european urology 54 (2008)

european urology 54 (2008) 427 437 available at www.sciencedirect.com journal homepage: www.europeanurology.com Benign Prostatic Obstruction Transurethral Photoselective Vaporization versus Transvesical Open Enucleation for Prostatic Adenomas >80 ml: 12-mo Results of a Randomized Prospective Study Gerasimos Alivizatos *, Andreas Skolarikos, Dimitrios Chalikopoulos, Christos Papachristou, Odysseas Sopilidis, Athanasios Dellis, Ioannis Kastriotis, Charalambos Deliveliotis Athens Medical School, 2nd Department of Urology, Sismanoglio Hospital, Athens, Greece Article info Article history: Accepted November 16, 2007 Published online ahead of print on December 11, 2007 Keywords: Benign prostatic hyperplasia Laser prostatectomy Open prostatectomy Photoselective vaporization Potassium-titanylphosphate laser Abstract Objectives: To compare the effectiveness and the safety of photoselective vaporization of the prostate (PVP) to open prostatectomy (OP) for the surgical treatment of large prostatic adenomas. Methods: A total of 125 patients with prostate glands >80 ml were randomly allocated to PVP (n = 65) or OP (n = 60) and prospectively evaluated at 1, 3, 6, and 12 mo postoperatively. International Prostate Symptom Score (IPSS) and peak urinary flow rate (Q max ) were chosen as primary treatment-related end points. Results: The patients who underwent PVP experienced a longer length of operation time, shorter time of catheterization, and shorter hospital stay. Adverse events were minor and of similar profiles in both groups, although patients who underwent OP showed a higher transfusion rate. All functional parameters improved significantly compared to baseline values in both groups. The IPSS did not differ between the two groups at 3, 6, and 12 mo postoperatively. Patients who underwent OP scored better in the IPSS quality of life score at 6 and 12 mo postoperatively. No significant differences between the two groups in the Q max, postvoid residual urine volume, and International Index for Erectile Function-5 questionnaire were detected. At 3 mo prostate volume was significantly lower in the OP group compared to the PVP group (median value 10 ml vs. 50 ml; p < 0.001) and remained as such throughout follow-up, whereas prostate-specific antigen values reached statistical difference at 6 mo (median value 2 ng/ml vs. 2.4 ng/ml; p = 0.028). Conclusions: Our results indicate that for a 12-mo period PVP is a highly acceptable treatment alternative to OP. # 2007 European Association of Urology. Published by Elsevier B.V. All rights reserved. * Corresponding author. Athens Medical School, 2nd Department of Urology, Sismanoglio Hospital, 4 Neophytou Vamva St, 10674, Kolonaki, Athens, Greece. Tel. +30 210 7214494; Fax: +30 210 7219714. E-mail address: gali@hol.gr (G. Alivizatos). 0302-2838/$ see back matter # 2007 European Association of Urology. Published by Elsevier B.V. All rights reserved. doi:10.1016/j.eururo.2007.11.044

428 european urology 54 (2008) 427 437 1. Introduction Surgical treatment of large prostatic adenomas is still a challenging task. Transurethral resection of the prostate (TURP) is of limited use mainly due to the advent of hemorrhage and transurethral resection syndrome (TURS) [1]. Therefore, until recently open prostatectomy (OP), despite considerable blood loss and prolonged recovery, has been the only therapeutic option for the treatment of large adenomas because less invasive alternatives have been missing [2 6]. Holmium laser has recently been proposed in randomized prospective studies as an excellent alternative to either TURP or OP for large glands causing obstruction [7 13]. Today, only a few studies on the surgical treatment of large prostates by photoselective vaporization of the prostate (PVP), using a high-power potassium-titanyl-phosphate (KTP) laser, have been published. PVP was safe and effective for the majority of patients treated on a day-case basis, with excellent symptom relief and improvement in flow rates, with low morbidity. However, these studies lacked a control arm of OP for comparison [14 17]. In this study, we compare the outcome of KTP laser prostatectomy to the outcome of OP in a randomized prospective trial on patients with prostatic glands >80 ml. 2. Patients and methods 2.1. Patients From March 2005 to April 2006, 125 patients were prospectively randomized to PVP or OP. Inclusion and exclusion enrollment criteria are presented in Table 1. Urodynamic studies have not been performed because they are not obligatory for the evaluation and treatment of patients with benign prostatic hyperplasia (BPH). Patients having an elevated prostatespecific antigen (PSA), abnormal digital rectal examination (DRE), or suspicious lesions on transrectal ultrasound (TRUS) had cancer ruled out by biopsy prior to enrollment. All patients signed an informed consent and the protocol was approved by the ethics committee of our hospital. 2.2. Randomization and blinding A urology registrar, not participating in the operations, enrolled the patients and allocated them to treatment, based on a randomization schedule from random-number tables balanced in blocks of 10. Outcome assessment was performed by another urologist blinded to patient treatment. 