slide deck (pdf) - CME Outfitters

Gaining Ground in Men’s 

Genitourinary Health: Maximizing 

Outcomes for Patients with Benign 

Prostatic Hyperplasia and Erectile 

Dysfunction 

Matt T. Rosenberg, MD 

Mid-Michigan Health Centers 

Jackson, MI 

July 17, 2013

Supported by an educational 

grant from Lilly USA, LLC. For 

further information concerning 

Lilly grant funding, visit 

www.lillygrantoffice.com.

Accreditation 

This program has been reviewed and is 

approved for a maximum of 1.00 hours of 

AAPA Category 1 CME credit by the 

Physician Assistant Review Panel. 

Physician Assistants should claim only 

those hours actually spent participating in 

the CME activity. 

This program was planned in accordance 

with AAPA’s CME Standards for Live 

Programs and for Commercial Support of 

Live Programs.

Accreditation 

CME Outfitters, LLC is accredited by the 

Accreditation Council for Continuing 

Medical Education to provide continuing 

medical education for physicians. 

CME Outfitters designates this live activity 

for a maximum of 1 AMA PRA Category 1 

Credit TM . Physicians should claim only the 

credit commensurate with the extent of 

their participation in the activity.

Learning Objectives 

! Explain the shared pathophysiology that underlies 

benign prostatic hyperplasia (BPH) and erectile 

dysfunction (ED) 

! Correlate the mechanistic activity of 

pharmacotherapy with the rational use of 

combination pharmacotherapy in men with BPH and 

concomitant ED 

! Demonstrate systematic, patient-centric and 

measurement-based mastery in the ability to employ 

an effective strategy for evaluating men at midlife 

and older who have genitourinary complaints 

! Implement American Urologic Association-compliant 

diagnostic and treatment plans for men with BPH, 

who may also have erectile dysfunction.



Department of Family Health 

Allegiance Health 

Jackson, MI


Disclosures 

Served as an advisor, consultant or 

speaker for: Astellas Pharma, Inc; 

Easai, Ferring Pharmaceuticals; 

Horizon Pharma; Lilly USA, LLC; 

Pfizer Inc.

Disclosures 

! Robert Kennedy, MA 

! (planning committee) has nothing to disclose 

! Monique Johnson, MD, CCMPE 


! Joy Bartnett Leffler, MLA, NASW, CSE 


! Sandra Haas Binford, MAEd 


! Sharon Tordoff, CCMEP 


! Jeffrey Helfand, DO, MS 

! (peer reviewer) has nothing to disclose 

! Jeffrey M. McEver, PA-C 

! (peer reviewer) has nothing to disclose

Disclosures 

! Faculty of this CE activity may include discussions of 

products or devices that are not currently labeled for 

use by the FDA. The faculty have been informed of 

their responsibility to disclose to the audience if they 

will be discussing off-label or investigational uses (any 

uses not approved by the FDA) of products or 

devices. 

! CME Outfitters, LLC, the faculty, and Lilly USA, LLC, 

do not endorse the use of any product outside of the 

FDA labeled indications. Medical professionals should 

not utilize the procedures, products, or diagnosis 

techniques discussed during this activity without 

evaluation of their patient for contraindications or 

dangers of use.

Reminder 

Presentation slides will be 

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www.CMEOutfitters.com/MM049

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Georgia Association of Physician 

Assistants (GAPA) Summer 

Meeting 

Gaining Ground in Men’s Genitourinary 

Health: Maximizing Outcomes for 

Patients with Benign Prostatic 

Hyperplasia and Erectile Dysfunction 

July 17, 2013



Jackson, MI


Disclosures 

Served as an advisor, consultant or 

speaker for: Astellas Pharma, Inc; 

Easai, Ferring Pharmaceuticals; 

Horizon Pharma; Lilly USA, LLC; 

Pfizer Inc.

