BPHBPH MANAGEMENTMANAGEMENT

MINIMALLY INVASIVE AND MINIMALLY INVASIVE AND ENDOSCOPIC TECHNIQUESENDOSCOPIC TECHNIQUES

BPH Minimally Invasive Rx BPH Minimally Invasive Rx

OptionsOptions

• Urethral stentsUrethral stents• TUNATUNA• Microwave thermotherapy- TUMTMicrowave thermotherapy- TUMT• Laser TherapyLaser Therapy• HydrothermotherapyHydrothermotherapy

Indications for Invasive Indications for Invasive Therapy for BPHTherapy for BPH

• Failure of medical therapyFailure of medical therapy• Urinary retention->1/3 bladder vol.Urinary retention->1/3 bladder vol.• Recurrent urinary infectionRecurrent urinary infection• VesicolithiasisVesicolithiasis• Recurrent hematuria- grossRecurrent hematuria- gross• AzotemiaAzotemia

Criteria for Utilization of Criteria for Utilization of Alternative Minimally Alternative Minimally

Invasive TherapiesInvasive Therapies

• Less adverse side-effectsLess adverse side-effects• Approaches or = surgical Approaches or = surgical

outcomes outcomes • No AnesthesiaNo Anesthesia• Shorter Hospital stayShorter Hospital stay• Less expensiveLess expensive• Safety profile = /> surgical therapySafety profile = /> surgical therapy

Treatment Options- Treatment Options- Minimally Invasive Minimally Invasive

TherapiesTherapiesAdvantagesAdvantages Less adverse effectsLess adverse effects No anesthesiaNo anesthesia No hospital stayNo hospital stay CheaperCheaper Approaches Approaches

outcomes of surgeryoutcomes of surgery

DisadvantagesDisadvantages Less favorable Less favorable

outcome, flow & sx’soutcome, flow & sx’s RetreatmentRetreatment Cost $ & suffering of Cost $ & suffering of

retreatmentretreatment Complications- Complications-

hematuria, dysuria, hematuria, dysuria, retentionretention

Urethral StentsUrethral Stents

• Initially conceived to relieve BOO 2º Initially conceived to relieve BOO 2º to BPH *, later to urethral strictureto BPH *, later to urethral stricture

• Types-Types-1. Temporary1. Temporary2. Permanent2. Permanent

Endoscopic insertionEndoscopic insertion Major role in patients unfit for surgeryMajor role in patients unfit for surgery

*Fabian,1980

Urethral Stent- Urethral Stent- TemporaryTemporary

• NonabsorbableNonabsorbableremoved or changed q6-36 mos.removed or changed q6-36 mos.topical with sedationtopical with sedationsuccess 50-90%success 50-90%no catheter or cysto with stent in situ no catheter or cysto with stent in situ complications-encrustation,migration, complications-encrustation,migration, breakage,stress incont. breakage,stress incont. UTI, hematuriaUTI, hematuria

Urethral Stent-TemporaryUrethral Stent-Temporary

• Intraurethral Catheter(polyurethrane)Intraurethral Catheter(polyurethrane)– de Pezzer proximal end(like a malecot)de Pezzer proximal end(like a malecot)– may used after TUMTmay used after TUMT– 16 Fr,variable to single lengths16 Fr,variable to single lengths– Nissenkorn, Barnes, Trestle(two components)Nissenkorn, Barnes, Trestle(two components)– Usually left for 1 monthUsually left for 1 month– Complications- hematuria, urinary retention,Complications- hematuria, urinary retention,– Await large multicenter RCTAwait large multicenter RCT

Urethral Stent- Urethral Stent- BiodegradableBiodegradable

• Polyglycolic acid reinforcedPolyglycolic acid reinforced• Placed after laser prostatectomy,TUMTPlaced after laser prostatectomy,TUMT• Voiding difficulty at 3-4 wks, transientVoiding difficulty at 3-4 wks, transient• Cost-effectiveness questioned,added toCost-effectiveness questioned,added to

