Abstract
Arab Journal of Urology (2014) 12, 245–250 Arab Journal of Urology (Official Journal of the Arab Association of Urology) www.sciencedirect.com ORIGINAL ARTICLE Diode laser vaporisation of the prostate vs. diode laser under cold irrigation: A randomised control trial Ravisankar G. Pillai , Ziad Al Naieb, Stephen Angamuthu, Tintu Mundackal Department of Urology, Royal Bahrain Hospital, Manama, Bahrain Received 1 September 2014, Received in revised form 19 October 2014, Accepted 22 October 2014 Available online 20 November 2014 KEYWORDS Abstract Objective: To compare the perioperative morbidity and early follow-up after diode laser vaporisation of the prostate (LVP) and its modification, diode Benign prostate laser under cold irrigation (LUCI) in patients with symptomatic benign prostatic hyperplasia; hyperplasia, as the main disadvantages of LVP are the postoperative pain, dysuria Diode laser and storage urinary symptoms. vaporisation; Patients and methods: This was a single-centre prospective randomised control Cold irrigation trial in which 100 patients were randomised to receive LVP (50) or LUCI (50) from June 2011 until July 2012. LUCI is similar to LVP except that it is done under ABBREVIATIONS normal irrigation with saline at 4 C instead of saline at room temperature. The LVP, diode laser primary outcome measures were the International Prostate Symptom Score (IPSS), vaporisation of the IPSS-Dysuria, a pain scale (PS), maximum flow rate (Q ), a quality-of-life (QoL) max prostate; score and the postvoid residual urine volume (PVR) after 1 month, then the IPSS, LUCI, (diode) laser Q , QoL, and PVR at 3 and 12 months. Secondary outcomes included intraoper- max under cold irrigation; ative surgical variables, e.g., the decline in core temperature, bleeding, peri- and Q , maximum postoperative morbidity. max urinary flow rate; Results: The baseline characteristics of both groups were similar. For the primary PVR, postvoid residual outcome measures, there was a statistically significant difference between the groups urine volume; in all variables except Q after 1 month, in favour of LUCI. The mean (SD) IPSS max PS, pain scale; at 1 month in the LVP group was 8.97 (1.68), statistically significantly different from This journal is partially supported by Karl Storz GmbH. That support had no influence on the peer-review of this paper, which was entirely independent of Karl Storz. Corresponding author at: Dip Urol, FEBU, Department of Urology, Royal Bahrain Hospital, Manama, Bahrain. E-mail address: gopakravi@gmail.com (R.G. Pillai). Peer review under responsibility of Arab Association of Urology. Production and hosting by Elsevier http://dx.doi.org/10.1016/j.aju.2014.10.001 2090-598X ª 2014 Arab Association of Urology. Production and hosting by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/). 246 Pillai et al. PVP, photoselective that after LUCI, of 6.89 (1.5) (P < 0.05). The mean IPSS-Dysuria at 1 month was vaporisation of the also significantly, at 2.32 (0.91) for LVP and 3.54 (1.07) for LUCI (P < 0.05). prostate; The respective mean PS at 1 month was 7.84 (2.92) and 5.7 (2.1) (P < 0.05). The QoL, quality-of-life QoL and PVR at 1 month were also significantly different. Within the first month (score); 17% of patients in the LVP group and 4% in the LUCI group complained of tran- KTP, potassium tita- sient urgency or stress incontinence, and this difference was statistically significant nyl phosphate; (P < 0.05). There was no significant bleeding in either group. The mean operative HOLEP, holmium time or applied energy of LVP was not statistically significant from that of LUCI, laser enucleation of the and there was no significant difference in the decline in core temperature between prostate the groups (P > 0.05). Conclusion: LUCI is a good modification for reducing the pain, dysuria and stor- age symptoms associated with LVP. The procedure appears to be safe, with no sig- nificant decrease in core temperature in either group. ª 2014 Arab Association of Urology. Production and hosting by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons. org/licenses/by-nc-nd/3.0/). Introduction Patients and methods BPH is a major cause of LUTS in elderly men, and From June 2011 until July 2012, 100 patients with surgical treatment remains the most effective option symptomatic BPH were recruited into a prospective, for men with symptomatic BPH who are refractory randomised, single-centre study to compare the peri- to medical treatment. TURP is considered to be the and postoperative variables between two techniques. standard surgical treatment for