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Keywords:

  • benign prostatic hyperplasia;
  • electrosurgery;
  • randomized controlled trial;
  • transurethral resection of prostate;
  • treatment outcome

Abstract

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES

Study Type – Therapy (RCT)

Level of Evidence 1b

What’s known on the subject? and What does the study add?

Short-term efficacy is similar but B-TURP is preferable due to a more favourable safety. a) first multicentre RCT, b) adequate quality, c) experience with a new bipolar device, d) morbidity standardize using the modified Clavien classification system.

OBJECTIVE

• To compare the perioperative efficacy and safety of bipolar (B-) and monopolar transurethral resection of the prostate (M-TURP) in an international multicentre double-blind randomized controlled trial using the bipolar system AUTOCON® II 400 ESU for the first time.

PATIENTS AND METHODS

• From July 2006 to June 2009, consecutive transurethral resection of the prostate (TURP) candidates with benign prostatic obstruction were prospectively recruited in four academic urological centres, randomized 1:1 into an M-TURP or B-TURP arm and followed up for 6 weeks after surgery.

• A total of 295 eligible patients were enrolled.

• Of these, 279 patients received treatment (M-TURP, n= 138; B-TURP, n= 141) and were analysed for immediate postoperative outcomes and perioperative safety. In all, 268 patients (M-TURP, n= 129; B-TURP, n= 139) were analysed for efficacy, which was quantified using changes in maximum urinary flow rate, postvoid residual urine volume and International Prostate Symptom Score at 6 weeks compared with baseline. Safety was estimated using sodium and haemoglobin level changes immediately after surgery and perioperative complication occurrence graded according to the modified Clavien classification system.

• Secondary outcomes included operation-resection time, resection rate, capsular perforation and catheterization time.

RESULTS

• No significant differences were detected between each study arm except that postoperative decreases in sodium levels favoured B-TURP (–0.8 vs –2.5 mmol/L, for B-TURP and M-TURP, respectively; P= 0.003). The lowest values were 131 mmol/L (B-TURP) and 106 mmol/L (M-TURP). Nine patients ranged between 125 and 130 mmol/L and the values for three patients were <125 mmol/L after M-TURP. The greatest decrease was 9 mmol/L after B-TURP (two patients). In nine patients (M-TURP) the decrease was between 9 and 34 mmol/L.

• These results were not translated into a significant difference in TUR-syndrome rates (1/138: 0.7% vs 0/141: 0.0%, for M-TURP and B-TURP, respectively; P= 0.495).

CONCLUSIONS

• In contrast to the previous available evidence, no clinical advantage for B-TURP was shown. Perioperative efficacy, safety and secondary outcomes were comparable between study arms.

• The potentially improved safety of B-TURP that is attributed to the elimination of dilutional hyponatraemia risk, a risk still present with M-TURP, did not translate into a significant clinical benefit in experienced hands.


Abbreviations
B-TURP

bipolar TURP

M-TURP

monopolar TURP

RCT

randomized controlled trial

Qmax

maximum urinary flow rate

PVR

postvoid residual urine volume

HRQL

health-related quality of life

AUR

acute urinary retention.

INTRODUCTION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES

Monopolar TURP (M-TURP) is considered to be the surgical ‘gold standard’ for benign prostatic obstruction (BPO), mainly because of its well documented long-term efficacy [1]. In the absence of strong, high-quality evidence favouring newer surgical methods [2,3], M-TURP remains clinically and cost-effective [4–6].

Although significant technical improvements during the past decades have reduced negative outcomes of the procedure, there are still concerns regarding complications such as TUR-syndrome, bleeding and urethral strictures [7,8]. In a large-scale, multicentre, observational study it was shown that TURP mortality and morbidity have anadays decreased but morbidity remains high (11.1%) [9].

The incorporation of bipolar technology has been the most significant modification to TURP; B-TURP addresses a fundamental flaw of M-TURP in that it can be performed using normal saline irrigation and has had promising results [10]. The bipolar systems Gyrus (ACMI Southborough, MA, USA), TURis® (Olympus, Tokyo, Japan), S(a)line Resectoscope (Richard Wolf GmbH, Knittlingen, Germany), Tekno Tom (Tekno-Medical, Tuttlingen, Germany) and AUTOCON® II 400 ESU (Karl Storz Endoscope, Tuttlingen, Germany) adhere to distinct electrophysiological principles regarding current flow [11,12]. Consequently, efficacy and, principally, safety should be cautiously and separately evaluated for each system [13]. We compared the perioperative efficacy and safety of B-TURP with that of M-TURP in an international multicentre randomized controlled trial (RCT) setting using the AUTOCON® II 400 ESU, for the first time, with the aim of fulfilling the Cochrane collaboration criteria for RCT quality assessment [14].