TULP or TUMTTULP or TUMT Await long term, multi-center RCTAwait long term, multi-center RCT

Urethral Stent-PermanentUrethral Stent-Permanent

• Attempt to permanently, definitivelyAttempt to permanently, definitively treat BOO 2º BPHtreat BOO 2º BPH Initial enthusiasm turned to presentInitial enthusiasm turned to present

literature silenceliterature silence Initially introduced to Rx USDInitially introduced to Rx USD Present use-USD,S-D dyssyner., Present use-USD,S-D dyssyner.,

post- post- brachytherapy, brachytherapy,

Urethral Stent- UrolumeUrethral Stent- Urolume• Manufactured by AMS, for BPH patientsManufactured by AMS, for BPH patients• Modified both stent and delivery deviceModified both stent and delivery device• Lengths vary from 1.5 –4.0 cmLengths vary from 1.5 –4.0 cm• Symptoms scores improve 8-9 pts.Symptoms scores improve 8-9 pts.• Flow rates improve 4-6cc/sec(peak)Flow rates improve 4-6cc/sec(peak)• Used in nonsurgical candidatesUsed in nonsurgical candidates• Interest has waned with Tuna and TUMTInterest has waned with Tuna and TUMT

Urethral Stent- UrolumeUrethral Stent- Urolume

• ComplicationsComplicationsepithelial hyperplasiaepithelial hyperplasiamigration of stentmigration of stentirritative voidingirritative voidingpainful ejaculationpainful ejaculation

Urethral Stent- OthersUrethral Stent- Others

• Memotherm- variable resultsMemotherm- variable results• ASI –withdrawn from productionASI –withdrawn from production• Ultraflex-43 fr, 2-6cm, nickel-titanium Ultraflex-43 fr, 2-6cm, nickel-titanium

alloy, used in BPH, D-S dysyner., alloy, used in BPH, D-S dysyner., epithelial hypperplasia and epithelial hypperplasia and

migration lowmigration low• Conclusion- temporary stents are Conclusion- temporary stents are

attractive after Tattractive after TUNAUNA and TUMT and TUMT

Transurethral Needle Transurethral Needle Ablation of the ProstateAblation of the Prostate

• Heat delivery system to induce Heat delivery system to induce necrosis necrosis of the prostate tissue to of the prostate tissue to relieve BOO relieve BOO 2º BPH2º BPH

• Aim to prostate temp >60º CAim to prostate temp >60º C• Uses low-level radio frequency energy Uses low-level radio frequency energy

delivered by needles into prostatedelivered by needles into prostate• Use of topical anesthesia adequateUse of topical anesthesia adequate

TUNA- Delivery of RF TUNA- Delivery of RF EnergyEnergy

• Produced by Vidamed, uses applicator Produced by Vidamed, uses applicator with two needleswith two needles

• Generator produces monopolar RF Generator produces monopolar RF signal of 490kHz to give excellent signal of 490kHz to give excellent tissue penetrationtissue penetration

• Grounding pad over sacrum large sizeGrounding pad over sacrum large size• Size of prostate lesion f: Size of prostate lesion f:

kHz,time,depth kHz,time,depth and position of and position of needle insertionneedle insertion

TUNA- Energy TUNA- Energy CharacteristicsCharacteristics

• RF produces molecular agitationRF produces molecular agitationgenerated heatgenerated heat

Heat generated p: 1/radius Heat generated p: 1/radius Heat lost by convection, vascularity Heat lost by convection, vascularity

affects lesion size as RF has no affects lesion size as RF has no effect on vessels > 2-3mm diametereffect on vessels > 2-3mm diameter

RF hotter central area and quick decline RF hotter central area and quick decline of temp as distance from needlesof temp as distance from needles

4

TUNA- Experimental DataTUNA- Experimental Data

• TUNA creates 1cm necrotic lesion with TUNA creates 1cm necrotic lesion with no damage to rectum, bladder base, or no damage to rectum, bladder base, or distal prostatic urethradistal prostatic urethra