Learning Objectives 

! Explain the shared pathophysiology that underlies 

benign prostatic hyperplasia (BPH) and erectile 

dysfunction (ED) 

! Correlate the mechanistic activity of pharmacotherapy 

with the rational use of combination pharmacotherapy in 

men with BPH and concomitant ED 

! Demonstrate systematic, patient-centric and 

measurement-based mastery in the ability to employ an 

effective strategy for evaluating men at midlife and older 

who have genitourinary complaints 

! Implement American Urologic Association-compliant 

diagnostic and treatment plans for men with BPH, who 

may also have erectile dysfunction.

In what percentage of your patients 

presenting with either benign prostatic 

hyperplasia (BPH) OR erectile 

dysfunction (ED) symptoms do you ask 

about the presence of the other 

condition? 

A. 0% 

B. 1% - 25% 

Pre-symposium Question #1 

C. 26% - 50% 

D. 51% - 75% 

E. 76% - 100%

What percentage of your patients with 

benign prostatic hyperplasia (with or without 

concomitant erectile dysfunction) do you 

treat in accordance with recommendations 

from the American Urological Association 

(AUA)? 

A. 0% 

B. 1% - 25% 

Pre-symposium Question #2 

C. 26% - 50% 

D. 51% - 75% 

E. 76% - 100%

Function of the Prostate 

Normal Function 

! Produces fluid for 

seminal emission 

! Does not grow into the 

urethra thereby 

allowing unobstructed 

flow 

Abnormal Function 

! Obstruction of 

urinary flow 

! Poor function seen 

as failure to void 

Rosenberg MT, et al. Int J Clin Pract. 2007;61(9):1535-1546. PMID: 17627768.

Physiology of BPH 

! Characterized by hyperplasia of prostatic stromal 

and epithelial cells, which results in the formation 

of large, fairly discrete nodules in the periurethral 

region of the prostate 

! When sufficiently large, 

the nodules compress 

and narrow the urethral 

canal to cause partial, or 

sometimes virtually 

complete obstruction 

McVary KT, et al. J Urol. 2011;185(5):1793-1803. PMID: 21420124.

Benign Prostatic Hyperplasia 

! A common condition as men age 

! By sixth decade: > 50% of men have 

some degree of hyperplasia 

! By eighth decade: > 90% of males will 

have hyperplasia 

! In only a minority of patients (about 

10%) with this hyperplasia be 

symptomatic and severe enough to 

require medical treatment or 

surgical intervention 

McVary KT, et al. J Urol. 2011;185(5):1793-1803. PMID: 21420124.

BPH, LUTS, and BOO 

Complex Interrelationships 

All Men >40 y 

Histologic 

BPH 

BOO 

LUTS 

BOO, bladder outlet obstruction; LUTS, lower urinary tract symptoms. 

Emberton M, et al. Int J Clin Pract. 2008;62(7):1076-1086. PMID: 18479366; Roehrborn CG. Rev Urol. 2005;7(Suppl 9):S3-S14. 

PMID: 16985902; Roehrborn CG. Med Clin N Am. 2011;95(1):87-100. PMID: 21095413.

Predominant Symptoms 

! The enlarged gland has been proposed to contribute to 

the overall lower urinary tract symptoms (LUTS) 

complex via at least two routes: 

! (1) direct bladder outlet obstruction (BOO) from enlarged 

tissue (static component) 

! (2) from increased smooth muscle tone and resistance within 

the enlarged gland (dynamic component) 

! Voiding symptoms have often been attributed to the 

physical presence of BOO. Detrusor overactivity is 

thought to be a contributor to the storage symptoms 

seen in LUTS 

McVary KT, et al. J Urol. 2011;185(5):1793-1803. PMID: 21420124

Function of the Bladder 

Normal Function 

! Storage capacity of 

300 – 500 ml of fluid 

! Empty to completion 

after a gentle urge 

Abnormal Function 

! Voiding frequently of 

small amounts (less 

than capacity) 