PATIENTS AND METHODS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES

STUDY DESIGN

From July 2006 to June 2009, consecutive TURP candidates with BPO were prospectively recruited in four academic urological centres (Centre 1: Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands; Centre 2: SLK Kliniken Heilbronn, University of Heidelberg, Heilbronn, Germany; Centre 3: Sismanoglio Hospital, University of Athens Medical School, Athens, Greece; Centre 4: San Luigi Hospital, University of Turin, Orbassano, Turin, Italy). The trial was initially intended to accrue patients in Centre 1 (Netherlands Trial Register, Registration No. NTR703). Centres 2–4 subsequently agreed to follow the same protocol in order to increase the number of cases, to obtain insights into differences among surgeons and to guarantee longer-term follow-up data. The trial was conducted according to the Declaration of Helsinki principles in compliance with the approved protocol by an independent local medical ethics committee at each centre, Good Clinical Practice guidelines and applicable regulatory requirements.

PATIENTS AND STUDY PROTOCOL

Patients who were able to void spontaneously (maximum urinary flow rate [Qmax]≤15 mL/s, International Prostate Symptom Score [IPSS]≥13, voided volume ≥125 mL) and patients on indwelling or intermittent catheterization [IC] were eligible. Exclusion criteria included: suspected malignant disease of the lower urinary tract including prostate cancer; impaired detrusor function (neurogenic bladder, postvoid residual urine volume [PVR] >400 mL); active urinary tract infection [UTI]; 5-α reductase inhibitor or α-blocker consumption within the last 3 months or 2 weeks before surgery, respectively; previous prostate surgery; cardiovascular disease necessitating anticoagulation continuation that might jeopardize outcome; and immunosuppression.

The baseline evaluation included medical history, digital rectal examination, self-reported IPSS, prostate volume estimation on transrectal ultrasound [TRUS], uroflowmetry, full blood count, prostate specific antigen [PSA], creatinine, electrolytes, urine analysis/urine culture. Efficacy and safety (primary outcomes) were compared between arms. Efficacy was quantified by Qmax, PVR and IPSS improvement at 6 weeks after surgery. Safety was estimated by changes in sodium and haemoglobin levels immediately after surgery and perioperative complications were graded according to the modified Clavien classification system [15] as previously proposed for TURP procedures [16]. Secondary outcomes included operation-resection time, resection rate (resected tissue weight divided by resection time), capsular perforation and catheterization time.

Sample size determination was based on sodium level changes immediately after surgery (main outcome). Using a one-sided t-test, setting the probability of type-I error (α) at 0.050, type-II error (β) at 0.100 and based on previous studies reporting on immediate postoperative sodium level decreases [17], the sample size in Centre 1 was calculated to be 47 patients per arm for detecting a difference in means of 1.6 ± 3.3 mmol/L (PS: power and sample size calculation 2.1.31). We opted for a one-sided test because B-TURP is intended to reduce the decline in sodium levels by allowing performance in normal saline.

A total of 295 patients were enrolled and randomized 1:1 into an M-TURP or B-TURP arm after written informed consent was obtained. Data were entered by one investigator per centre through a trial web-based central electronic system (http://www.turp.nl). Randomization numbers were assigned using a stratified permuted computer algorithm after completing eligibility screening. Stratification factors included prostate volume and age. Randomization was performed within 24 h prior to treatment application, which was done blindly among centres through the central electronic system to minimize potential selection bias and guarantee allocation concealment.

The nature of the intervention made blinding of treatment providers impossible and thus surgeons were not blinded. However, the outcome assessors were different from the surgeons. Outcome assessors and patients were both blinded for the intervention type (double-blind RCT). Postoperative bladder irrigation with normal saline was applied until efflux was sufficiently clear. One urologist per centre (the outcome assessor) made the decision on catheter removal. Catheters were normally removed within 24 h after irrigation was stopped.

