Vol. 169, No.4, Supplement, Wednesday, April 30, 2003 THE JOURNAL OF UROLOGY® 465

METHODS: To date, 98 patients, between the ages of 46-82 years, diagnosedwith lower urinary tract symptoms (LUTS) secondary to BPH underwentphotoselective vaporization of the prostate utilizing an 80W quasi-continuous KTPlaser with a 70° side-firing fiber. The preoperative mean ultrasound volume of theprostate was 55.1 ::': 32 cc. All patients underwent extensive pre-operativeevaluation including AUA symptom index (minimum of 13 at baseline), QOLscore, peak urinary flow rate (maximum of 15cc/sec at baseline), post-void residualand TRUS prostate volume measurement. Biochemical assessment included PSA,Serum Sodium and Creatinine measurements. Ongoing follow-up evaluationsincluded 1, 3, 6 and l2-month assessment of all pre-operative parameters.Statistical analysis was performed using the t-test,

RESULTS: Data is presented in the table below. Improvements in AUA SI,QOL, Q-max and PVR were significant and durable up to 12 months post­operatively. The mean operative time was 36::': 17 minutes and 71% (N=7l) ofpatients were treated as outpatients. Prostate volumes decreased significantly andmean catheter removal times were 16 ::': 13 hours (0-72). Minor complicationsincluded hematuria (7%), transient retention (3%), transient incontinence (3%),UTI (1%), short-term transient dysuria (16%), long-term dysuria (2%) andimpotence (0%).

CONCLUSIONS: The PVP treatment is safe and effective for providing rapidsymptomatic and urodynamic relief of BPH symptoms. Moreover, the PVPtreatment can be performed in an outpatient setting with minimal morbidity andrecovery time.

Treatment Outcomee at1,3,6and12months posttreatment

1746TRANSURETHRAL MICROWAVE THERMOTHERAPY(TUMT) USING THE THERMATRX TMX-2000: DURABILITYEXHIBITED IN A STUDY COMPARING TUMT WITH A SHAMPROCEDURE IN PATIENTS WITH BENIGN PROSTATICHYPERPLASIA (BPH) David M Albala*, Durham, NC; GeraldAndriole, St. Louis, MO; Bradley E Davis, Overland Park, KS; Gregg R Eure,Norfolk, VA; John N Kabalin, Scottsbluff, NE; James E Lingeman,Indianapolis, IN; Joseph Nuzzarello, Wheaton, IL; Ilene Risk, Sandy, UT

INTRODUCTION AND OBJECTIVE: One of the ongoing questionsregarding TUMT therapy has been durability. A randomized, blinded, sham­controlled study has been performed to investigate the safety, efficacy anddurability of TUMT using the TherMatrx TMX-2000. In addition to comparison tothe sham arm, the full cohort has now reached 36 month post-treatment follow-up,and many patients have reached the 48 month post-treatment follow-up.

METHODS: 200 patients with an AUA symptom index (AUA SI) of >12, apeak flow rate of <12 mllsec, and cystoscopic BPH were randomized 2:1 (activeto sham) and treated in 7 physician offices. Durability continues to be examined aswe follow patients continuously; not all patients have yet reached the 4 year followup mark.

RESULTS: Durability is demonstrated for the 119 treated patients evaluable 12months after treatment with statistically significant improvements from baseline forthe following key parameters: AUA SI from 22.5 to 11.9 (47.1%), Bother scorefrom 18.0 to 9.1 (49.4%), Quality of Life from 11.4 to 5.8 (49.1%), and Peak FlowRate from 8.6 to 13.6 (58.1%, n= 111). Beyond the one year follow up, patientscontinue to be followed and AUA SI score improvements are tracking as followsfrom a baseline of 22.5 : 18 months to 12.5 (44%), 24 months to 12.8 (43%), 30months to 12 (47%), 36 months to 13.3 (41%),42 months to 13.4 (40%) and 48months to 12.4 (45%). Importantly, no urethral strictures, incontinence, loss ofejaculation, or other serious side effects have occurred. The patients experienced arapid recovery and resumed normal activities as soon as the catheter was removed(average 3 days).

CONCLUSIONS: The long-term results reported above indicate that in a shamcontrolled, randomized, blinded study, TUMT with the TherMatrx TMx-2000 hasbeen found to be an extremely durable, effective, well-tolerated office procedurefor the treatment of BPH.

Source of Funding: None.

N/D= not done:tP value <.0001(t-lest); Standard Deviation values rounded

Source of Funding: Laserscope.

