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@ BorawskiKristy Refractory Overactive Bladder @ BorawskiKristy Refractory Overactive Bladder

@ BorawskiKristy Refractory Overactive Bladder - PowerPoint Presentation

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@ BorawskiKristy Refractory Overactive Bladder - PPT Presentation

in Men Kristy M Borawski MD Associate Professor Department of Urology University of North Carolina Overall prevalence of OAB is significant EPIC study 118 with OAB NICE study 1864 yo 3 urinary incontinence ID: 912744

bladder urol men oab urol bladder oab men patients overactive treatment incontinence 2018 combination mirabegron urodyn group refractory 2015

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Slide1

@BorawskiKristy

Refractory Overactive Bladder

in Men

Kristy M. Borawski, MDAssociate ProfessorDepartment of UrologyUniversity of North Carolina

Slide2

Overall prevalence of OAB is significantEPIC study11.8% with OAB

NICE study18-64 y/o: 3% urinary incontinence

>65: 8.5%28.5% of these with clinically significant urge urinary incontinence

Irwin, et al. Eur Urol 2006; 50:1306-1314. Morant SV, et al. Int J Clin Pract 2008; 62:688-694

Slide3

Overall prevalence of OAB is significantStewart, et al. US based study

16% prevalence of OAB in menOAB wet symptoms increase with age with substantial increases after age 64 Lower Urinary Tract Dysfunction Research Network (LURN)

51% of responders reported any urinary incontinence46% urge incontinenceOlder patients with higher odds of nocturia & urgency

Stewart, et al. World J Urol 2003; 20(6):327-336. Cameron, et al. J Urol 2018; 199(4):1023-1031.

Slide4

Coyne KS, et al. Urol 2011; 77(5): 1081-1087.

Slide5

Economic Impact

$76.2 billion in 2015

Coyne KS, et al. J Manag Care Pharm 2014; 20(2):130-140.

Slide6

$0.24/pad, 3 per day

$21.60/month

$259 / year

$0.24/pad, 6 per day$43.20/month$518 / year

Slide7

$0.68/brief, 3 per day

$61/month

$734 / year

Avg Social Secutity Monthy Benefit: $1461

4% of monthly income on depends

Slide8

Are we ignoring male OAB?Morant

et al25% men diagnosed with OAB6-7% of men with storage LUTS were placed on

anticholinergics36% of men with LUTS/BPH received alpha blocker and/or 5-alpha reductase inhibitor

Morant, et al. Int J Clin Pract 2008; 62:688-694.

Slide9

Pathophysiology of OAB in menHormonal changes

Bladder outlet obstructionAgingIschemiaNeurologic conditions

Gomelsky, et al.

Ther Adv Urol 2009; 1(4):209-221.

Slide10

Nadir Osman and Christopher Chapple

. Bladder outlet obstruction and the overactive bladder. In Overactive Bladder: Practical Management. 2015.

Slide11

Will OAB symptoms improve after treatment of bladder outlet obstruction?

Slide12

Will OAB symptoms improve after treatment of BOO?

Symptomatic OAB persists in ~25-30% of patients post TURPUK: 10 year follow-up post TURPIncrease in detrusor overactivity from 40-60% in those who remain unobstructed

Nadir Osman and Christopher

Chapple. Bladder outlet obstruction and the overactive bladder. In Overactive Bladder: Practical Management. 2015.. Thomas AW. J Urol 2005 174: 1887-1891.

Slide13

Will OAB symptoms improve after treatment of BOO?

Persistent OAB symptoms associated with:Advanced ageLower maximum cystometric

capacityEarly onset detrusor overactivityHigh amplitude detrusor overactive contraction

Antunes et al. J Urol 2015; 193: 2028-2032. Nadir Osman and Christopher Chapple. Bladder outlet obstruction and the overactive bladder. In Overactive Bladder: Practical Management. 2015.

Slide14

Management for male refractory OAB

f

Slide15

Weight Modification

Slide16

8% weight loss resulted in a 70% reduction in all incontinence episodes (both stress and urge incontinence)

NEJM 360, 2009.

Slide17

Combination medical therapy

f

Slide18

Combination therapySolifenacin + mirabegron

Mueller, et al.

Neurol Urodyn 2019; 38: 779-792.

Slide19

Solifenacin 5mg + mirabegron 50mg

Combination group with greater improvement over monotherapyIncontinence episodes / 24 hrMicturitions / 24

hr

Mueller, et al. Neurol Urodyn 2019; 38: 779-792.

Slide20

Solifenacin 5mg + mirabegron 50mgSafety

47.2% all patients reported at least one adverse event

Higher incidence in combination groupIncrease in mean pulse rates from baseline of >1bpm were noted in combination & mirabegron group only in younger age groupsBlood pressure: all three groups had minor increase in systolic blood pressureNo clinically significant change in combination group compared to monotherapy groups

Mueller, et al. Neurol Urodyn 2019; 38: 779-792.

Slide21

Solifenacin 5mg + mirabegron 50mgSafety

Increased residual urine volumeNo patients in mirabegron group had increased PVR

No patients in solifenacin group had increased PVR3/1206 had increased PVR in combination groupNo data on gender availableAge: 2 were <75 y/o

Mueller, et al. Neurol Urodyn 2019; 38: 779-792.

