BPH - Evaluation and Treatment The GreenLight PVP Workshop PowerPoint Presentation gives an overview of how a KTP laser works, how different lasers generate different tissue effects, and why a high power KTP laser is the ideal tool to treat BPH. The Photoselective Vaporization of the Prostate (PVP) procedure is explained. The presentation closes with clinical data of a multi-center study and a single center long-term durability study. The presentation is designed as 60 minute workshop didactic. It should be supplemented by a lecture on laser safety included in the file “GreenLight PVP Workshop Presentation – Laser Safety Supplement” We encourage urologists to include their own experience in the presentation. Sample slides can be found at the beginning and end of the presentation. These slides can easily be customized by replacing the placeholders “<>” with specific information. The slides entitled “Personal Experience” are hidden by default. To show them in the presentation, select the slides and select the “Hide Slide” button in the Slide Show pull-down menu. To give presenters some guidance in how to narrate the slides, a manuscript was prepared that can be found in the note section of each slide. Please review the manuscript before giving a presentation as it contains specific details about the PVP Procedure. The manuscript extends in some parts beyond the content that can actually be covered in a real presentation. Some text slides spell out the synopsis of preceding illustrations or videos. These text slides are intended to re-emphasize take home messages. For questions or suggestions, please contact Kester Nahen, Ph.D., Laserscope Director of Professional Education and Clinical Applications, phone (408) 895-6775, knahen@laserscope.com. The presentation can directly be run from the CD-ROM. To run the presentation from a hard drive, the Power Point file (ppt) and video clips (wmv, mpg) must be copied to the same folder on the computer’s hard drive. The speakers of the computer should be turned off during the presentation as some video clips include an unrelated voice-over. The presentation was prepared with Power Point 97 on a Windows 2000 PC. C. Ryan Barnes, M.D. Virginia Urology

BPH (Benign Prostatic Hyperplasia) What is BPH? BPH is a medical term for enlarged prostate. It is not cancer and does not lead to cancer. It is a quality of life condition It is very common affecting millions of men Half of all men over age 50 Symptoms increase with age

Illustration of Normal Prostate Anatomy

Illustration of the Prostate Anatomy with BPH

BPH Symptoms Feeling a repeated & instant need to urinate Interrupting your sleep to urinate Waiting for urine to start flowing Weak stream Pain or burning during urination Inability to completely empty the bladder

BPH Symptoms Obstructive Irritative Weak stream Hesitancy Intermittency Straining Inability to completely empty Irritative Frequency Urgency Nocturia

Differential Voidings symptoms may be caused by: Bladder cancer/CIS Prostate cancer UTIs Urethral stricture Distal ureteral stones Bladder stones

Initial Evaluation Detailed medical history Physical exam Urinalysis including DRE and neurologic exam Urinalysis Serum creatinine no longer mandatory PSA Symptom assessment (AUA-SS, IPSS)

IPSS

Optional Evaluation International Prostate Symptom Score (IPSS) Voiding diary Bladder scan or cath PVR Urine flow rate Urodynamic study

How can it be treated? Watchful Waiting Drug Therapy Surgery alpha blockers 5-alpha reductase inhibitors Combination Surgery Radio Frequency Microwave Therapy Transurethral laser procedures Vaporization Enucleation Transurethral resection (TURP) Simple prostatectomy Urethral lift

Medical Therapy Alpha adrenergic blockers 5-alpha reductase inhibitors Combination therapy Medical agents are less effective than surgery, but associated with fewer and less severe adverse events

Alpha adrenergic blockers Alfuzosin 10mg Silodosin 4,8mg Tamsulosin 0.4,0.8mg Doxazosin 2,4,8mg Terazosin 1-10mg Prazosin or phenoxybenzamine are not recommended

Clinical effectiveness (4-6 pt improvement) is equal at max dose Differences only in side-effect profile Side effects Orthostatic hypotension/dizziness Asthenia Ejaculatory problems Nasal congestion

5-alpha reductase inhibitors Finasteride Dutasteride Effective for symptoms (3-5 point change) in patients with prostatic enlargement Decrease prostate size and increase flow rates Reduce chance for acute urinary retention as well as surgical interventions

5-alpha reductase inhibitors Potential adverse effects Decreased libido Ejaculatory dysfunction Erectile dysfunction Gynecomastia

Combination therapy Long term followup (at least 5 year) suggests combination therapy is more effective than monotherapy with either agent MTOPS (Medical Therapy of Prostate Symptoms) Reduction in Progression Reduction in Retention Reduction in Surgery Alpha blocker 39% 31% 0% Reductase Inhib 34% 67% 64% Combination 79%

Indications for Procedural Intervention Failure of medical therapy Recurrent UTIs Bladder stones Hematuria Retention Renal Impairment

Radiofrequency Ablation

TUNA

TUNA

Microwave Thermotherapy Prolieve TM Dual-action thermodilatation technology that both heats & dilates the prostate leading to necrosis 45 minute treatment time

Laser Treatment of BPH Greenlight PVP TM (532nm) Protouch TM (1470nm) Holmium (2100nm) Thulium (2000nm) Evolve TM (980nm)

Laser Procedure Before we go into the details of the procedure, let me show you some short video clips of a GreenLight PVP Procedure. Gland size for this video is 55 cc, treatment time was 25 min.