! Uncontrollable urge 

(urgency) to empty 

! Incomplete emptying 

! Poor function seen 

as failure to store 

Rosenberg MT, et al. Int J Clin Pract. 2007;61(9):1535-1546. PMID: 17627768

Definition of OAB 

International Continence Society 

(ICS) 

A syndrome including: 

! Urinary urgency (the intense, sudden 

desire to void) with or without 

incontinence; 

! Urinary frequency (voiding to often 

during the day); and 

! Nocturia (wakening at night to void) 


Using LUTS to Distinguish the 

Bladder or Prostate as the Origin 

Urine 

storage 

Urine 

Voiding 

Post 

Micturition 

Urgency 

Hesitancy 

Dribbling 

Frequency 

Weak stream 

Incomplete 

emptying 

Urgency 

incontinence 

Intermittence 

Nocturia 

Straining 

Kapoor A. Can J Urol. 2012;19 Suppl 1:10-17. PMID: 23089343.

How to differentiate the etiology of 

LUTS? 

! Weak flow – think prostate 

! Voiding small amounts – think bladder 

! Leakage of urine – think bladder or 

sphincter 

! Good flow, normal volume – think too 

much fluid production and evaluate 

accordingly 

It’s about volume and flow 


Audience Response Question 

Which would you estimate would be the 

three most prevalent comorbid 

conditions with BPH-LUTS? 

A. Heart disease, diabetes, arthritis 

B. Hypertension, high cholesterol, erectile 

dysfunction 

C. Diabetes, pain, depression 

D. Digestive tract disorders, allergies, 

arthritis

Common Comorbidities in 

BPH-LUTS 

Comorbidity with BPH-LUTS 

(N = 6,909) 

Hypertension 53 

High cholesterol 45 

Erectile or other sexual 

dysfunction 

% 

36 

Digestive tract disorder 21 

Arthritis 20 

Heart disease/Heart failure 18 

Diabetes 17 

Depression/Anxiety/Sleep 

disorder 

16 

Allergies/cold/flu/congestion 15 

General pain/inflammation 11 

Roehrborn CG, et al. BJU Int. 2007;100(4):813-819. PMID: 17822462.

LUTS-BPH and ED 

Common Risk Factors and Comorbidities 

Risk Factors 

• Increasing LUTS severity 

or symptom worsening 

• Increasing serum 

dihydrotestosterone 

• Enlarged prostate; >30 

mL 

• Inflammation 

• Elevated IPSS 

• Refractory to treatment 

• Poor flow 

• Genetics 

• History of AUR 

• High waist circumference 

• Increasing age 

• PSA >1.5 ng/dL 

• PVR >50 mL 

• Increasing bother 

• Reduced physical activity 

LUTS-BPH 

Comorbidities 

• Cardiovascular disease 

• Diabetes/Disrupted glucose 

homeostasis 

• Erectile dysfunction 

• Metabolic syndrome 

• Obesity 

Risk Factors 

• Increasing age 

• Smoking 

• High waist 

circumference 

ED 

Comorbidities 

• Cardiovascular disease 

• Depression 

• Diabetes 

• Hypercholesterolemia 

• Lower urinary tract 

symptoms 

• Metabolic syndrome 

• Obesity 

AUR, acute urinary retention. 

Lee RK, et al. BJU Int. 2012;110(4):540-455. PMID: 22243806; Parsons JK. Curr 

Bladder Dysfunct Rep. 2010;5(4):212-218. PMID: 21475707; Robert G, et al. 

Curr Opin Urol. 2011;21(1):42-48. PMID: 21045706; Roehrborn CG. BJU Int. 

2006;97(S2):7-11. PMID: 16507046; Rosen R, et al. Eur Urol. 2003;44(6): 

637-649. PMID: 14644114 ; Shabsigh R, et al. BMC Urol. 2010;10:18. PMID: 

21054874; Woo HH, et al. Med J Aust. 2011;195(1):34-39. PMID: 21728939.


Fact: ED and BPH share co-morbidities. 

Question: Does the severity of one affect 

the other? 