2.6±1t

O.40±1t

3O.7±6t

3±5

30.3±15

12month(n=12)

2.9±2t

O.58±1t

24.1±7t

7.2±11t

4.9±3t

12±1t

21.7±6t

14.5±26t

7.9±4t

2.1±1t

20±8t

30.1±52t

1month(n=94) 3 monlh(n=82) 6 month(n=55)

23.9±6t

4.5±1t

7.6±3t

109.8±128t

Basellne(n=98)

AUAsymptomscoreQuality ofLifeScoreQ·maxPost-voldreeldualProstateVolume 55.1±32t N/D NlD 3O.5±14t

RESULTS: The distribution of patient metastases among the prostate cancerpatients imaged changed significantly from the first 100 cases to the subsequent300 with the trend being toward imaging patients at earlier stages of their disease,which means that more patients are now candidates for prostatectomy or radiationtherapy. Concerning the former, mapping of the pathological distribution of thecancer in excised prostates of six patients will be compared with their in vivoSPECT and PET images on a slice-by slice basis at 4 mm increments. Concerningradiation therapy, cases of capromab pendetide/CT imaging guiding both brachyand external radiation therapy will be presented. In addition, our initial efforts tofollow the course of treatment of the disease of several patients via multiplecapromab pendetide/CT imaging sessions will be presented.

CONCLUSIONS: The value of optimized capromab pendetide/CT imaging onthe management of patient cancer patients will be illustrated through case reportsselected from the >400 patients we have imaged. These studies illustrate thatcapromab pendetide/CT imaging can be used to guide both surgery and radiationtherapy in addition to following the progress of patients' disease. Since capromabpendetide targets PSMA, this study also suggests a key role of PSMA in theetiology of prostate cancer.

Source of Funding: Partially funded by Cytogen, Inc.

Benign Prostatic Hyperplasia: SurgicalTherapy and New Technology (II)

PodiumWednesday, April 30, 2003 10:00 AM-12:00 PM

1745PHOTOSELECTIVE LASER VAPORIZATION OF THEPROSTATE (PVP) FOR TREATMENT OF BENIGN PROSTATICHYPERPLASIA (BPH): THE FIRST MULTI-CENTERPROSPECTIVE TRIAL Alexis E Te*, New York, NY; Terrance RMalloy, Philadelphia, PA; Barry S Stein, Providence, RI; James C Ulchaker,Cleveland, OH; Mahmood A Hai, Westland, MI; Unyime 0 Nseyo, Richmond,VA; Reza S Malek, Rochester, MN

INTRODUCTION AND OBJECTIVE: Photoselective Laser Vaporizationof the Prostate (PVP) is a new high-power potassium-titanyl-phosphate(KTP) laser prostatectomy. The objective of this study is to demonstrate thatPVP can safely and effectively remove prostate adenoma with minimalcomplications and result in significant symptomatic and urodynamicimprovement of BPH symptoms. Preliminary results of this on-goingmulticenter study are presented.

1744ACCURACY OF EVALUATING COMPLICATED RENALCYSTS BY CT AND MRT IMAGING Steffen Schrodter", Oliver WHakenberg, Sven Oehlschliiger, Manfred P Wirth, Dresden, Germany

INTRODUCTION AND OBJECTIVE: The vast majority of renal cystscan be diagnosed by ultrasound as simple cysts. However, the diagnosticevaluation of complicated renal cysts in view of potential malignancy withimaging studies can be difficult and at times inconclusive. The aim of our studywas to evaluate the value of computerized tomography (CT) and magneticresonance imaging (MRT) and the BOSNIAK classification of imaging findingsin this respect.

METHODS: Over a period of 5 years out of 551 primary surgical proceduresfor renal malignancies, 16 patients underwent exploration for complicated renalcysts. All 16 patients had undergone ultrasonography and CT scanningpreoperatively, 9 patients had received an additional MRT. In all cases, thecomplicated cysts were removed, either by nephrectomy (n=5) or partialnephrectomy (n= 11). Renal cell carcinoma was found in 7/16 cases. The CT andMRT films of all patients were reanalysed by a radiologist unaware of thehistological results. Findings were classified using the BOSNIAK classification ofcomplicated renal cysts.

RESULTS: Mean size of the cysts was 6.5 cm (2.5-12). Classificationaccording to BOSNIAK based on CT scanning gave false negative results in 1/16and false positive results in 3/16 cases. In the 9 cases with additional MRT therewere no false negative findings and 3 false positive results.

CONCLUSIONS: CT imaging alone with the use of the BOSNIAKclassification will clarify therapeutic uncertainties in cases with complicated renalcysts in only 75% of cases. False-negative CT findings occur and an additionalMRT is needed in inconclusive cases.

Source of Funding: None.

466 THE JOURNAL OF UROLOGY® Vol. 169, No.4, Supplement, Wednesday, April 30, 2003

in the TURP group were impotence (15%), micturition urgency (13%) and urethraldisorder (8%), while impotence (11%), PSA increase (4%) and haematuria (4%)were most common in the PLFT group.