SURGICAL PROCEDURES

All procedures were performed using the AUTOCON® II 400 ESU radiofrequency generator, compatible resectoscopes and disposables (Karl Storz Endoscope, Tuttlingen, Germany). AUTOCON® II 400 ESU, introduced in 2007, provides an automode applying only the minimum amount of high frequency current together with voltage regulation. It has a liquid crystal touchscreen offering a multitude of preprogrammed monopolar and bipolar modes. The compatible bipolar resectoscope comes with various sized loops for single or multiple uses. Bipolar functionality is achieved through the special resectoscope mirrored dual-loop distal tip design consisting of an active (resection loop) and passive electrode opposed. The system is considered to be truly bipolar as it meets the 1998 International Electrotechnical Commission definition (http://www.iec.ch) that requires both electrodes to be attached to a single-port system.

The resection technique used was at the investigator’s discretion in each centre, but there was no difference between study arms within centres. Both procedures were performed using a 24/26-F bipolar or monopolar resectoscope of continuous or intermittent flow. For B-TURP, a 24-F bipolar cutting loop (catalogue code: 27040 GPV) was used, the preferred preprogrammed cutting and coagulating effect was set to level 5 and the bladder was irrigated with normal saline intraoperatively. For M-TURP, a 24/26-F monopolar cutting loop (diameter 0.8 mm, delivered with a wire diameter 0.35 mm) was used, cutting and coagulating power across centres was 120–240 W and 60–120 W, respectively and the bladder was irrigated with hypotonic solution intraoperatively. All operations were performed under general or spinal anaesthesia by a senior urological surgeon in each centre. Patients were treated similarly apart from the surgical technique used. They received antibiotics and discontinued anticoagulants perioperatively according to the protocol of each centre. A three-way Foley catheter was used for bladder irrigation with normal saline after surgery in all cases. The preferred general settings and conditions used in each centre are summarized in Table 1.

Table 1.  Preferred general settings and conditions in each centre
Recruitment periodCentre 1 (Netherlands)Centre 2 (Germany)Centre 3 (Greece)Centre 4 (Italy)
July 2006–February 2009October 2006–June 2009January 2007–September 2008January 2008–May 2009
M-TURPB-TURPM-TURPB-TURPM-TURPB-TURPM-TURPB-TURP
  • *

    The sizes of the intermittent flow and the continuous flow resectoscope were 24 F and 26 F, respectively.

  • †Proportions do not differ significantly between arms in the total populaiton.

  • Purisole® (Fresenius-Kabi AG, Bad Homburg): sorbitol 27%-mannitol 5.4%.

Resectoscope (Karl Storz)24 Fr24 Fr24F or 26F*24F or 26F*26 F26 F24 F24 F
 Intermittent flow patients (%)47/47 (100)46/46 (100)24/33 (72.7)18/32 (56.3)0/35 (0.0)0/38 (0.0)0/23 (0.0)0/25 (0.0)
 Continuous flow patients (%)0/47 (0.0)0/46 (0.0)9/33 (27.3)14/32 (43.7)35/35 (100)38/38 (100)23/23 (100)25/25 (100)
Cutting power120 W5230 W5240 W5200 W5
Coagulating power80 W580 W5120 W560 W5
Irrigation fluid during surgerysorbitol 5%normal salinesorbitol-manitolnormal salinewater for injectionnormal salineglycine 1.5%normal saline
Type of anaesthesia        
 General (%)19/47 (40.4)11/46 (23.9)31/33 (93.9)32/32 (100)2/35 (5.7)3/38 (7.9)1/23 (4.3)0/25 (0.0)
 Spinal (%)28/47 (59.6)35/46 (76.1)2/33 (6.1)0/32 (0.0)33/35 (94.3)35/38 (92.1)22/23 (95.7)25/25 (100)
Patients with suprapubic trocar0/47 (0.0)0/46 (0.0)6/33 (18.2)2/32 (6.3)0/35 (0.0)0/38 (0.0)10/23 (43.5)12/25 (48.0)
Bladder catheter (three-way)20 Fr20 Fr22 Fr22 Fr20 Fr20 Fr20 Fr20 Fr

