A prospective randomised controlled study comparing bipolar plasma vaporisation of the prostate to monopolar transurethral resection of the prostate
A prospective randomised controlled study comparing bipolar plasma vaporisation of the prostate...
Elsakka, Ahmed M.; Eltatawy, Hssan H.; Almekaty, Khaled H.; Ramadan, Ahmed R.; Gameel, Tarik A.; Farahat, Yasser
2016-12-01 00:00:00
Arab Journal of Urology (2016) 14, 280–286 Arab Journal of Urology (Official Journal of the Arab Association of Urology) www.sciencedirect.com PROSTATIC DISORDERS ORIGINAL ARTICLE A prospective randomised controlled study comparing bipolar plasma vaporisation of the prostate to monopolar transurethral resection of the prostate a a a Ahmed M. Elsakka , Hssan H. Eltatawy , Khaled H. Almekaty , a a b, Ahmed R. Ramadan , Tarik A. Gameel , Yasser Farahat Department of Urology, Tanta University, Tanta, Egypt Sheikh Khalifa General Hospital, Dubai, United Arab Emirates Received 15 June 2016, Received in revised form 17 September 2016, Accepted 20 September 2016 Available online 2 November 2016 KEYWORDS Abstract Objectives: To compare the safety and efficacy of bipolar transurethral plasma vaporisation (B-TUVP) as an alternative to the ‘gold standard’ monopolar Benign prostatic transurethral resection of the prostate (M-TURP) for the treatment of benign pro- hyperplasia (BPH); static hyperplasia (BPH) in a prospective randomised controlled study. Bladder outlet Patients and methods: In all, 82 patients indicated for prostatectomy were assigned obstruction (BOO); to two groups, group I (40 patients) underwent B-TUVP and group II (42 patients) Transurethral resection underwent M-TURP. The safety of both techniques was evaluated by reporting peri- of prostate (TURP); + + operative changes in serum Na , serum K , haematocrit (packed cell volume), and Lower urinary tract any perioperative complications. For the efficacy assessment, patients were evaluated symptoms (LUTS); subjectively by comparing the improvement in International Prostate Symptom Score International Prostate and objectively by measuring the maximum urinary flow rate (Q ) and post-void max Symptom Score (IPSS) residual urine volume (PVR) before and after the procedures. Results: In group II, there was a significant perioperative drop in serum Na ABBREVIATIONS (from 137.5 to 129.4 mmol/L) and haematocrit (from 42.9% to 38.2%) (both BNO, bladder neck P < 0.001). Moreover, one patient in group II had TUR syndrome. The remote Corresponding author at: Sheikh Khalifa General Hospital, Urology, Umm Alquain, Dubai, United Arab Emirates. E-mail address: yasserafarhat@yahoo.com (Y. Farahat). Peer review under responsibility of Arab Association of Urology. Production and hosting by Elsevier http://dx.doi.org/10.1016/j.aju.2016.09.005 2090-598X 2016 Production and hosting by Elsevier B.V. on behalf of Arab Association of Urology. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). B-TUVP vs M-TURP 281 obstruction; postoperative complication rate was (15%) in group I and comprised of stress urinary PVR, post-void resi- incontinence (5%), bladder outlet obstruction (5%), and residual adenoma (5%). In dual urine volume; group II, the remote postoperative complication rate was (4.8%), as two patients Q , maximum urin- developed urethral stricture. There were statistically significant improvements in mic- max ary flow rate turition variables postoperatively in both arms, but the magnitude of improvement was statistically more significant in group II. Conclusion: B-TUPV seems to be safer than M-TURP; however, the lack of a tis- sue specimen and the relatively high retreatment rate are major disadvantages of the B-TUVP technique. Moreover, M-TURP appears to be more effective than B-TUPV and its safety can be improved by careful case selection and adequate haemostasis. 2016 Production and hosting by Elsevier B.V. on behalf of Arab Association of Urology. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/). Introduction suspected of prostatic carcinoma were excluded from the study. All patients were evaluated preoperatively with a full BPH can be associated with bothersome LUTS that can clinical assessment including IPSS, uroflowmetry and affect quality of life [1]. It is the most frequent tumour ultrasonography with post-void residual urine volume requiring surgical treatment in ageing men [2]. When (PVR) measurement. active intervention becomes mandatory, i.e. prostatec- In all, 84 patients were initially enrolled in this study tomy, TURP is the most widely available option in most and were divided into two groups by 1:1 block randomi- clinical centres [3]. sation. Group I included 42 patients who underwent New strategies intend to achieve clinical efficacy com- B-TUVP, Group II also included 42 patients who under- parable to that of conventional TURP with lower intra- went M-TURP. However, two patients in group I were operative and postoperative morbidity [2]. The general lost during follow-up and excluded from the study morbidity of TURP has been estimated at 18% and (Fig. 1). the overall mortality rate is 0.17–0.77% [4]. One of these new strategies is bipolar vaporisation of the prostate. B-TUVP/M-TURP techniques The supporters of this technique claim that it has the advantage of less blood loss, lesser morbidity from the Plasma vaporisation requires a bipolar high-frequency effects of water absorption and TUR syndrome, and a generator, a vaportrode and a continuous flow setup shorter learning curve than other prostatectomy tech- to ensure excellent visibility and sufficient elimination niques. Conversely, others report that bipolar vaporisa- of vaporisation bubbles. Saline 0.9% was used as the tion of the prostate results in less debulking of the gland, irrigant fluid. Vaporisation was performed in a near- lesser improvements in micturition parameters, and contact technique (hovering technique) leaving a TUR- more postoperative dysuria [5,6]. like cavity at the end. In the shadow of this argument, we decided to com- The monopolar generator for M-TURP was of the pare the outcomes of bipolar transurethral vaporisation Berchtold type and glycine 1.5% was the