A. Erectile functioning remains the same while 

BPH-LUTS worsens 

B. Erectile functioning continues on a 

fluctuating course BPH-LUTS declines 

C. Erectile functioning declines as BPH-LUTS 

declines 

D. Erectile functioning improves BPH-LUTS 

declines

Erectile Function Declines 

With LUTS Severity 

No ED 

30 

No 

Mild 

Incidence, % 

20 

10 

22.3 

21.1 

18.9 

14.9 

19.2 

18.3 

15.8 

12.4 

15.3 

13.2 

Moderate 

Severe 

10.3 

7.5 

0 

50-59 Years 60-69 Years 70-79 Years 

Severe ED 

n=10,636 sexually active men within the last 4 weeks. 

McVary KT, et al. BJU Int. 2006;97(suppl 2):23-28. PMID: 16507050.

BPH-LUTS and ED 

Common Pathophysiologic Mechanisms 

Reduced NO– 

cGMP signaling 

Increased RhoA– 

ROCK signaling 

Autonomic 

hyperactivity 

Pelvic 

atherosclerosis 

FUNCTIONAL 

CONSEQUENCES 

AT TISSUE LEVEL 

(corpora cavernosa, 

prostate, urethra, and 

bladder functional 

alterations) 

• Reduced function of nerves 

and endothelium 

• Altered smooth muscle 

relaxation or contractility 

• Arterial insufficiency, reduced 

blood flow, and hypoxia-related 

tissue damage 

BPH-LUTS 

ED 

Chronic inflammation 

Steroid hormone unbalance 

Comorbidities 

Hypertension, Metabolic Syndrome, Diabetes, etc. 

cGMP, cyclic guanosine monophosphate; NO, nitric oxide; ROCK, Rho-associated protein kinase. 

Gacci M, et al. Eur Urol. 2011;60(4):809-825. PMID: 21726934.

The evaluation of LUTS in the Primary 

Care office can be done in quickly and 

efficiently in 5 minutes or less? 

A. YES 

B. NO 

Audience Response Question

What to Keep in Mind in the 

Evaluation of LUTS 

• Lower Urinary Tract Symptoms 

(LUTS) can be of urologic origin, 

which includes the prostate and 

bladder, or can be medical in 

nature 

• A comprehensive history, physical 

and lab evalua?on will generally 

provide the needed clues 


LUTS Evaluation 

Focused HPE 

UA/PSA Blood Sugar 

Unlikely OAB/BPH/SI 

Treat or Refer 

Likely OAB/BPH/SI 

Provisional 

OAB/SI 

Desires 

Treatment 

Yes 

Treat for BPH 

Assess and 

Treat OAB/SI 

Refer 

Provisional BPH 

Ineffective 

Ineffective 

No 

Effective 

Effective 

Watchful 

Waiting 

Continue 

Medication 

Continue 

Medication 

HPE, history and physical exam; PSA, prostate-specific antigen; SI, stress incontinence; UA, urinalysis. 


The Evaluation of LUTS: 

History, Physical and Labs 

are Essential 

! Medical and surgical history 

! Medications 

! Voiding diary 

! Focused physical examination 

! Labs 

McVary KT, et al. J Urol. 2011;185(5):1793-1803. PMID: 21420124. 

AUA Guidelines available at: http://www.auanet.org/education/guidelines/benign-prostatic-hyperplasia.cfm

Examples in the Medical or Surgical History 

That Can Cause or Confound LUTS 

! Poorly controlled diabetes causing polyuria/polydipsia 

! Antihypertensive diuretics can frequency and urgency 

whereas some cold medications (e.g., α-agonists) 

commonly cause flow problems 

! Congestive heart failure causing nighttime fluid 

mobilization 

! Recent surgery causing immobilization or constipation 

! Poor urinary hygiene 

The temporal rela3onship may offer a clue 

Rosenberg MT, et al. Int J Clin Pract. 2007;61(9):1535-1546. PMID: 17627768. 