Slide22

Solifenacin 5mg + mirabegron 50mgSafety

Urinary retention Mirabegron: 1 (0.3%) patient >65 y/oSolifenacin: 1 (0.3%) patient <65 y/o

Combination group: 6 (0.5%) patients all <75No data on gender available

Mueller, et al. Neurol Urodyn 2019; 38: 779-792.

Slide23

Slide24

OnabotulinumtoxinA

Slide25

OnabotulinumtoxinA

Slide26

Slide27

Placebo vs OnabotA

100U60% vs 29% positive response

5.4% retention rate350+ = CIC200-350mL based on symptoms88.4% female

Slide28

Placebo vs OnabotulinumA

100 USimilar outcomes to EMBARK study6.9% CIC PVR >350mL = CIC

PVR 200-350mL based on symptoms84.5% female

Slide29

Placebo vs OnabotA

50U/100U/150U/200U/300U

92% female

Slide30

Male subjects >18 years of age with confirmed detrusor overactivity on urodynamics who received

intradetrusor

BoNT-A from 2004 – present65 men received 133 BoNT-A treatments6 had prior BOO procedure9 had prior prostatectomy

100 units most common dose in menUrology 2018; 123: 242-246.

Slide31

Faure Walker et al. Urol 2018; 123: 242-246.

Slide32

Faure Walker et al. Urol 2018; 123: 242-246.

CIC recommended for PVR >150mL with symptoms

Slide33

Faure Walker et al. Urol 2019; 123: 242-246.

Baseline urodynamics in men

Men with good bladder contractility (BCI >150) had lower de novo CIC but did not reach significance

BCI =

PdetQMax

+ (5 x

Qmax

)

Slide34

88 male patients with mean follow up of 69 months

Success defined as patient still on treatment at last follow-up or stopped

botox treatment due to cure of symptomsNeurol

Urodyn 2017; 36: 1855 – 1859.

Slide35

Slide36

75% of patients stopped treatment due to either insufficient results or side effects

Slide37

Side effects

5% required de novo CIC PVR >250mL

12.5% UTI

Slide38

2 center double blinded RCT in patients with OAB secondary to BOO refractory or anticholinergic medication & persistent >3 months after surgical intervention for BOO

Placebo vs 200U onabotulinumtoxinA

Randomized, double-blind, placebo controlled pilot study of

intradetrusor injections of onabotulinumtoxinA for the treatment of refractory overactive bladder persisting following surgical management of benign prostatic hyperplasia.Chughtai B1, Dunphy C, Lee R, Lee D,

Sheth S,

Marks L,

Kaplan SA,

Te AE.

Can J Urol 2014; 2: 7217 – 7221.

Slide39

OnabotulinumtoxinA group with improved QOL scores at 180 & 270 days after treatment

Lower ICIQ (incontinence questionnaire) scoresDecreased urinary frequency (11 8/day) although statistical significance not achieved

IPSS, PVR & urgency were unchanged postoperatively in both groups

Randomized, double-blind, placebo controlled pilot study of intradetrusor injections of onabotulinumtoxinA for the treatment of refractory overactive bladder persisting following surgical management of benign prostatic hyperplasia.Chughtai B1, Dunphy C,

Lee R,

Lee D,

Sheth S,

Marks L,

Kaplan SA,

Te AE.

Slide40

Electrical Stimulation

Slide41

Sacral Nerve Stimulation

Slide42

Sacral Nerve StimulationSuccess rates 33-88% at 6 months widely reported for refractory urge incontinence

Slide43

Slide44

Neurourol Urodyn 2015; 24: 224-230.

Slide45

J Urol 2018; 199: 229-236.

Slide46

J Urol 2018; 199: 229-236.

Slide47

J Urol 2018; 199: 229-236.

Slide48

J Urol 2018; 199: 229-236.

Slide49

Does Gender Influence Response Rates to Sacral Neuromodulation?

Anger, et al. 2016. Outcomes of SNM in a privately insured population

Laudano et al. 2015. Disparities in the use of SNM among Medicare beneficiariesCameron, et al. 2011. National trends in the usage of sacral nerve test stimulation

Less men undergo placement of impulse generator (IPG) compared to women

Slide50

Int Urol Neph

2018; 50: 825-832.

92% women vs. 82% men had initial success & went onto placement of generatorMen

More overall improvement in urge incontinence episodes per dayLess incontinence severityAlthough improvement in incontinence severity only seen in womenSimilar QOL parameters

Slide51

Sacral neuromodulation after

botox failure?

Slide52

20 patients, 4 men16/20 responded to test phase (70%)11/16 were still improved at 1 year

J Urol 2013; 190: 2148-2152.

Slide53

36 patients, 1 male63.9% responded to test phaseLone male was a non responder

At last follow-up, 73.9% of initial responders were still satisfied (29.1 months)

Slide54

Adverse Events

Overall surgical intervention 33% due to lack or loss of efficacy19.1% had explantation of device

IneffectiveNeed for MRINo data on gender influence on AEs

J Urol 2018; 199: 229-236.

Slide55

Posterior Tibial Nerve Stimulation

Slide56

24 men in PTNS arm (21.8%)

J Urol 2010; 183: 1438-1443.

Slide57

J Urol 2010; 183: 1438-1443.

Slide58

J Urol 2010; 183: 1438-1443.

Slide59

J Urol 2013; 189: 2194 – 2201.

~ 1 maintenance treatment per month

Slide60

Male OAB is an often untreated condition with significant QOL / financial implications

Paucity of data for refractory OAB / urge incontinence in menCannot assume that outcomes in women = men

Slide61