUNP Mercy Health Pelvic Medicine and Urogynecology Muskegon, Michigan

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1 Overactive Bladder Jennifer Mosher, WHNP-BC, CUNP Mercy Health Pelvic Medicine and Urogynecology Muskegon, Michigan

2 Speaker Disclosure I have nothing to disclose. 2

3 Learning Objectives Define OAB Identify OAB patients Understand OAB treatment options 3

4 Definition of Overactive Bladder International Continence Society: A symptom syndrome of urinary urgency, with or without urge incontinence, usually with increased daytime frequency and nocturia in the absence of a pathologic or metabolic condition. 4

5 Normal Bladder Function 5

6 So what causes OAB? Urinary tract infections Interstitial cystitis Benign prostatic obstruction Spinal cord injury OAB Transitional cell carcinoma Anxiety disorders 6

7 OAB Symptoms ICS 7

8 OAB Prevalence In the US, OAB affects more than 15% of adults older than 40 years. Prevalence increases with age. Association of OAB with depression and increased fall risk 8

9 OAB Prevalence Increasing age Female sex Obesity Impaired functional status Depression Recurrent UTI Diabetes Some neurologic disorders Bladder symptoms in childhood are associated with overactive bladder, with or without urgency urinary incontinence September 2010, NEJM 9

10 OAB Burden Urinary incontinence results in more than $20 billion in health care costs annually. Incontinence is associated with: Falls Fractures Increased caregiver burden Increased nursing home care 10

11 Identifying OAB Patients 11

OAB Assessment Patient evaluation: History: onset, duration, characteristics, surgeries Physical exam: vaginal, rectal, functional, cognitive Urinalysis: persistent, recurring or new UTI?

12 OAB Assessment Patient evaluation: History: onset, duration, characteristics, surgeries Physical exam: vaginal, rectal, functional, cognitive Urinalysis: persistent, recurring or new UTI? Voiding log: frequency, incontinence, fluid intake Post void residual Medication review Previous treatment and responses Co-morbidities Environmental considerations Lifestyle contributions Rule out transient causes of OAB 12

13 Effects of other medications on bladder function 13

14 AUA/SUFU Guidelines for OAB Purpose: Provide direction for clinicians Conduct a valid diagnostic process and approach to treatment This guide was created to serve as a guide to all types of providers who evaluate and treat OAB Conducted as part of the Agency for Healthcare Research and Quality (AHRQ) Evidence Report Treatment of OAB in Women (2009) Literature search from , & then an AUA amendment process from Jan 2012-Feb

15 Diagnosis and Treatment Algorithm: AUA/SUFU 15

16 OAB Treatment OAB may compromise quality of life but generally does not affect survival Weigh benefit versus risk with all treatments Duration of potential AE s Reversibility of AE s Overactive bladder symptoms are rarely cured, however symptoms and quality of life can usually be improved upon. All patient s deserve education regarding their condition Be very sure you have the right diagnosis!!! 16

Treatment Considerations Patient goals: Be realistic Start with short term goals Individualized approach: Cognition Mobility Realization that OAB is a chronic

17 Treatment Considerations Patient goals: Be realistic Start with short term goals Individualized approach: Cognition Mobility Realization that OAB is a chronic syndrome without an ideal treatment and no treatment will cure the condition in most patients Be prepared to manage the transitions between treatment levels appropriately 17

18 OAB Treatment Options 18

19 OAB Treatment Goals Reduction / elimination of urgency incontinence episodes Reduction in number of urgency episodes Increase time interval between voids Set realistic treatment goals Understand that progress is gradual 19

First Line Treatment for OAB: Behavioral Interventions Avoid bladder irritants: Caffeine, artificial sweeteners, grapefruit/juice Tomatoes, spices, citrus, excessive milk, alcohol Encourage healthy

20 First Line Treatment for OAB: Behavioral Interventions Avoid bladder irritants: Caffeine, artificial sweeteners, grapefruit/juice Tomatoes, spices, citrus, excessive milk, alcohol Encourage healthy habits: Weight loss, Smoking cessation Fluid management: 6-8 cups per day for the incontinent person Creatively space fluids throughout the day Avoid fluids after supper or 3 hours before bedtime Use diuretics judiciously and not before bedtime Elevate legs before bedtime in patients with edema Make toilet easier to get to: bedside commode, urinal Bladder re-training with urge reduction techniques 20