irrigant fluid of the prostate (B-TUVP) to the standard monopolar used. The procedures were performed using a 26-F TURP (M-TURP). continuous-flow resectoscope using the same surgical technique (Mauermayer technique). All procedures were Patients and methods performed by a single senior surgeon with extensive experience in both techniques and under spinal After approval by our local ethics committee, this study anaesthesia. was conducted on patients admitted to the Urology The primary endpoint was assessment of changes in Department in Tanta University Hospital in Egypt from IPSS, Q and PVR to evaluate the efficacy of both max 1 April 2010 to the 1 January 2012 and indicated for techniques. Safety was also evaluated by assessing peri- prostatectomy. + + operative changes in serum Na ,K and haematocrit Inclusion criteria were: patients with LUTS sec- (packed cell volume). These were measured before and ondary to BOO with an IPSS of P8, low maximum uri- immediately after the procedures. Intraoperative and nary flow rate (Q ) < 15 m/s, not responding to max early postoperative complications were reported as well. medical treatment, and/or BPH complications such as Moreover, patients attended a routine follow-up 1 week refractory retention or recurrent haematuria, and pros- later and they were also evaluated at 3 and 6 months tate size <80 mL. Patients unfit for surgery and those postoperatively for the evaluation of long-term improve- 282 Elsakka et al. Assessed for eligibility (n = 125) Excluded (n = 41) Randomised (n =84), 1:1 42 cases were allocated 42 cases were allocated to B-TUVP (group I) to M-TURP (group II) Lost to follow-up (n = 2) Lost to follow-up (n = 0) Due to socio-economic reasons, excluded from the study Analysed (n = 40) Analysed (n = 42) Figure 1 Consolidated Standards of Reporting Trials (CONSORT) flowchart of study cases. ment in micturition parameters and any remote postop- Table 1 Preoperative data. erative complications. Variable, mean (SEM) B-TUVP M-TURP P Statistical analysis Age, years 56.9 (1.2) 55.6 (3.1) 0.147 Prostate size, mL 50.9 (5.3) 53.8 (8.1) 0.064 IPSS 24.3 (5.3) 24.2 (4.4) 0.978 Statistical analysis was conducted using the mean, stan- Q , mL/s 7.5 (3.1) 6.5 (2.7) 0.268 max dard error, t-test and Fisher’s exact test by SPSS (Statis- PVR, mL 215 (7.3) 202.1 (63.1) 0.565 tical Package for the Social Sciences) for Windows V12. + Na , mmol/L 139.3 (5.20) 137.5 (5.45) 0.154 Statistically significant differences were considered at K , mmol/L 4.9 (0.47) 4.8 (0.50) 0.587 Haematocrit,% 42.9 (2.51) 42.9 (2.3) 0.871 P < 0.05. Results obstruction (BNO), urethral stricture, and residual ade- Indications for intervention were: LUTS that were not noma. Table 3 shows the details of the reported compli- responding to medical treatment, in acute urine reten- cations in both groups. tion, and haematuria in 73 (89%), three (3.7%) and For the safety of both techniques, we measured the + + six (7.3%) patients, respectively. perioperative changes in serum Na , serum K and Both groups had no statistically significant differ- haematocrit (Table 2). ences in baseline characteristics including the patients’ There was a statistically significant decrease in the age, prostate size, preoperative micturition and labora- postoperative values of serum Na in the patients in tory parameters, and operative time (Table 1). group II (8 mmol/L drop). Similarly and in the same There were no cases of perioperative mortality. There group, there was a statistically significant decrease in was no significant difference in the complication rate the postoperative haematocrit (4.7% drop). Whilst, between the groups. The intraoperative complications there was no statistically significant change in the peri- were bleeding requiring transfusion and TUR syn- operative serum K values. drome. Early postoperative complications were minor Considering the duration and amount of postopera- in nature e.g. UTI, clot retention and re- tive catheter irrigation were used as an additional indi- catheterisation. As the long-term follow-up of patients rect indicator for the assessment of haemostasis or should extend to P6 months, we tried to record the haemorrhagic complications. The mean amount and remote postoperative complications e.g. bladder neck duration of irrigation was significantly higher in group Follow-up Analysis Allocation Enrolment B-TUVP vs M-TURP 283 Table 2 Perioperative data. Variable, mean (SEM) B-TUVP M-TURP P Operative time, min 48.6 (5.0) 51.2 (11.2) 0.626 Amount of intraoperative irrigation, L 11.1 (4.2) 12.6 (2.0) 0.267 Amount of postoperative irrigation, L 14.861 (2.62) 18.741 (2.05) <0.001 Duration of postoperative irrigation, h 12.227 (4.66) 24.537 (6.24) <0.001 Duration of catheterisation, h 36.900 (4.024) 48.283 (6.61) <0.001 + * Na , mmol/L 138 (7) 129.4 (6.60) <0.001 P value (pre- and postoperative) 0.511 <0.001 K , mmol/L 4.8 (0.483) 4.3 (0.42) 0.576 P value (pre- and postoperative) 0.524 0.304 Haematocrit,% 42.7 (2.04) 38.2 (1.90) <0.001 P value (pre- and postoperative) 0.824 <0.001 IPSS 3 months 15.2 (1.8) 7.8 (1.8) <0.001 6 months 12.2 (1.0) 7.1 (1.9) <0.001 * * P value preoperative vs 6 months postoperative <0.001 <0.001 Q , mL/s 3 months 16.6 (2.2) 18.8 (2.0) 0.002 max 6 months 16.7 (1.5) 19.5 (1.6) <0.001 * * P value preoperative vs 6 months postoperative <0.001 <0.001 PVR, mL 3 months 65.4 (10.8) 34.9 (10) <0.001 6 months 60.2 (9.4) 33.5 (2.3) <0.001 * * P value preoperative vs 6 months postoperative <0.001 <0.001 Statistically significant P < 0.05. Table 3 Complications and secondary intervention. B-TUVP M-TURP P (n = 40), n (%) (n = 42), n (%) Total complications 16 (40) 11 (26.2) 0.241 Bladder perforation 2 (5) 0 0.235 Clot retention 2 (5) 2 (4.8) 1 Re-catheterisation 4 (10) 2 (4.8) 0.427 UTI 2 (5) 2 (4.8) 1 SUI 2 (5) 0 0.235 BNO 2 (5) 0 0.235 Residual adenoma 2 (5) 0 0.235 Bleeding 0 2 (4.8) 0.494 necessitating transfusion TUR syndrome 0 1 (2.4) 1 Figure 2 Magnitude of improvement in micturition parameters. Stricture urethra 0 2 (4.8) 0.494 Modified Clavien System dent in group II and this improvement was more evident Grade I 8 (20) 4 (9.5) 0.221 in the Q than the IPSS