STATISTICAL ANALYSIS

All variables were treated as continuous (including IPSS because of its reasonable amount of categories; 0–35) apart from quality of life (QoL) score (ordinal) and those addressing complications (categorical). Continuous variables were tested for normality and equality of variances using the Shapiro–Wilk W-test and the Levene F-test, respectively. Baseline patient characteristics (age, body mass index, prostate volume, PSA and creatinine levels) were tested using univariate ANOVA models including a four-level nominal variable indicating the centre of data origin to adjust for potential differences among centres. Continuous outcome variables were tested in univariate or repeated measure ANOVA models (for single-measure or repeated measure outcome analysis, respectively) adjusted for centre and baseline characteristics that were found to differ significantly between arms (if any). QoL score was analysed using the Mann–Whitney U-test or Wilcoxon test for single-measure or repeated measure outcome analysis, respectively. Categorical variables were analysed using the Pearson chi-squared test with continuity correction or Fisher’s exact test. Descriptive statistics were presented as mean (sd), irrespective of the variable distribution, for uniformity purposes. Data were analysed using the Statistical Package for Social Sciences (SPSS 15.0 for Windows, Chicago, IL, USA) with a two-tailed P value ≤0.050 considered to indicate statistical significance.

RESULTS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES

The flow diagram showing the RCT phases is shown in Fig. 1. Assessment of outcomes was based on >80% of randomized patients. All patients receiving the allocated intervention were included in the analysis except one, who was excluded in retrospect owing to a suspicion of bladder cancer invading the prostate on preresection cystoscopy, which was verified on biopsy. Post-treatment withdrawal rates did not differ significantly (9/138: 6.5% vs 2/141: 1.4%, for M-TURP and B-TURP, respectively; P= 0.060; Fig. 1).

image

Figure 1. Flow diagram of the phases of the present RCT (Centre 1: Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands; Centre 2: SLK Kliniken Heilbronn, University of Heidelberg, Heilbronn, Germany; Centre 3: Sismanoglio Hospital, University of Athens Medical School, Athens, Greece; Centre 4: San Luigi Hospital, University of Turin, Orbassano, Turin, Italy). TUIP, transurethral incision of the prostate.

Download figure to PowerPoint

Baseline patient characteristics were comparable between study arms (Table 2). Statistical and/or clinical efficacy was shown for each surgical method with no significant differences between arms (Tables 3,4). No differences were detected in safety or secondary outcomes except that the drop in sodium level was significantly greater after M-TURP (–2.5 vs –0.8 mmol/L; P= 0.003; Table 5). The lowest values were 131 and 106 mmol/L (patient with TUR-syndrome) after B-TURP and M-TURP, respectively. The sodium values in nine patients were 125–130 mmol/L and in three patients the value was <125 mmol/L after M-TURP. Sodium levels decreased by the greatest amount, 9 mmol/L, in two patients after B-TURP. In nine patients in the M-TURP arm the decrease was 9–34 mmol/L. These results were not translated into a significant difference in TURP-syndrome rates (1/138: 0.7% vs 0/141: 0.0%, for M-TURP and B-TURP, respectively; P= 0.495; Table 6), TUR-syndrome being defined as sodium levels <125 mmol/L and one or more circulatory and/or neurological symptoms. Haemoglobin levels decreased significantly in each study arm but, the decrease was similar between arms. Fifty-five complications were recorded in 44 patients (morbidity: 44/279 patients; 15.8%). Two complications in the M-TURP arm were fatal (myocardial infarction) vs no complication in the B-TURP arm (2/138 vs 0/141 patients, P= 0.244; overall mortality was 2/279 patients; 0.7%). The morbidity did not differ significantly between arms (26/138 vs 18/141, for M-TURP and B-TURP, respectively; P= 0.220). Specific complication rates and their grading based on the modified Clavien classification system are shown in Tables 6 and 7. No differences were detected in any specific complication rate or Clavien grade between arms. Three patients presented acute urine retention (AUR) after catheter removal and finally failed to void. Two of them were re-operated for residual adenoma and one was placed permanently on IC. These cases were considered treatment failures rather than complications based on the modified Clavien classification system (Table 7).

Table 2.  Patient distribution and baseline patient characteristics
 M-TURPB-TURPP
  1. *Applicable only in patients not on catheterization before surgery. Data are presented as mean (sd).