CONCLUSIONS: We conclude that the outcome of microwave thermotherapywith intraprostatic temperature monitoring (PLFT) is comparable with the resultsseen after TURP. As per safety, PLFT appears to be more favorable.

ResultsPLFT vsTURP; meanvalues

PLFT PLFT12 PlFT24 TURP TURP12 TURP24baseline months months baseline months months

IPSS 21.0 7.2 70 20.4 7,1 5.0Qol 4.3 1.4 1.3 4.2 1.5 0.9Qmal

7.6 113 12.4 7.9 152 15.6(mils)Prostatevolume 49 34 37 53 26 25(ml)Residualvolume 106 49 55 94 54 40(ml)

Source of Funding: ProstaLund Operations AB.

1750A MULTI CENTRE PROSPECTIVE, RANDOMISED, DOUBLE­BLIND PLACEBO-CONTROLLED TRIAL OF ASPIRIN DURINGTRANSURETHRAL RESECTION OF THE PROSTATE (TURP)Roland Donat"; Ian Wilson, Edinburgh, UK; Asif Raza. Derek J Byrne,Dundee, UK; Gordon Smith, Laurence H Stewart, Edinburgh, UK

INTRODUCTION AND OBJECTIVE: Many TURP patients take aspirin(about 11%). Aspirin might have a beneficial cardiovascular protective effect ifcontinued surrounding surgery. The question whether concurrent medication withaspirin during TURP causes a significant increase in perioperative bleedingremains controversial and many urologists feel it is safe to continue aspirinperioperatively. We conducted a prospective randomised trial to assess the

1749LONG TERM SAFETY AND EFFICACY IN 147 PATIENTSTREATED WITH PROSTATE STENTS FOR BENIGNPROSTATIC HYPERPLASIA (BPH): 12 - YEAR RESULTSKimberly L Cooper"; Alexis E Te, Steven A Kaplan, New York, NY

INTRODUCTION AND OBJECTIVE: Prostate stents have had a limitedrole in the treatment of BPH. In part, this is due to perceived intolerable sideeffects such as migration, encrustation and irritative symptoms. Nevertheless,they do have a potential role in select patients. Moreover, little long-term dataexists from the U.S. on the longterm efficacy of this minimally invasivetreatment. We report our 12 year, single institution experience using prostatestents in men with EPH.

METHODS: The records of all men with BPH treated with prostate stents atthe New York Presbyterian Hospital were prospectively analyzed (intent to treatanalysis). Parameters of evaluation were divided into: 1) efficacy: AUA SymptomScore (Sx), peak flow rate (Qmax)and post void residual urine (PVR); 2) sexualfunction and ejaculation; and 3) adverse events.

RESULTS: 127 men (mean age 71.6 +/- 9.8 years) have undergone prostatestent placement between 1990 and 2002. Mean follow up is 9.8 years (range 1 to12 years). Of these, 37 (29%) have died and 24 (19%) have been lost to followup.31 (24%) were treated with the Titan stent (balloon expanded); the remaining 96(76%) with the Urolume Wallstent. 75 (59%) presented with urinary retention(Group 1) and 52 (41%) presented with symptoms (Group 2). Table 1 lists theefficacy parameters. The results were significant at all time points. Significantdysuria occurred in 110 (87%) men lasting a mean of 32.6 days, urinary tractinfection in 39 (31%), stent encrustation in 12 (9%) and stent migration in 27(21%).21 (17%) required placement of a second stent; none were removed. 39 men(31%) men were potent preoperatively, 1 was impotent postoperatively; 34 (27%)experienced retrograde ejaculation. 5 (4%) had urinary incontinence which wasurodynamically diagnosed as detrusor instability and treated with medication.None had sphincteric incontinence.

CONCLUSIONS: These long term data demonstrate that in select patients,particularly elderly men with retention, prostate stents are safe and effectivealthough persistent irritative symptoms are common.

Table1: Efficacy Parameters

256966364

PVR(ml)6.215.314.614.3

Qmax (mllsec)SI1897.38.98.2

N127

111 (87%)66(52%)29(23%)

Source of Funding: None.

Baseline1year5 year12year

ResultsAMS001 & GETS Combined

Evaluation Baseline 1 Month 3 Month 6 Month 12Month p-values'IPSSn=164, 152,

21.2 ±5.99 13.9± 10.3± 9.9± 10.7± <.0001148,143,118 7.07 6.89 6.44 6.41Qoln=166,155,

4.4 ± 0.90 2.8± 2.2± 2.1 ± 2.1 ± <.0001149,143,116 1.60 1.49 1.46 130Qmal(m1/sec)n=197,183, 9.3±3.14

11.9 ± 131 ± 13.2± 13.7± <.0001178,158,130 6.27 5.75 562 5.77

ProstateSize 378(grams)n=195,l13, 44.2± 380 ± 0.003793 1893 ±19.23 17.57

• Follow-up £wults weresignificantly improved from baseline

Source of Funding: American medical systems.