BPH [1], but the peri- The study plan was approved by the appropriate operative morbidity, e.g., bleeding requiring blood ethics committee. After giving informed consent, 50 transfusion (25%), TUR syndrome (2%), stress incon- patients had diode LVP and 50 patients had LUCI. tinence (2.2%), urethral stricture (3.8%), bladder neck Patients were randomised using a computer program, contracture (4%), retrograde ejaculation (65–70%) and on a 1:1 basis, to receive LVP or LUCI. Patients were prolonged catheterisation time has encouraged the included if they had a maximum urinary flow rate search for alternatives that can reduce these complica- (Q )of 615 mL/s, transvesically measured postvoid max tions and offer at least similar clinical results [1–4]. residual urine volume (PVR) of >50 mL, an IPSS Laser vaporisation of prostate (LVP) is one such of >10 and a prostate volume of <80 mL. All method for symptomatic BPH. Different types of laser patients underwent a treatment trial with at least are available for this method, e.g., potassium-titanyl one of the given a-blockers (tamsulosin or alfuzosin) phosphate (KTP), holmium, diode and thulium. Of for P6 weeks before surgery. Patients with definite these, the photoselective vaporisation of the prostate indications for surgery who already had trial of (PVP) using the KTP laser, and holmium laser enucle- a-blocker therapy were directly included. All patients ation of the prostate (HOLEP) are gaining popularity underwent a general and urological standard evalua- [5,6]. tion before, including a DRE, urine analysis and The diode laser is considered to be the best in terms culture, transvesical ultrasonographic measurement of of haemostatic properties, but is less acceptable due to the prostate, an ultrasonographic evaluation of the postoperative dysuria, pain and storage urinary symp- kidney, blood sample analysis, including a measure- toms [7]. Here we introduce a new concept, using cold ment of the PSA level, IPSS, Q , a quality of life max irrigation to reduce the wound oedema and modify the score (QoL), and estimate of PVR. In three patients coagulation zone, and thus improve the postoperative with a PSA level of >4 ng/mL with a normal DRE, urinary symptoms. The rationale behind this idea is TRUS-guided biopsies were taken before inclusion from previous dichromatic absorptiometry studies to into the study. quantify oedema, which showed that the immediate Patients were excluded if they had a neurogenic blad- application of cold irrigation might reduce the massive der disorder, urethral strictures, a PVR of >400 mL and wound oedema associated with burning [8]. Thus previous lower urinary tract surgery. A urodynamic we compared the perioperative morbidity and early study was done before inclusion in any patients with a follow-up after diode LVP and its modification, diode suspected overactive bladder. Two patients showing laser under cold irrigation (LUCI) in patients with detrusor overactivity in the urodynamic study were symptomatic BPH. excluded from the study. Diode laser vaporisation of the prostate vs. diode laser under cold irrigation 247 All LVP and LUCI procedures were performed by Results one surgeon who had formal training in LVP. The pri- mary outcome measures after surgery were the IPSS, The baseline variables were similar between the groups the IPSS-Dysuria, a pain scale (PS), Q , QoL score max (Table 1). At 1 month after surgery there was a statisti- and PVR at 1 month, then the IPSS, Q , QoL and max cally significant difference between the groups in all vari- PVR at 3 and 12 months. The IPSS-Dysuria was adopted ables except Q , in favour of LUCI. The mean IPSS at max from a previous study on dysuria after brachytherapy [9], 1 month in the LVP group was statistically significantly and was assessed by a questionnaire which asks ‘During different from that in the LUCI group (P < 0.05), as the last month or so how often have you had a burning was the mean IPSS-Dysuria, the mean PS, the mean sensation while passing urine’, and the score is given Q , QoL and PVR (all P < 0.05). Within the first max similar to the standard IPSS (0–5). The PS was a month 17% of patients in the LVP group and 4% in standard 11-point numeric rating scale to represent the LUCI group complained of transient urgency or pain, asking ‘If you have had a burning sensation, rate stress incontinence (also statistically significant, the severity of the pain on a 0–10 scale’. The secondary P < 0.05). All these symptoms resolved before the next outcomes included intraoperative surgical variables, follow-up visit. Only one