BPH MANAGEMENT MINIMALLY INVASIVE AND ENDOSCOPIC TECHNIQUES BPH Minimally Invasive Rx Options • Urethral stents • TUNA • Microwave thermotherapy- TUMT • Laser Therapy • Hydrothermotherapy Indications for Invasive Therapy for BPH • Failure of medical therapy • Urinary retention->1/3 bladder vol. • Recurrent urinary infection • Vesicolithiasis • Recurrent hematuria- gross • Azotemia Criteria for Utilization of Alternative Minimally Invasive Therapies • Less adverse side-effects • Approaches or = surgical outcomes • No Anesthesia • Shorter Hospital stay • Less expensive • Safety profile = /> surgical therapy Treatment Options- Minimally Invasive Therapies Advantages Less adverse effects No anesthesia No hospital stay Cheaper Approaches outcomes of surgery Disadvantages Less favorable outcome, flow & sx’s Retreatment Cost $ & suffering of retreatment Complicationshematuria, dysuria, retention Urethral Stents • Initially conceived to relieve BOO 2º to BPH *, later to urethral stricture • Types1. Temporary 2. Permanent Endoscopic insertion Major role in patients unfit for surgery *Fabian,1980 Urethral Stent- Temporary • Nonabsorbable removed or changed q6-36 mos. topical with sedation success 50-90% no catheter or cysto with stent in situ complications-encrustation,migration, breakage,stress incont. UTI, hematuria Urethral Stent-Temporary • Intraurethral Catheter(polyurethrane) – de Pezzer proximal end(like a malecot) – may used after TUMT – 16 Fr,variable to single lengths – Nissenkorn, Barnes, Trestle(two components) – Usually left for 1 month – Complications- hematuria, urinary retention, – Await large multicenter RCT Urethral Stent- Biodegradable • Polyglycolic acid reinforced • Placed after laser prostatectomy,TUMT • Voiding difficulty at 3-4 wks, transient • Cost-effectiveness questioned,added to TULP or TUMT Await long term, multi-center RCT Urethral Stent-Permanent • Attempt to permanently, definitively treat BOO 2º BPH Initial enthusiasm turned to present literature silence Initially introduced to Rx USD Present use-USD,S-D dyssyner., postbrachytherapy, Urethral Stent- Urolume • Manufactured by AMS, for BPH patients • Modified both stent and delivery device • Lengths vary from 1.5 –4.0 cm • Symptoms scores improve 8-9 pts. • Flow rates improve 4-6cc/sec(peak) • Used in nonsurgical candidates • Interest has waned with Tuna and TUMT Urethral Stent- Urolume • Complications epithelial hyperplasia migration of stent irritative voiding painful ejaculation Urethral Stent- Others • Memotherm- variable results • ASI –withdrawn from production • Ultraflex-43 fr, 2-6cm, nickel-titanium alloy, used in BPH, D-S dysyner., epithelial hypperplasia and migration low • Conclusion- temporary stents are attractive after TUNA and TUMT Transurethral Needle Ablation of the Prostate • Heat delivery system to induce necrosis of the prostate tissue to relieve BOO 2º BPH • Aim to prostate temp >60º C • Uses low-level radio frequency energy delivered by needles into prostate • Use of topical anesthesia adequate TUNA- Delivery of RF Energy • Produced by Vidamed, uses applicator with two needles • Generator produces monopolar RF signal of 490kHz to give excellent tissue penetration • Grounding pad over sacrum large size • Size of prostate lesion f: kHz,time,depth and position of needle insertion TUNA- Energy Characteristics • RF produces molecular agitation generated heat Heat generated p: 1/radius 4 Heat lost by convection, vascularity affects lesion size as RF has no effect on vessels > 2-3mm diameter RF hotter central area and quick decline of temp as distance from needles TUNA- Experimental Data • TUNA creates 1cm necrotic lesion with no damage to rectum, bladder base, or distal prostatic urethra • Necrosis maximal @ 7 days, fibrosis by 15 days • Treated areas have absence of staining of PSA,smooth mus. actin, -adrenergic nerual tissue(maximal @ 1-2 weeks) TUNA-Experimental Data • Sequential injury to different types of nerve endings may occur NOS* most vulnerable • Central core Temp- 90-100ºC, edge of zone 50ºC • Treatment times of 5-7 min. needed to produce coagulation necrosis in Rx Site *NOS- nitric oxide synthase TUNA-Instruments TUNA-Instruments RF needles deployed Note insulation and bare tips TUNA-Treatment • Position- dorsolithotomy • Anesthesia-local, sedation, SAB, Gen • Instrument/needle placed with 0º telescope • Needle deployed/activated-20x10mm lesion • Two lesions/needle deployment-1 