3Prostate Nerve Supply Nerve supply received from neurovascular bundles Innervated by autonomic and sensory nervesOriginates from the pelvic and hypogastric fibersNerves coalesce at tips of seminal vesicles to form the pelvic plexus
4Importance of Nerve Supply Neurovascular bundles responsible for erectile functionConsideration for comfort control during PROSTIVA® RF Therapy procedure
5Prostate Blood Supply Two main arteries supply the prostate Positioned at 11 and 1 o’clockReduced blood supply will impede growth of prostateThe prostate gland is surrounded by vessels and nervesTwo main arteries which supply the prostate come in at 5 and 7 o’clock positionInterference of blood supply will impede abnormal cellular activities
6Clinical Implications for Benign Prostatic Hyperplasia (BPH) Therapy Stroma (fibromuscular) predominant BPHResponds to -adrenergic blockers which exert their effect on the muscleEpithelial (glandular) predominant BPHResponds to androgen suppression therapy such as 5- reductase inhibitors, which inhibits the conversion of testosterone to DHTAlpha blockers were initially tested for the treatment of high blood pressure and were soon found to relieve BPH symptomsIssa M, Contemporary Diag and Mgmt,
7-Adrenergic Receptor Distribution in the Lower Urinary Tract -1D adrenoreceptors-1A adrenoreceptors
8Prostate Zones - Peripheral zone - 70% of prostate - Central zone - 25% of prostate- Transitional zone - 5% of prostateWhere BPH occurs; small percentage of total prostateZonal classification is mainly for pathologic purposesPractical purposes for various conditions of the prostate such as BPH.BPH primarily affects the transition zoneMost prostate cancer (approx 70%) is found in the peripheral zoneIssa M, Marshall F. Contemporary Diagnosis and Management of Diseases of the Prostate. 3rd ed. Newtown, Pa: Handbooks in Healthcare Co; 2005.
9Located anteriorly but surrounds the urethra Transitional ZoneLocated anteriorly but surrounds the urethraBPH primarily affects the transitional zonePercentage of the prostatePeripheral zone - 70%Central zone - 25%Transitional zone - 5%
11Symptomatic BPH Population US Prevalence: 14.9 MillionUS Incidence: 500,000Translates to: 50% of men over 5060% of men over 6070% of men over 7080% of men over 80US Census; Millennium Research, 2006; A.G. Edwards & Son, 2006.
12Why Treat BPH?BPH is not cancer but it can lead to unwanted complications if not correctedUrine retention and strain on the bladder can lead toUrinary tract infectionsBladder or kidney damageBladder stonesIncontinenceWhen BPH is diagnosed and treated early, there is a lower risk of developing such complications
13Quality of Life of Untreated BPH Before PROSTIVA® RF TherapyI couldn’t play golf because if I’d get out there I had to stop and find a bathroom to go. --HaroldI just had to go an awful lot – five or six times a night. --PaulI didn’t really mind so much the fact that it was difficult to start urination, but what I really did mind was having the leakage. --BillIt has an impact because first of all when you go into a strange store or a strange building, the first thing you have to zero in on is where are the restrooms. --RichardI carried a cup in the car so I could urinate. I’ve urinated to relieve myself going 60 miles an hour! --MosesAfter PROSTIVA RF TherapyThe RF Therapy has changed my life. It has allowed me to do things that I couldn’t do without conditions before. --RichardPrior to the RF Therapy, I was on two expensive medications for prostate problems and one of them I had to take twice a day. And after the Therapy, I’ve been able to drop them and don’t have to take them anymore which is great. --BobbyPROSTIVA RF Therapy is the best thing I ever did in my life. --Harold
14Click box to activate video This video clip is one patient’s experience only and may not reflect other patients' experiences
15Benign Prostatic Hyperplasia (BPH) Patient Evaluation and Diagnosis
16BPH Diagnosis and Treatment Algorithm Initial EvaluationHistoryDRE & Focused PEUrinalysisPSAPresence ofRefractory retention or any of the following clearly related to BPHPersistent gross hematuriaBladder stonesRecurrent UTIsRenal insufficiencyAUA/IPSS Symptom Index Assessment of Patient BotherModerate/Severe Symptoms (AUA/IPSS 8)Mild Symptoms(AUA/IPSS 7) or No Bothersome SymptomsSurgeryOptional Diagnostic TestsUroflowPVRDiscussion of Treatment OptionsOptional Diagnostic TestsPressure flowUrethrocystoscopyProstate ultrasoundPatient Chooses Noninvasive TherapyPatient Chooses Invasive TherapyWatchful WaitingMedical TherapyMinimally Invasive TherapiesSurgeryAUA Guideline 2003/updated 2006.
