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Lynn Della Grotta Spring 2013 Biomaterials

Lynn Della Grotta Spring 2013 Biomaterials. 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. Benign Prostatic Hyperplasia (BPH).

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Lynn Della Grotta Spring 2013 Biomaterials

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  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. Alpha Blockers 5-Alpha-Reductase Inhibitors • Selective: • tamsulosin(Flomax) • alfusozin (Uroxatral) • silodosin(Rapaflo) • Nonselective: • terazosin (Hytrin) • doxazosin (Cardura) • Finasteride (Proscar) • dutasteride (Avodart) Side Effects: • Erectile dysfunction • Lowered libido • Decreased semen during ejaculation Side Effects: • Hypotension, headache • Stuffy, runny nose • Decreased ejaculate • intraoperative floppy iris syndrome (IFIS)- selective • Blocks conversion of testosterone to DHT • Better with significant prostate enlargement • Increase urinary flow, shrink prostate • 6-12 months before full benefits; continuous use • 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

  8. Transurethral Resection of Prostate (TURP) • 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

  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 • Implant: • Nitinol capsular tab • Stainless steel urethral end piece • Size 0 polyethylene teraphthalate (PET) nonabsorbable monofilament • 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

  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.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-Procedure Post-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. <http://www.canjurol.com/html/free-articles/V19I2-17_DrBarkin.pdf>. • “Prostate Laser Surgery”. Mayo Clinic. Mayo Foundation for Medical Education and Research, 22 July 2011. Web. 23 April 2013. <http://www.mayoclinic.com/health/prostate-laser-surgery/MY00611/DSECTION=why%2Dits%2Ddone>. • Simon, Harvey. “Benign Prostatic Hyperplasia”. University of Maryland Medical Center. UMMC, 8 July 2009. Web. 22 April 2013. <http://www.easybib.com/reference/guide/mla/website>. • “Transurethral Microwave Therapy (TUMT)”. Mayo Clinic. Mayo Foundation for Medical Education and Research, 11 May 2011. Web. 23 April 2013. <http://www.mayoclinic.com/health/tumt/MY00607/DSECTION=why%2Dits%2Ddone>. • “Transurethral Resection of Protstate (TURP)”. Mayo Clinic. Mayo Foundation for Medical Education and Research, 10 May 2011. Web. 23 April 2013. <http://www.mayoclinic.com/health/turp/MY00633/METHOD=print&DSECTION=all>. • “Transurethral Resection of Protstate (TURP)”. Wikipedia. Wikipedia, 28 February 2013. Web. 23 April 2013. <http://en.wikipedia.org/wiki/Transurethral_resection_of_the_prostate>. • UroLift. Relief. In Sight. NeoTract, 2011-2012. Web. 22 April 2013. <http://www.neotract.com/default.aspx>.

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