Patients randomized149146 
A. Patients analysed (B+C):138141 
 Age, years68.9 (8.7)69.4 (8.4)0.655
 Body mass index, kg/m226.2 (3.1)26.0 (3.1)0.578
 Prostate volume, mL63.2 (30.2)64.0 (29.4)0.765
 PSA, ng/mL5.3 (7.7)5.7 (7.9)0.663
 Creatinine, µmol/L112.9 (96.9)94.7 (31.3)0.042
 Serum sodium, mmol/L139.9 (3.6)140.6 (3.3)0.142
 Haemoglobin, mmol/L8.8 (0.9)8.9 (0.8)0.470
B. Patients on catheterization preoperatively (%):63 (45.7)50 (35.5)0.107
 Age, years70.4 (9.5)72.2 (8.6)0.297
 Body mass index, kg/m226.2 (3.3)25.3 (2.5)0.088
 Prostate volume, mL69.5 (37.2)72.6 (35.7)0.635
 PSA, ng/mL7.2 (10.5)9.0 (11.6)0.411
 Creatinine, µmol/L130.6 (121.6)96.7 (32.0)0.067
C. Patients not on catheterization preoperatively (%):75 (54.3)91 (64.5)0.107
 Age, years67.7 (7.9)67.9 (7.9)0.884
 Body mass index, kg/m226.2 (3.0)26.4 (3.3)0.659
 Prostate volume, mL57.9 (21.6)59.3 (24.3)0.748
 PSA, ng/mL3.8 (3.9)3.9 (4.0)0.882
 Creatinine, µmol/L98.5 (68.5)93.6 (30.9)0.534
 Qmax, mL/s*8.7 (2.3)9.2 (3.3)0.344
 PVR, mL*91.6 (70.4)88.1 (67.9)0.739
 IPSS*23.0 (5.2)23.2 (5.0)0.787
 QoL score*4.2 (1.1)4.3 (1.1)0.491
Table 3.  Efficacy at 6 weeks after surgery in patients on catheterization before surgery
 M-TURPB-TURPP
  1. Data are presented as mean (sd).

Number of patients5449 
Qmax, mL/s20.0 (9.2)16.6 (8.2)0.073
PVR, mL40.4 (39.6)40.1 (70.8)0.998
IPSS10.0 (6.1)9.9 (5.7)0.930
QoL score1.5 (1.3)2.1 (1.6)0.104
Table 4.  Efficacy at 6 weeks after surgery in patients not on catheterization before surgery
Number of patientsM-TURPB-TURPP
7590
  1. Data are presented as mean (sd).

Qmax, mL/s   
 Preoperatively8.7 (2.3)9.2 (3.3)0.526
 Postoperatively19.9 (11.0)19.3 (7.0)
 P<0.001<0.001
PVR, mL   
 Preoperatively91.6 (70.4)88.1 (67.9)0.852
 Postoperatively29.6 (39.6)23.5 (27.2)
 P<0.001<0.001
IPSS   
 Preoperatively23.0 (5.2)23.2 (5.0)0.675
 Postoperatively9.5 (5.1)9.4 (4.4)
 P<0.001<0.001
HRQL score   
 Preoperatively4.2 (1.1)4.3 (1.1)0.886
 Postoperatively1.5 (1.3)1.7 (1.3)
 P<0.001<0.001
Table 5.  Immediate-postoperative serum sodium changes, haemoglobin changes and secondary outcomes
Number of patientsM-TURPB-TURPP
138141
  1. Data are presented as mean (sd).

Serum sodium, mmol/L   
 Preoperatively139.9 (3.6)140.6 (3.3) 
 Postoperatively137.4 (5.4)139.8 (2.6) 
 Change−2.5 (5.3)−0.8 (3.2)0.003
 P<0.0010.002 
Haemoglobin, mmol/L   
 Preoperatively8.8 (0.9)8.9 (0.8) 
 Postoperatively7.9 (1.0)8.1 (0.9) 
 Change−0.9 (0.8)−0.8 (0.7)0.548
 P<0.001<0.001 
Operation time, min50.8 (18.8)52.0 (21.7)0.702
Resection time, min38.9 (16.8)39.7 (19.0)0.822
Resection rate, mL/min0.8 (0.4)0.7 (0.3)0.081
Capsular perforation, n (%)32 (23.2)31 (22.1)0.948
 Minor28290.672
 Severe42
Catheterization time, days3.0 (1.2)3.1 (1.2)0.436
Table 6.  Complications during the perioperative period
Number of patientsM-TURPB-TURPP
138141
  1. *Cerebral microangiopathy decompensation (dementia), ischemic colitis, pulmonary embolism, myocardial infarction (death) (see Table 7). †Based on the modified Clavien classification system the total number of complications is M-TURP: n= 29, B-TURP: n= 26. This is because three cases with AUR were considered failures rather than complications (patients failed to void finally; M-TURP: n= 2, B-TURP: n= 1; see Table 7).