Burgio KL, et al. Int J Clin Pract. 2013;67(6):495-504.PMID: 23679903.

Medications Can Cause or 

Exacerbate BPH-LUTS 

Medication 

Sedatives 

Alcohol, caffeine, diuretics 

Anticholinergics 

Α-Agonists 

ß-Blockers 

Calcium-channel blockers 

Angiotensin-converting 

enzyme 

First-generation 

antihistamines 

Cholinesterase inhibitors 

Opioids 

LUTS-Related Effect 

Confusion, secondary incontinence 

Diuresis 

Impaired contractility, voiding difficulty, overflow incontinence 

Increased outlet resistance, voiding difficulty 

Decreased urethral closure, stress incontinence 

Reduce bladder smooth muscle contractility 

Induce cough, stress urinary incontinence 

Increase outlet resistance 

Precipitate urge incontinence 

Constipation 

DeBeau CE. J Urol. 2006;175(3, pt 2):S11-S15. PMID: 16458733; Gill SS, et al. Arch Intern Med. 2005;165(7):808-813. 

PMID: 15824303; Lavelle JP, et al. Am J Med. 2006;119(3, suppl 1):37-40. PMID: 16483867; Newman DK. 

Nurse Pract. 2009;34(12):33-45. PMID: 19952586; Wyman JF, et al. Int J Clin Pract. 2009;63(8):1177-1191. PMID: 19575724.

A Focused Physical Examination 

! Abdominal 

! Tenderness, masses, distension 

! Neurological 

! Mental and ambulatory status, 

neuromuscular function 

! Genitourinary 

! Meatus and testes 

! Rectal 

! Tone 

! Prostate size, shape, nodules and 

consistency 

Rosenberg MT, et al. Int J Clin Pract. 2007;61(9):1535-1546. PMID: 17627768; 

Rosenberg MT, et al. Int J Clin Pract. 2010; 64(4):488-496. PMID: 20039975

Laboratory Tests 

! Urinalysis 

! Infection, blood, crystals 

! The urine is not an adequate screener for diabetes since the blood 

sugar must be above 180 mg/dl before it spills into the urine 

! A random or fasting blood sugar 

! Diabetes 

! Prostate specific antigen 

! Prostate specific not cancer specific but can be used in screening 

! Excellent as a surrogate marker for prostate size 

! PSA is more accurate than a DRE when estimating prostate 

size 

! A PSA of 1.5 ng/ml equates to a prostate volume of at least 30 

grams(ml) 

Rosenberg MT, et al. Int J Clin Pract. 2007;61,9,1535-1546. PMID: 17627768;. Bosch J, et al. Eur Urol. 2004;46:753-759. PMID 

15548443. Roerborn CG, et al. Urology. 1999;53;581-589. PMID: 10096388

Assessment: DRE vs. PSA 

! There is a strong and clinically 

useful relationship between 

serum PSA and prostate volume, 

which enables the clinicians to 

estimate prostate size in men with 

LUTS and BPH, and also to 

identify men with prostate above 

certain thresholds 

! Digital rectal examination (DRE) 

is quite inaccurate in estimating 

the correct prostate size when 

compared to either transrectal 

ultrasound (TRUS) or other 

imaging modalities. 

Log-linear relationship 

between serum PSA 

and prostate volume 

Roehrborn CG. Int J Impot Res. 2008;20 Suppl 3:S19-26. PMID: 19002120.


The most widely adopted evidencebased 

screening tool for BPH is the: 

A. Prostate Review Questionnaire 

B. AUA Assessment of Prostate 

Functioning Tool 

C. International Prostate Symptom Score 

Questionnaire 

D. Prostate Symptom Checklist

International Prostate Symptom 

Score (I-PSS) Questionnaire 

McVary KT, et al. J Urol. 2011;185(5):1793-1803. PMID: 21420124. 