patient, who was 80 years old, e.g., the decline in core temperature (the core rectal in the LUCI group complained of occasional urgency temperature was measured at the beginning and end of incontinence even after 3 months. At 3 months, three the procedure), bleeding, and peri- and postoperative more patients were lost to follow-up in the LVP group morbidity. and two in the LUCI group. At 1 year, 35 patients in Parametric numeric data were compared using the LVP group and 40 in the LUCI group were available Student’s t-test and nonparametric data using the for follow-up. There was no statistically significant Wilcoxon signed-rank test. The categorical data were difference in any variables at the 3- and 12-month analysed using Fisher’s exact test. follow-up (Table 1). LVP and LUCI (Fig. 1a–d) was performed with a For the secondary outcomes, the perioperative semiconductor diode laser at a wavelength of variables of both groups also showed no significant 980 ± 10 nm (HPLAS I, 150 W laser, Wuhan Gigaa differences (Table 1). Even on anticoagulant therapy, Optronics Technology Ltd, China) using a 600-lm intraoperative bleeding was not a problem in both side-firing fibre or ‘hook-shot’ fibre, or those combined. groups, as assessed by the clear irrigation fluid at the The diode laser machine used was a Sino-German tech- end of the procedure. The mean operative time of nology having both continuous and pulsed-wave mode. LVP (59.8) was not statistically significantly different For aiming, a red pilot beam of 635 nm was used, with a from that of LUCI (62.4; P > 0.05). The mean applied maximum power of 4 mW. Both groups had diode LVP energy was also similar in both groups (Table 1, under normal saline irrigation (0.9%) at room tempera- P > 0.05). There was no significant difference in the ture for the LVP group and at 4 C for the LUCI group. decline in core temperature between the groups Both procedures used the same standard techniques. (P > 0.05; Table 1). All patients had a standard trial The working space was made by vaporising the lateral without catheter, the catheter being removed after lobes. The middle lobe was vaporised using a side-firing 2 days. Six patients in the LVP group required re-inser- fibre (600 lm) or hook-shot fibre, or combined, tion of the Foley catheter on the second day, mainly due depending on the anatomy. The laser power setting to severe storage symptoms. Of these six men, three had was 80–120 W. The vaporisation was done through a the catheter removed successfully after 5 days and 24 F Karl Storz continuous-flow laser resectoscope. A another three after 7 days. Three patients in the LUCI temperature regulation mechanism was used to group also needed re-insertion of the Foley catheter at maintain the temperature of cold irrigation at 4 C. 2 days, two of whom had a successful removal at 5 days The procedure was done under general or spinal anaes- and one 7 days. thesia, depending on the indications and patient prefer- ence. A 20–22 F three-way Foley catheter was inserted Discussion over a ‘road runner’ guidewire, avoiding any trauma and no further irrigation in most patients. Throughout LVP is one of the latest methods being used to replace the procedure the core temperature was closely standard TURP in the developed world [5,6]. PVP and monitored. HOLEP are considered as good alternatives to TURP After surgery all patients were placed on antibiotic for treating BPH because of increasing evidence from prophylaxis for 72 h and anti-inflammatory medication various studies [5,6]. However, the main disadvantages for 1 week, except in those for whom this was of laser surgery for BPH are the lack of long-term data contraindicated. on its benefits and the severe pain, dysuria and storage 248 Pillai et al. Figure 1 (a) Starting LVP; (b) Vaporisation of the lateral lobes; (c) A view at the level of the verumontanum; (d) A good prostate cavity after vaporisation. symptoms associated with it [5,6]. Some retrospective laser can be applied continuously or in pulsed mode. We studies showed that diode LVP provides excellent intra- use the continuous wave mode for LVP. From ex-vivo operative safety, instant tissue removal, and immediate studies, the tissue ablative property of the diode laser is relief from obstructive voiding symptoms, similar to double that of the KTP laser [16]. The tissue ablative the results of TURP, and with minimal bleeding and capacity of the diode laser is 7.24 (1.48) g/10 min [16], no TUR syndrome [7]. As the absorption of fluid is which is much less than standard TURP, with a resection minimal, the chance of cold