2.3. Objectives, outcomes, and sample size The study was designed to obtain long-term results at 5 yr. The International Prostate Symptom Score (IPSS) and peak urinary flow rate (Q max ) were chosen as primary treatment-related end Table 1 Inclusion and exclusion criteria Inclusion Age >50 yr Lower urinary tract symptoms due to benign prostatic enlargement Prostate volume on TRUS >80 cm 3 IPSS >12 Medical therapy failure No a-blockers during the last month No 5a-reductase over the last 3 mo Postvoid residual <150 ml Peak urinary flow rate <2 ml/s (voided volume 150 ml) Able to complete QoL, IPSS, and IIEF-5 questionnaires Operation within 4 wk of randomization. Able to give fully informed consent Exclusion Neurogenic bladder History of the adenocarcinoma of the prostate Urethral stricture Any previous prostatic, bladder-neck, or urethral surgery No urethral catheter at baseline History of bladder cancer Indwelling urethral catheter TRUS = transrectal ultrasound; IPSS = International Prostate Symptom Score; QoL = quality of life; IIEF-5 = International Index of Erectile Function-5. points. A relevant difference in IPSS scores of 2 points 3 SD and in peak flow rates of 3 6 ml/s was assumed. With a = 0.05 and a power of 80% a sample size of 45 patients per group was calculated. 2.4. Study design At enrollment all patients were evaluated by medical history record, physical examination, full blood count, renal function tests, PSA, and urinalysis/urine culture. American Society of Anesthesiologists (ASA) score, nature and duration of symptoms, IPSS, single question quality-of-life score (IPSS-QoL), Q max, postvoid residual (PVR) urine volume, TRUS-calculated prostatic volume (PV), and International Index for Erectile Function-5 questionnaire (IIEF-5) were also documented. Intraoperative and immediate postoperative measured parameters included length of operation (LO); type and volume of irrigation fluid; number of laser fibers used; total amount of energy spent; postoperative day 1 serum hemoglobin (Hb), sodium (Na), blood urea nitrogen (BUN), and creatinine (Cr) concentrations; length of catheterization (LOC); and duration of hospital stay (HS). Intraoperative and early/late postoperative complication rates were also documented prospectively. All patients were reevaluated at 1, 3, 6, and 12 mo postoperatively. At each point IPSS, IPSS-QoL, Q max, PVR, DRE, IIEF-5, and adverse events were assessed. TRUS-calculated PV and PSA were measured at 3, 6, and 12 mo postoperatively. 2.5. Technique All surgical procedures were completed by four experienced surgeons, all of whom had performed >100 OPs and >15 PVPs. PVP was performed with an 80-W KTP side-firing laser (Laserscope 1 ; Greenlight PV TM, San Jose, CA) system [18].

european urology 54 (2008) 427 437 429 Table 2 Baseline characteristics of the two groups Median (25th 75th centile) KTP Open prostatectomy p (Mann-Whitney test) (2-sided Fisher exact test) Patient age, yr 74 (67 80) 67.5 (65 74) 0.03 ASA score 2 (1 3) 2 (1 2.75) 0.491 Nature of symptoms (obstructive [1] vs. irritative [2]) 1 (1 2) 1 (1 2) 0.710 Duration of symptoms, mo 36 (19 72) 36 (12 72) 0.447 Preoperative values IPSS 20 (15 22) 21 (16.25 23.75) 0.399 IPSS-QoL 3 (2 4) 3 (2.25 4) 0.520 IIEF-5 12 (8 16) 12 (7 16) 0.969 PSA, ng/dl 6.2 (3.1 8.44) 6.3 (2.9 8.6) 0.860 Q max, ml/s 8.6 (6.7 10.5) 8 (5.8 10.2) 0.283 PVR, ml 97 (65 124) 89 (50 120) 0.524 Vpro, ml 93 (85 100) 96 (86 100) 0.628 Hb, g/dl 13.9 (12.8 14.8) 14.05 (13.42 15.47) 0.051 Na, mmol/l 142 (140 143) 142 (140 143.75) 0.679 Cr, mmol/l 95 (80 101) 96 (85.25 109) 0.233 BUN, mmol/l 5.3 (3.6 7.1) 6 (4.5 7.1) 0.108 KTP = potassium-titanyl-phosphate; ASA = American Society of Anesthesiologists; IPSS = International Prostate Symptom Score; QoL = quality of life; IIEF-5 = Internation Index of Erectile Function-5; PSA = prostate-specific antigen; Q max = maximal flow rate; PVR = postvoid residual; Vpro = prostate volume; Hb = hemoglobin; Na = sodium; Cr = creatinine; BUN = blood urea nitrogen. A flexible Green-Light PV ADDStat fiber was used through a modified 23F continuous irrigation 128 Storz cystoscope. Isotonic saline was always used for irrigation. Vaporization began at the median lobe, using a sweeping painting motion. Next, the tissue from the bladder neck to the verumontanum was removed. The operation continued with the same technique while rotating to each lateral lobe. The technique continued, rotating the instrument 1808 for the ventral part of the prostate. At the end of the procedure, which was determined based on the surgeon s individual preference, the bladder and the prostate were inspected for effective hemostasis and a 20F triple-lumen catheter was inserted into the bladder for irrigation to start. The standard transvesical approach was used to perform OP [19]. At the end of the procedure a 22F triple-lumen catheter was also inserted into the bladder and irrigation was initiated. A suprapubic catheter was inserted whenever the surgeon thought extra irrigation was needed. 2.6. Statistical analysis Results were recorded on a SPSS12 statistical program. Data distribution for all primary and secondary outcomes did not meet standard normality assumptions. Therefore, nonparametric tests were used for statistical analysis. Baseline characteristics, perioperative data, IPSS, Table 3 Perioperative and immediate postoperative data of the two groups KTP Median (25th 75th centile) Open prostatectomy p (Mann-Whitney test) (Wilcoxon signedrank test) Energy/case, kj 196.690 51.877 (107.858 353.000) Fibers used/case 1.32 (1 3) Irrigation volume/case, l 17.40 (6 39) Tissue retrieved, g 73.5 65 87 (40 352) Histology, no. of patients BPH (60), chronic prostatitis (10), cancer (0) phb vs. post-hb, g/dl 13.9 (12.8 14.8) vs. 13.0 (12.1 14) <0.001 14.05 (13.42 15.47) vs 12.5 (11.02 14.45) <0.001 Hb loss, g/dl 0.6 (0.1 1.2) 1.3 (0.3 3.3) 0.001 pna vs. post-na, mmol/l 142 (140 143) vs. 140 (138 142) 0.001 142 (140 143.75) vs. 141 (139 142) 0.018 Decrease in serum Na, mmol/l 1 (0 3) 0 (0 3) 0.346 Operation time, min 80 (70 90) 50 (45 60) <0.001 Catheter removal, h 24 (20 36) 120 (96 144) <0.001 Hospital stay, h 48 (24 48) 144 (120 144) <0.001 KTP = potassium-titanyl-phosphate; BPH = benign prostatic hyperplasia; p = preoperative; Hb = hemoglobin; Na = sodium.