pair/3cm, 2 pair/4cm, additional pair/cm urethral length; Rx bilaterally • RF power delivered @2-15W for 5min., catheter is optional TUNA-World Experience TUNA-Summary of Data for 546 Patients* mpkFlow increase % 6ml/sec 77 mSI decrease 13.1 Summary of world experience @12 months follow-up % 58 TUNA- Adverse Effects • Urinary retention-13-42% • Irritative voiding-40% (1-7days) • UTI-3% • Urethral stricture-1.5% • Hematuria-33%, mild, short-lived • Reoperation-12-14% in 2 yrs TUNA-Indications • BPH/BOO • Lateral lobe enlargement • Prostate volume <60gms • Median lobe not ideal, but can be Rx • Bladder neck hypertrophy not ideal candidate TUMT-Transurethral Microwave Therapy • Evaluated for past decade • Widely used, variable urologist attitude • Evolution from low-energy to high-energy • Presently most commonly used devices are Prostatron and Targis • Current methods use either urethral cooling catheter or non-cooling catheter TUMT- Method of Action • Heat induced hemorrhagic necrosis, sympathetic nerve injury, apoptosis • Tissue exposed to 45ºC for 60 min suffered hemorrhagic necrosis • Sympathetic nerve injury histologically confirmed in 2 reports… • Suggests thermal injury to adrenergic fibers likely accounts for symptoms TUMT-Method of Action • Targis antenna(902-1928MHz) exceeds Prostatron(1296MHz) in efficiency of delivery of thermal energy 1-adrenoreceptor density after TUMT Adrenergic nerve fibers remain in lamina propria and epithelial layers, virtually absent in smooth muscle layers TUMT- Method of Action • Apoptosis induced by moderate thermal energy for longer period of time • Hemorrhagic necrosis induced by higher thermal energy over shorter time • Brehmer and Svennson demonstrated poptosis in 76% of cultured prostate cells 24 hrs after heat exposure, only 14% were necrotic Thermatrix vs High Energy, Cooled Microwave ThermoRx delivery energy effect tolerance TherMatrix TUMT Urethral Cath High Power Cooled Rx Urethral Cath Microwave: Avg 6 watts Tissue Necrosis Oral meds only Microwave: 40-49 watts Tissue Necrosis Parental Recommended Thermatrix vs High Energy Microwave, Cooled ThermoRx TherMatrix TUMT AUA SI @ 12m 47% decrease PFR@12M Side Effects 58% decrease Minor ,Selfresolving SAE(FDA filed None MDRs) High Power Cooled Rx 44-51% decrease 45-55% decrease Significant,long er duration Rectal fistula, penile necrosis 5mm-62.4ºC 10mm-50.5ºC 15mm-temp =urethral Larson and Collins, 1995 TUMT- Clinical Results Three months duration- TUMT vs Sham # of Patients 110 Sham 35 pts TUMT 75 pts SxIndex 14.9-10.8 13.9-6.3 pFlow 7.4-9.4cc/sec 7.2-11.5cc/sec Blute et al 1996, TUMT- Clinical Results Six Months Duration- TUMT vs Sham # of Patients 125 Sham 44 pts TUMT 79 pts Sx Index 21.3-14.3 20.8-10.5 pFlow 7.8-9.8 cc/sec 7.8-11.8 cc/sec Larson et al 1998 TUMT- Clinical Results Twelve Months Duration- Prostatron 2.5 vs Turp # of Patients TUMT-31(26) TURP-21(18) Sx Index 13.2-4.2 13.8-2.8 pFlow 10.6-16.9 cc/sec 9.3-18.6cc/sec Press/Flow(0Obstructed Obstructed 6m) 62-40% 76-15% Catheter: time 12.7 days(6-35) 4.1 days(4-5) Irritative void 29% 19% D’Ancona et al 1999, @ 24 mos 8/31TUMT & 1/21 needed other Rx TUMT-Conclusion • Symptomatic improvement after TUMT appears to be energy related • Objective improvement after TUMT may be insignificant • Symptomatic improvement may be significant without objective improvement Laser Therapy • Types Neodynium:Yttrium-Aluminum-Garnet wavelength-1064nn Potassium Titanyl Phosphate wavelength-532nn Holmium: Yttrium-Aluminum-Garnet wavelength-2100nn Diode- most energy efficient Laser Therapy • Methods of delivery End firing, Bare tip, Sculpted tip, Sapphire tip, Side firing, Metal or Glass reflector, Prismatic internal reflector, interstitial, Diffuser tip, Diffuser tip with temperature transducer Laser Theraapy-Method of Action • 45-50ºC -tissue desiccation • 50-100ºC - tissue coagulation, irreversible effects • 100ºC +- tissue boils, vaporizes, carbonized Laser Therapy- Summary • There is incomplete and insufficient quality data at present in the medical literature to allow statement of the safety and efficacy of Laser prostatectomy. Hydrothermotherapy • Recent Appliance availablilty • Recent Application attempts • Insufficient Outcome Evidence to permit definitive statement of safety or efficacy Office-Based Transurethral Microwave Thermotherapy for BPH Using TheraMatrix TMx-2000 Results of Multi-Center, Prospective, Randomized, Sham-Controlled Study