17Further Evaluation Warranted? Abnormal DREAbnormal PSAPrior therapy for LUTS/BPHNon-response to medical therapy<50 years of ageHistory of diabetesHistory of pelvic surgery/ traumaNeurologic symptoms/ diseaseRenal insufficiencyIf results of the initial evaluation of the patient are not consistent with BPH or reveal other pathologies, additional diagnostic testing is warranted. Listed on this slide are the conditions/states that warrant further evaluation of those presenting with symptoms suggestive of BPH.Although BPH is extremely common in men aged 50 years or older, symptoms of prostatism occurring in men less than 50 years of age requires further assessment.The evaluation of PSA levels in patients with BPH is optional. It is also complicated by the elevations in serum PSA levels normally associated with BPH and the effects of BPH medications on PSA levels. Still, an abnormal level must be further explored for its potential in detecting a prostate cancer.LUTS associated with BPH also can be associated with other diseases. Men who have previously been treated but failed to respond require additional evaluation, either as a first step in a revised treatment approach or to identify another condition.A history of prior instrumentation, prostate surgery, trauma, or urethritis may suggest urethral stricture and should be investigated.As noted above, LUTS can occur in other conditions. The differential diagnosis for LUTS in older men includes diabetes, neurologic conditions, and congestive heart failure, among others. Patients with severe symptoms, including renal insufficiency, most likely require more extensive evaluation and subsequent surgery.Finally, treatment nonresponders require further work-up to determine the next appropriate course of action.1. Arrighi HM, Guess HA, Metter EJ, et al. Symptoms and signs of prostatism as risk factors for prostatectomy. Prostate ;16:2. McConnell JD, Barry MJ, Bruskewitz RC, et al. Benign Prostatic Hyperplasia: Diagnosis and Treatment. Clinical Practice Guideline, Number 8. AHCPR Publication No Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services. February 1994.3. Ziada A, Rosenblum M, Crawford ED. Benign prostatic hyperplasia: an overview. Urology. 1999;53:1-6.AUA Guideline 2003/updated 2006.
18Questions to Ask Relative to History Oral intakeTimingCaffeineAlcoholMedications affecting volumeDiureticsStool-bulking agentsMedications affecting voidingAntihistaminesDecongestantsDiseasesDiabetesCongestive heart failureNeurologicThe detailed medical history focuses on the general health issues and issues specific to the urinary tract. It provides the clinician a chance to ask about previous surgical procedures or fitness for a future surgical procedure. The history-taking also provides a chance to identify other causes of voiding dysfunction or comorbidities.1,2At the time of history-taking, questions to focus on include the following:oral intake of fluids, including the types of fluid, when taken, and how muchcurrent medicationsconfounding/concomitant diseasesDiabetes is a risk factor for BPH. It also has symptoms similar to BPH and should be ruled out. Other conditions that are part of the differential diagnosis of BPH include congestive heart failure and neurologic conditions, such as stroke, multiple sclerosis, and Parkinson’s disease.ReferencesAUA Guideline 2003McConnell JD, Barry MJ, Bruskewitz RC, et al. Benign Prostatic Hyperplasia: Diagnosis and Treatment. Clinical Practice Guideline, Number 8. AHCPR Publication No Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services. February 1994.Ziada A, Rosenblum M, Crawford ED. Benign prostatic hyperplasia: an overview. Urology. 1999;53:1-6.AUA Guideline 2003/updated 2006.