Available at http://www.urospec.com/uro/Forms/ipss.pdf

The Purpose of the Voiding Diary 

! Identifies voiding frequency and volumes 

! Differentiates behavioral problems as opposed to ones of 

pathologic origin 

! Voiding frequently after drinking the 40 ounce cola at lunch or 

break (behavioral) 

! Voiding frequently of small amounts only at work as a result of 

always being in a rush (behavioral) 

! Voiding frequently of small amounts (OAB) 

! Voiding frequently of large amounts (overproduction of fluid – 

medical cause or excessive intake) 

! Alerts the patients as to their habits and may offer 

opportunities for improvement 

! Can help monitor efficacy of treatment 

Wyman JF, et al. Int J Clin Pract. 2009; 63(8):1177-1191. PMID: 19575724.

LUTS and Indications for 

Referral 

! Suspicion of neurologic cause of symptoms 

! History of recurrent UTI or other infection 

! Findings or suspicion of urinary retention 

! Abnormal prostate exam (nodules) 

! Microscopic or gross hematuria 

! History of genitourinary trauma 

! Prior genitourinary surgery 

! Uncertain diagnosis 

! Meatal stenosis 

! Elevated PSA 

! Pelvic pain 

Rosenberg MT, et al. Int J Clin Pract. 2007;61(9):1535-1546. PMID: 17627768. 


Rosenberg MT, et al. Publication Pending 

Clinical Management: 

The Next STEP


The Next STEP: 

Step 1

STEP 1: Informed Surveillance 

If the patient has symptoms but no bother 

and no complications 

Patients who opt for this option may benefit from: 

! Lifestyle changes (exercise, weight management) 

! Limitations of fluids 

! Bladder training focused on timed and complete voiding 

! Medication modification 

! Although LUTS secondary to BPH is not often a lifethreatening 

condition, the impact of LUTS/BPH on 

quality of life (QoL) can be significant and should not be 

underestimated 

Burgio KL, et al. Int J Clin Pract. 2013;67(6):495-504.PMID: 23679903



Step 2a and Step 2b

Clinical Management 

Step2a: Alpha Blockers (AB) 

Single medication therapy with an AB is appropriate 

for the symptomatic patient who has identified 

bother and has a PSA of < 1.5 ng/ml 

! Generally fast acting, relieving symptoms 

within days 

! Does not affect progression of prostate growth 

Rosenberg MT, et al. Int J Clin Pract. 2010; 64(4):488-496. PMID: 20039975.

Alpha – Blockers 

Inhibit α1-adrenergic mediated contraction of 

prostate smooth muscle, thereby relieving bladder outlet 

obstruction 

Non - Uroselective 

Terazosin 1, 2, 5, 10 mg daily 

Doxazosin 1, ,2, 4, 8 mg daily 

Uroselective 

Tamsulosin 0.4 mg daily 

Alfuzosin 10 mg daily 

Silodosin 8 mg daily 

§ Poten?al side effects (decreased incidence with uroselec?ve agents) 

– Asthenia, fa?gue, dizziness 

– Postural hypotension 

– Conges?on, rhini?s 

– Abnormal ejacula?on 

Physician’s Desk Reference, 64 ed. Montvale, NJ:Thomson PDR; 2010. 

Lepor H. Rev Urol. 2007;9:181-190. PMID: 18231614 

Roehrborn CG. Rev Urol. 2009;11(Suppl 1):S1-8. PMID: 20126606


Step2b: Phosphodiesterase 5 Inhibitors 

(PDE5i) 

Single medication therapy with a PDE5-I is appropriate for 

the symptomatic patient who has identified bother and has a 

PSA of < 1.5 ng/ml. The potential impact of this therapy on 

male sexual function should be considered 

! New as a treatment for BPH-LUTS 

! It is believed that the PDE5i increase the signaling of 

the NO/cGMP pathway, which reduces smooth 

muscle tone in the lower urinary tract 

! It is not believed that use of a PDE5i will reduce 

progression of prostate growth 

Roehrborn CG, et al. J Urol. 2008;180(4):1228-1234. PMID: 18722631. 

