Lynn Della GrottaSpring 2013Biomaterials

Pertinent PhysiologyPertinent 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 Benign Prostatic Hyperplasia (BPH)(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 pubertyEstrogen: 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

Symptoms of BPHSymptoms 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

ScopeScope• 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

Treatment OptionsTreatment 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

5-Alpha-Reductase 5-Alpha-Reductase InhibitorsInhibitors

• 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 BlockersAlpha Blockers

– 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 Transurethral Resection of Prostate (TURP)Prostate (TURP)

ThermotherapiesThermotherapies• 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

Why UroLift?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

UroLift DeviceUroLift 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

UroLift ProceduresUroLift 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

Recovery ProtocolsRecovery 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

Expected ImprovementsExpected 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-Procedurehttp://www.neotract.com/formedicalprofessionals_ous-q10095-c10049-UroLift_System.aspx

Expected ComplicationsExpected 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

Cost and InsuranceCost 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

ReferencesReferences• 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>.