1747TRANSURETHRAL ETHANOL ABLATION OF THE PROS­TATE (TEAP), INITIAL LONG TERM REPORT OF TWOPROSPECTIVE MULTI-CENTRE STUDIES Jorge Gutierrez­Aceves*, Guadalajara, Mexico; Peter Gilling, Tauranga, New Zealand;Manlio Schettini, Roma, Italy; Phillipe Grise, Rauen, France; Jose MartinezSagarra, Valladolid, Spain; Carlos Hernandez, Madrid, Spain

INTRODUCTION AND OBJECTIVE: Previous studies have shown thatabsolute ethanol injected into prostatic tissue produces cellular lysis and tissuenecrosis and resulted reduction in symptoms of bladder outlet obstruction. Twoprospective multi-center studies have been conducted evaluate the efficacy andsafety of TEAP in men with symptomatic BPH and to validate clinical outcomesin a global population.

METHODS: 200 men (age 51-88, mean 67. 2 years) from 25 differentinstitutions with symptomatic BPH (TRUS prostate volume 12-113, mean 44.2grams) underwent the TEAP procedure. Ethanol injection was performed withProstaJect (TM) device, the alcohol dose was determined by prostate size andurethral length (3.0-26 mean 13.6 cc) injected into the lateral lobes and, ifnecessary, into the median lobe. Urinary catheter was left in place for 96 hours andfollow-up visits occurred at 1, 3, 6 and 12 months.

RESULTS: Results are reported on the table. 5( 17.5 %) patients had urinaryretention after Foley catheter removed, the retention resolved in 14 days or less.Transient hematuria were detected in 26 patients (13.0%). Irritative voidingsymptoms were observed in 43 (21.5%) patients. The only major complicationreported from a single site was a case of bladder necrosis.

CONCLUSIONS: This results suggests that intraprostatic absolute ethanolprovides clinical improvement in men with obstruction related to BPH. This resultshave been reproduced in different centers and support the use of TEAP as a viabletreatment for BPH. A long term follow-up is still underway in order to access theclinical relevance of this initial results.

1748PROSTALUND MICROWAVE FEEDBACK TREATMENTCOMPARED WITH TURP FOR TREATMENT OF BHP; APROSPECTIVE RANDOMIZED MULTICENTER STUDY WITH24 MONTHS FOLLLOW UP Lennart Wagrell*, Uppsala, Sweden;Sonny Schelin, Kalmar, Sweden; Jorgen Nordling, Herlev, Denmark; JonasRichthoff, Ljungby, Sweden; Bo Magnusson, Maddy Schain, Kristianstad,Sweden; Thayne Larson, Scottsdale, AZ; Emmett Boyle, Toledo, OH; JensDuelund, Kurt Kroyer, Frederiksberg, Denmark; Hakon Ageheim,Hudiksvall, Sweden; Anders Mattiasson, Lund, Sweden

INTRODUCTION AND OBJECTIVE: In this prospective randomizedmulticenter study the effect of ProstaLund Feedback Treatment® (PLFT®) fortreatment of BPH was compared to TURP, 24 months post treatment.

METHODS: The study was conducted at 10 centers in the USA andScandinavia. A total of 154 patients with BPH were randomized to PLFT or TURPin a 2:1 ratio. Treatment outcome was evaluated on basis of TRUS, IPSS, QoL,Qmax, full urodynamics study and adverse events. Patients were followed up at 3,6, 12 and 24 months post treatment. The intraprostatic temperature guided thePLFT treatment; the microwave power was adjusted for tissue temperature of55°C.

RESULTS: Improvements in IPSS, QoL and Qmax were observed for bothPLFT and TURP. As previously reported, the 12 months follow up showed nostatistically significant differences in clinical outcome between PLFT and TURPregarding IPSS, QoL, Qmax or urodynamics (pressure flow). Both subjective (IPSSand QoL) and objective improvements (Qmax) were maintained also at the 24months follow up (see table), although the statistical analysis indicates a slighttrend in favor of TURP. Responders were defined as patients with IPSS :5 7 orminimum 50% gain and/or Qmax 2: 15 mils or minimum 50% gain (deWildt,J Urol 154:1775, 1995). Using these criteria 82% of the patients were respondersin the PLFT group and 92% in the TURP group. The most frequent adverse events

'Presenting author.