and PVR (Fig. 2). max Grade II 4 (10) 4 (9.5) 1 Secondary intervention was required in four patients Grade III 4 (10) 2 (4.8) 0.427 (10%) in group I vs two in group II (4.8%). In group I Grade IV 0 1 (2.4) 1 Grade V 0 0 (B-TUVP arm), re-treatment comprised bladder neck Secondary 4 (10) 2 (4.8) 0.427 incision in two patients with BNO and re-TURP for intervention another two patients with residual adenoma. Whilst in group II (M-TURP arm), two patients developed bul- bomembranous urethral strictures and visual internal urethrotomy was required. II at 18.7 L and 24.5 h vs 14.9 L and 12.2 h for group I patients. Also, the mean duration of catheterisation was Discussion significantly longer in group II at 48.3 h vs 36.9 h in group I patients (Table 2). As shown in Table 2, there were statistically signifi- Treatment of BPH varies from watchful waiting to open cant improvements in the IPSS and Q accompanied prostatectomy. Whenever active invention becomes max by significant reductions in the PVR for both groups mandatory (prostatectomy), TURP is the most widely after 6 and 12 months, especially in group II. For the available option in most clinical centres [4]. magnitude of improvement, it was statistically more evi- 284 Elsakka et al. In recent years, TURP has been challenged by the Perioperative changes in haematocrit were significant development of several minimally invasive procedures. in group II (4.7% drop) vs 0.2% drop in group I. Also, The advent of bipolar technology is the latest modifica- the duration and amount of postoperative catheter irri- tion of the standard TURP technique [6,7]. gation were considered additional indirect parameters In the present study, we compared B-TUPV to M- for assessment of haemostasis or haemorrhagic compli- TURP in two comparable groups of patients with cations. M-TURP patients required larger amounts of BPH/benign prostatic obstruction-related LUTS, irrigation fluid (mean 18.7 L) and also had a longer patients were randomly assigned to active treatment duration of postoperative catheter irrigation (mean with B-TUVP (group I) and M-TURP (group II). 24.5 h) until the urine became clear, in addition, two After a Medline search, we found a paucity of well- patients, in group II, had frequent clot retention and designed studies evaluating bipolar vaporisation; only required catheter exchange. four randomised studies evaluating the bipolar vaporisa- TUR syndrome is another critical issue, which is tion technique were reported. Ahyai et al. [8] 2010 commonly referred to in arguments against TURP. Only reported that there was no statistically significant differ- one patient in the M-TURP arm developed TUR syn- ence in the safety of both techniques. Whilst, the study drome and was managed with diuretics and recovered of Kaya et al. [9] agreed with our present study that both smoothly. In earlier monopolar TUR series, TUR syn- techniques have similar complication rates, but that B- drome was reported in 2% [16] to 2.8% [17]. There TUVP has a higher secondary intervention rate (12% has been a remarkable decline in more recent series, vs 6.6%). down to 0% to 0.8% [18]. Generally speaking, the inci- Early experience with TURP showed that the proce- dence of TUR syndrome increases with a gland size of dure was highly morbid, with overall morbidity and >45 g and resection times of >90 min. mortality rates approaching 18% [4] and 2.5% [10], A common agreement amongst individual studies respectively. There is no doubt that recent technological comparing bipolar to monopolar current is the occur- advances and progression in the learning curve have rence of TUR syndrome in the monopolar TURP arms transformed TURP from a morbid operation to a rou- vs none in the bipolar arms, although the difference was tine safe procedure with rapid convalescence and a statistically insignificant in our present study and other marked reduction in the mortality of the procedure studies, when data were pooled into a systemic meta- down to 0.1% and 11% overall morbidity [11]. analysis, the overall difference was significant [8]. A sec- There were no perioperative mortalities in our pre- ondary benefit of bipolar technology application is to sent study. Table 3 shows the complications encountered extend the safe resection or vaporisation time, which in both groups and classifies them according to the mod- in turn allows coping with larger glands without com- ified Clavien–Dindo system. Despite B-TUVP having promising safety of the patient. better electrolyte stability, less postoperative irrigation, The safety of the bipolar vaporisation technique is and less postoperative catheterisation time, this did further confirmed by laboratory monitoring of perioper- not translate into statistical superiority in terms of pro- ative changes in serum Na . Falahatkar et al. [19] found cedure safety. However, postoperative dysuria was vir- that the mean (SD) perioperative drop in serum Na tually a constant feature of all B-TUVP cases, but no was 1.7 (0.19) mmol/L. In our present series, we were alteration of postoperative care was required except in unfortunately confronted with a single case of TUR syn- four patients who failed to void after catheter removal drome in group II (2.38%) vs none in group I. Retro- necessitating re-catheterisation (10%). Whilst in group spective analysis of the operative notes of this patient II, re-catheterisation was required in two patients showed a prolonged resection time and subsequent over (4.8%) due to clot retention. use of irrigation fluid, both of which occurred during In early standard TURP series, the transfusion rates pursuing a bleeding prostatic sinus. Similar to published approached 20% [12], in recent series this rate has dra- data, biochemical monitoring of perioperative changes matically dropped to 2.9% [11]. Recently, several in serum Na showed that these changes were signifi- ex vivo studies have confirmed the superior capability of cant in M-TURP patients when compared to those trea- bipolar current to achieve better haemostasis through ted with B-TUVP; an 8 mmol/L drop in the mean deeper coagulation and through the so called ‘cut-and- serum Na level occurred in group II patients. seal’ effect of plasma produced by bipolar current [13–15]. It should be noted that different centres use variable In our present series, complications related to blood protocols for removal of the catheter after a transure- loss were generally few. None of the patients treated thral procedure, thus it is usually difficult to compare with B-TUVP had either significant operative bleeding catheter removal with other studies. We removed or required a transfusion, whilst two patients treated catheters 24 h after the urine became clear. The mean with M-TURP had intraoperative bleeding mandating period of catheterisation in our present series was transfusion (4.8%). 