Pelvic Muscle Rehabilitation Kegel exercises alone: 56%- 95% effectiveness (cognitively intact) Kegel exercises with biofeedback: 54%-87% effectiveness

21 Pelvic Muscle Rehabilitation Kegel exercises alone: 56%- 95% effectiveness (cognitively intact) Kegel exercises with biofeedback: 54%-87% effectiveness (cognitively intact) Kegel exercises use of the ball (cognitively impaired) Kegel exercises pelvic floor stimulation (efficacy varies with type of UI and length of tx) 21

22 Bladder Training Prompted Voiding Caregiver dependent Definition: Specific behavioral protocol with opportunity to toilet at regular intervals Opportunity (prompt) to toilet every 2 hours Toileting assistance if requested Social interaction and verbal feedback Habit Training Voiding according to one s schedule Use bladder records as guideline 86% effective Can be caregiver dependent Re-Training Use of Kegel exercises, urge reduction techniques and timing

23 Effectiveness of OAB Behavioral Interventions 50-80% reduction in the frequency of incontinence with use of pelvic floor therapy, toileting programs and specific techniques to control urgency and empty the bladder. 47% reduction in incontinence with 8% weight loss 25% reduction of fluids and bladder irritants will result in decreased frequency and urgency No single component of behavioral therapy appears to be essential or superior to efficacy. Evidence strength B 23

24 First Line Treatment Behavioral therapy presents essentially NO RISKS to patients and should be offered to ALL. Behavioral therapies may be combined with pharmacologic management. (Evidence Strength C) 24

Second Line Treatments Oral anti-muscarinics or oral β 3 -adrenoceptor agonists Several factors influence the decision to use pharmacologic therapy Proper diagnosis Degree and bother of symptoms

25 Second Line Treatments Oral anti-muscarinics or oral β 3 -adrenoceptor agonists Several factors influence the decision to use pharmacologic therapy Proper diagnosis Degree and bother of symptoms Discomfort, distress, complications Risk for side effects Responsiveness to toileting Cost Best candidates are patients who attempt to toilet, but remain wet Compliance Use of other medications 25

26 OAB Drug Comparison Medication Adverse Events ( > 5%) Tolterodine (Detrol )LA 2 mg/4 mg Dry mouth 23% Headache 6% Constipation 6% Oxybutynin (Ditropan IR) Oxybutynin (Ditropan XL (Extended release) 5 mg/10 mg/15 mg Oxybutynin (Gelnique ) 3%/10% Darifenacin (Enablex ) 7.5 mg/15 mg Dry mouth 29% Diarrhea 7% Constipation 7% Headache 6% Dry mouth 7% UTI 7% Constipation 21% Dry mouth 19% Headache 7% Mirabegron (Myrbetriq) 25mg/50mg Hypertension 11.3% Nasopharyngitis 3.5% UTI 4.2% Oxybutynin (Oxytrol ) Patch Site pruritis 21% Site erythema 8% Trospium (Sanctura )20 mg Dry mouth 20% Drug/ Drug Interactions Half-Life Comments None 8 hours Oral meds cannot be crushed Studies not conducted 12 hours Likely to cross blood brain barrier Studies not conducted Digoxin, Ketoconazole, Clarithromycin, etc Not recommended for elderly hours Highest percentage of constipation of all drugs in the class (see Package Insert) Drugs metabolized by 50 hours 1 st of new class of OAB drugs: β3 Agonist CYP2D6 (e.g., Metoprolol Fewer gastrointestinal side effects and Desiprimine), Digoxin Studies not conducted 7-8 hours More convenient form of delivery Fewer gastrointestinal side effects None 20 hours Must take on an empty stomach Trospium sulfate (Sanctura )XR 60 mg Fesoterodin (Toviaz ) 4 mg/8 mg Constipation 10% Dry mouth 19% Constipation 5% Other antimuscarinics and anticholinergics 7 hours Hot environment caution Solifenacin (Vesicare ) 5 mg/10 mg Dry mouth 10.9% Constipation 5.4% None 50 hours Lowest percentage of side effects Increase in warning time 26