Vol. 169, No.4, Supplement, Wednesday, April 30,2003 THE JOURNAL OF UROLOGY ® 467

intraoperative blood loss and any postoperative complications associated with theuse of aspirin.

METHODS: A prospective, randomised, double-blind, placebo-controlled trialof 99 patient. undergoing TURP was done. All patients had a nonn al preoperativeclotting profile. The main outcome measure was the intraoperative blood loss. Wealso monitored haemoglobin measures on day 0, day I, and day 3 postoperat ively,blood transfusion rate, number of postoperative bladder washouts and delay incatheter removal due to bleeding. Other factors recorded included the tissue weightresected, operating time, surgeon, previous carheterisatlou, use of finasteride,presence of cancer and any cardiovascular complications. Statistical analysis wasdone by multiple linear regression analysis, chi square test and spearman rankcorrelation.

RESULTS: Thc average intraoperative blood Joss (+/- SEM ) adj usted forprostate weight was 10.1 mllg ( +/- 1) for the aspirin group and 9.1 m1/g (+ /- 1)for the placebo group (p=0.07, not significant). Thirty aspirin patients requiredat least one bladder washout comp ared to 15 placebo patients (p=O.014).Nineteen aspirin patients had a delayed catheter removal compared to 4 placebopat ient s (p< O.OI). Four aspirin patients required blood transfusion forprolo nged postoperative bleeding and one of these needed reoperation forbleedin g. No transfusions were requi red in the placebo group. One patient inthe aspirin group had transient atrial fibrillation. There were no othercardi ovascul ar complications.

CONCLUSIONS: Aspirin has no major effect on intraoperative blood loss, butsignificantly increases postoperative bleeding complications.

Source of Funding: None.

1751IMPROVED HIGH-FREQUENCY SURGERY FOR TRANS­URETHRAL RESECTION OF THE PROSTATE: REPORTFROM A MULTICENTER TRIAL AND IDENTIFICATION OFRISK GROUPS Florian May", Markus Guenther, Munich, Germany;Karl Fastenmeier, Neubiberg, Germany; Rudolf Hartung. Munich, Germany

INTRODUCTI ON AND OBJECTIVE: In spite of excellent long-term resultsand immediate treatment success, bleeding requiring blood transfusion remains themost important complication of transurethral resection of the prostate (TURP). Inorder to reduce the perioperative morbidity, we developed an improved high­frequency technique, Coagulating Intermittent Cutting (CIe) that was evaluated ina multicenter trial.

METHODS: A standard high-freque ncy generator was extended in itsfunct ion in several steps including ex vivo experiments and used in amulticenter trial including 778 pat ient s from 5 differe nt Euro pean institutions .The data were compared to our own retrospective dat a of 1000 pat ients whounderwe nt classical TURP between 1990-1994. Rate of blood transfusion,clinical signs of irrigation fluid absorption, I-PSS, uroflowmetry and postvoidresidual urine were analysed pre- and post operatively. In order to identify riskgroup s for blood transfusions data were furthermore analysed regarding patientage, resection weight and comorbidity. For analysis a nonparametric statisticaltest was used.

RESULTS: The overall rate of perioper ative blood transfusions showed adram atic reduct ion compared to our own historical series. 25/778 pat ients(3.2%) in the multicenter group and 14/543 patients (2.6%) in the Munich CICgroup requ ired a blood transfusion vs. J6.5 % in the historical Munich TURPseries. The transfusion rate of the last 100 consecutive operat ions in Munichwas 2% . Data ana lysis showed that blood transfusions were mainly given to asub group of relatively old pat ients (mean age 75 vs 61 years in the whole ser ies ,p<0.05) with severe concomitant cardio vascular diseases and a resectionweigh t of 57 vs 33 g in the whole series (p<0.05). Clin ical signs of irrigationfluid absorpt ion were significantly reduced using the improved technology andfurther significant improvem ents were ach ieved regarding voiding parametersand I-PSS .

CONCLUSIONS : A small subgroup of patients at increased risk for bleedingcould be identified. In the vast majority of patient. the operation is performedwithout any major complications. Altogether Coagulating Intermittent Cuttingimproves the gold standard ofTURP by dramatically lowering perioperative bloodloss.

Source of Funding: None.

1752THE UW TURP SIMULATOR: A VALIDATED TOOL TO TRAINRESECTION SKILLS Robert M Sweet», Timothy M Kowalewski, PeterOppenheimer, Jeff Berkley. Richard Sutava, James R Porter, SuzanneWeghorst. Seattle. WA

INTRODUCTION AND OBJEC11VE: We have completed version 1.0 of aprototype training simulator for TURP. Value of such a training tool is evident onlythrough validation protocols . We present our ongoing work in validating the UWTURP simulator as a training tool.