19Optional Diagnostic Tests Following initial evaluationUroflowUrinary flow-rate recording (Qmax)PVRIf patient chooses invasive therapyPressure flowUrethrocystoscopyProstate ultrasoundOptional tests may help in the decision making process when the initial evaluation suggests:Nonprostatic cause for the patient’s symptomsPatient selects invasive therapyUrinary flow-rate recording and measurement of post void residual urine (PVR) may be appropriate. These tests usually are not necessary prior to the institution of watchful waiting or medical therapy. However, they may be helpful in patients with a complex medical history ( i.e.., neurologic or other diseases known to affect bladder function or prior failure of BPH therapy) and in those desiring invasive therapy.If patient chooses invasive therapyAdditional diagnostic tests may be helpful when outcome of the pressure-flow study may impact choice of intervention or if the prostate size and anatomical configuration are important considerations for a given treatment modality.Pressure Flow Urodynamic study: directly measures the relative contribution of the bladder and bladder outlet and the contributions of the prostate to lower urinary tract function, dysfunction or symptoms.Urethrocystoscopy: may guide the choice of therapy in patients who have already decided to proceed within invasive approachTransrectal or transabdominal prostate ultrasound: may guide choice of therapy based upon size and shape of the prostateAUA Guideline 2003/updated 2006.
20Standard Questionnaires for Patient’s Perception of BPH Symptoms AUA Symptom ScoreInternational Prostate Symptom Score (IPSS)BPH Impact Index (Bother Score)From the patient’s perspective, the morbidity of BPH is largely due to the symptoms of prostatism. BPH is associated with bothersome symptoms that can severely impact QOL, with effects on general health, physical well-being, and mental health.Instruments for evaluating symptoms and assessing their impact on QOL have been developed. Tools are not a replacement for personal discussion of symptoms with the patient. Tools for measuring symptoms include:AUA Symptom ScoreIPSSBPH Impact Index (Bother Score)Assessment of QOL
21AUA Symptom Score Index Seven-item questionnaire related to BPH symptomsValidated and reproducibleDetermines disease severityDocuments response to therapyAllows standardized comparisons of symptom relief when evaluating treatmentsAUA Symptom Index and the identical IPSS.Validated, patient-administered, seven-item questionnaire that assigns a numerical value to symptoms and helps classify the disease for treatment planning and follow-up purposes. For quantification of symptoms, the preferred instrument is the patient-administered AUA Symptom Score Index. It contains seven questions related to BPH symptoms. It has been validated and is reproducible.ReferencesAUA Guideline 2003McConnell JD, Barry MJ, Bruskewitz RC, et al. Benign Prostatic Hyperplasia: Diagnosis and Treatment. Clinical Practice Guideline, Number 8. AHCPR Publication No Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services. February 1994.Barry MJ, Fowler FJ, O’Leary MP, et al. The American Urological Association Symptom Index for benign prostatic hyperplasia. J Urol :AUA Guideline 2003/updated 2006.
23Classification of AUA Symptom Scores The possible total runs from 0-35 points with higher scores indicating more severe symptoms. Scores lower than 7 are considered mild and generally do not warrant treatment.Classification rangesMild (0-7)Moderate (8-19)Severe (20-35)Without bother or bothersomeAUA Guideline 2003/updated 2006.
24Initial Management and Discussion Using AUA Symptom Score Patients with mild symptoms (AUA symptom score ≤ 7)andPatients with moderate or severe symptoms (AUA symptom score ≥ 8) who are not bothered by their symptomsOffer watchful waitingReassure patientReassess periodicallyUsing a scoring system, BPH symptoms experienced by the patient are classified as mild (score of 0–7), moderate (8–19), or severe (20–35), thus assigning severity to the disease. Although it should not be used as the sole means of diagnosis, the AUA Symptom Score Index can be used for treatment planning and follow-up.Depending on the score derived from the patient’s response to the index, the treatment approaches can be determined.Patient education materials can help patients make informed choices or discuss matters of concern with their doctors.
