Results from an international multicentre double‐blind randomized controlled trial on the perioperative efficacy and safety of bipolar vs monopolar transurethral resection of the prostate

Abstract

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.

Bipolar versus Monopolar Transurethral Resection of Prostate (TURP), Advantages and Disadvantages in 6-Month Follow-Up

“…In our study, the rate of urethral stricture was not clearly different in two groups as like as the result of Mamoulakis et al study (14). A significant correlation between erectile dysfunction and the LUTS was found in many recent studies (11,15).…”

In-Hospital Outcomes and Cost Assessment Between Bipolar Versus Monopolar Transurethral Resection of the Prostate

“…4,6 In addition, Mamoulakis and associates 15 performed a subgroup analysis focused on a bipolar device, the PlasmaKinetic system, and detected an improved safety benefit regarding transfusion. One 16 of six RCTs regarding the TURis system [16][17][18][19][20][21] and no trials regarding the Vista system 22 or AUTOCON II 400 system 23 showed significant differences for transfusion. As theoretical support, some ex vivo experiments have shown that a bipolar current has the nature of deep coagulation and a ''cut-and-seal'' property.…”

Bipolar Transurethral Resection Versus Monopolar Transurethral Resection for Benign Prostatic Hypertrophy: A Systematic Review and Meta-Analysis

“…The combined search strategies identified 31 trials [9][10][11][12][13][14][15][16][17][18][19][20][21][22][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40] that included 3,669 patients who met the inclusion criteria. All the studies were RCTs, and almost all were reported in English, except for one in Korean 32 and one in Chinese.…”

“…The technique has revealed promising results. 6,7 A meta-analysis published in 2009 reported no clinically relevant differences in short-term efficacy between the two techniques, although B-TURP was preferred because of its more favorable safety profile (lower TUR syndrome and clot retention rates) and shorter duration of irrigation and catheterization. However, the meta-analysis also indicated a lack of well-designed, multicenter, and international randomized, controlled trials (RCTs) with long-term follow-up and cost analysis of the B-TURP technique.…”

“…8 In recent years (2009-2013), a number of new RCTs, including multicenter and international studies, have been published. [9][10][11][12][13][14][15][16][17][18][19][20][21][22] Therefore, it is necessary to conduct a new systematic review and metaanalysis of RCTs that assesses the efficacy and safety (primary outcomes) of M-TURP and B-TURP in patients with BPO.…”