METHODS: At the AUA 2002, I J J Urologists and trainees completed a5-minute resection task as efficiently as possible, attempting to maintain the leastamou nt of blood loss, while conserving irrigant, Metri cs were logged for eachsubject and compared with 10 novices. Resection styles were correlated withefficiency and all metrics were stratified with respect to experience level, videogame experience and demographic data. Feedback with regards 10 acceptabilitywas obtained after the simulation task and comparisons made between and withingroups.

RESULTS : After the simulat ion task , 93% of expe rt and traineeparticipants believed that the vers ion 1.0 of the UW TURP simulator would beuseful as a training tool. 8&% fclt that it should be implemented into thecurriculum of res idency programs and 58% fe lt that it should be used foraccreditation. The various components of the simulator were individually ratedand all means were above the acceptabili ty threshold. The board- certifiedurologists and trainees resected more tissue (mean 6 grams versus 1.4 gramsp= .OJ3), with more grams per cut pedal pressed (p= .024) and less bloodloss/gra m resected (p= .006) and had no operat ive errors compared with 5/10nov ices who resected the sph inct er despite instruction not to prior toperforming the task. 5/11/ (4.5%) of the experts experienced redout, comparedwith 4/10 (40%) of the novices.

CONCLUSIONS: We have established face, content and some aspects ofconstruct and concurrent validity for version 1.0 of the University of WashingtonTURP simulator to train resection skills. Such a tool will shorten the learning curvein the operating room and allow for focused training out of the operating room onthe skills necessary to perform TURP .

Source of Funding: ACMI.

1753HIGH ENERGY TUMT AND ADJUVANT ALPHA BLOCKADESIGNIFICANTLY IMPROVES SYMPTOMS IN MEN WITHPROSTATITIS BUT REQUIRES SEDOANALGESIA. APROSPECTIVE NON·RANDOMIZED 3 YEAR STUDY ChristianSeitz, Bob Djavan", Michael Dobrovits, Saeid Alavi, Piotr Dobronski,Stephan Hruby, Keywan Ghawidel, Michael Marberger, Vienna. Austria

INTRODUCTION AND OBJECTIVE: To com-pare directly the ef-fi-cacyand safety of tar-geted high-energy transurethral mi-cro-wave thermo-therapy(TUMT) in patients with chronic prostatitis/chronic pelvic pain syndrome(CP/CPPS).

METHODS : In this comparative study 32 pa-tients with Category TIm CPPSwere evaluated and un-der-went high-energy TUMT without medical pretreatment.Pa-tient eval-u-a-tion in-cluded de-ter-mi-na-tion of Patients Subjective GlobalAssessment (SGA), the total NIH Chronic Prostatitis Symptom Index (CPS!), thepain (VAS score), voiding and quality of life/impact domains of the CPSI, safetydata, In-ter-na-tional Pros-tate Symp-tom Score (lPSS), obstructive (OSS) andirritative (ISS) symptom score, peak flow rate (Qmax), and quality of life (QOL)score, total and TZ prostate volume, serum PSA prior to TUMT and at pe-ri-odicintervals up to 3 years.

RESULTS: 75% and 82% at I year, 69% and 78% at 2 years and 67% and 77%of patients at 3 years reported at least a mild improvement of the SGA andNIH-CPSI, respectively. At I year 55% and 60%, at 2 years 49% and 51%, and at3 years 48% and 49% of patients reported a marked improvement of the SGA andNIH-CPSI respectively. Prostate volume did not change significantly whereas totalPSA decreased by 22 % from Baseline . Adjuvant alpha blockers enhance thecumulative improvement rates by J8% as compared to a matched group of patientstreated with HE-TUMT alone. By 24 mo and 36 months, 64.7% and 63.5%, and84.3% and 84,7% of pa-tients lwith the combination of HE-TUMT and adjuvantalpha blockade dem-on-strated a 50% or greater im-prove-ment in IPSS and QOLscore, re-spec-tively, com-pared with 51% and 49,6%, and 62.6% and 59,8%, in amatched HE-TUMT group alone.

CONCLUSIONS: This multicen ter study suggests HE-TUMT provides asignificant clinical benefit in patients with Category II1B CPPS.The improvementin patients SGA and NIH-CPSI are durable despite a light decrease over 3 years .Adjuvant alpha blockers enhance the efficacy of HE-TUMT and thus, thecombination of HE-TUMT and alpha blockers may offer a suitable option forpatients having failed medical therapy.

Source of Funding: None .

468 THE JOURNAL OF UROLOGY® Vol. 169, No.4, Supplement, Wednesday, April 30, 2003

Results are expressed interms ofmean± SD. ' =pvalue <0.001 ..., = No records available.

Source of Funding: None.