27 Potential Adverse Effects of Anti-muscarinic Drugs Iris/ciliary body = blurred vision CNS Lacrimal gland = dry eyes Dizziness Somnolence Impaired cognition Salivary glands = dry mouth Heart = tachycardia Stomach = dyspepsia Colon = constipation Bladder = retention Adapted from Abrams P et al. The Overactive Bladder- A Widespread and Treatable Condition

Mirabegron Beta 3 adrenergic agonist Relaxes the smooth muscle during the storage phase of fill cycle by activation of beta-3 AR which increases bladder capacity Dosed at 25 and 50 mg, once daily

28 Mirabegron Beta 3 adrenergic agonist Relaxes the smooth muscle during the storage phase of fill cycle by activation of beta-3 AR which increases bladder capacity Dosed at 25 and 50 mg, once daily Effectiveness within 8 weeks Side effects minimal Hypertension, nasopharyngitis, UTI, headache No food effects Drug interactions: CYP206, digoxin Use with caution in bladder outlet obstruction No contraindications Not recommended with severe renal impairment or moderate hepatic impairment 28

29 Frail OAB Patient Always use caution in prescribing OAB medications in the frail OAB patient. The use of OAB medications may in these patients may have a lower therapeutic index and a higher adverse drug event profile. For example: A 2016 study of adults older than 65 who were exposed to 5mg/day of oxybutynin for more than 3 years had a 23% increased risk for dementia, compared to low risk or no exposure groups. Frail patients: Mobility deficits (require support to walk, have slow gait speed, difficulty raising without assistance. Weight loss and weakness without medical cause Cognitive defects 29

30 Atrophic Vaginitis/Urethritis Vaginitis: topical, vaginal estrogen Urethritis: one fingertip of estrogen cream to urethra every other HS There is evidence that vaginal estrogen helps with urge urinary incontinence 30

$Refractory OAB Patients who are refractory to behavioral and pharmacologic therapy should be$

31 Refractory OAB Patients who are refractory to behavioral and pharmacologic therapy should be evaluated by an appropriate specialist if they desire additional therapy. -AUA/SUFU Guidelines 31

$Refractory Overactive Bladder (AUA/SUFU Definition) Patient who has failed a trial of symptom appropriate treatments 8-12 week trial of$

32 Refractory Overactive Bladder (AUA/SUFU Definition) Patient who has failed a trial of symptom appropriate treatments 8-12 week trial of behavioral therapy 4-8 week trial of at least one antimuscarinic Failure is based on efficacy and/or inability to tolerate adverse effects Refractory OAB 32

33 Third Line Therapies OnabotulinimtoxinA (BOTOX ) Sacral Nerve Stimulation (InterStim ) PTNS (Urgent PC or NURO system)

(PTNS ) or central (Interstim ) Consider treatment after failures of behavior modification,

34 Neuromodulation: A summary Safe and effective Mechanism of action: electrical stimulation modulates somatic afferent inhibition of sensory processes, mode of application: peripheral (PTNS ) or central (Interstim ) Consider treatment after failures of behavior modification, pelvic floor therapy and medications Documentation of all treatments including bladder diaries required 34

35 Percutaneous Tibial Nerve Stimulation (PTNS) Minimally invasive therapy Therapy delivered in office setting, 30 minutes Therapy can be delivered by NP/RN or PA under physician s direction (need MD order) Series of 12 treatments, typically once a week Non-drug, non-surgical therapy Adverse events relatively uncommon site pain, skin inflammation, bleeding at the site Used for OAB patients who Do not want drugs Cannot tolerate drug therapy Failed conservative therapy including two medications 35

PTNS Mechanism of Action Posterior tibial

tibial nerve to the sacral nerves stimulating

36 PTNS Mechanism of Action Posterior tibial nerve arises from L4-S3 spinal roots L4-S3 nerve roots innervate the bladder and pelvic floor Impulses travel from the ankle along the tibial nerve to the sacral nerves stimulating the afferent pathway traveling to the sacral nerve plexus

37 Patient Preparation for PTNS Review of the process Contraindicated in pregnancy, with pacemaker or internal defibrillator, peripheral nerve damage, diabetic neuropathy What to expect General efficacy Length of treatments 12 weeks On-going, variable according to patient need Continued commitment to behavioral treatments Bladder records, initial, 6th visit and end of 12th visit Maintained on drugs until 5th visit, wean, off at 7th visit if symptoms better 37

