The Enlarged Prostate Symptoms, Diagnosis and Treatment

Financial support for this seminar has been provided by 1 MAC00031-01 Rev G NeoTract, Inc., the manufacturer of the UroLift® System. Today’s Agenda

• What is BPH

• How it is diagnosed

• What are the treatment options

2 Overview of the Prostate

• Walnut sized gland at base of the male bladder BLADDER • Surrounds the PROSTATE

• Produces fluid that transports

during URETHRA

3 of a Prostate Over Time

The prostate grows to a normal size in teenage years and then begins to grow again around the age of 50

SIZE PROSTATE PROSTATE

Age 1 Age 5 Age 10 Age 15 Age 25 Age 35 Age 50 Ag 75

4 Prostate Conditions

Prostatitis • Swelling/ of the prostate

Prostate • Very common among men Cancer • Typically a slow growing cancer Enlarged • Enlargement of the prostate gland Prostate

Each condition affects the prostate differently Having one condition does not mean you will have another

5 Aging and the Prostate

Age 50 Age 60 Age 80

10 % of Men with BPH 40 30 60 70 % of Men without BPH 90

• Affects nearly 40 million men each year in the United States • By age 60, 70% of all men have an enlarged prostate • Affects nearly 90% of men by age 80

Berry, et al., J Urol 1984 6 Roehrborn, et al., and Prostatic Diseases 2006; 2015 U.S. Census population estimates What is BPH?

• Benign Prostatic Hyperplasia (BPH) is the clinical term for enlarged prostate

• Non-cancerous enlargement of the prostate gland – BPH is not an indication or a predictor of cancer – PSA rises with both BPH and prostate cancer, so PSA alone cannot tell you which is the issue

7 Normal vs. Enlarged Prostate

• As the prostate enlarges, pressure can be put on the urethra • Causes urinary problems • In general, the size of the prostate does not correlate to severity of symptoms

Normal Prostate Anatomy Enlarged Prostate (BPH) Anatomy

BLADDER HYPERTROPHIED

PROSTATE

OBSTRUCTED URETHRA URINARY FLOW

Roehrborn CG, McConnell JD. In: Walsh PC et al, eds. Campbell’s . 8th ed. Philadelphia, Pa: Saunders; 2002:1297-1336. 8 What Happens if BPH is Not Treated?

Not treating enlarged prostate can lead to bladder deterioration

9 BPH Disease Progression

Images courtesy Dr. Steven Gange 10 Recognizing the Symptoms of BPH

• Frequent • Multiple trips to the bathroom at night • Sudden urge to urinate • Difficult or painful urination • Weak or slow flow • Incomplete elimination of urine • Stopping and starting of flow

Abrams, et al., Neurourology and Urodynamics 2002; Maximilian, et al., BJU Intl 2012 11 BPH Affects Quality of Life

• Many men who suffer from BPH experience a reduction in quality of life – Avoiding travel – Interruption of leisure activities – Using the bathroom stalls instead of urinals – Disruption of sleep patterns

For nearly half of men in the U.S. with BPH, their symptoms are severe enough to disrupt their lifestyle and cause them to seek treatment

Abrams, et al., Neurourology and Urodynamics 2002; Maximilian, et al., BJU Intl 2012 12 How is an Enlarged Prostate Diagnosed?

• Medical history • Physical exam – Bladder scan () • residual urine assessment – Digital Rectal Exam (DRE) • approximate prostate size • texture and symmetry • Symptoms – AUA Symptom Score • How much of a bother is it to you?

13 How is an Enlarged Prostate Diagnosed?

Optional Studies • Uroflow • Pressure flow studies • Transrectal Ultrasound (TRUS) – With or without •

14 International Prostate Symptom Score (IPSS)

Symptoms • Incomplete bladder How is the IPSS scored? emptying 0-7 | Mild

• Frequency 8-19 | Moderate • Intermittency 20-35 | Severe • Urgency • Weak stream How is Quality of Life scored? • Straining 0-6

• Nocturia Regardless of the score, if your symptoms are bothersome you should notify your doctor

Abrams P et al. The standardisation of terminology of lower urinary tract function. Report from the International Continence 15 Society. Am J . Obstet. Gynecol 2002 187: 116-126. Treatment Options for Enlarged Prostate

Different treatments are appropriate for different patients

16 Watchful Waiting

Advantages Disadvantages • No • May not have • Cheaper than drugs symptom improvement • No side effects • Risk that symptoms will worsen

17 Medications/Herbal Remedies

Medication Flomax, Avodart, Duodart, Cialis Herbal Remedies Advantages Advantages • No surgery • No surgery • May provide enough symptom relief • No drugs • No side effects Disadvantages Disadvantages • Must be taken daily, from now on • May not have symptom improvement – • Potential side effects* none have shown benefit in clinical trials – Lowered sexual drive, erection • Risk that symptoms will worsen problems, ejaculation problems, • Potential down stream issues dizziness, lack of energy – Bladder stones; bladder health, • High out-of-pocket cost kidney function • Over time may stop working • Future treatments may be less effective

AUA Guidelines 2010, 2003 *Side effects may vary depending on medication type. 18 Prostatic Urethral Lift (PUL) The UroLift® System

Advantages Disadvantages • In-office procedure • Some discomfort • Preserves sexual function • Potential for blood in urine – No new and lasting • Increased urgency problem with erections after procedure or ejaculation • Rapid, durable relief – Typically return to normal within 5-9 days • Typically no catheter

Roehrborn Urology Clinics 2016 McVary et al. J Med 2013 Shore et al. Can J Urology 2014 19 How PUL Works

The delivery device is Implants are placed through a needle that comes out of The delivery device is placed through the the delivery device to hold the enlarged prostate tissue removed, leaving a more urethra to access the out of the way. open urethra. enlarged prostate.

20 Heat & Steam-Based Therapies TUMT – Microwave; TUNA – Radiofrequency; Rezum

Advantages Disadvantages • In-Office procedure • Catheter for days • Oral sedative after treatment • Paid by most insurers • 4-6 weeks until symptom relief • Fewer side effects • Potential for than surgery

AUA Guidelines 2010, 2003 21 How Heat & Steam Based Therapies Work

http://www.prostatetreatmentindore.in/treatment-of-prostate-cancer.php 22 Major Surgery TURP – Resection; Greenlight – Laser Vaporization

Advantages Disadvantages • Maximizes flow and symptom relief • Hospital procedure with general or • Removes prostate tissue regional anesthesia • Durable • TURP requires hospitalization • Low retreatment rate – Laser shows less and typically no overnight hospital stay • Catheter for 1-5 days • 6 weeks restricted activity • 10% have erectile problems • 40%-65% lose ejaculation • 3% incontinence • 7% strictures

AUA Guidelines 2010, 2003 23 How TURP & Laser Based Therapies Work

https://www.indiamart.com/thechennai-speciality-klinic/endourology.html 24 What Next?

• Pay attention to your symptoms before your appointment – Each solution has unique risks, benefits, and costs – Let’s find the right solution for YOU!

We are here to help improve your quality of life!

25 Questions?

MAC00031-01 Rev G Financial support for this seminar has been provided by NeoTract, Inc., the manufacturer of the UroLift® System.