1754TRANSURETHRAL NEEDLE ABLATION OF THE PROSTATE(TUNA) IN THE TREATMEMT OF BENIGN PROSTATICHYPERPLASIA; A PROSPECTIVE, RANDOMISED STUDY,LONG TERM RESULTS Ponnambalam Chandrasekar*, Jaspal S Virdi,Faiya: Kapasi, Harlow, Essex, UK

INTRODUCTION AND OBJECTIVE: TUNA is a method used to deliver lowlevel radiofrequency waves through a catheter device outfitted with adjustableneedles placed in selected prostate tissue areas. Objectives were used to study theclinical efficacy, durability and safety of TUNA in the treatment of symptomaticBPH and to compare with transurethral resection of the prostate.

METHODS: From April 1994 to October 1998, 152 patients were enrolled inthe study with randomisation of 1:1; 76 patients underwent TUNA and 76 hadTURP. The age of the patients ranged from 47- 87 years (mean 67.5) and thevolume of the prostate varied between 20- 88 cc (mean 43.3). Assessmentparameters were I-PSS, QOL, Uroflow, post void residual urine and transrectalultrasound assessment of the prostate.

RESULTS: Table I shows the treatment outcomes of TUNA and TURP. Noejaculatory dysfunction was reported with TUNA compared to 57% in TURP. Noblood transfusion was required in TUNA as compared to 10.5% in TURP. In TURPgroup, stricture urethra in 2.6% and bladder neck obstruction in 2.6% wererecorded. In the Tuna group, 1.3% stricture urethra was found. Mean hospital staywas 1.2 days following TUNA and 3.5 days after TURP. Failure rate in TUNA was3 (3.9%) 1st year, 2 (2.6%) 2nd year, 2(2.6%) 3rd year, 2 (2.6%) 4th year, 2 (2.6%)5th year, and none in 6th and 7th year. Four patients were started on alpha blockers(2 after 4 years, I after 5 and 6 years). In TURP I (1.3%) required re-resection at2nd year.

CONCLUSIONS: In our experience TUNA produces minimal morbidity andgood patient tolerance. No serious complications were recorded. Patientsatisfaction was compatible in both the groups. The cumulative failure rate inTUNA group during the seven years was 19.7%. This treatment is highlyrecommended where ejaculatory dysfunction is a major concern.

TABLE 1

TUNA (n=76)~PSS QOL Q.Max

Pre·op 19.1 ±5 4.1 ±1 7.5±2Hear 7.8±5' 1.6±1' 15.0±5'2Years 8.1±6 1.8±1 14.2±6Hears 8.9±6' 1.9±1' 13.8±6'Hears 7.6±6' 1.7±1' 12.6±7'6Years 9.8±5' 1.9±1' 12.5±7'7 Years 11.9±9* 2.1±1' 9.6±2

I·PSS20.5±55.1±4'5.1 ±5'5.7±5

TURP (n=76)QOL

3.8±11.2±1'1.2±1'1.0±1

Q·Max8.3±219.6 ±7'19.3±7'19.2±7

preoperatively to 7.5+ 1.1 at 6 months in TURP group. The mean maximumflow rates increased from 5.3+3.7 mllsec preoperatively to 18.3+3.5 ml/sec at6 months and from 6.1 +3.7 ml/sec preoperatively to 17.5+4.3 mllsec at 6months in groups I and II, respectively. Re-catheterization was necessary in atotal of 4 cases (2 in Group I, 2 in Group 2). Urethral stricture was observedin 3 cases (2 in Group I and I in Goup 2) while incontinence was not observedin any case during follow up.

CONCLUSIONS: Our preliminary results demonstrate similar improvement interms of symptom score and urinary flow rate in both groups. Excluding expensesrelated to the device and its loops, decreased operation, catheterization andhospitalization times as well as shorter learning curve render PlasmaKineticadvantageous in the surgical treatment of BPH.

Source of Funding: None.

1756SERUM PROSTATE SPECIFIC ANTIGEN LEVELS FOL­LOWING TRANSURETHRAL MICROWAVE THERMOTHER­APY Matthew B Gretzer", B T Trock, BALTIMORE. MD; W ue: R Ugarte,EDINA, MN; S Kaplan, NEW YORK, NY; T Larson, Scottsdale, AZ; M Blute,Rochester, MN; C Roehrborn, DALLAS, TX; Alan W Partin, BALTI­MORE, MD

INTRODUCTION AND OBJECTIVE: Prostate specific antigen (PSA) iscurrently the most useful clinical marker for the detection of prostate cancer. Weevaluated the PSA changes that occur following transurethral microwavethermotherapy (TUMT) to establish whether men receiving this therapy for benignprostatic hyperplasia (BPH) warrant any modification to routine PSA surveillance.