430 european urology 54 (2008) 427 437 IPSS-QoL, Q max, PVR, PV, PSA, and IIEF-5 scores of the two groups were compared using the Mann-Whitney test. Related variables were compared using the Wilcoxon signed-rank test. Perioperative and postoperative adverse events were compared using 2-tailed x 2 test (Fisher exact test). To describe the correlation between baseline and changes from baseline the Spearman rank-based coefficient was used. 3. Results Sixty-five and 60 men were randomized to undergo PVP and OP, respectively. All patients were followed for 12 mo. Baseline characteristics and operative and immediate postoperative data are listed in Tables 2 and 3, respectively. The patients who underwent Table 4 Follow-up of 125 patients who underwent KTP (n = 65) or open prostatectomy (n = 60) for adenomas >80 g Preoperative Postoperative follow-up 1 mo 3-mo 6 mo 12 mo Median (25th 75th centile) KTP IPSS 20 (15 22.5) 12 (12 13.5) 10 (8 12) 9 (7 12) 9 (7 12) p * <0.001 <0.001 0.009 0.295 IPSS-QoL 3 (2 4) 2 (1 2) 1 (1 2) 1 (1 2) 1 (1 2) p * <0.001 0.526 0.002 0.507 Q max, ml/s 8.6 (6.7 10.5) 13.4 (10.7 15) 16 (14 18) 16 (13.9 18.8) 16 (13.7 19) p * <0.001 <0.001 0.400 0.828 PVR, ml 97 (6 124) 25 (11 47.5) 20 (2.5 40) 20 (0 37.5) 17 (2.5 34.5) p * <0.001 0.009 0.583 0.069 IIEF-5 12 (8 16) 12 (7 17) 12 (7 17) 12 (7 17) 12 (7.5 17) p * 0.585 0.982 0.661 0.84 Prostate size, ml 93 (85 100) 50 (40 60) 50 (40 64) 55 (45 65) p * <0.001 0.253 0.395 PSA, ng/dl 6.2 (3.1 8.44) 2.5 (1.5 3.85) 2.4 (1.7 3.75) 2.4 (1.7 3.5) p * <0.001 0.320 1.000 Open prostatectomy IPSS 21 (16.2 23.7) 12 (10 16) 10 (7 12) 9.00 (7 12) 8 (7 12) p * <0.001 <0.001 <0.001 0.295 IPSS-QoL 3 (2.25 4) 2 (1 2) 2 (1 2) 1 (0.25 1) 1 (1 1) p * <0.001 0.003 <0.001 1.000 Q max, ml/s 8 (5.8 10.2) 12.5 (10.7 15) 15.1 (12.6 17) 15.6 (12.8 17.1) 15.1 (13 17.5) p * <0.001 <0.001 0.400 0.839 PVR, ml 89 (50 120) 32.5 (6.25 45) 21 (0 45) 12.5 (0 35.5) 12 (0 28.75) p * <0.001 0.140 0.011 0.466 IIEF-5 12 (7 16) 12 (8 15.75) 12 (7 15) 12 (9 15.75) 12 (8 16) p * Prostate size, ml 96 (86.2 100) 10 (5 19) 10 (5 15.75) 10 (5 15) p * <0.001 0.982 0.802 PSA, ng/dl 6.3 (2.9 8.6) 2 (1.2 2.6) 2 (1.2 2.6) 2 (1.4 2.8) p * <0.001 0.709 0.991 p y IPSS 0.399 0.019 0.743 0.224 0.128 IPSS-QoL 0.520 0.283 0.995 0.024 0.035 Q max 0.283 0.552 0.255 0.220 0.186 PVR 0.524 0.969 0.822 0.213 0.221 IIEF-5 0.969 0.964 0.850 0.940 0.964 Prostate size 0.628 <0.001 <0.001 <0.001 PSA 0.860 0.062 0.028 0.062 Comparison within the same group (Wilcoxon signed-rank test) and between the two groups (Mann-Whitney test) of IPSS scores, bother scores, peak urinary flow rates, residual volumes, IIEF-5, PSA, prostate size. KTP = potassium-titanyl-phosphate; IPSS = International Prostate Symptom Score; QoL = quality of life; Q max = maximal peak flow rate; PVR = postvoid residual; IIEF-5 = International Index of Erectile Function-5; PSA = prostate-specific antigen. * Comparison to the previous control, within each group (Wilcoxon test). y Comparison of KTP group and open prostatectomy group (Mann-Whitney U test).

