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

• Published in: BJU international Vol. 109; no. 2; pp. 240 - 248
• Main Authors: Mamoulakis, Charalampos, Skolarikos, Andreas, Schulze, Michael, Scoffone, Cesare M., Rassweiler, Jens J., Alivizatos, Gerasimos, Scarpa, Roberto M., de la Rosette, Jean J.M.C.H.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.01.2012; Wiley-Blackwell; Wiley Subscription Services, Inc
• Subjects: Aged; benign prostatic hyperplasia; Biological and medical sciences; Double-Blind Method; electrosurgery; Gynecology. Andrology. Obstetrics; Humans; Hyponatremia - etiology; Male; Male genital diseases; Medical sciences; Nephrology. Urinary tract diseases; Postoperative Complications - etiology; Prospective Studies; Prostate - surgery; Prostatic Hyperplasia - surgery; randomized controlled trial; transurethral resection of prostate; Transurethral Resection of Prostate - adverse effects; Transurethral Resection of Prostate - methods; Treatment Outcome; Tumors; Tumors of the urinary system; Urinary tract. Prostate gland; Nephrology; Urinary system disease; Prognosis; Prostate disease; Toxicity; Treatment efficiency; Surgical resection; Electrosurgery; Transurethral route; Randomized controlled trial; treatment outcome; Urology; Perioperative; Treatment; transurethral resection of prostate; Surgery; Benign prostatic hyperplasia; Surgical approach; Benign neoplasm; Urogenital system; Male genital diseases; Prostate; Comparative study; International
• ISSN: 1464-4096; 1464-410X; 1464-410X
• DOI: 10.1111/j.1464-410X.2011.10222.x

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.