• Necrosis maximal @ 7 days, fibrosis by Necrosis maximal @ 7 days, fibrosis by 15 days15 days

• Treated areas have absence of staining Treated areas have absence of staining of PSA,smooth mus. actin, of PSA,smooth mus. actin, -adrenergic -adrenergic nerual tissue(maximal @ 1-2 weeks) nerual tissue(maximal @ 1-2 weeks)

TUNA-Experimental DataTUNA-Experimental Data

• Sequential injury to different types of Sequential injury to different types of nerve endings may occur NOS* nerve endings may occur NOS*

most most vulnerablevulnerable• Central core Temp- 90-100ºC, edge of Central core Temp- 90-100ºC, edge of

zone 50ºCzone 50ºC• Treatment times of 5-7 min. needed to Treatment times of 5-7 min. needed to

produce coagulation necrosis in Rx produce coagulation necrosis in Rx SiteSite

*NOS- nitric oxide synthase

TUNA-InstrumentsTUNA-Instruments

TUNA-InstrumentsTUNA-Instruments

RF needles deployedNote insulation and bare tips

TUNA-TreatmentTUNA-Treatment• Position- dorsolithotomyPosition- dorsolithotomy• Anesthesia-local, sedation, SAB, GenAnesthesia-local, sedation, SAB, Gen• Instrument/needle placed with 0º telescopeInstrument/needle placed with 0º telescope• Needle deployed/activated-20x10mm Needle deployed/activated-20x10mm

lesionlesion• Two lesions/needle deployment-1 pair/3cm, Two lesions/needle deployment-1 pair/3cm,

2 pair/4cm, additional pair/cm urethral 2 pair/4cm, additional pair/cm urethral length; Rx bilaterallylength; Rx bilaterally

• RF power delivered @2-15W for 5min., RF power delivered @2-15W for 5min., catheter is optionalcatheter is optional

TUNA-World Experience TUNA-World Experience

TUNA-Summary of Data TUNA-Summary of Data for 546 Patients*for 546 Patients*

mpkFlow mpkFlow increaseincrease

%% mSI decreasemSI decrease %%

6ml/sec6ml/sec 7777 13.113.1 5858

Summary of world experience @12 months follow-up

TUNA- Adverse EffectsTUNA- Adverse Effects

• Urinary retention-13-42%Urinary retention-13-42%• Irritative voiding-40% (1-7days)Irritative voiding-40% (1-7days)• UTI-3%UTI-3%• Urethral stricture-1.5%Urethral stricture-1.5%• Hematuria-33%, mild, short-livedHematuria-33%, mild, short-lived• Reoperation-12-14% in 2 yrsReoperation-12-14% in 2 yrs

TUNA-IndicationsTUNA-Indications

• BPH/BOOBPH/BOO• Lateral lobe enlargementLateral lobe enlargement• Prostate volume <60gmsProstate volume <60gms• Median lobe not ideal, but can be Median lobe not ideal, but can be

RxRx• Bladder neck hypertrophy not ideal Bladder neck hypertrophy not ideal

candidatecandidate

TUMT-Transurethral TUMT-Transurethral Microwave TherapyMicrowave Therapy

• Evaluated for past decadeEvaluated for past decade• Widely used, variable urologist attitudeWidely used, variable urologist attitude• Evolution from low-energy to high-energyEvolution from low-energy to high-energy• Presently most commonly used devices Presently most commonly used devices

are Prostatron and Targis are Prostatron and Targis • Current methods use either urethral Current methods use either urethral

cooling catheter or non-cooling cathetercooling catheter or non-cooling catheter

TUMT- Method of ActionTUMT- Method of Action

• Heat induced hemorrhagic necrosis, Heat induced hemorrhagic necrosis, sympathetic nerve injury, apoptosissympathetic nerve injury, apoptosis