25Initial Management and Discussion Using AUA Symptom Score Patients with bothersome, moderate to severe symptoms (AUA Symptom Score ≥ 8)Watchful waitingDiscuss BPH treatment options, including benefits and risksProvide patient education materials
26International Prostate Symptom Score (IPSS) AUA Symptom Score Index plus additional question on QOL as a function of urinary symptoms:“If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?”Scale of 0 to 6 (delighted to terrible)Note: While symptoms may be prevalent, they may not be troublesomeThe difference between the IPSS and the AUA Symptom Score Index is the one question on QOL that appears in the IPSS. The question asks patients to rate their QOL should their urinary symptoms persist and never change, thereby giving some idea of how troublesome or bothersome the symptoms are in relation to daily activities.Because patient tolerances to symptoms vary, clinicians should keep in mind that symptoms may be prevalent but not bothersome.IPSS was originally designed as a research tool but is among the best-known tools in the clinical arena for evaluating symptoms.O’Leary MP. LUTS, ED, QOL: alphabet soup or real concerns to aging men? Urology. 2000;56(suppl 5A):7-11.O’Leary MP. Urology
27BPH Impact Index (Bother Score) None Only a little Some A lot1. Over the past month, how much physical discomfort did any urinary problems cause you?2. Over the past month, how much did you worry about your health because of any urinary problems?Not at all Bothers Bothers Bothers bothersome me a little me some me a lot3. Overall, how bothersome has any trouble with urination been during the past month?None of A little of Some of Most of All of the time the time the time the time the timeThe BPH Impact Index is shown on this slide. The BPH Impact Index measures the impact of symptoms on QOL, with assessment of physical discomfort, anxiety/worry, bothersomeness, and effect on activities of daily living.1. Barry MJ, Fowler FJ Jr, O’Leary MP, et al, for the Measurement Committee of the American Urological Association. Measuring disease-specific health status in men with benign prostatic hyperplasia. Med Care. 1995;33(suppl 4):AS145-AS155.2. O’Leary MP. LUTS, ED, QOL: alphabet soup or real concerns to aging men? Urology. 2000;56(suppl 5A):7-11.4. Over the past month, how much of the time has any urinary problem kept you from doing the kinds of things you would usually do?AUA Guideline 2003/updated 2006.
29DefinitionsCurrent - the number or amount of electrons flowing past a fixed point for a fixed amount of timeCurrent density - the amount of current flowing per unit area of a conductor surfaceElectricity - the flow of atoms through various mediums such as fluids or metals that are called conductors. There are negatively charged particles inside the atoms called electrons. The electrons will move through a conductor if force or pressure is applied.
30Definitions - continued Hyperthermia therapy - prostate tissue is heated to the range of 42 to 44 C. Tissue effect is temporary.Resistance/impedance - resistance encountered by the electrons as they move through a conductor. Resistance/ impedance is measured in ohms.Voltage - the force or pressure that moves electrons through a conductor.
32Basic FunctionThe PROSTIVA® RF Therapy system generator produces the voltage (force) necessary to move the electrons through the prostate tissue to the grounding pad.Electrons moving through the tissue vibrate the tissue causing heat from friction.Temperature/time45 C – 60 Minutes55 C – 20 Minutes60 C – 5 Minutes70 C – 2 MinutesBoschef, et al. ASME, 2001.
33Impact of Heat on Tissue The heat generated in the tissue by the needles can be described as forming two zones.Pathological lesionProduced when temperatures reach > 55° CDescribed as coagulative necrosis (dead tissue surrounded by healthy tissue)Physiological lesionOccurs at temperatures > 47° CSurrounds the pathological lesion and is described as the gelatinized zoneTissue is not killed, but damagedResult is injury to the tissue that is accompanied with inflammation and edema, resembling a gelBoschef, et al. ASME, 2001.
34Delivery of RF Energy Through Needles RF energy disperses quickly and predictably in tissue. The energy creates heat through “cellular friction.” The heat created measures 115° C for PROSTIVA® RF Therapy at the center of the lesion (pathological lesion). The temperature of the heat drops between 5° to 15° C every 2 mm away from the needles (physiological lesion).Medtronic internal data on file.
35Science Behind the Technology Based on reasonable scientific analysis, PROSTIVA® RF Therapy works in the following ways:DenervationDevascularization
36DenervationAlpha-receptors have the highest concentration at and around the bladder neck; alpha-blocker medications target this area.PROSTIVA® RF Therapy is the only therapy that delivers lethal, controlled doses of 115° C temperatures precisely to this area while protecting the bladder neck’s functionality.The system’s right angle delivery of the predetermined needle length and the known centimeter spheroid lesion size ensures this.The destruction of these alpha-receptor nerve fibers has been shown histologically.PROSTIVA RF Therapy Model 8930 System User Guide; 4-3.Perchino M. Eur Urol 1993.
38DevascularizationTwo main arteries which supply the prostate come in at 11 and 1 o’clock positions.The growth and proliferation of the abnormal cells requires blood flow in order to progress.The interference of the blood supply will impede the abnormal cellular activities within the transitional zone of the prostate.This can be influenced by creating lesions or scar tissue by delivering RF energy to this exact area.