Rosenberg MT, et al. Publication Pending.

Phosphodiesterase type 5 

Inhibitors for use in BPH-LUTS 

Medication Dose Indication 

Tadalafil 2.5 mg per day BPH 

Tadalafil 5.0 mg per day BPH and ED 

Common side effects: headache, back pain, dizziness, flushing and dyspepsia. 

Contraindicated in patients who use nitrates, potassium channel openers, or 

non-selective 2nd generation Abs. Cardiac status must be assessed for patient 

risk before taking this medications. 

1.Roehrborn CG, et al. J Urol. 2008;180(4):1228-1234. PMID: 18722631. 

2.Oelke M, et al. Eur Urol. 2013;64(1):118-140. PMID: 23541338. 

3.Nehra A, et al. Mayo Clin Proc. 2012;87(8):766-778. PMID: 22862865.



Step 3


STEP 3a: Addition of an 

antimuscarinic or beta-3 agonist 

If the patient has symptoms of both 

obstruction and irritation as well as bother 

! In multiple studies the combination of antimuscarinics were 

more efficacious in reducing voiding frequency, nocturia, or 

IPSS compared to α-blockers or placebo alone. 

! The β3 agonist class is newly available and has not been 

studied in combination with an AB. 

! Neither antimuscarinics or β3 agonists have been studied 

in combinations with PDE5i medications. 

Oelke M, et al. Eur Urol. 2013;64(1):118-140. PMID: 23541338. 

Rosenberg MT, et al. Publication pending.

Antimuscarinics – Immediate 

Release 

exact mechanism of action unknown 

(may work on efferent or afferent pathway) 

Drug Frequency Dose 

Oxybutynin IR 

2 – 4 times per 

day 

5 mg 

Tolterodine IR Twice per day 1 -2 mg 

Trospium Chloride Twice per day 

20 mg 

Physcians’ Desk Reference. 64st ed. Montvale, NJ: Thomson PDR; 2010.

Antimuscarinics – Extended 

Release 

extended release medications have a better 

tolerability than their immediate release 

counterparts 

Drug Frequency Dose 

Darifenacin Daily 7.5 mg, 15 mg 

Fesoterodine Daily 4 mg, 8 mg 

Oxybutynin ER Daily 5 – 30 mg 

Oxybutynin TDS Twice per week 3.9 mg 

Oxybutynin 10% 

gel 

Daily 

100 mg 

Solifenacin Daily 5 mg, 10 mg 

Tolterodine ER Daily 5 mg 

Trospium Chloride Daily 

60 mg 

Physcians’ Desk Reference. 64st ed. Montvale, NJ: Thomson PDR; 2010.

! Dry Mouth 

! Constipation 

! Headaches 

! Blurred vision 

Common Side Effects 

of Antimuscarinics 

Side effects are greater with the immediate release 

medications as compared to the extended release 

medications 

Some patients have symptoms that are severe enough they 

would tolerate significant problems, whereas that may not be 

the same for others. 

Steers WD. Urol Clin North Am. 2006;33:475-482. PMID: 17011383. 

Erdam N, et al. Am J. Med 2006;119(suppl 1):29-36. PMID: 16483866. 

Oelke M, et al. Eur Urol. 2013;64(1):118-140. PMID: 23541338.

Common Contraindications of 

Antimuscarinics 

! Urinary or gastric retention 

! Uncontrolled narrow-angle glaucoma 

! Clinically significant bladder outlet 

obstruction 

Physicians’ Desk Reference. 64st ed. Montvale, NJ: Thomson PDR; 2010. 

Oelke M, et al. Eur Urol. 2013;64(1):118-140. PMID: 23541338.

Beta 3 Agonists 

Drug 

Mirabegron 

Dosing 

25 – 50 mg per day 

Common side effects: hypertension, nasopharyngitis, urinary tract 

infections and headache. 

Caution should be used in patients with clinically significant bladder 

outlet obstruction. 