METHODS: PSA values for 541 men between 45 and 85 years of age wereretrospectively evaluated from 6 study locations of men undergoing TUMT.Changes in both PSA values and PSA density at baseline, 6 weeks, 3 months, 6months, and one year were evaluated.

RESULTS: As illustrated in the accompanying table, PSA values becomemildly elevated during the first 6 weeks following therapy. With continuedfollow-up, the values continue to decline, and by 6 months are less than baseline.While not significantly different form baseline, the values at one year remain lessthan those prior to TUMT. While PSA density is also observed to increase duringthe first 6 weeks, this value returns to baseline by 6 months and is not significantlychanged from baseline at one year.

CONCLUSIONS: The change in PSA values following TUMT suggestappropriate thermoablation of the transition zone of the prostate. After one year,PSA values are unlikely to be artificially elevated as a consequence of treatment.Thus, men receiving this form of treatment may return to routine prostate cancersurveillance, with the usual workup for elevated PSA.

PSA andPSAD AFTER TUMT

1755PROSPECTIVE, RANDOMIZED STUDY OF ELECTRO·VAPORIZATION WITH GYRUS DEVICE (PLASMAKINETIC )AND TRANSURETHRAL RESECTION OF PROSTATE (TURP)IN MEN WITH BPH Ahmet Tefekli", Ahmet Yaser Muslumanoglu, MuratBaykal, Omer Sarilar, Sahin Kabay, Murat Binbay, Yalcin Berberoglu,Istanbul, Turkey

INTRODUCTION AND OBJECTIVE: To compare efficacy and cost­effectiveness of TURP versus transurethral electrovaporization with Gyrus device(PlasmaKinetic ), with its special features such as rapid tissue removal usingbipolar electrocautery under saline irrigation.

METHODS: During a 2 year period, men with BPH, having failed medicaltherapy, were randomly assigned to either electrovaporization with Gyrus device(Group I) or TURP (Group II). Men with suspected cancer, confirmed by digitalrectal examination and PSA tests, or neurogenic bladder (eg diabetics) wereexcluded, and a total of 96 men with a mean age of 68.4 6.4 (range: 53-78) yearswere enrolled in the study. Preoperatively, AUA symptom score, uroflowmetry,and ultrasound were obtained. Postoperatively, the patients were seen at I, 3 and6 months with the above studies obtained at follow-up.

RESULTS: Mean prostate volumes were 50.1+17.3 g and 54.0+15.2 g ingroups I (n:49) and H(n:47), respectively (p>0.05). The mean operative timewas 40.3+11.4 minutes in group I and 57.8+13.4 minutes in group H (p<0.01). Mean volume of saline irrigation during PlasmaKinetic procedure wassignificantly lower than that of hyperosmolar solution irrigation during TURP.Mean time for postoperative continuos bladder irrigation was 1.3 +0.5 days ingroup I, and 1.9+0.5 days in group II (p<O.OI). Mean catheterization time was2.3+0.7 days in the former group and 3.87+0.7 days in the latter group(p<0.05). Bleeding necessitating blood transfusion was not encountered in anycase. The mean AUA symptom score declined from 22.5+3.1 preoperatively to7.2+ 1.3 at 6 months in PlasmaKinetic group, while it declined from 21.7+3.5

*Presenting author.

PSA APSA PSAD APSADvs.vI.BASELlNE p

BASELINE P

BASELINE 3.n 0.0856wk 3.97 0.36 0.019 0.149 0.057 0.00013mo 3.62 -0.13 0.383 0.134 0.036 0.0206mo 3.34 -0.36 0.0001 0.088 -0.001 0.9721yr 3.51 -0.19 0.125 0.093 0.009 0.63

Source of Funding: departmental.

Renal Transplantation, RenalVascular Surgery (I)

PodiumWednesday, April 30,2003 10:00 AM-12:00 PM

1757ENGINEERING OF RENAL TISSUE USING THERAPEUTICCLONING Robert P Lanza. Ho-Yun Chung, James J Yoo*, PeterWettstein, Nancy Borson, Erik Hofmeister, Shay Soker, Catherine Blackwell,Carlos T Moraes, Michael D West, Anthony Atala, Boston, MA

INTRODUCTION AND OBJECTIVE: Nuclear transfer could provide asource of cells for regenerative therapy. Although the cloned cells would carry thenuclear genome of the patient, the presence of mitochondria (mt) inherited from therecipient oocyte raise questions regarding the histocompatibility of the resultingcells. We investigated the feasibility of engineering syngeneic renal tissues in vivousing cloned cells.

METHODS: Nuclear material from bovine dermal fibroblasts weretransferred into unfertilized enucleated donor bovine eggs. Renal cells from the