How Long with a Catheter? Recovery room: 50% Within 24 hours: 95% Consider leaving in longer if: very large gland bladder function questionable

Post-Operative Care Antibiotic Non-steroidal anti-inflammatory (opt.) Mild analgesic (opt.) No strenuous activities or sex for 2 wks Return to normal activities in 2 or 3 days

Pre-Laser Treatment This is a pre-op picture.

Immediate Post-Laser Treatment This picture, taken immediately post-PVP, shows the capsular fiber and the typical roughness of the tissue at the end of the procedure. It may not look as clean as a TURP but...

3-Months Post-Laser Treatment as you see here, 3 months post PVP, a smooth epithelial lining has formed. The small fibers that you saw immediately post-op were released the first days and weeks after the procedure. The speaker may want to mention at this point that the sloughing of the thin coagulated tissue layer can cause some mild hematuria. A few drops of blood can be seen in the urine when the dead tissue sloughs off and the tissue underneath isn’t fully epithelialized yet.

Lateral Lobes Obstructing Bladder Neck pre-op Here is a picture of a 41 cc gland pre-op. The patient had a Qmax of 8.1 milliliters per second.

2-yr. Follow-up Mid Prostatic Fossa This is the fossa 2 years after PVP.

Lasers - Conclusion Safety - relatively bloodless Procedure time equal to TURP No continuous bladder irrigation Catheter free less than 24 hours Outpatient Patients can return to work within 2-3 days Durability excellent (85% without recurrence of symptoms at 10 years) Let me conclude by saying that the PVP procedure can be considered safe. It’s virtually bloodless and even patients on anti-coagulants can be treated. The procedure is relatively fast with treatment times comparable to TURP. There is no need for continuous bladder irrigation and the patient is typically catheter free in less than 24 yours. PVP is an outpatient procedure which results in cost reductions. The patients can return to work within a couple of days. For the surgeon, it is a relatively short learning curve.

Monopolar TURP Standard of care; effective, durable, low retreatment rates Requires non-isotonic solution presenting risk for dilutional changes and fluid shifts 60 minutes resection TURP syndrome – hyponatremia, AMS, seizures Need for blood transfusion (5%) Improvements in technology, technique, and monitoring have lessened complications

Bipolar TURP Normal saline irrigation TURP syndrome is rare

Open/Robotic Simple Prostatectomy Very effective Removal of entire adenoma Leaves peripheral prostatic tissue (still at risk for prostate cancer) Open Significant risk for transfusion 2-3 day hospital stay Robotic (transvesical/retropubic) Select patients

Urethral Lift Advantages In-office procedure Preserves sexual function No new and lasting problem with erections or ejaculation Rapid, durable relief Typically return to normal within 5-9 days Typically no catheter Disadvantages Some discomfort, small amount of blood in urine, and increased urgency after procedure (as with any transurethral procedure) Mayo Clinic: http://www.mayoclinic.com/health/prostate-gland-enlargement/DS00027 Roehrborn Urology Clinics 2016 McVary et al. J Sex Med 2013 Shore et al. Can J Urology 2014

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

UroLift® Animation New Animation Here MAC00100-01 Rev A

UroLift® Treatment Images Before Treatment: Obstructed Channel After Treatment: Open Channel PRE POST Images courtesy of Dr. Peter Chin, Wollongong, NSW, Australia

Post-Treatment Expectations Symptom improvement may start within 2 weeks, may continue to improve up to 3 months Some irritation such as pain upon urinating, small amount of blood in urine, pelvic discomfort or urgency for some time after the procedure Typically return to preoperative activity level within 5-9 days Symptom relief lasts for 4 years or longer 4 years is the maximum length of published clinical follow-up thus far Roehrborn Urology Clinics 2016 Chin et al. Urology 2012 Shore et al. Can J Urology 2014

Questions & Answers

References Contemporary Diagnosis and Management of Benign Prostatic Hyperplasia. Claus Roehrborn, MD 2007 Contemporary Diagnosis and Management of Diseases of the Prostate. Issa/Marshall, MD 2004 Malek, R. Long term PVP follow up data (unpublished)