Febrile UTI (%)2 (1.4)1 (0.7)0.620
Clot retention (%)7 (5.1)9 (6.4)0.831
Blood transfusion (%)4 (2.9)9 (6.4)0.273
TUR-syndrome (%)1 (0.7)0 (0.0)0.495
AUR (%)8 (5.8)5 (3.5)0.543
Urethral strictures (%)5 (3.6)2 (1.4)0.279
Other (%)*4 (2.9)1 (0.7)
Total number of complications3127 
Table 7.  Complications during the postoperative period classified according to the modified Clavien system
CentrePatient ID*Number of complicationsGrade(%)ComplicationManagement
M-TURPB-TURPM-TURPB-TURP
Netherlands415, 4412IClot retention (n= 8)Bedside clot evacuation via catheter ± catheter change ± bladder irrigation
Germany4, 376121
Italy72811
Netherlands4911, 4012AUR (n= 10)Bedside recatheterization (spontaneous voiding after catheter trial)
Germany6, 8, 362231
Italy2, 142821
Greece588011Bulbar urethral stricture (n= 2)Dilation
Grade I rate (%) P  11/37.99/26 (34.6)20/55 (36.4)  
0.799
Netherllands44, 5002IIHaematuria (n= 13)Transfusion
Germany35, 50, 7013, 18, 42, 48, 6235
Greece527511
Italy2501
Netherlands7301Febrile UTI (n= 3)Antibiotics
Germany3410
Italy3410
Germany1301Cerebral microangiopathy decompensation (dementia) (n= 1)Pharmacological treatment
Grade II rate (%) P  6/29 (20.7)11/26 (42.3)17/55 (30.9)  
0.083
Netherlands27, 6350, 9222IIIClot retention (n = 8)Endoscopic evacuation ± revision
Germany7042, 6212
Italy2501
Greece2, 28, 32, 737541Bulbar urethral stricture (n = 5)Optical urethrotomy
Germany2510Ischaemic colitis (n = 1)Bowel surgery (colostoma)
Grade III rate (%) P  8/29 (27.6)6/26 (23.1)14/55 (25.5)  
0.702
Germany5010IVTUR-syndrome (n = 1)Admission to ICU
Germany7010Pulmonary embolism (n = 1)Admission to ICU
Grade IV rate (%) P  2/29 (6.9)0/26 (0.0)2/55 (3.6)  
0.492
Netherlands3910VDeath due to myocardial infarction (n = 2) 
Greece5610
Grade V rate (%) P  2/30 (6.7)0/25 (0.0)2/55 (3.6)  
0.495
Grand Total  292655  
   Patients that failed to void   
  1. *The distribution of patients with at least one complication (n= 44) across grades (when highest grade counted) between arms does not differ significantly (P= 0589); †Discovered at 6 weeks postoperatively; ‡Patient withdrawn from the study; ICU = intensive care unit.

Netherlands354511TreatmentAUR (n= 3)Re-operation or permanent IC (failure to void after cathter trial)
Germany4510Failure
Failure rate (%)  2/138 (1.4)1/141 (0.7)3/279 (1.1)  
P  0.620   

DISCUSSION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES

Although B-TURP was introduced several years ago, its true merits over M-TURP remain unclear [18] and the vivid interest of the urological community. The high level of interest in B- and M-TURP is reflected in the number of RCTs that appeared in the literature in just one year [19–25] after the publication of meta-analysis by Mamoulakis et al. [17]. This RCT-based profound meta-analysis, which compared the efficacy and safety of the two techniques [17], was the largest one compared to those previously published [2–5,26] and provided evidence for the first time that no clinically relevant differences exist between the techniques in short-term efficacy and complication rates (AUR after catheter removal, transfusions or urethral strictures) but that B-TURP was preferable owing to a more favourable safety profile defined by clinically relevant differences regarding TUR-syndrome and clot retention rates. In addition, this study [17] pointed out the lack of well designed international/multicentre RCTs and the low methodological quality of the existing trials as assessed by the use of the Dutch Cochrane Collaboration checklist, which is in accordance with Table 8.5.a of the Cochrane Handbook for Systematic Reviews of Interventions [14]. The present study is the first to be based on data derived from an international, multicentre RCT in the field and its methods fulfil the suggested quality criteria [14]. Futher more it is the first reported clinical experience of using the AUTOCON® II 400 ESU. Operators were easily accustomed to the dual-loop tip design of the resectoscope, coagulation was effective and visibility throughout the procedure excellent. Cutting was sharp and effortless, occurring smoothly when the orange glow of activated plasma surrounded the resection loop after a very short initiation delay on tissue contact.