european urology 54 (2008) 427 437 431 Table 5 Cumulative adverse events at 12 mo postoperatively Adverse events KTP, % Open prostatectomy, % p (two-sided Fisher exact test) Intraoperative TURP-hemostasis 5 (7.69) 0 Perioperative blood transfusion 0 8 (13.3) 0.002 Transurethral resection syndrome 0 Urethrorrhagia 1 (1.54) 0 1.000 Pulmonary infection 0 1 (1.67) 1.000 Prolonged dysuria 5 (7.6) 7 (11.6) 0.549 Culture-confirmed UTI 11 (17) 14 (23) 0.382 Recatheterization 5 (7.69) 10 (16.67) 0.132 Reoperation (urethral stricture, bladder-neck contracture, apical resection) 3 (4.62) 3 (5) 1.000 Death 1 (1.54) 0 1.000 Total 14 (21.54) 19 (31.67) 0.187 KTP = potassium-titanyl-phosphate; TURP = transurethral resection of the prostate; UTI = urinary tract infection. laser prostatectomy had a significantly longer operative time, but they experienced a significantly shorter LOC and HS. No patient in either group required early endoscopic or open reintervention for bleeding. However, in five patients in the laser group, the resectoscope was used at some point of the operation to achieve hemostasis. When optimal view was restored, the KTP laser was reused to finish the operation. No significant resection was performed in these patients and their functional results were incorporated into those of the PVP group. However, the need for transurethral hemostasis was recorded as a complication. Comparative data for the two groups at 1, 3, 6, and 12 mo postoperatively are presented in Table 4. Postoperative IPSS score, IPSS-QoL, Q max, and PVR showed significant improvement compared to baseline measurements at all intervals in both groups. PV and PSA values were significantly reduced when compared to baseline values at all intervals in both groups as well. There was a statistically significant greater reduction of PV following OP compared to PVP. In both groups the IIEF-5 score remained unchanged during follow-up. Patients who underwent PVP experienced an earlier improvement in their symptoms compared to patients who underwent OP (1 mo follow-up). However, the two groups did not differ at 3, 6, and 12 mo postoperatively. Patients who underwent OP scored better in the IPSS-QoL at 6 and 12 mo postoperatively. At 1, 3, 6, and 12 mo postoperatively the groups did not differ in the Q max, PVR, and IIEF-5 parameters. PSA value was significantly lower in the OP group at 6 mo. At 3 mo, PV was significantly lowered in the OP group and remained as such throughout follow-up. The most common transient adverse reaction was early postoperative dysuria, defined as burning associated with frequency and urgency. It affected 15% and 20% of the patients in the PVP and OP groups, respectively. It spontaneously resolved in a mean time of 6 wk. Prolonged dysuria, slowly resolving over a 3-mo period was experienced by 7.6% and 11.6% of patients in the two groups, respectively (Table 5). No patient in either group had urge or stress incontinence before or following the operation. Mild transient hematuria, with a mean duration of 3 wk, occurred in 7 and 17 patients of the two groups, respectively. Six patients needed reoperation, three due to urethral stricture (2 in the PVP and 1 in the OP group), two due to bladder neck contracture, both in the OP group, and one PVP patient due to persistent bladder outflow obstruction symptoms. Visual urethrotomy, bladder-neck incision, and apical resection were successfully performed, respectively. One patient in the PVP group died 11 mo postoperatively due to liver cancer. 4. Discussion Our study showed that patients who underwent PVP achieved subjective and functional results comparable to those of OP. Moreover, catheterization time and hospital stay were significantly shorter in the laser group. In general, the complication profile of the two procedures was similar, although more patients in the OP group required blood transfusion perioperatively. TURP has been the gold surgical standard over the past 30 yr. However, its role in treating large prostate glands is limited mainly due to intraoperative and postoperative morbidities such as bleeding with the need for transfusion, TURS, urethral strictures, and the need for reoperation [1]. Open simple prostatectomy has traditionally been the alternative option to TURP for prostate

432 european urology 54 (2008) 427 437 Table 6 Outcome and complications of KTP laser prostatectomy, HoLEP prostatectomy, and open prostatectomy in contemporary series of treating large glands KTP laser prostatectomy HoLEP Open prostatectomy Present study a Previous series References 14 17 7 13 2 6, 8 10 Mean preoperative prostate volume, ml 93 101 142.9 77.8 170.2 83.9 138.5 Mean operative time, min 80 81.6 135 72 197 58.3 213.8 Mean hospital stay, d 2 0 0.9 1.1 2.8 5.4 12 Mean IPSS decrease 11 10.3 17.2 12.2 21.7 14.5 23.3 Mean peak flow increase, ml/s 7.4 5 11.7 11.3 26.1 1323.3 % Urinary tract infection 17 1.5 9.2 0 1.7 0 12.5 % Surgical revision 4.6 5 11.5 b 0 10.6 0 20 % Blood transfusions 0 0 0 4 0 35.7 c Overall mortality 1.5 d 0 3.4 0 0 0.2 KTP = potassium-titanyl-phosphate; HoLEP = holmium laser enucleation of the prostate; IPSS = International Prostate Symptom Score. a Median values are presented. b The higher rate of 11.5% was noted in the study of Rajbabu et al [15] at 24 mo of follow-up. c One patient died of liver cancer. d The higher blood transfusion rate (35.7% [5]) includes autologous (28.6%) and allogenic (7.1%) blood transfusions. glands of big volume. This procedure is highly successful and results in low reoperation rates [2 6]. In a contemporary prospective study of 56 patients who underwent OP for a mean prostate size of 138.53 58.6 ml, the baseline American Urological Association symptom index decreased from a mean of 18.5 1.9 to 4 1.7 within 1 mo. Similarly the QoL score was 3.1 0.5 preoperatively, which