38 PTNS Moderate to severe baseline UI with refractory OAB symptoms Studies report 1-3 UI, 2-5 frequency and 1-2 nocturia episodes, QoL Compared to Tolterodine (2010), with Tolterodine to SHAM (2010), and long term (52 weeks) with positive results 77% maintained improved results after 3 years (Peters, K. 2013) Improvements maintained as long as treatment maintained 38

Sacral Nerve Stimulation: InterStim An implantable system that stimulates the sacral nerves modulating the neural reflexes that influences the bladder, sphincter, and pelvic floor Indications: SNS is

39 Sacral Nerve Stimulation: InterStim An implantable system that stimulates the sacral nerves modulating the neural reflexes that influences the bladder, sphincter, and pelvic floor Indications: SNS is used to treat urinary retention, fecal incontinence and the symptoms of OAB, including urinary urge incontinence and significant symptoms of urgencyfrequency in patients who have failed or could not tolerate more conservative therapies. 39

40 SNS: Theory of Mechanism The InterStim system electrically stimulates the sacral nerve which is thought to normalize neural communication between the bladder and brain and between the bowel and brain. Urge incontinence: Modulation enables more normal detrusor muscle behavior Urgency-frequency: Modulation helps reduce detrusor and pelvic floor muscle spasticity Non-obstructive urinary retention: inhibition of the guarding reflex Fecal incontinence: offers both motor and sensory improvements 40

41 SNS: Patient Selection Failure of first and second line therapy Moderate to severe symptoms Cognitively able to use the remote device to maximize treatment Psychiatric status Accept the fact that diagnostic MRIs below the neck are contraindicated Patient expectations Be aware of adverse events including additional surgeries, periodic replacement of battery, fracture of lead wires, infection Multiple sclerosis, back or neurological problems Consider co-morbidities and benefits versus risk/burden Contraindications: Outlet obstruction, bladder cancer, severe debility, inadequate response to testing, unstable 41

42 SNS Evaluation Basic Evaluation (also referred to as Peripheral Nerve Evaluation or PNE): initiated through a simple, in-office procedure Trial up to 7 days Advanced Evaluation (also referred to as Stage 1): is initiated through an outpatient procedure performed in a hospital or surgical center. Trial is 1-2 weeks Both: Both evaluations are short-term, and the effects are reversible by removing the leads or turning off the device. a portable, external stimulator generates the stimulation which is delivered via a lead the patient wears this stimulator throughout the evaluation Patients complete a symptom diary prior to the evaluation to establish a baseline measure of incontinence; and during the evaluation to measure improvement. Complications can occur with the evaluation, including movement of the wire, technical problems with the device, and some temporary pain. 42

43 SNS: Basic Evaluation 43

SNS: Advanced Evaluation Either evaluation allows patients to try the therapy and assess not only its efficacy but also its tolerability and sensation so that they and their provider can make an

44 SNS: Advanced Evaluation Either evaluation allows patients to try the therapy and assess not only its efficacy but also its tolerability and sensation so that they and their provider can make an educated decision whether or not to proceed with an InterStim system implant. In general, the evaluation is considered a success if the patient experiences a significant reduction in his or her bladder control. 44

45 Advantages and Disadvantages of SNS Advantages Long-Term Relief Effective Continuous therapy: 24 hr/day stimulation Restoration of bladder function/retraining bladder Possible improvement other symptoms Interstitial Cystitis, Bladder pain, Bowel incontinence Testable Reversible Disadvantages Complex placement Multiple steps required Need for intraoperative placement Implantable Foreign Body Expensive Adverse effects Site infection Migration/ lead disruption Site Pain (15%) Battery depletion Undesirable location or change in stimulation (22%) Need for additional surgery 45

46 InterStim Efficacy Sustained at 5 years Defined as 50% improvement in symptoms and QOL Mean reduction 2 leaks/day, 5.4 voids/day, 39% continent 67% therapeutic success, 82% using completers analysis 85% patient satisfaction 46