40PROSTIVA® RF Therapy Procedure and Its Impact on Size Recall that 5- reductase inhibitors block free testosterone from binding to 5- reductasePROSTIVA RF Therapy may kill:5- reductase that is in the lesionThe blood vessels that carry the free testosterone to the transitional zonePROSTIVA RF Therapy could decrease the size of the prostate
41Mechanism of Action Animation Click to play movie
42MRI Movie Sequence Click to play movie Used by permission - Thayne Larson, M.D.
43MRI Movie Sequence Click to play movie Used by permission - Thayne Larson, M.D.
44MRI Lateral Lobe Lesions Coronal View These MRI images were obtained by Dr. Thayne Larson one week after Medtronic RF therapy. The patients were injected with gadolinium contrast, which is shown as the bright areas in the MRI images. The lesions are depicted in the dark areas and indicate the absence of blood flow into those areas.Reference: Thayne Larson, M.D., Institute for Medical ResearchUsed by permission - Thayne Larson, M.D.
45MRI Lateral Lobe Lesions Horizontal View These MRI images were obtained by Dr. Thayne Larson one week after Medtronic RF therapy. The patients were injected with gadolinium contrast, which is shown as the bright areas in the MRI images. The lesions are depicted in the dark areas and indicate the absence of blood flow into those areas.Reference: Thayne Larson, M.D., Institute for Medical ResearchUsed by permission - Thayne Larson, M.D.
46MRI Median Lobe Lesions Coronal View These MRI images were obtained by Dr. Thayne Larson one week after Medtronic RF therapy. The patients were injected with gadolinium contrast, which is shown as the bright areas in the MRI images. The lesions are depicted in the dark areas and indicate the absence of blood flow into those areas.Reference: Thayne Larson, M.D., Institute for Medical ResearchUsed by permission - Thayne Larson, M.D.
47MRI Median Lobe Lesions Horizontal View These MRI images were obtained by Dr. Thayne Larson one week after Medtronic RF therapy. The patients were injected with gadolinium contrast, which is shown as the bright areas in the MRI images. The lesions are depicted in the dark areas and indicate the absence of blood flow into those areas.Reference: Thayne Larson, M.D., Institute for Medical ResearchUsed by permission - Thayne Larson, M.D.
48Treatment Options for Benign Prostatic Hyperplasia (BPH)
49How do you balance the challenges of providing a good in-office experience versus long-term symptom relief for your patients?
51Treating BPH Minor symptoms usually do not require treatment. Moderate to severe symptoms tend to interfere with sleep and daily activities and usually require treatment.
52Three Categories of Treatment Options Drug TherapyOffice ProcedureSurgical-blocker5- reductase inhibitorCombinationRadio FrequencyHigh energy TUMTLow energy TUMTILCTURPTUIPPVPHoLAPEXPLAIN DIFFERENCE BETWEEN HIGH ENERGY AND LOW ENERGY
53Drug Therapy Advantages Disadvantages No surgery Effective for mild to moderate symptomsDisadvantagesLifelong commitment to therapyEffectiveness may decrease over timeDrug therapy can cause multiple side effectsImpotence, dizziness, headaches, fatigue, and decreased libidoMust take a daily pill for the rest of your life to maintain symptom relief and costs approximately $1,000 per year
54Surgical – Transurethral Resection of the Prostate (TURP) AdvantagesAvailability of long-term outcomes dataGood clinical resultsTreats prostates <150 gLow retreatment rateLow mortalityDisadvantagesRequires two to four days hospitalizationRequires general or spinal anesthesiaPotential surgical risks include:ImpotenceRetrograde ejaculationIncontinenceInfectionExcessive blood lossTURP offers several potential advantages for the treatment of BPH. First, it is associated with good clinical results. Indeed, with the possible exception of open prostatectomy, no other surgical modality has been shown to be its equal in terms of symptom improvement. TURP allows for treatment of glands with masses of up to 100 g; and the retreatment rates in patients who undergo TURP are low.One of the disadvantages of this procedure is its reliance on the skill of the individual surgeon. Moreover, although improvements in technology and technique have resulted in marked reductions in postoperative mortality and morbidity, postoperative bleeding and impairments in sexual function, such as retrograde ejaculation, are still disturbing complications of TURP.Borth CS, Beiko DT, Nickel JC. Impact of medical therapy on transurethral resection of the prostate: a decade of change. Urology. 2001;57:Debruyne FMJ, Djavan B, DeLaRosette J, et al. Interventional therapy for benign prostatic hyperplasia. In: Benign Prostatic Hyperplasia. 5th International Consultation on Benign Prostatic Hyperplasia (BPH). Eds: Chatelain C, Denis L, Foo KT, et al. World Health Organization–International Union Against Cancer. Paris, France. June 25-28, 2000:Mebust WK, Holtgrewe HL, Cockett ATK, Peters PC, for the Writing Committee. Transurethral prostatectomy: immediate and postoperative complications. A cooperative study of 13 participating institutions evaluating 3,885 patients. J Urol. 1989;141:Wagner JR, Russo P. Urologic complications of major pelvic surgery. Semin Surg Oncol. 2000;18:Borth CS et al, Urology, Mebust WK et al, J Urol, 1989.Wagner JR et al, Semin Surg Oncol, 2000.