decreased to 0.6 0.5 postoperatively. These improvements were maintained throughout follow-up [5]. However, OP is still considered invasive and is currently performed in a minority of patients suffering from BPH [2 6]. In a recent study of 902 patients who underwent OP for prostates of mean size 96.3 37.4 ml, the overall complication rate was 17.3% and the overall mortality rate was 0.2%. The most relevant complications were bleeding requiring transfusion in 68 cases (7.5%), urinary tract infection in 46 (5.1%), and surgical revision due to severe bleeding in 33 (3.7%) [6]. Holmium laser enucleation of the prostate (HoLEP) emerged as an effective alternative to OP in treating large adenomas. Randomized studies with medium- to long-term follow-up show that HoLEP has several advantages over other treatments. These include the possibility of removing a large amount of tissue, the possibility of having a histologic evaluation, and the possibility to treat other entities, such as strictures and stones [20,21]. Prospective randomized studies showed that HoLEP was associated with a reduced LOC and HS compared to OP when large adenomas were enucleated. In addition, outcome measures were also similar or superior in patients undergoing HoLEP [7 13]. In contemporary series of HoLEP the mean operative time ranged from 72 to 197 min and the mean hospital stay was 1.1 2.8 d. The mean peak flow rate increase ranged from 11.3 to 26.1 ml/s. Similarly to other procedures, patients who underwent HoLEP experienced complications. The most frequent ones were urinary tract infection (0 1.7%), the need for surgical revision (0 10.6%), and the need for transfusion due to bleeding (0 4%; Table 6) [7 13]. Moreover, HoLEP is associated with a steep learning curve because the adenoma needs to be skillfully enucleated and directed into the bladder where it is subsequently morcellated to facilitate removal. This technique has limited acceptance by most urologists mainly due to its technical difficulty. PVP has recently gained attention for the treatment of prostate obstruction. PVP has some inherent disadvantages such as the lack of definitive histology and a lower reduction in PV and PSA. However, randomized and nonrandomized comparative studies have shown that when small or moderately sized prostates are being treated, this technique is similar to TURP in improving symptoms and urinary flows and better in the terms of related morbidity [22]. Moreover, PVP has a very shallow learning curve [14]. Although, PVP has been successfully and safely used in patients with large prostates, these studies are scarce and nonrandomized and lack a control arm [14 17]. Sandhu et al and Rajbabu et al have treated 64 and 54 patients with a mean prostate size of 101 40 cm 3 and 135 22.9 cm 3, respectively [14,15]. Mean operative time was 123 and 81.6 min, respectively. Q max improved from a preoperative value of 7.9 and 8.0 ml/s to 18.9 and 17.9 ml/s at 12 mo. IPSS dropped from a value of 18.4 and 22.9 to 6.7 and 6.3 at 12 mo,

european urology 54 (2008) 427 437 433 indicating an excellent symptom relief. IPSS-QoL and PVR showed similar improvements, and there was a statistically significant reduction in PSA level and PV in both studies. In the study of Sandhu et al, the majority of the patients were treated on an outpatient basis and 88% of them were catheter free within 24 h postoperatively [14]. In the study of Rajbabu et al the mean HS and LOC were 11.0 h (range: 0 48 h) and 23.0 h (range: 0 72 h), respectively [15]. Similar results were achieved by Chandrasekera et al, who treated 29 patients with a mean PV of 142 ml (range: 100 240 ml). The authors showed a PV reduction of 35 67%, reflecting the efficacy of tissue vaporization of the KTP laser in these huge glands [16]. In our study a slight discrepancy between the reduction of PV and the reduction of PSA was noted. Approximately 40% and 90% of prostatic tissue was removed following PVP and OP, whereas the median serum PSA was reduced by 40% and by 70% at 12 mo, respectively. The reduction rate of PSA after OP in our series was lower than the rate (90%) published in the series of Helfand et al [5]. However, other authors have shown similar PSA reduction rates (75 80%) to ours [23,24]. The reduction rates of PSA and PV after PVP in our series were similar to those presented in other series as well (50% volume reduction; 50% PSA reduction) [14,15]. In all studies, no patient required a blood transfusion, nor did any patient display evidence of postoperative hyponatremia. In five patients of the PVP group, the resectoscope was used to achieve hemostasis. This was due to the fact that the surgeon could not achieve adequate hemostasis with the laser to obtain clear vision. Complications were rare and their profile was similar to the profile of complications in our study (Table 6). Recently, a modification of the 80-W KTP laser prostatectomy technique was introduced for the treatment of the large prostates [17]. The vaporization-incision technique (VIT) was originally introduced to treat large prostates in a more timeeffective manner, while at the same time ensuring adequate removal of tissue through the use of anatomic landmarks. A midline incision in the median lobe from the trigone to the verumontanum was initially performed. Subsequently four incisions were made, two immediately lateral to the median lobe followed by two high lateral lobe incisions. The first 20 patients who underwent PVP-VIT had an average PV of 123 ml. The procedure took an average time of 135 min. IPSS decreased by 9.7 points and maximum flow rates increased by 6.1 ml/s at 1 mo and 10.3 points and 11.7 ml/s at 3 mo. No development of dilutional hyponatremia or need for blood transfusion were encountered [17]. In our study, due to insurance policies, it was not possible