• Tissue exposed to 45ºC for 60 min Tissue exposed to 45ºC for 60 min suffered hemorrhagic necrosissuffered hemorrhagic necrosis

• Sympathetic nerve injury histologically Sympathetic nerve injury histologically confirmed in 2 reports…confirmed in 2 reports…

• Suggests thermal injury to adrenergic Suggests thermal injury to adrenergic fibers likely accounts for symptomsfibers likely accounts for symptoms

TUMT-Method of ActionTUMT-Method of Action

• Targis antenna(902-1928MHz) exceedsTargis antenna(902-1928MHz) exceedsProstatron(1296MHz) in efficiency of Prostatron(1296MHz) in efficiency of delivery of thermal energydelivery of thermal energy

1-adrenoreceptor density after TUMT1-adrenoreceptor density after TUMT Adrenergic nerve fibers remain in lamina Adrenergic nerve fibers remain in lamina

propria and epithelial layers, virtually propria and epithelial layers, virtually absent in smooth muscle layersabsent in smooth muscle layers

TUMT- Method of ActionTUMT- Method of Action• Apoptosis induced by moderate thermal Apoptosis induced by moderate thermal

energy for longer period of timeenergy for longer period of time• Hemorrhagic necrosis induced by higher Hemorrhagic necrosis induced by higher

thermal energy over shorter timethermal energy over shorter time• Brehmer and Svennson demonstrated Brehmer and Svennson demonstrated

poptosis in 76% of cultured prostate poptosis in 76% of cultured prostate cells 24 hrs after heat exposure, only cells 24 hrs after heat exposure, only 14% were necrotic14% were necrotic

Thermatrix vs High Thermatrix vs High Energy, Cooled Microwave Energy, Cooled Microwave

ThermoRxThermoRxTherMatrixTherMatrixTUMTTUMT

High PowerHigh PowerCooled RxCooled Rx

deliverydelivery Urethral CathUrethral Cath Urethral CathUrethral Cathenergyenergy Microwave:Microwave:

Avg 6 wattsAvg 6 wattsMicrowave:Microwave:40-49 watts40-49 watts

effecteffect Tissue Tissue NecrosisNecrosis

Tissue Tissue NecrosisNecrosis

tolerancetolerance Oral meds Oral meds onlyonly

Parental Parental RecommendeRecommendedd

Thermatrix vs High Thermatrix vs High Energy Microwave, Cooled Energy Microwave, Cooled

ThermoRxThermoRxTherMatrixTherMatrixTUMTTUMT

High PowerHigh PowerCooled RxCooled Rx

AUA SI @ 12mAUA SI @ 12m 47% decrease47% decrease 44-51% 44-51% decreasedecrease

PFR@12MPFR@12M 58% decrease58% decrease 45-55% 45-55% decreasedecrease

Side EffectsSide Effects Minor ,Self-Minor ,Self-resolvingresolving

Significant,lonSignificant,longer durationger duration

SAE(FDA filed SAE(FDA filed MDRs)MDRs)

NoneNone Rectal fistula, Rectal fistula, penile penile necrosisnecrosis

5mm-62.4ºC

10mm-50.5ºC

15mm-temp =urethral

Larson and Collins, 1995

TUMT- Clinical ResultsTUMT- Clinical Results

# of Patients# of Patients110110

ShamSham35 pts 35 pts

TUMTTUMT75 pts75 pts

SxIndex SxIndex 14.9-10.814.9-10.8 13.9-6.313.9-6.3

pFlow pFlow 7.4-9.4cc/sec7.4-9.4cc/sec 7.2-11.5cc/7.2-11.5cc/secsec

Blute et al 1996,

Three months duration- TUMT vs Sham

TUMT- Clinical ResultsTUMT- Clinical Results

# of Patients# of Patients125125

ShamSham44 pts44 pts

TUMTTUMT79 pts79 pts

Sx Index Sx Index 21.3-14.321.3-14.3 20.8-10.520.8-10.5

pFlow pFlow 7.8-9.8 7.8-9.8 cc/seccc/sec

7.8-11.8 7.8-11.8 cc/seccc/sec

Larson et al 1998

Six Months Duration- TUMT vs Sham

TUMT- Clinical ResultsTUMT- Clinical Results

# of Patients# of Patients TUMT-31(26)TUMT-31(26) TURP-21(18)TURP-21(18)Sx Index Sx Index 13.2-4.213.2-4.2 13.8-2.813.8-2.8pFlow pFlow 10.6-16.9 10.6-16.9