55Surgical - GreenLight PVP™ Hospital-based procedureRequires general anesthesiaBetter for smaller prostatesTURP-like results
56Holmium laser ablation of the prostate (HoLAP) Surgical - HoLAPHolmium laser ablation of the prostate (HoLAP)Performed as an outpatient procedureTissue ablation is roughly equivalent to GreenLight PVP™Versatility of performing across multiple specialties and treating other urology conditions including strictures, tumors and stones
57Avoid the need to take daily medication Office ProceduresAvoid the need to take daily medicationAvoid some of the risks and complications associated with surgery
58Radio Frequency Therapy (PROSTIVA®) Microwave Thermotherapy (TUMT) Office ProceduresRadio Frequency Therapy (PROSTIVA®)Microwave Thermotherapy (TUMT)Interstitial Laser Coagulation (ILC)Definitions – ILC definition
59Office Procedure - TUMT Microwaves used to heat and destroy excess prostate tissueProcedure takes about one hourSome require 2 to 14 days of catheterization which can result in urinary tract infection
60Office Procedure - ILCLaser energy coagulates obstructing tissue of the enlarged prostate glandThe tissue that is destroyed is absorbed by the body and BPH symptoms decrease over timeMay require extended post-procedural catheterization which can result in higher rates of urinary tract infectionProcedure takes less than one hourRequires 5 to 14 days of catheterization
61PROSTIVA® RF Therapy Indication for Use PROSTIVA® Radio Frequency Therapy is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3.PROSTIVA® RF Therapy System User Guide.
62PROSTIVA® RF TherapyDelivers low-level radio frequency energy into the middle of the prostate and relieves obstruction without causing damage to the urethraCan be performed with a sedative and local anesthetic in a urologist’s officeProcedure takes less than one hourCatheterization, if required, is 0-2 days on averageIntended for men over age 50
63Temperature ChartProlieve, Prostatron, Thermatrx, Targis, Indigo Instructions for Use.PROSTIVA RF Therapy System User Guide.
64What Side Effects are Associated with PROSTIVA® RF Therapy? Possible side effects include:ObstructionCatheterization (for urinary retention)Bleeding/blood in urinePain/discomfortUrgency to urinateIncreased frequency of urinationUrinary tract infectionPatients may also experience a minor burning sensation when urinating for one to two weeks following the treatmentCompared to traditional surgical treatments, fewer side effects and adverse eventsPROSTIVA RF Therapy side-effects/adverse events include obstruction, catheterization, bleeding, pain/discomfort, urgency, frequency and urinary tract infectionPossible side effects include:Obstruction, bleeding, blood in urine, pain/discomfort, urgency to urinate, increased frequency of urination and urinary tract infection.Patients may also experience a minor burning sensation when urinating for one to two weeks following the treatment.PROSTIVA® RF Therapy System User Guide.
66Nearly 100,000 patients treated worldwide Five-year efficacy data Proven RF TechnologyNearly 100,000 patients treated worldwideFive-year efficacy dataAfter five years:IPSS - 55%Qmax +29%QOL +68%115º C core lesion temperature89 published articles on RF therapy for BPHHill, et al, J Urol, 2004.