to treat our patients on an outpatient basis. Due to the large PV of the glands treated, and mostly due to the diversity of surgeons who performed the operations, 70.8% and 96.9% of patients in the PVP group had their catheter removed within 24 and 48 h postoperatively, respectively. Moreover, 43%, 78.5%, and 91% of patients were discharged within 24, 48, and 72 h postoperatively, respectively. In addition, the median LO in the PVP group was shorter (80 min) when compared to other series [14,15,17]. This is mainly due to the smaller size of the prostates treated in our series (90 ml vs. 101, 135, and 123 ml) and perhaps to the different technique used to vaporize the gland [14 16]. Moreover, the procedures in our study have been performed by four different surgeons. As a result, several factors may have influenced LO in the PVP group. The operation was ended based on surgeon s preference when a sufficient cavity was created or when the operative time was judged to be long enough. Functional results were comparable to other series (Table 6). In fact, although the new VIT technique decreased operative time per PV from 1.24 min/ml of tissue to 1.10 min/ml of tissue when compared to the standard PVP technique performed by the same authors, the IPSS and flow rates at postoperative months 1 and 3 showed no significant differences between the two techniques [14,17]. Long-term follow-up and comparison of our results to those that can be achieved with the newly released 120-W PVP machine or with other minimally invasive procedures such as laparoscopic adenomectomy would also be of interest. Our study incorporates the advantages of a prospective randomized study. Because patients had to sign an informed consent for a new procedure our study was not double-blinded. However, no patient crossed over from PVP to OP or vice versa after group allocation was revealed to them. The power of the study was chosen to be 80%, because the number of the patients needed to be recruited was thought to be achievable in our department. The relevant differences in IPSS score and in peak flow rates and the multiple numbers of surgeons in our study also served the same purpose. 5. Conclusions Our results indicate that for a 12-mo period the use of KTP laser to ablate enlarged prostates is a highly promising treatment. The efficacy of PVP to treat large prostates has to be further evaluated in the

434 european urology 54 (2008) 427 437 future by other groups and by longer follow-up assessments. Conflicts of interest The authors have nothing to disclose. References [1] Seki N, Naito S. Instrumental treatments for benign prostatic obstruction. Curr Opin Urol 2007;17:17 21. [2] Tubaro A, Carter S, Hind A, Vicentini C, Miano L. A prospective study of the safety and efficacy of suprapubic transvesical prostatectomy in patients with benign prostatic hyperplasia. J Urol 2001;166:172 6. [3] Adam C, Hofstetter A, Deubner J, et al. Retropubic transvesical prostatectomy for significant prostatic enlargement must remain a standard part of urology training. Scand J Urol Nephrol 2004;38:472 6. [4] Varkarakis I, Kyriakakis Z, Delis A, Protogerou V, Deliveliotis CH. Long-term results of open transvesical prostatectomy from a contemporary series of patients. Urology 2004;64:306 10. [5] Helfand B, Mouli S, Dedhia R, McVary KT. Management of lower urinary tract symptoms secondary to benign prostatic hyperplasia with open prostatectomy: results of a contemporary series. J Urol 2006;176:2557 61. [6] Gratzke C, Schlenker B, Seitz M, et al. Complications and early postoperative outcome after open prostatectomy in patients with benign prostatic enlargement: results of a prospective multicenter study. J Urol 2007;177:1419 22. [7] Gilling PJ, Kennett KM, Fraundorfer M. Holmium laser enucleation of the prostate for glands larger than 100 g: an endourologic alternative to open prostatectomy. J Endourol 2000;14:529 31. [8] Moody JA, Lingeman JE. Holmium laser enucleation for prostate adenoma greater than 100 gm: comparison to open prostatectomy. J Urol 2001;165:459 62. [9] Kuntz RM, Lehrich K. Transurethral holmium laser enucleation versus transvesical open prostatectomy for prostate adenoma greater than 100 gm: a randomized prospective trial of 120 patients. J Urol 2002;168:1465 9. [10] Naspro R, Suardi N, Salonia A, et al. Holmium laser enucleation of the prostate versus open prostatectomy for prostates >70 g: 24-month follow-up. Eur Urol 2006; 50:563 8. [11] Wilson LC, Gilling PJ, Williams A, et al. A randomized trial comparing holmium laser enucleation versus transurethral resection in the treatment of prostates larger than 40 grams: results at 2 years. Eur Urol 2006;50:569 73. [12] Elzayat EA, Elhilali MM. Holmium laser enucleation of the prostate (HoLEP): the endourologic alternative to open prostatectomy. Eur Urol 2006;49:87 91. [13] Matlaga BR, Kim SC, Kuo RL, Watkins SL, Lingeman JE. Holmium laser enucleation of the prostate for prostates >125 ml. BJU Int 2006;97:81 4. [14] Sandhu JS, Ng C, Vanderbrink BA, Egan C, Kaplan SA, Te AE. High-power potassium-titanyl-phosphate photoselective laser vaporization of prostate for treatment of benign prostatic hyperplasia in men with large prostates. Urology 2004;64:1155 9. [15] Rajbabu K, Chandrasekara SK, Barber NJ, Walsh K, Muir G. Photoselective vaporization of the prostate with the potassium-titanyl-phosphate laser in men with prostates of >100 ml. BJU Int 2007;100:593 8. [16] Chandrasekera SK, Barber NJ, Walsh K, et al. Greenlight PVP: safety and efficacy in large prostates >100 cm 3. J Urol 2005;173(Suppl 3):425 (abstract no. 1569). [17] Gonzalez RR, Sandhu JS, Lee RK, Te AE. Laser prostatectomy. In: Scardino PT, Slawin KM, editors. Atlas of the prostate, ed. 3. Philadelphia, PA: Current Medicine; 2006. p. 62 78. [18] Malek RS, Nahen K. Photoselective