irrigation-induced core- capacity of 8.28 (0.38) g/30 s, but far better than the KTP temperature change is minimal. laser, which has an ablative rate of 3.99 (0.48) g/10 min. Diode LVP and PVP are comparable in terms of the The coagulation zone of the KTP laser is more than twice improvement in subjective and objective variables for as dense as that of the diode laser, due to its affinity for assessing BPH [10]. One of the most common side-effects haemoglobin. From experimental studies the coagula- of diode laser surgery was dysuria (18%) and storage tion zone depth of a 100-W diode laser is 255.1 (28.2) symptoms (34%) after the surgery, which can last for lm. With the diode laser, a large amount of energy is 4–6 weeks [10]. There are many short-term follow-up absorbed at the surface, resulting in vaporisation of the studies of up to 12 months which show the efficacy of tissue [16]. From dichromatic absorptiometry studies to diode LVP. Few studies showed a significant improve- quantify oedema, we know that the immediate applica- ment in urodynamic variables (Q and PVR). The tion of cold irrigation can reduce the massive wound max reduction in PSA was used as a surrogate marker for oedema associated with burning [8]. The same studies the reduction of prostate volume in some studies showed that cold treatment beginning 2 min after the [11–15]. The diode laser at a wavelength of 980 nm offers burning did not decrease oedema formation and the highest simultaneous absorption of water and hae- impaired resorption. Based on this information we moglobin (Fig. 2), which is why it has the best tissue- introduced the concept of cold irrigation during laser ablative capacity. The peculiar absorption pattern of this surgery. This might reduce the wound oedema and wavelength also gives a better haemostatic property. The modify the coagulation zone, which in effect can reduce bleeding increases with decreasing frequency, while the the postoperative pain, dysuria and urinary storage ablation and coagulation zones are unaltered. The diode symptoms. Diode laser vaporisation of the prostate vs. diode laser under cold irrigation 249 Table 1 Baseline, peri- and postoperative variables. Mean (SD or range) LVP LUCI P Age (years) 58.21 (45–74) 59.9 (42–82) Body mass index (kg/m ) 27.64 (3.37) 27.78 (4.58) >0.05 Prostate volume (mL) 48.4 (12.5) 48.29 (16.47) >0.05 PSA level (ng/mL) 2.27 (1.62) 2.24 (1.94) >0.05 PVR (mL) 158.0 (69.5) 154.8 (83.1) >0.05 Q (mL/s) 8.22 (2.35) 7.87 (2.88) >0.05 max IPSS 20.75 (4.45) 21.4 (4.8) >0.05 QoL score 3.4 (1.9) 3.9 (1.7) >0.05 Anticoagulant (n patients) Aspirin 11 15 Warfarin 2 1 Clopidogrel 5 3 Perioperative Operative time (min) 59.8 (15.0) 62.4 (22.5) >0.05 Applied energy (kJ) 287.0 (148.8) 299.3 (107.8) >0.05 Irrigation during surgery (L) 2.64 (0.79) 2.55 (0.69) >0.05 Catheterisation time (days) 2.53 (1.36) 2.23 (0.93) >0.05 Core temperature decrease (C) 3.08 (0.77) 3.38 (0.89) >0.05 1-month follow-up No. of patients 46 49 Occasional haematuria (%) 96 92 Bleeding requiring intervention 0 0 IPSS 8.97 (1.68) 6.89 (1.50) <0.05 IPSS-Dysuria 2.32 (0.91) 3.54 (1.07) <0.05 PS 7.84 (2.92) 5.70 (2.10) <0.05 Q (mL/s) 20.82 (5.37) 21.4 (5.12) >0.05 max QoL score 2.5 (1.18) 1.9 (0.95) <0.05 PVR (mL) 37.1 (22.40) 23.7 (20.4) <0.05 Urgency/stress incontinence, n (%) 8 (17) 2 (4) <0.05 3-month follow-up n patients 43 47 IPSS 5.9 (1.9) 5.6 (1.8) >0.05 Q (mL/s) 20.34 (3.40) 20.73 (4.28) >0.05 max QoL score 1.4 (0.9) 1.2 (0.9) >0.05 PVR (mL) 14.1 (18.2) 13.5 (22.2) >0.05 Bladder neck stenosis, n 2 1 12-month follow-up No. of patients 35 40 IPSS 4.9 (1.6) 4.52 (1.8) >0.05 Q (mL/s) 19.37 (2.11) 19.58 (2.40) >0.05 max QoL score 1.1 (0.9) 1.1 (0.8) >0.05 PVR (mL) 13.9 (20.2) 13.1 (18.3) >0.05 In the present study the computer-based task of randomisation of patients was done by the theatre staff, but the surgeon was aware of the temperature of the irrigation solution, so this is considered to be a limitation of the study. A major concern was the possibility of hypo- thermia in such surgery, but there was no significant dif- ference in the decrease in core body temperature between the groups. This agrees with the results of the various studies showing no significant fluid absorption in laser prostate surgery [11]. There was a statistically significant difference between the groups in variables such as the IPSS, QoL, IPSS-Dysuria, PS, PVR and transient incon- tinence at 1-month follow-up, in favour of LUCI, which suggests that cold irrigation can modify the side-effects of Figure 2 Absorption coefficients of various lasers. 