67Precise Therapy Delivery 360 degrees of precision to treat exactly the area you wantSix different needle length options to treat varying prostate sizes and shapes15 computer-monitored safety checks
68Evolution of RF Therapy 1992TUNA 3minLesion (manual)Catheter – 22F26 gauge needlesManual power, impedance and temperature controlsPhysician dependent1997200020032006ProVu 5.5 – 7 min lesionProVu Delivery SystemPrecision 4 min lesionPrecision Plus 3 min lesionPROSTIVA 2 min 20 sec lesionFirst automatic system models 7205 & 760018.5F/26 gauge needlesTemperature measured by shield thermocouples18.5F delivery systemHighest quality optics with proximal and distal positioning6 preset needle lengthsAutomatic shield deploymentUrethral thermocoupleReusable handle w/ disposable cartridgeTarget temperature of 110° CHollow tip needlesThermocouples in shields and both needle tipsShield length = 6mmDesigned for officeLesion time 25% faster than PrecisionLarger needle (24 gauge) provides for consistent heating in all types of tissueNew RF generatorLesion time 22% faster than Precision PlusTarget temp of 115 ° CIntegrated disposable hand piece
69PROSTIVA® RF Therapy Designed by Medtronic Target lesion temperature of 115°C2 min 20 second per lesionEasy set-upUser interface with touch screen controlsPlatform of the futureDesigned and built by Medtronic from the ground up, this is our new generator.
71Generator Features Computer Monitored Safety Checks: Monitors urethral and prostatic temperatures six times per secondControls RF power 5000 times per secondMeasures impedance and power 50 million times per secondComputerized graphics allow physician to view treatment in real timeDesigned and built by Medtronic from the ground upThe PROSTIVA generator is fast and easy to use -- features effectiveness, and safety that physicians have grown accustomed to.This is the platform for the Future – upgradeable.
72Hand Piece Features Single sterile use Tubing system connects to hand pieceTubing connects to an irrigation source which supplies cooling fluid during procedure
73Telescope FeaturesReusable, but must be cleaned and sterilized before each procedureAllows physician to directly view anatomical landmarks and the needle deployment siteBoth 0º and 15º telescopic angles available
75Examples of prostate shapes that PROSTIVA® RF Therapy can treat Patient SelectionExamples of prostate shapes that PROSTIVA® RF Therapy can treat20-50 grams Long LobesShort LobesAsymmetric GlandMedian Lobe*PROSTIVA RF therapy treats the median and lateral lobe as well as asymmetrical prostates. With an exception of the median lobes that protrude into the bladder and collapse over the bladder neck.*Excluding a ball valve median lobe that grows up into bladder and obstructs opening
76Contraindications Patients with active urinary tract infection Neurogenic, decompensated, or atonic bladderUrethral strictures or muscle spasms that prevent insertion of the hand piece sheathBleeding disorders or patients taking anticoagulation medications unless antiplatelet medication has been discontinued for at least 10 daysASA class group V patientsClinical or histological evidence of prostatic cancer or bladder cancerProstate gland <34 mm or >80 mm in transverse diameterPresence of any prosthetic device in the region that may interfere with the procedurePatients whose prostate has been previously treated with non-pharmacological therapiesPresence of a cardiac pacemaker, implantable defibrillator, or malleable penile implantsPatients with any component(s) of an implantable neurostimulation system
78PROSTIVA® RF Therapy Procedure Prepare patientAdminister comfort controlMeasure prostateDetermine number of treatment planesTreat median lobe if necessaryCreate lesions
79Comfort Control Protocol Describe your comfort control protocolSee Medtronic PROSTIVA® RF Therapy procedural video for several comfort control options, which can be used during the PROSTIVA RF procedure. Medical practice is solely the responsibility of the individual physician and not Medtronic.
80Treatment ApproachGuidelines for determining the number of treatment planes are based on the distance from the bladder to the verumontanumIdeally, a minimum of two planes should be treated, provided that the distance from the needle placement to the bladder neck and from the needle placement to the veru remains cmA treatment plane consists of delivery of energy to the right and left lobes at the same levelDetermination of the number of treatment planes is the clinician’s sole medical judgment.PROSTIVA® RF Therapy System User Guide.
81Determining Number of Treatment Planes Recommended guidelinesPROSTIVA® RF Therapy System User Guide.