vaporization of the prostate (PVP): KTP laser therapy of obstructive benign prostatic hyperplasia. AUA Update 2004;23:153 60. [19] Witherington R, Shelor Jr WC. Suprapubic prostatectomy. Modified Hryntschak technique. Urology 1974;4:550 6. [20] Kuntz RM. Current role of lasers in the treatment of benign prostatic hyperplasia (BPH). Eur Urol 2006;49: 961 9. [21] Naspro R, Freschi M, Salonia A, et al. Holmium laser enucleation versus transurethral resection of the prostate. Are histological findings comparable? J Urol 2004;171:1203 6. [22] Chandrasekera S, Muir G. Potassium titanyl phosphate laser prostatectomy: a review. Curr Opin Urol 2007;17: 22 6. [23] Hosseini SY, Salimi M, Hosseini Moqhaddam SM. Changes in serum prostate specific antigen level after prostatectomy in patients with benign prostatic hyperplasia. Urol J 2005;2:183 8. [24] Scattoni V, Raber M, Montorsi F, et al. Percent of free serum prostate-specific antigen and histological findings in patients undergoing open prostatectomy for benign prostatic hyperplasia. Eur Urol 1999;36:621 30.

european urology 54 (2008) 427 437 435 Editorial Comment on: Transurethral Photoselective Vaporization versus Transvesical Open Enucleation for Prostatic Adenomas >80 ml: 12-mo Results of a Randomized Prospective Study Alexander Bachmann Department of Urology, University Hospital Basel, Basel, Switzerland bachmanna@uhbs.ch For decades open prostatectomy was the standard procedure for patients with enlarged prostates suffering from obstructive voiding disorders. Since the mid-1980s transurethral resection of the prostate (TURP), a less invasive alternative, has become the standard treatment for men suffering from benign prostatic hyperplasia (BPH) due to lower urinary tract symptoms (LUTS). Since then, various laser procedures have tried to achieve a comparable status to TURP in our daily practice. However, because laser treatment was previously associated with a high reoperation rate and significant dysuria, laser prostatectomy increasingly became an obsolete surgical treatment option [1,2]. As a result of a continuous technical improvement photoselective vaporization of the prostate (PVP) using the 80-W power setting has become widely accepted among urologists recently. As we urologists always try to provide effective prostate surgery to our patients, patients themselves are mainly interested in looking for the safest procedure first because they fear possible complications. This is the reason, despite profound and excellent long-term results of TURP, new emerging laserprocedureshavebecomemoreacceptedby men with BPH. Even in patients with large prostates, the surgical standard could be redefined in the near future. Interestingly, this present study [3] compares the initial standard procedure for BPH with one of the most attractive and emerging laser technologies for prostate surgery. Alivizatos et al studied 125 patients with LUTS and large prostates who were prospectively randomized to undergo either open adenoma enucleation or 80-W potassium-titanyl-phosphate (KTP) laser vaporization. Patients in the KTP group were significantly older (by about 6.5 yr), but all other preoperative parameters were comparable. Perioperatively, patients in the open group had 13.3% transfusions, but overall the complication rate was clinically comparable (p = 0.187) in the two groups. Although the operation time in the KTP group was longer than in the open group, time until catheter removal and hospital stay were dramatically reduced (p < 0.001). Overall, as other studies have shown previously, this study confirms again the excellent hemostatic properties of KTP laser vaporization while obtaining excellent functional results [4,5]. Although randomized clinical trials in transurethral prostate surgery are urgently needed, there are some critical comments to this study. First, it is always very difficult to have a true randomization of two completely different surgical techniques in a single-hospital setting. Because the surgeon is often personally involved in the study, he possibly wants to demonstrate the advantage or disadvantage of one personally preferred technique. Additionally, blinding of the surgeon is not possible. This is a remaining bias of all surgical quasi randomized single-hospital trials. Therefore, the results of this paper have to be evaluated in this context. Accordingly, after experience with our own prospective clinical studies, it seems remarkable, that after explaining the pros and cons of the two completely different surgical approaches, no patient was interested in changing the treatment group. What was the reason for the patient accepting randomization to the open group if he could achieve comparable functional results more safely with less invasiveness? When looking at the functional results after open prostatectomy and considering the average 6.5- yr younger patient population in this group, postoperative flow rates are questionable in both groups and not comparable to previously published series after KTP laser, open prostatectomy or TURP [6 8]. Thus, the conclusion that in patients with large prostates 80-W KTP laser vaporization provides comparable functional results to open prostatectomy has to be interpreted with care in addition to the fact that the follow-up was also short. Alivizatos et al [3] report on the first prospective (randomized) study comparing 80-W KTP PVP to open adenoma enucleation of the prostate in large glands. In general, the conclusion of the study is important. Because currently several effective and minimally invasive treatment alternatives are available, open adenoma enucleation is getting less important. Thus, it is only a question of time before open prostatectomy for BPH with large adenoma will be completely replaced by other less invasive surgical techniques.

