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
Article first published online: 9 MAY 2011
© 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL
Volume 109, Issue 2, pages 240–248, January 2012
How to Cite
Mamoulakis, C., Skolarikos, A., Schulze, M., Scoffone, C. M., Rassweiler, J. J., Alivizatos, G., Scarpa, R. M. and de la Rosette, J. J.M.C.H. (2012), 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. BJU International, 109: 240–248. doi: 10.1111/j.1464-410X.2011.10222.x
- Issue published online: 23 DEC 2011
- Article first published online: 9 MAY 2011
- Accepted for publication 20 January 2011
- benign prostatic hyperplasia;
- randomized controlled trial;
- transurethral resection of prostate;
- treatment outcome
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.
• 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.
• 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).
• 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.