82Median Lobe Treatment Visualize size and structure Needles should be deployed 1 cm away from the proximal margin of the bladder neckSelect needle length of 12 or 14 is recommendedDetermination of median lobe treatment locations and appropriate needle length is the clinician’s sole medical judgment.PROSTIVA System User GuidePROSTIVA® RF Therapy System User Guide.
83Median Lobe Treatment Locations Recommendedtreatment locationsProximal (upper) end10, 12, and 2 o’clockDistal (lower) end6 o’clock location is for therapy at distal endPROSTIVA® RF Therapy System User Guide.
89Reimbursement Status PROSTIVA® RF Therapy coverage: Medicare in all 50 statesMany private pay and managed care insurance companiesMost patients will be responsible for a deductible and/or co-paymentMedicare reimburses physicians for performing the PROSTIVA RF Therapy procedure in their offices (there is a site of service differential)
91OutcomesWould you perform the PROSTIVA® RF Therapy procedure on your father?Why do you think PROSTIVA RF Therapy works?
92PROSTIVA® RF Therapy Long-term Durability Can you speak to long-term durability?Hill B, Belville W, Bruskewitz R, Issa M, Perez-Marrero R, Roehrborn C, Terris M, Naslund M, “Transurethral Needle Ablation versus Transurethral Resection of the Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia: 5-Year Results of a Prospective, Randomized, Multicenter Clinical Trial,” J Urol, 2004;171:Zlotta, AR, Giannakopoulos X, Maehlum O, Ostrem T, Schulman CC, “Long-Term Evaluation of Transurethral Needle Ablation of the Prostate (TUNA) for Treatment of Symptomatic Benign Prostatic Hyperplasia: Clinical Outcome Up To Five Years From Three Centers,” Eur Urol, 2003; 44:89-93Boyle P, Robertson C, Vaughan E D, Fitzpatrick J, “A Meta-Analysis of Trials of Transurethral Needle Ablation for Treating Symptomatic Benign Prostatic Hyperplasia”, British Journal of Urology Intl, 2004; 94:AUA Guidelines 2004, “Management of Benign Prostatic Hyperplasia: Diagnosis and Treatment Recommendations” Chapter 1, page 27.
93ReferencesIssa M, Marshall F. Contemporary Diagnosis and Management of Diseases of the Prostate. 3rd ed. Newtown, Pa: Handbooks in Healthcare Co; 2005.American Urological Association Education and Research, Inc. AUA Guideline 2003/Updated 2006.O’Leary MP. LUTS, ED, QOL: alphabet soup or real concerns to aging men? Urology, 2000;56(suppl 5A):7-11.Boschef, et al., “In vitro assessment of the efficacy of thermal therapy in human benign prostate hyperplasia,” ASME, 2001 Nov; 2001.PROSTIVA RF Therapy Model 8930 System User Guide, 4-3.Perchino M, et al., “Does transurethral thermotherapy induce a long-term alpha blockade? An immunohistochemical study,” Eur Urol, 1993, 23:Larson, Thayne. Institute of Medical Research and Lance Mynderse, M.D., Mayo Clinic. “MRI study of 12 patients with average age of 64, treatment focus on bladder neck and lateral lobe,” 2006 Medtronic RF Therapy Study.Accessed March 7, 2006.PROSTIVA® RF Therapy System User Guide. Safety information from System User Guide is available at
94ReferencesHill B, Belville W, Bruskewitz R, Issa M, Perez-Marrero R, Roehrborn C, Terris M, Naslund M, “Transurethral Needle Ablation versus Transurethral Resection of the Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia: 5-Year Results of a Prospective, Randomized, Multicenter Clinical Trial,” J Urol, 2004;171:Nickel JC, “Long-term implications of medical therapy on benign prostatic hyperplasia end points,” Urology, 1998;51(suppl 4A):50-57.Borth CS, Beiko DT, Nickel JC, “Impact of medical therapy on transurethral resection of the prostate: a decade of change,” Urology, 001;57:Mebust WK, Holtgrewe HL, Cockett ATK, Peters PC, for the Writing Committee. “Transurethral prostatectomy: immediate and postoperative complications. A cooperative study of 13 participating institutions evaluating 3,885 patients,” J Urol, 1989;141:Wagner JR, Russo P, “Urologic complications of major pelvic surgery,” Semin Surg Oncol, 2000;18:For more information about PROSTIVA® RF Therapy, call (800) , x6000; or visitCAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.