1. Lynn Della Grotta Spring 2013 Biomaterials

2. Pertinent Physiology Urethra Prostate gland –Surrounds urethra –Secretes fluid that mixes with sperm to make semen http://www.umm.edu/graphics/images/en/10053.jpg

3. Benign Prostatic Hyperplasia (BPH) Benign (non-cancerous) cell growth of prostate –Growth of microscopic nodules –Hormonal changes: DHT(dihydrotestosterone): stimulates cell growth in prostate lining(glandular epithelium) during puberty Estrogen: testosterone decreases as male ages, higher ratio of estrogen levels –Late cell growth activation presses on and can block urethra http://www.neotract.com/forpatients_ous-q10085-c10048-BPH_Overview.aspx

4. Symptoms of BPH Frequent urination Weak/slow stream Delay/Difficulty in beginning urination Urinary stream that starts and stops Painful or burning sensation with urination Feeling that bladder has not completely emptied Urgent need to urinate and difficulty postponing urination *Size of prostate enlargement is not correlated to the severity of the symptoms May have BPH with few or no symptoms Symptoms collectively known as LUTS: Lower Urinary Tract Symptoms

5. Scope 40% of men in 50s 70% of men in 60s 80-90% of men >70 years old ~33% of men with BPH have symptoms that disrupt their lifestyle Risk factors: age, family history, obesity, high blood pressure, low levels of HDL cholesterol, diabetes, peripheral artery disease

6. Treatment Options If mild symptoms- monitor –Limit alcohol, caffeine, excessive fluid intake –Pelvic floor muscle training –Avoid antihistamines, decongestants, and diuretics If treatment deemed necessary: –Medications: Alpha blockers 5-alpha-reductase inhibitors combination –Surgery: Transurethral Resection of Protstate (TURP) Thermotherapies: Laser Resection of the Prostate, TUMT UroLift

7. 5-Alpha-Reductase Inhibitors Finasteride (Proscar) dutasteride (Avodart) Blocks conversion of testosterone to DHT Better with significant prostate enlargement Increase urinary flow, shrink prostate 6-12 months before full benefits; continuous use Side Effects: –Erectile dysfunction –Lowered libido –Decreased semen during ejaculation Relax smooth muscles (bladder, urethra neck, prostate) Often first line of treatment Benefits in days/week Continuous dosage needed Improve urine flow, but don’t shrink prostate Side Effects: –Hypotension, headache –Stuffy, runny nose –Decreased ejaculate –intraoperative floppy iris syndrome (IFIS)- selective Selective: –tamsulosin(Flomax) –alfusozin (Uroxatral) –silodosin(Rapaflo) Nonselective: –terazosin (Hytrin) –doxazosin (Cardura) Alpha Blockers

8. –Resectoscope inserted into urethra through penis and trim away excess prostate tissue –Spinal or general anesthesia –4-6 weeks recovery (1-2 days in hospital); catheter for 4-7days –Complications: heavy bleeding, erectile dysfunction, UTI –Additional procedures 5-10 years later –Gold standard in surgery for treating BPH Transurethral Resection of Prostate (TURP)

9. Thermotherapies Laser Resection of the Prostate –Visual scope and laser inserted into urethra through penis; prostate tissue removed –Risks: UTI, retrograde ejaculation,erectile dysfunction, narrowing of urethra(scar tissue formation) Transurethral Microwave Therapy (TUMT) –Outpatient procedure: small microwave antenna inserted into urethra up to prostate. Microwaves heat up and destroy tissue. –Risks: damage to genitals, UTI, retrograde ejaculation, erectile dysfunction, narrowing of urethra, need for re- treatment

10. Why UroLift? Medications are usually tried before UroLift considered Over 25% of patients on medications discontinue use because of side effects or inadequate effectiveness –Medication are short term treatments Only 2.7% of BPH patients elect for surgery –Complications: sexual function –Invasive, risks UroLift –When medications aren’t effective or too many side effects and want less invasive surgery –Preserves sexual function –Less invasive, less risks –Quicker symptomatic relief –Prostate less than 100cc