The perioperative efficacy, safety and secondary outcomes in the present study did not differ significantly between arms. Comparable results on efficacy parameters are in accordance with those previously published [17].

The present trial is the first to standardize morbidity using the modified Clavien classification system. No significant differences were detected in safety apart from in postoperative decline in sodium levels. Sodium levels decreased significantly in both arms, as previously reported in a large RCT focusing on dilutional hyponatraemia [22]. Nevertheless, the decline was significantly greater after M-TURP, in line with previously published results [17,22]. In accordance with all individual RCTs these results were not translated into significant differences in TUR-syndrome rates [17,22,24,25]. Nevertheless, they show that while B-TURP may not prevent fluid absorption, it eliminates the risk of dilutional hyponatraemia, which is significantly increased with M-TURP [17]. Therefore, bipolar technology fulfils the expectation to provide more time for larger resection, coagulation and training without compromising safety. Although the clinical significance of this protective effect might not be considered such an important issue in experienced hands, B-TURP might be preferable, especially in less experienced settings.

A major M-TURP complication is bleeding, which is clinically relevant mainly if it results in clot retention, transfusion or reoperation. The haemostatic capacity of the bipolar current has been reported to be superior in ex vivo studies, possibly because of deeper coagulation depths and the ‘cut-and-seal’ effect [10]. The present RCT failed to show differences in bleeding tendency between arms. Haemoglobin levels decreased similarly and clot retention or transfusion rates did not differ significantly. These data are in accordance with the general clinical impression [18] and most individual RCT results on haemoglobin decline [17,22], clot retention [17,21] or transfusion rates [17,20,21,24]. Nevertheless, there are still contrary reports on haemoglobin decline [20,23,24], clot retention [27] and transfusion rate [23], favouring B-TURP. In addition, a previously general pooled and subgroup analysis (using the plasmaKinetic device) of RCT results on clot retention and transfusion rates showed a significant difference favouring B-TURP[17].

Catheterization duration has been reported to be significantly shorter for B-TURP, in a pooled, sensitivity analysis of double-blind RCTs [17]. This result was not verified in the present RCT. Consistent with all previous RCTs [17,19–21,24], no significant differences were detected in any other complications, such as AUR after catheter removal and urethral strictures. Thus, as previously noted [17], the serious concerns raised about bipolar technology regarding urethral strictures [28,29] are not justified. Nevertheless, accrual of increased numbers of patients and/or longer follow-up, which is still limited [19,20,30] might change these results [17]. The short follow-up period is a potential limitation of the present study, however, our aim was to focus mainly on the perioperative results, for which a longer follow-up period is redundant.

In conclusion, the present study provides a valuable addition to the international literature in that it is based on several trial characteristics that were not included in previously published RCTs in the field. These may be summarized as follows: a) it is the first international, multicentre RCT; b) its methodology fulfils the suggested quality criteria; c) it presents data on the first clinical experience with a relatively new bipolar device; d) it attempts to standardize perioperative morbidity using the modified Clavien classification system.

In contrast to the previous available evidence, the present trial shared no clinical advantage for B-TURP. Perioperative efficacy, safety and secondary outcomes were shown to be comparable in both surgical techniques, while the potentially improved safety of B-TURP that is attributable to the elimination of dilutional hyponatraemia risk, which is still present with M-TURP, did not translate into a significant clinical benefit in experienced hands.

ACKNOWLEDGEMENTS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES

We acknowledge the support of Karl Storz Endoscope, Tuttlingen, Germany in providing all the equipment used in this trial. We would like to thank Mrs S.A. Lagerveld-Zaaijer and Mrs A.D. Bakker, trial nurses at the Trial Centre of Urology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands for administrative and technical support.

REFERENCES

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES
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