PI for mirabegron. Drugs@FDA Website. http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202611s000lbl.pdf. 2013. 

Rosenberg MT, et al. Publication pending.


The Next STEP 

Step 3


Step3b: Adding a 5 Alpha Reductase 

Inhibitor (5ARI) 

The addition of a 5ARI is appropriate for the 

symptomatic patient with BPH-LUTS who has 

identified bother and has a PSA of 1.5 ng/ml or 

greater 

! Prostate growth is stimulated by dihydrotestosterone (DHT) with is 

converted from testosterone by the 5-alpha reductase enzyme 

! Decreasing DHT may induce prostatic epithelial apoptosis and atrophy 

which can lead to approximately 18% – 28% reduction in prostate size 

and approximately a 50% reduction in PSA levels after 6 - 12 months 

Naslund MJ, et al. Clin Ther. 2007;29(1):17-25. PMID: 17379044. 

Rosenberg MT, et al. Int J Clin Pract. 2010; 64(4):488-496. PMID: 20039975

Risk Evaluation of BPH-LUTS 

Progression 

Baseline Factors as Predictors 

Five risk factors 

1. Total prostate volume ≥31 mL 

2. PSA ≥1.6 ng/mL 

3. Age ≥62 

Not usually evaluated by the PCP 

4. Q max

5 Alpha Reductase Inhibitors (5ARI) 

blocks conversion of testosterone to 

dihydrotestosterone, thereby inhibiting prostate growth 

Drug 

Finasteride 5 mg daily 

Dutasteride 0.5 mg daily 

5 mg daily 

0.5 mg daily 

Dosage 

§ Poten?al side effects 

– Diminished ejaculatory volume 

– Erec?le dysfunc?on 

– Decreased libido 

– Gynecomas?a 

– Increase risk of high grade CaP 

Physician’s Desk Reference, 64 ed. Montvale, NJ:Thomson PDR; 2010. 

Andriole G, et al. J Urol. 2004;172:399-403. PMID: 15371854.

Combination Therapy 

• Starting with combination therapy may allow immediate 

symptom relief from the AB while facilitating prostate 

reduction from the 5ARI 

• Two studies (MTOPS and CombaT) have shown that 

combination therapy is better than either monotherapy alone 

• Expert opinion supports the long term use of combination 

therapy in the patient with an enlarged prostate 

• The combination of a PDE5i and a 5ARI is being studied 

Crawford ED, et al. Urology. 2006;175:1422-‐7. 

Roehrborn CG, et al. Eur Urol. 2009;55(2): 461-‐71. 

Kaplan S. Urology. 2009;73:2417.

Rosenberg MT, et al. Publication Pending. 

The Next STEP 

Step 4


Step 4: Referral 

For the patient with symptoms and bother 

who is refractory to therapy 

! Alpha blockers, PDE5is, antimuscarinics 

and β3 agonists work quickly. 

! 5 ARIs work slowly 

! Failure to respond in a reasonable 

amount of time warrants reevaluation 

and possible referral 

Rosenberg MT, et al. Int J Clin Pract. 2010; 64(4):488-496. PMID: 20039975. 

Rosenberg MT, et al. Publication Pending.

Clinical Connections: Summary 

! Treatment of LUTS-BPH should be a patient-centered, shared 

decision process 

! There appears to be a shared pathophysiology that underlies 

benign prostatic hyperplasia (BPH) and erectile dysfunction 

(ED) 

! Pharmacotherapy of BPH-LUTS and ED takes place in a stepwise 

algorithm that depends on symptom severity. 

! Diagnosis and treatment plans in accordance with the American 

Urological Association recommendations can improve the 

management of patients with BPH and ED

American Urological 

Association Guidelines 

American Urological Association 

Guideline: Management of Benign 

Prostatic Hyperplasia (BPH) 

Available at: 

http://www.auanet.org/education/ 

guidelines/benign-prostatichyperplasia.cfm

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