cc/seccc/sec9.3-18.6cc/sec9.3-18.6cc/sec

Press/Flow(0-Press/Flow(0-6m)6m)

Obstructed Obstructed 62-40%62-40%

Obstructed Obstructed 76-15%76-15%

Catheter: Catheter: timetime

12.7 days(6-12.7 days(6-35)35)

4.1 days(4-5)4.1 days(4-5)

Irritative voidIrritative void 29%29% 19%19%

Twelve Months Duration- Prostatron 2.5 vs Turp

D’Ancona et al 1999, @ 24 mos 8/31TUMT & 1/21 needed other Rx

TUMT-ConclusionTUMT-Conclusion

• Symptomatic improvement after TUMT Symptomatic improvement after TUMT appears to be energy relatedappears to be energy related

• Objective improvement after TUMT may Objective improvement after TUMT may be insignificant be insignificant

• Symptomatic improvement may be Symptomatic improvement may be significant without objective improvementsignificant without objective improvement

Laser TherapyLaser Therapy

• TypesTypesNeodynium:Yttrium-Aluminum-GarnetNeodynium:Yttrium-Aluminum-Garnet

wavelength-1064nnwavelength-1064nnPotassium Titanyl PhosphatePotassium Titanyl Phosphate

wavelength-532nnwavelength-532nnHolmium: Yttrium-Aluminum-GarnetHolmium: Yttrium-Aluminum-Garnet

wavelength-2100nnwavelength-2100nnDiode- most energy efficient Diode- most energy efficient

Laser TherapyLaser Therapy

• Methods of deliveryMethods of deliveryEnd firing, Bare tip, Sculpted End firing, Bare tip, Sculpted

tip, tip, Sapphire tip, Side firing, Metal Sapphire tip, Side firing, Metal or or Glass reflector, Prismatic Glass reflector, Prismatic internal internal reflector, interstitial, reflector, interstitial, Diffuser tip, Diffuser tip, Diffuser tip with Diffuser tip with temperature temperature transducertransducer

Laser Theraapy-Method of Laser Theraapy-Method of ActionAction

• 45-50ºC -tissue desiccation45-50ºC -tissue desiccation• 50-100ºC - tissue coagulation, 50-100ºC - tissue coagulation,

irreversible effectsirreversible effects

• 100ºC +- tissue boils, vaporizes, 100ºC +- tissue boils, vaporizes, carbonizedcarbonized

Laser Therapy- SummaryLaser Therapy- Summary

• There is incomplete and insufficient There is incomplete and insufficient quality data at present in the medical quality data at present in the medical literature to allow statement of the literature to allow statement of the safety and efficacy of Laser safety and efficacy of Laser prostatectomy.prostatectomy.

HydrothermotherapyHydrothermotherapy

• Recent Appliance availabliltyRecent Appliance availablilty• Recent Application attemptsRecent Application attempts• Insufficient Outcome Evidence to Insufficient Outcome Evidence to

permit definitive statement of permit definitive statement of safety or efficacysafety or efficacy

Office-Based Transurethral Office-Based Transurethral Microwave Thermotherapy for Microwave Thermotherapy for

BPH Using TheraMatrix TMx-2000BPH Using TheraMatrix TMx-2000

Results of Multi-Center, Prospective, Results of Multi-Center, Prospective, Randomized, Sham-Controlled StudyRandomized, Sham-Controlled Study