47 PTNS vs. SNS Efficacy: improvement and cure rates PTNS SNS 59-88% 37-79% * *Reported for implanted patients only Technique OP: 12 treatments, 30 min each No anesthesia Evaluation of lead placement: motor and sensory responses (toes/feet) OP: 1st stage testing in office ~30min procedure, local anesthesia, single wire stimulation through S3 foramen (vagina, scrotum, rectum, toe flex) Staged procedure in OR Permanent implantation in OR Contraindications Adverse events Pts with defibrillators, pacemakers, prone to excessive bleeding, nerve damage, pregnancy Rare: minor bleeding, pain or bruising at site Pts with neurological diseases, defibrillators, pacemakers, diathermy, pregnancy. Use in MRI Infection, pain at implantation site, lead migration, urinary and bowel problems Post treatment No restrictions Activity restricted 3-6 weeks post-op 47

48 OnabotulinumtoxinA (Botox) Intradetrusor onabotulinumtoxina (100 units) can be offered as a third-line treatment in the carefully selected and thoroughly-counseled patient who has been refractory to first and second line OAB treatments. The patient must be able and willing to return for frequent post-void residual (PVR) evaluation and able and willing to perform self-catheterization if necessary Evidence Strength B 48

49 OnabotulinumtoxinA (Botox) Define: Acetylcholine release inhibitor and a neuromuscular blocking agent FDA approved usage for: Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition e.g. spinal cord injury or multiple sclerosis Treatment of idiopathic overactive bladder with symptoms of urge urinary incontinence, urgency and frequency in patients who cannot use or do not adequately respond to anticholinergic medications 49

Dosage and Administration of Botox OAB: 100

5 ml (5 units) injections across 20 sites into

Treatments can be repeated after 12 weeks.

Overactivity associated with a Neurologic

50 Dosage and Administration of Botox OAB: 100 units as 0.5 ml (5 units) injections across 20 sites into the detrusor. Treatments can be repeated after 12 weeks. Mean repeat time is 24 weeks Detrusor Overactivity associated with a Neurologic condition: 200 units and should not be exceeded Treatments can be repeated after 12 weeks. Mean time to re-injection was weeks 50

51 OnabotulinumtoxinA (Botox) Adverse Reaction Patients with OAB Botox 100 u (N=552) Urinary tract infection 99 (18%) diabetics 25 (31%) Placebo (N=542) 8 (12%) Dysuria 50 (9%) 36 (7%) Urinary retention 31 (6%) 2 (0%) Bacteriuria 24 (4%) 11 (2%) Residual urine volume 17 (3%) 1 (0%) Adverse Reaction OAB with Neurologic Disease Botox 200 u (N=262) Placebo (N=272) Urinary tract infection 64 (24%) 47 (17%) Urinary retention 45 (17%) 8 (3%) Hematuria 10 (4%) 8 (3%)

OnabotulinumtoxinA (Botox) Efficacy Proven effective Variation in data 4-6 weeks: Improvement seen 60-80% patients» Reduction in symptoms by at least 50% Average

52 OnabotulinumtoxinA (Botox) Efficacy Proven effective Variation in data 4-6 weeks: Improvement seen 60-80% patients» Reduction in symptoms by at least 50% Average decrease 3-5 episodes/day 25% with incontinence dry 12 weeks: frequency: -3.4, incontinence: months: -3.9 episodes/day 3.5 years: frequency -3.8, incontinence

53 Which Third Line Option? Patient-Centered Approach Balance of multiple aspects: Efficacy Side effects/tolerability Time-commitment/Maintenance Co-morbidities QOL Cost Insurance coverage 53

54 Which Third Line Option? 54

55 Which Third Line Option? 55

56 Follow up on OAB Treatment Assess compliance Important to ask patients regarding symptom improvements, adverse events Offer alternatives Use of voiding diaries, validated OAB specific instruments Baseline measures should be the same as on-going measurements Treatment durations should be 4-8 weeks to give the best response 56

57 In Summary Organize a plan of care for your OAB patients Plan should be based on patient goals Patient education is key when it comes to patients ability to make informed decisions Always keep in mind risk/benefit ratios Follow up is critical. OAB is a chronic disease needing on-going support, treatment and changes in direction as required by patient symptoms 57

58 Questions?? 58

Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline.

Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. TARGET POPULATION Eligibility Decidable (Y or N) Inclusion Criterion non-neurogenic OAB Exclusion Criterion