11. UroLift Device In post-market study in U.S.; available for use in Canada, Europe, and Australia http://www.neotract.com/formedicalprofessionals_ous-q10100-c10095-UroLift_Devices.aspx Implant: –Nitinol capsular tab –Stainless steel urethral end piece –Size 0 polyethylene teraphthalate (PET) nonabsorbable monofilament

12. UroLift Procedures Local, general, or spinal anesthesia Cystoscopy: telescope inserted into rigid sheath of UroLift system; advanced through urethra up to bladder Telescope replaced with UroLift delivery device place device at targeted area of obstruction, unlock needle safety lock, depress trigger to fire spring-loaded 19 gauge needle, retract needle to leave a tab on prostate capsule attached to polyester filament, depress release button to install urethral end piece –Each implant length is tailored to the various prostates and prostate locations No contact with lateral lobes until ready to deploy implant; compress lobe before deploying implant Number of implants determined by surgeon Most critical target area is that of the urethra just distal to the bladder neck movie: http://www.neotract.com/formedicalprofessionals_ous-q10096-c10095- Animation.aspxhttp://www.neotract.com/formedicalprofessionals_ous-q10096-c10095- Animation.aspx http://www.neotract.com/formedicalprofessionals_ous-q10095-c10049-UroLift_System.aspx

13. Recovery Protocols Specifics decided by surgeon No extreme exercise and no sexual activity for 2 weeks Sometimes catheterization needed: on average about 1.5 days Refrain from alcohol after surgery Report any fever to physician Can climb stairs, go to bathroom

14. Expected Improvements Symptomatic improvement within 1 day or 2; return to normalcy within 1 week 40% mean improvement in IPSS(International Prostate Symptom Score) and urinary flow at 2 years 48% improvement in QoL(Quality of Life) score at 1 year No reports of erectile dysfunction or retrograde ejaculation Improvements are comparable to the TURP surgery Pre-ProcedurePost-Procedure http://www.neotract.com/formedicalprofessionals_ous-q10095-c10049-UroLift_System.aspx

15. Expected Complications Most common adverse events: dysuria, hematuria, and frequency –Typically resolved in 2 weeks In 64 man study, reported serious events: Urinary retention(3), epididymo-orchitis(1), rigors(1), myocardial infarction(1) –Resolved with standard treatment

16. Cost and Insurance United Kingdom: –Consultation: £210.00 ($315) –Self-Pay: Surgery(surgeon’s fee, hospital fee, anaesthetist fee, follow-up consultation): £7,000 ($10,500) –Insurance(Code M7080): £575 ($863) for surgeon and £240 ($360) for anaesthetist According to Bristol Urology

17. References Barkin, Jack. “UroLift System for Relief of Prostate Obstruction Under Local Anesthesia”. The Canadian Journal of Urology. April 2012. Web. 27 April 2013.. “Prostate Laser Surgery”. Mayo Clinic. Mayo Foundation for Medical Education and Research, 22 July 2011. Web. 23 April 2013.. Simon, Harvey. “Benign Prostatic Hyperplasia”. University of Maryland Medical Center. UMMC, 8 July 2009. Web. 22 April 2013.. “Transurethral Microwave Therapy (TUMT)”. Mayo Clinic. Mayo Foundation for Medical Education and Research, 11 May 2011. Web. 23 April 2013.. “Transurethral Resection of Protstate (TURP)”. Mayo Clinic. Mayo Foundation for Medical Education and Research, 10 May 2011. Web. 23 April 2013.. “Transurethral Resection of Protstate (TURP)”. Wikipedia. Wikipedia, 28 February 2013. Web. 23 April 2013.. UroLift. Relief. In Sight. NeoTract, 2011-2012. Web. 22 April 2013..