250 Pillai et al. Source of funding None declared. References [1] European Association of Urology. Management of Male LUTS, including BPO. EAU Guidelines 2012: 40–59. [2] Wasson JH, Reda DJ, Bruskewitz RC, Elinson J, Keller AM, Henderson WG. A comparison of transurethral surgery with watchful waiting for moderate symptoms of benign prostatic hyperplasia. N Engl J Med 1995;332:75–9. 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Thus intraoperative bleeding [7] Zhao Y, Liu C, Zhou G, Yu C, Zhang Y, Ouyang Y. A was never a problem in both groups, even in patients on retrospective evaluation of benign prostatic hyperplasia treatment anticoagulant treatment. Another concern was whether by transurethral vaporization using a 1470 nm laser. Photomed Laser Surg 2013;31:626–9. the cold irrigation would slow the vaporisation and [8] Demling RH, Mazess RB, Wolberg W. The effect of immediate increase the lasing time, but there was no significant and delayed cold immersion on burn edema formation and difference in lasing time or energy used in either group. resorption. J Trauma 1979;19:56–60. All patients had a standard trial without catheter [9] Merrick GS, Butler WM, Wallner KE, Galbreath RW, Murray B, after 2 days. Urgency or stress incontinence is a com- Zeroski D, et al. Dysuria after permanent prostate brachyther- apy. Int J Rad Oncol Biol Phys 2003;55:979–85. mon complaint after transurethral laser surgery and [10] Chiang PH, Chen CH, Kang CH, Chuang YC. GreenLight HPS during the first month more patients in the LVP than laser 120-W versus diode laser 200-W vaporization of the in the LUCI group complained of such problems, with prostate: comparative clinical experience. Lasers Surg Med a statistically significant difference between them. How- 2010;42:624–9. ever, all these symptoms resolved before the next follow- [11] Kim Y, Seong YK, Kim IG, Han BH. Twelve-month follow-up results of photoselective vaporization of the prostate with a 980- up visits. Two patients in the LVP group and one in the nm diode laser for treatment of benign hyperplasia. Korean J Urol LUCI group developed stenosis of the bladder neck or 2013;54:677–81. prostate region, probably due to adhesion from ‘hang- [12] Chen CH, Chiang PH, Chuang YC, Lee WC, Chen YT. ing’ tissues (Fig. 3). All these patients were easily man- Preliminary results of prostate vaporization in the treatment of aged by one dilatation. Considering the overall benign prostatic hyperplasia by using a 200-W high-intensity diode laser. Urology 2010;75:658–63. pattern, there was a statistically significant improvement [13] Erol A, Cam K, Tekin A, Memik O, Coban S, Ozer Y. High from baseline in all variables in both groups, which is power diode laser vaporization of the prostate: preliminary results consistent with previous studies. for benign prostatic hyperplasia. J Urol 2009;182:1078–82. In conclusion, diode LVP provides instant tissue [14] Rieken M, Kang HW, Koullick E, Ruth GR, Bachmann A. Laser removal and immediate relief from obstructive voiding vaporization of the prostate in vivo: experience with the 150-W 980-nm diode laser in living canines. Lasers Surg Med symptoms, but it is associated with postoperative pain, 2010;42:736–42. dysuria and storage symptoms that can last for a month. [15] Ruszat R, Seitz M, Wyler SF, Muller G, Rieken M, Bonkat G, LUCI is a good modification for reducing such symp- et al. Prospective single-centre comparison of 120-W diode- toms. The procedure appears to be safe, causing no signif- pumped solid-state high-intensity system laser vaporization of icant decrease in core temperature associated with the use the prostate and 200-W high-intensive diode-laser ablation of the prostate for treating benign prostatic hyperplasia. BJU Int of cold irrigant. We need further randomised controlled 2009;104:820–5. trials with various lasers to assess the effects of this mod- [16] Wendt-Nordahl G, Huckele S, Honeck P, Alken P, Knoll T, ification on a larger scale and over the longer term. Michel MS, et al. 980-nm diode laser. A novel laser technology for vaporization of the prostate. Eur Urol 2007;52:1723–8. Conflict of interest None.
Journal
Arab Journal of Urology
– Taylor & Francis
Published: Dec 1, 2014
Keywords: Benign prostate hyperplasia; Diode laser vaporisation; Cold irrigation; LVP, diode laser vaporisation of the prostate; LUCI, (diode) laser under cold irrigation; Q max , maximum urinary flow rate; PVR, postvoid residual urine volume; PS, pain scale; PVP, photoselective vaporisation of the prostate; QoL, quality-of-life (score); KTP, potassium titanyl phosphate; HOLEP, holmium laser enucleation of the prostate