36.9 h and 48.3 h in groups I and II, respectively. B-TUVP vs M-TURP 285 Re-catheterisation was required in six patients, four in 2% and 0.5%, respectively. Surprisingly, the risk of group I (10%) and two in group II (4.8%). bladder neck stenosis is more than double (5%) after For effectiveness, B-TUVP was comparable to treatment with a potassium titanyl phosphate (KTP) M-TURP, which was maintained at the 3- and at laser [8]. 6-month follow-up visits. The longest published follow-up period after bipolar For measurable outcome parameters, M-TURP can vaporisation does not extend beyond 3 years [22]. The produce up to 10 mL/s or 165% improvement in the re-treatment and secondary intervention rate after Q , a 70% reduction in the IPSS, and another 70% B-TUVP is 2.4% [23]. max improvement in the quality-of life scores compared with In our present series, the follow-up of our patients preoperative levels [8]. extended up to 6 months after the initial procedure. In the present study, both techniques were statisti- The successful results reported at the 3-month visit were cally effective with a marginal superiority of M-TURP also maintained at 6 months. over B-TUVP. At the 3-month follow-up, group II The long-term complications and secondary interven- patients had a greater reduction in the symptom score tion rates were 10% and 4.76% in groups I and II, at 67.8% vs 37.4% for group I. In the subsequent respectively, which was not statistically significant. 6-month follow-up visit, group II patients still had a Another point that should be considered is that greater overall reduction in the IPSS (70.6% vs 49.7% B-TUVP does not provide a tissue specimen for in group I), all differences were statistically significant histopathology, which can mean that prostate cancer is in comparison to the preoperative levels. missed in 1.4% of cases [24,25]. Similarly, group II patients had a greater reduction in Limitations of the present study are a lack of long- the PVR at the 3-month follow-up visit (82.7%) than term reporting (>6 months) and financial assessment. group I patients (69.6%). This improvement was main- Also, sexual function, postoperative prostate volume, tained at the 6-month follow-up visit. and PSA level reduction should have been evaluated. The 3-month, improvement of Q was 121% and Post hoc analysis showed a relatively low study power max 189.3% in groups I and II, respectively. At 6 months (60%), thus further well-designed studies are needed to postoperatively, the Q improvement was 122.4% vs consolidate our present results. max 201% in groups I and II, respectively. Contrary to our present results, Zhang et al. [20] con- Conclusion cluded that B-TUVP is superior to M-TURP in terms of efficacy parameters. Conversely, a meta-analysis study In the present study, B-TUVP did not prove to be supe- evaluating B-TUVP found that its efficacy is compara- rior to standard M-TURP, with both techniques having ble to M-TURP for IPSS and PVR improvement, whilst comparable safety and efficacy. However, the lack of a M-TURP is marginally superior for Q changes [8]. max tissue specimen and postoperative irritative LUTS are Data taken from a nationwide analysis from Austria clear disadvantages of the B-TUVP technique. comparing the morbidity of TURP to open prostatec- B-TUVP is a safe and effective alternative, but M- tomy confirms that re-operation and secondary inter- TURP can still defend its position. ventional procedures for correction of long-term TURP complications (mainly bladder neck stenosis, Conflicts of interest urethral stricture and prostatic re-growth) are relatively high, approaching 2.9%, 5.8% and 7.4% at 1, 5 and None. 8 years, respectively. The overall incidence of a sec- ondary endourological procedure (TURP, internal Source of funding urethrotomy, bladder neck incision) within 8 years after the initial TURP is 14.7% following the initial TURP None. procedure [21]. It seems that urethral stricture is a common sequela References to any transurethral procedure. The urethral stricture rates following M-TURP and B-TUVP are 4% and [1] McNeal JE. Origin and evolution of benign prostatic enlarge- 2%, respectively [8]. As these figures are nearly compa- ment. Invest Urol 1978;15:340–5. [2] Donnell RF. Changes in medicare reimbursement: impact on rable, we believe that factors other than the type of the therapy for benign prostatic hyperplasia. Curr Urol Rep current used are responsible, for instance; the overall 2002;3:280–4. manoeuvre time, the size, and the insulation of the [3] Black L, Naslund MJ, Gilbert Jr TD, Davis EA, Ollendorf DA. working instruments. 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A prospective randomised controlled study comparing bipolar plasma vaporisation of the prostate to monopolar transurethral resection of the prostate
A prospective randomised controlled study comparing bipolar plasma vaporisation of the prostate to monopolar transurethral resection of the prostate
Abstract
AbstractObjectives To compare the safety and efficacy of bipolar transurethral plasma vaporisation (B-TUVP) as an alternative to the ‘gold standard’ monopolar transurethral resection of the prostate (M-TURP) for the treatment of benign prostatic hyperplasia (BPH) in a prospective randomised controlled study.Patients and methods In all, 82 patients indicated for prostatectomy were assigned to two groups, group I (40 patients) underwent B-TUVP and group II (42 patients) underwent...