436 european urology 54 (2008) 427 437 References [1] Schatzl G, Madersbacher M, Djavan R, et al. Two-year results of transurethral resection of the prostate versus four less invasive treatment options. Eur Urol 2000;37:695 701. [2] Reich O, Gratzke C, Stief CG. Techniques and long-term results of surgical procedures for BPH. Eur Urol 2006;49:970 8. [3] Alivizatos G, Skolarikos A, Chalikopoulos D, et al. Transurethral photoselective vaporization versus transvesical open enucleation for prostatic adenomas >80 ml: 12-mo results of a randomized prospective study. Eur Urol 2008;54:427 37. [4] Rajbabu K, Chandrasekara SK, Barber NJ, Walsh K, Muir GH, et al. Photoselective vaporization of the prostate with the potassium-titanyl-phosphate laser in men with prostates of >100 ml. BJU Int 2007;100:593 8. [5] Ruszat R, Wyler S, Seifert H-H, et al. Photoselective vaporization of the prostate: experience with prostate adenomas >80 cm 3. Urologe A 2006;45:858 64. [6] Kuntz RM, Lehrich K, Ahyai SA. Holmium laser enucleation of the prostate versus open prostatectomy for prostates greater than 100 grams: 5-year follow-up results of a randomised clinical trial. Eur Urol 2008;53:160 8. [7] Madersbacher S, Marberger M. Is transurethral resection of the prostate still justified? BJU Int 1999;83:227 37. [8] Bachmann A, Schürch L, Ruszat R, et al. Photoselective vaporization (PVP) versus transurethral resection of the prostate (TURP): a prospective bi-centre study of perioperative morbidity and early functional outcome. Eur Urol 2005;48:965 72. DOI: 10.1016/j.eururo.2007.11.045 DOI of original article: 10.1016/j.eururo.2007.11.044 Editorial Comment on: Transurethral Photoselective Vaporization versus Transvesical Open Enucleation for Prostatic Adenomas >80 ml: 12-mo Results of a Randomized Prospective Study Oliver Reich Ludwig-Maximilians-University Munich, University-Hospital Munich-Großhadern, 81377 Munich, Germany oliver.reich@med.uni-muenchen.de In general, the authors should be congratulated for their efforts in conducting the first randomized study comparing Greenlight PV TM potassium-titanyl-phosphate laser vaporization with open prostatectomy [1]. To evaluate the role of this rapidly emerging laser technique in the treatment of lower urinary tract symptoms, controlled randomized trials are mandatory but scarce. In fact, only one randomized trial with very limited follow-up comparing Greenlight laser vaporization with conventional transurethral resection of the prostate has been published to date [2]. In this article [1], Greenlight laser vaporization displayed a very low overall morbidity. On the other hand, the functional results, described as equivalent by Alivizatos et al, must be seen in the light of rather poor results (given, for example, peak urinary flow rate of 15ml/s postoperatively and a recatheterization rate of 17%) for the open prostatectomy cohort compared to the literature. Nevertheless, the paper demonstrates that Greenlight laser vaporization yields a convincing functional outcome while offering a favorable safety profile also for large glands. From our own experience of >700 cases in Munich-Grosshadern, I strongly feel that an average energy application of 196 kj for an average baseline prostate volume of 93 ml is very low and might generate insufficient tissue ablation. Moreover, I clearly oppose the authors statement that Greenlight laser vaporization has a very shallow learning curve. This judgment might be accurate for urologists, who are well experienced in transurethral surgery, but could deceive others to avoid appropriate proctoring and training. This could be harmful to patients and could discredit the procedure. Because the ultimate merits of any surgical procedure for benign prostatic hyperplasia have to be judged on long-term outcome [3], I sincerely advocate that the authors take advantage of their unique chance to follow these patients on a longterm basis to learn if this promising procedure can withstand the test of time. References [1] Alivizatos G, Skolarikos A, Chalikopoulos D, et al. Transurethral photoselective vaporization versus transvesical open enucleation for prostatic adenomas >80 ml: 12-mo

european urology 54 (2008) 427 437 437 results of a randomized prospective study. Eur Urol 2008;54:427 37. [2] Bouchier-Hayes DM, Anderson P, Van Appledorn S, Bugeja P, Costello AJ. KTP laser versus transurethral resection: early results of a randomized trial. J Endourol 2006;20:580 5. [3] Reich O, Gratzke C, Stief CG. Techniques and long-term results of surgical procedures for BPH. Eur Urol 2006;49:970 8. DOI: 10.1016/j.eururo.2007.11.046 DOI of original article: 10.1016/j.eururo.2007.11.044