Arab Journal of Urology (2016) 14, 280–286 Arab Journal of Urology (Official Journal of the Arab Association of Urology) www.sciencedirect.com PROSTATIC DISORDERS ORIGINAL ARTICLE A prospective randomised controlled study comparing bipolar plasma vaporisation of the prostate to monopolar transurethral resection of the prostate a a a Ahmed M. Elsakka , Hssan H. Eltatawy , Khaled H. Almekaty , a a b, Ahmed R. Ramadan , Tarik A. Gameel , Yasser Farahat Department of Urology, Tanta University, Tanta, Egypt Sheikh Khalifa General Hospital, Dubai, United Arab Emirates Received 15 June 2016, Received in revised form 17 September 2016, Accepted 20 September 2016 Available online 2 November 2016 KEYWORDS Abstract Objectives: To compare the safety and efficacy of bipolar transurethral plasma vaporisation (B-TUVP) as an alternative to the ‘gold standard’ monopolar Benign prostatic transurethral resection of the prostate (M-TURP) for the treatment of benign pro- hyperplasia (BPH); static hyperplasia (BPH) in a prospective randomised controlled study. Bladder outlet Patients and methods: In all, 82 patients indicated for prostatectomy were assigned obstruction (BOO); to two groups, group I (40 patients) underwent B-TUVP and group II (42 patients) Transurethral resection underwent M-TURP. The safety of both techniques was evaluated by reporting peri- of prostate (TURP); + + operative changes in serum Na , serum K , haematocrit (packed cell volume), and Lower urinary tract any perioperative complications. For the efficacy assessment, patients were evaluated symptoms (LUTS); subjectively by comparing the improvement in International Prostate Symptom Score International Prostate and objectively by measuring the maximum urinary flow rate (Q ) and post-void max Symptom Score (IPSS) residual urine volume (PVR) before and after the procedures. Results: In group II, there was a significant perioperative drop in serum Na ABBREVIATIONS (from 137.5 to 129.4 mmol/L) and haematocrit (from 42.9% to 38.2%) (both BNO, bladder neck P < 0.001). Moreover, one patient in group II had TUR syndrome. The remote Corresponding author at: Sheikh Khalifa General Hospital, Urology, Umm Alquain, Dubai, United Arab Emirates. E-mail address: yasserafarhat@yahoo.com (Y. Farahat). Peer review under responsibility of Arab Association of Urology. Production and hosting by Elsevier http://dx.doi.org/10.1016/j.aju.2016.09.005 2090-598X 2016 Production and hosting by Elsevier B.V. on behalf of Arab Association of Urology. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). B-TUVP vs M-TURP 281 obstruction; postoperative complication rate was (15%) in group I and comprised of stress urinary PVR, post-void resi- incontinence (5%), bladder outlet obstruction (5%), and residual adenoma (5%). In dual urine volume; group II, the remote postoperative complication rate was (4.8%), as two patients Q , maximum urin- developed urethral stricture. There were statistically significant improvements in mic- max ary flow rate turition variables postoperatively in both arms, but the magnitude of improvement was statistically more significant in group II. Conclusion: B-TUPV seems to be safer than M-TURP; however, the lack of a tis- sue specimen and the relatively high retreatment rate are major disadvantages of the B-TUVP technique. Moreover, M-TURP appears to be more effective than B-TUPV and its safety can be improved by careful case selection and adequate haemostasis. 2016 Production and hosting by Elsevier B.V. on behalf of Arab Association of Urology. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/). Introduction suspected of prostatic carcinoma were excluded from the study. All patients were evaluated preoperatively with a full BPH can be associated with bothersome LUTS that can clinical assessment including IPSS, uroflowmetry and affect quality of life [1]. It is the most frequent tumour ultrasonography with post-void residual urine volume requiring surgical treatment in ageing men [2]. When (PVR) measurement. active intervention becomes mandatory, i.e. prostatec- In all, 84 patients were initially enrolled in this study tomy, TURP is the most widely available option in most and were divided into two groups by 1:1 block randomi- clinical centres [3]. sation. Group I included 42 patients who underwent New strategies intend to achieve clinical efficacy com- B-TUVP, Group II also included 42 patients who under- parable to that of conventional TURP with lower intra- went M-TURP. However, two patients in group I were operative and postoperative morbidity [2]. The general lost during follow-up and excluded from the study morbidity of TURP has been estimated at 18% and (Fig. 1). the overall mortality rate is 0.17–0.77% [4]. One of these new strategies is bipolar vaporisation of the prostate. B-TUVP/M-TURP techniques The supporters of this technique claim that it has the advantage of less blood loss, lesser morbidity from the Plasma vaporisation requires a bipolar high-frequency effects of water absorption and TUR syndrome, and a generator, a vaportrode and a continuous flow setup shorter learning curve than other prostatectomy tech- to ensure excellent visibility and sufficient elimination niques. Conversely, others report that bipolar vaporisa- of vaporisation bubbles. Saline 0.9% was used as the tion of the prostate results in less debulking of the gland, irrigant fluid. Vaporisation was performed in a near- lesser improvements in micturition parameters, and contact technique (hovering technique) leaving a TUR- more postoperative dysuria [5,6]. like cavity at the end. In the shadow of this argument, we decided to com- The monopolar generator for M-TURP was of the pare the outcomes of bipolar transurethral vaporisation Berchtold type and glycine 1.5% was the irrigant fluid of the prostate (B-TUVP) to the standard monopolar used. The procedures were performed using a 26-F TURP (M-TURP). continuous-flow resectoscope using the same surgical technique (Mauermayer technique). All procedures were Patients and methods performed by a single senior surgeon with extensive experience in both techniques and under spinal After approval by our local ethics committee, this study anaesthesia. was conducted on patients admitted to the Urology The primary endpoint was assessment of changes in Department in Tanta University Hospital in Egypt from IPSS, Q and PVR to evaluate the efficacy of both max 1 April 2010 to the 1 January 2012 and indicated for techniques. Safety was also evaluated by assessing peri- prostatectomy. + + operative changes in serum Na ,K and haematocrit Inclusion criteria were: patients with LUTS sec- (packed cell volume). These were measured before and ondary to BOO with an IPSS of P8, low maximum uri- immediately after the procedures. Intraoperative and nary flow rate (Q ) < 15 m/s, not responding to max early postoperative complications were reported as well. medical treatment, and/or BPH complications such as Moreover, patients attended a routine follow-up 1 week refractory retention or recurrent haematuria, and pros- later and they were also evaluated at 3 and 6 months tate size <80 mL. Patients unfit for surgery and those postoperatively for the evaluation of long-term improve- 282 Elsakka et al. Assessed for eligibility (n = 125) Excluded (n = 41) Randomised (n =84), 1:1 42 cases were allocated 42 cases were allocated to B-TUVP (group I) to M-TURP (group II) Lost to follow-up (n = 2) Lost to follow-up (n = 0) Due to socio-economic reasons, excluded from the study Analysed (n = 40) Analysed (n = 42) Figure 1 Consolidated Standards of Reporting Trials (CONSORT) flowchart of study cases. ment in micturition parameters and any remote postop- Table 1 Preoperative data. erative complications. Variable, mean (SEM) B-TUVP M-TURP P Statistical analysis Age, years 56.9 (1.2) 55.6 (3.1) 0.147 Prostate size, mL 50.9 (5.3) 53.8 (8.1) 0.064 IPSS 24.3 (5.3) 24.2 (4.4) 0.978 Statistical analysis was conducted using the mean, stan- Q , mL/s 7.5 (3.1) 6.5 (2.7) 0.268 max dard error, t-test and Fisher’s exact test by SPSS (Statis- PVR, mL 215 (7.3) 202.1 (63.1) 0.565 tical Package for the Social Sciences) for Windows V12. + Na , mmol/L 139.3 (5.20) 137.5 (5.45) 0.154 Statistically significant differences were considered at K , mmol/L 4.9 (0.47) 4.8 (0.50) 0.587 Haematocrit,% 42.9 (2.51) 42.9 (2.3) 0.871 P < 0.05. Results obstruction (BNO), urethral stricture, and residual ade- Indications for intervention were: LUTS that were not noma. Table 3 shows the details of the reported compli- responding to medical treatment, in acute urine reten- cations in both groups. tion, and haematuria in 73 (89%), three (3.7%) and For the safety of both techniques, we measured the + + six (7.3%) patients, respectively. perioperative changes in serum Na , serum K and Both groups had no statistically significant differ- haematocrit (Table 2). ences in baseline characteristics including the patients’ There was a statistically significant decrease in the age, prostate size, preoperative micturition and labora- postoperative values of serum Na in the patients in tory parameters, and operative time (Table 1). group II (8 mmol/L drop). Similarly and in the same There were no cases of perioperative mortality. There group, there was a statistically significant decrease in was no significant difference in the complication rate the postoperative haematocrit (4.7% drop). Whilst, between the groups. The intraoperative complications there was no statistically significant change in the peri- were bleeding requiring transfusion and TUR syn- operative serum K values. drome. Early postoperative complications were minor Considering the duration and amount of postopera- in nature e.g. UTI, clot retention and re- tive catheter irrigation were used as an additional indi- catheterisation. As the long-term follow-up of patients rect indicator for the assessment of haemostasis or should extend to P6 months, we tried to record the haemorrhagic complications. The mean amount and remote postoperative complications e.g. bladder neck duration of irrigation was significantly higher in group Follow-up Analysis Allocation Enrolment B-TUVP vs M-TURP 283 Table 2 Perioperative data. Variable, mean (SEM) B-TUVP M-TURP P Operative time, min 48.6 (5.0) 51.2 (11.2) 0.626 Amount of intraoperative irrigation, L 11.1 (4.2) 12.6 (2.0) 0.267 Amount of postoperative irrigation, L 14.861 (2.62) 18.741 (2.05) <0.001 Duration of postoperative irrigation, h 12.227 (4.66) 24.537 (6.24) <0.001 Duration of catheterisation, h 36.900 (4.024) 48.283 (6.61) <0.001 + * Na , mmol/L 138 (7) 129.4 (6.60) <0.001 P value (pre- and postoperative) 0.511 <0.001 K , mmol/L 4.8 (0.483) 4.3 (0.42) 0.576 P value (pre- and postoperative) 0.524 0.304 Haematocrit,% 42.7 (2.04) 38.2 (1.90) <0.001 P value (pre- and postoperative) 0.824 <0.001 IPSS 3 months 15.2 (1.8) 7.8 (1.8) <0.001 6 months 12.2 (1.0) 7.1 (1.9) <0.001 * * P value preoperative vs 6 months postoperative <0.001 <0.001 Q , mL/s 3 months 16.6 (2.2) 18.8 (2.0) 0.002 max 6 months 16.7 (1.5) 19.5 (1.6) <0.001 * * P value preoperative vs 6 months postoperative <0.001 <0.001 PVR, mL 3 months 65.4 (10.8) 34.9 (10) <0.001 6 months 60.2 (9.4) 33.5 (2.3) <0.001 * * P value preoperative vs 6 months postoperative <0.001 <0.001 Statistically significant P < 0.05. Table 3 Complications and secondary intervention. B-TUVP M-TURP P (n = 40), n (%) (n = 42), n (%) Total complications 16 (40) 11 (26.2) 0.241 Bladder perforation 2 (5) 0 0.235 Clot retention 2 (5) 2 (4.8) 1 Re-catheterisation 4 (10) 2 (4.8) 0.427 UTI 2 (5) 2 (4.8) 1 SUI 2 (5) 0 0.235 BNO 2 (5) 0 0.235 Residual adenoma 2 (5) 0 0.235 Bleeding 0 2 (4.8) 0.494 necessitating transfusion TUR syndrome 0 1 (2.4) 1 Figure 2 Magnitude of improvement in micturition parameters. Stricture urethra 0 2 (4.8) 0.494 Modified Clavien System dent in group II and this improvement was more evident Grade I 8 (20) 4 (9.5) 0.221 in the Q than the IPSS and PVR (Fig. 2). max Grade II 4 (10) 4 (9.5) 1 Secondary intervention was required in four patients Grade III 4 (10) 2 (4.8) 0.427 (10%) in group I vs two in group II (4.8%). In group I Grade IV 0 1 (2.4) 1 Grade V 0 0 (B-TUVP arm), re-treatment comprised bladder neck Secondary 4 (10) 2 (4.8) 0.427 incision in two patients with BNO and re-TURP for intervention another two patients with residual adenoma. Whilst in group II (M-TURP arm), two patients developed bul- bomembranous urethral strictures and visual internal urethrotomy was required. II at 18.7 L and 24.5 h vs 14.9 L and 12.2 h for group I patients. Also, the mean duration of catheterisation was Discussion significantly longer in group II at 48.3 h vs 36.9 h in group I patients (Table 2). As shown in Table 2, there were statistically signifi- Treatment of BPH varies from watchful waiting to open cant improvements in the IPSS and Q accompanied prostatectomy. Whenever active invention becomes max by significant reductions in the PVR for both groups mandatory (prostatectomy), TURP is the most widely after 6 and 12 months, especially in group II. For the available option in most clinical centres [4]. magnitude of improvement, it was statistically more evi- 284 Elsakka et al. In recent years, TURP has been challenged by the Perioperative changes in haematocrit were significant development of several minimally invasive procedures. in group II (4.7% drop) vs 0.2% drop in group I. Also, The advent of bipolar technology is the latest modifica- the duration and amount of postoperative catheter irri- tion of the standard TURP technique [6,7]. gation were considered additional indirect parameters In the present study, we compared B-TUPV to M- for assessment of haemostasis or haemorrhagic compli- TURP in two comparable groups of patients with cations. M-TURP patients required larger amounts of BPH/benign prostatic obstruction-related LUTS, irrigation fluid (mean 18.7 L) and also had a longer patients were randomly assigned to active treatment duration of postoperative catheter irrigation (mean with B-TUVP (group I) and M-TURP (group II). 24.5 h) until the urine became clear, in addition, two After a Medline search, we found a paucity of well- patients, in group II, had frequent clot retention and designed studies evaluating bipolar vaporisation; only required catheter exchange. four randomised studies evaluating the bipolar vaporisa- TUR syndrome is another critical issue, which is tion technique were reported. Ahyai et al. [8] 2010 commonly referred to in arguments against TURP. Only reported that there was no statistically significant differ- one patient in the M-TURP arm developed TUR syn- ence in the safety of both techniques. Whilst, the study drome and was managed with diuretics and recovered of Kaya et al. [9] agreed with our present study that both smoothly. In earlier monopolar TUR series, TUR syn- techniques have similar complication rates, but that B- drome was reported in 2% [16] to 2.8% [17]. There TUVP has a higher secondary intervention rate (12% has been a remarkable decline in more recent series, vs 6.6%). down to 0% to 0.8% [18]. Generally speaking, the inci- Early experience with TURP showed that the proce- dence of TUR syndrome increases with a gland size of dure was highly morbid, with overall morbidity and >45 g and resection times of >90 min. mortality rates approaching 18% [4] and 2.5% [10], A common agreement amongst individual studies respectively. There is no doubt that recent technological comparing bipolar to monopolar current is the occur- advances and progression in the learning curve have rence of TUR syndrome in the monopolar TURP arms transformed TURP from a morbid operation to a rou- vs none in the bipolar arms, although the difference was tine safe procedure with rapid convalescence and a statistically insignificant in our present study and other marked reduction in the mortality of the procedure studies, when data were pooled into a systemic meta- down to 0.1% and 11% overall morbidity [11]. analysis, the overall difference was significant [8]. A sec- There were no perioperative mortalities in our pre- ondary benefit of bipolar technology application is to sent study. Table 3 shows the complications encountered extend the safe resection or vaporisation time, which in both groups and classifies them according to the mod- in turn allows coping with larger glands without com- ified Clavien–Dindo system. Despite B-TUVP having promising safety of the patient. better electrolyte stability, less postoperative irrigation, The safety of the bipolar vaporisation technique is and less postoperative catheterisation time, this did further confirmed by laboratory monitoring of perioper- not translate into statistical superiority in terms of pro- ative changes in serum Na . Falahatkar et al. [19] found cedure safety. However, postoperative dysuria was vir- that the mean (SD) perioperative drop in serum Na tually a constant feature of all B-TUVP cases, but no was 1.7 (0.19) mmol/L. In our present series, we were alteration of postoperative care was required except in unfortunately confronted with a single case of TUR syn- four patients who failed to void after catheter removal drome in group II (2.38%) vs none in group I. Retro- necessitating re-catheterisation (10%). Whilst in group spective analysis of the operative notes of this patient II, re-catheterisation was required in two patients showed a prolonged resection time and subsequent over (4.8%) due to clot retention. use of irrigation fluid, both of which occurred during In early standard TURP series, the transfusion rates pursuing a bleeding prostatic sinus. Similar to published approached 20% [12], in recent series this rate has dra- data, biochemical monitoring of perioperative changes matically dropped to 2.9% [11]. Recently, several in serum Na showed that these changes were signifi- ex vivo studies have confirmed the superior capability of cant in M-TURP patients when compared to those trea- bipolar current to achieve better haemostasis through ted with B-TUVP; an 8 mmol/L drop in the mean deeper coagulation and through the so called ‘cut-and- serum Na level occurred in group II patients. seal’ effect of plasma produced by bipolar current [13–15]. It should be noted that different centres use variable In our present series, complications related to blood protocols for removal of the catheter after a transure- loss were generally few. None of the patients treated thral procedure, thus it is usually difficult to compare with B-TUVP had either significant operative bleeding catheter removal with other studies. We removed or required a transfusion, whilst two patients treated catheters 24 h after the urine became clear. The mean with M-TURP had intraoperative bleeding mandating period of catheterisation in our present series was transfusion (4.8%). 36.9 h and 48.3 h in groups I and II, respectively. B-TUVP vs M-TURP 285 Re-catheterisation was required in six patients, four in 2% and 0.5%, respectively. Surprisingly, the risk of group I (10%) and two in group II (4.8%). bladder neck stenosis is more than double (5%) after For effectiveness, B-TUVP was comparable to treatment with a potassium titanyl phosphate (KTP) M-TURP, which was maintained at the 3- and at laser [8]. 6-month follow-up visits. The longest published follow-up period after bipolar For measurable outcome parameters, M-TURP can vaporisation does not extend beyond 3 years [22]. The produce up to 10 mL/s or 165% improvement in the re-treatment and secondary intervention rate after Q , a 70% reduction in the IPSS, and another 70% B-TUVP is 2.4% [23]. max improvement in the quality-of life scores compared with In our present series, the follow-up of our patients preoperative levels [8]. extended up to 6 months after the initial procedure. In the present study, both techniques were statisti- The successful results reported at the 3-month visit were cally effective with a marginal superiority of M-TURP also maintained at 6 months. over B-TUVP. At the 3-month follow-up, group II The long-term complications and secondary interven- patients had a greater reduction in the symptom score tion rates were 10% and 4.76% in groups I and II, at 67.8% vs 37.4% for group I. In the subsequent respectively, which was not statistically significant. 6-month follow-up visit, group II patients still had a Another point that should be considered is that greater overall reduction in the IPSS (70.6% vs 49.7% B-TUVP does not provide a tissue specimen for in group I), all differences were statistically significant histopathology, which can mean that prostate cancer is in comparison to the preoperative levels. missed in 1.4% of cases [24,25]. Similarly, group II patients had a greater reduction in Limitations of the present study are a lack of long- the PVR at the 3-month follow-up visit (82.7%) than term reporting (>6 months) and financial assessment. group I patients (69.6%). This improvement was main- Also, sexual function, postoperative prostate volume, tained at the 6-month follow-up visit. and PSA level reduction should have been evaluated. The 3-month, improvement of Q was 121% and Post hoc analysis showed a relatively low study power max 189.3% in groups I and II, respectively. At 6 months (60%), thus further well-designed studies are needed to postoperatively, the Q improvement was 122.4% vs consolidate our present results. max 201% in groups I and II, respectively. Contrary to our present results, Zhang et al. [20] con- Conclusion cluded that B-TUVP is superior to M-TURP in terms of efficacy parameters. Conversely, a meta-analysis study In the present study, B-TUVP did not prove to be supe- evaluating B-TUVP found that its efficacy is compara- rior to standard M-TURP, with both techniques having ble to M-TURP for IPSS and PVR improvement, whilst comparable safety and efficacy. However, the lack of a M-TURP is marginally superior for Q changes [8]. max tissue specimen and postoperative irritative LUTS are Data taken from a nationwide analysis from Austria clear disadvantages of the B-TUVP technique. comparing the morbidity of TURP to open prostatec- B-TUVP is a safe and effective alternative, but M- tomy confirms that re-operation and secondary inter- TURP can still defend its position. ventional procedures for correction of long-term TURP complications (mainly bladder neck stenosis, Conflicts of interest urethral stricture and prostatic re-growth) are relatively high, approaching 2.9%, 5.8% and 7.4% at 1, 5 and None. 8 years, respectively. The overall incidence of a sec- ondary endourological procedure (TURP, internal Source of funding urethrotomy, bladder neck incision) within 8 years after the initial TURP is 14.7% following the initial TURP None. procedure [21]. It seems that urethral stricture is a common sequela References to any transurethral procedure. The urethral stricture rates following M-TURP and B-TUVP are 4% and [1] McNeal JE. Origin and evolution of benign prostatic enlarge- 2%, respectively [8]. As these figures are nearly compa- ment. Invest Urol 1978;15:340–5. [2] Donnell RF. Changes in medicare reimbursement: impact on rable, we believe that factors other than the type of the therapy for benign prostatic hyperplasia. Curr Urol Rep current used are responsible, for instance; the overall 2002;3:280–4. manoeuvre time, the size, and the insulation of the [3] Black L, Naslund MJ, Gilbert Jr TD, Davis EA, Ollendorf DA. working instruments. 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Origin and evolution of benign prostatic enlargement
Changes in medicare reimbursement: impact on therapy for benign prostatic hyperplasia
An examination of treatment patterns and costs of care among patients with benign prostatic hyperplasia
Transurethral prostatectomy: immediate and postoperative complications. A cooperative study of 13 participating institutions evaluating 3,885 patients
Bipolar transurethral resection of the prostate, the golden standard reclaims its leading position
Rapid communication: bipolar PlasmaKinetic transurethral resection of the prostate: reliable training vehicle for today’s urology residents
Technological advances in transurethral resection of the prostate: bipolar versus monopolar TURP
Meta-analysis of functional outcomes and complications following transurethral procedures for lower urinary tract symptoms resulting from benign prostatic enlargement
The long-term results of transurethral vaporization of the prostate using plasmakinetic energy
Mortality and reoperation after open and transurethral resection of the prostate for benign prostatic hyperplasia
Morbidity, mortality and early outcome of transurethral resection of the prostate: a prospective multicenter evaluation of 10,654 patients
Mortality, morbidity and complications following transurethral resection of the prostate for benign prostatic hypertrophy
The Vista system: a new bipolar resection device for endourological procedures: comparison with conventional resectoscope
New bipolar resection device for transurethral resection of the prostate: first ex-vivo and in-vivo evaluation
The hemostatic properties of transurethral plasmakinetic resection of the prostate: comparison with conventional resectoscope in an ex vivo study
Survey of urological centres and review of current practice in the pre-operative assessment of prostatism
Transurethral prostatectomy: mortality and morbitidy
Long-term followup after electrocautery transurethral resection of the prostate for benign prostatic hyperplasia
Bipolar transurethral vaporization: a superior procedure in benign prostatic hyperplasia: a prospective randomized comparison with bipolar TURP
Efficacy and safety of bipolar plasma vaporization of the prostate with “button-type” electrode compared with transurethral resection of prostate for benign prostatic hyperplasia
Prostate Study Group of the Austrian Society of Urology. Management of lower urinary tract symptoms of elderly men in Austria
Bipolar plasmakinetic technology for the treatment of symptomatic benign prostatic hyperplasia: evidence beyond marketing hype?
Gyrus bipolar versus standard monopolar transurethral resection of the prostate: a randomized prospective trial
A hybrid technique using bipolar energy in transurethral prostate surgery: a prospective, randomized comparison
A prospective, randomized trial comparing conventional transurethral prostate resection with plasmakinetic vaporization of the prostate: physiological changes, early complications and long-term followup
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