Bipolar plasma enucleation of the prostate vs open prostatectomy in large benign prostatic hyperplasia cases - a medium term, prospective, randomized comparison.

UNLABELLED: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: According to the EAU Guidelines 2012, large size benign prostatic hyperplasia (BPH) cases (>80 mL) continue to have open prostatectomy as the first line treatment alternative, despite the substantial peri-operative morbidity and extended catheterization and convalescence periods related to this undoubtedly invasive approach. During the past two decades, holmium laser enucleation of the prostate was constantly described as a successful choice for this category of patients. According to rather numerous studies, the technique displayed superior results in terms of surgical safety and postoperative recovery compared with the open procedure. On the other hand, the concept of electrosurgical enucleation of the prostate, using either a monopolar or bipolar cutting current, materialized into several technical applications that eventually failed to gain general acknowledgement as reliable alternatives to the BPH transurethral approach. While keeping in mind the already proved advantage of enucleating substantial quantities of BPH tissue, bipolar plasma enucleation of the prostate was introduced as a novel endoscopic approach in cases of large prostates. The present trial represents the first prospective, medium-term, randomized comparison to be published of this innovative technique with standard open prostatectomy. Basically, the premises for a viable alternative relied on the practical advantages provided by the 'button' electrode, mainly the large surface creating the conditions for a fast enucleation process, continuous vaporization and concomitant haemostasis. Eventually, it was concluded that the plasma enucleation procedure distinguished itself as a successful treatment option in large BPH patients, characterized by good surgical efficiency, significantly reduced complications, faster postoperative recovery, similar prostatic tissue ablation capabilities and satisfactory follow-up results compared with the open technique. Most importantly, plasma-button enucleation patients benefited from a similar 12 months' outcome from the perspectives of symptom scores and voiding parameters when drawing a parallel with open surgery results, thus underlining the reliable viability of this type of endoscopic approach.
OBJECTIVES: To evaluate the viability of bipolar plasma enucleation of the prostate (BPEP) by comparison with open transvesical prostatectomy (OP) in cases of large prostates with regard to surgical efficacy and peri-operative morbidity. To compare the medium-term follow-up parameters specific for the two methods. PATIENTS AND METHODS: A total of 140 benign prostatic hyperplasia (BPH) patients with prostate volume >80 mL, maximum flow rate (Qmax ) <10 mL/s and International Prostate Symptom Score (IPSS) >19 were randomized in the two study arms. All cases were assessed preoperatively and at 1, 3, 6 and 12 months after surgery by IPSS, Qmax , quality of life score (QoL) and post-voiding residual urinary volume (PVR). The prostate volume and prostate specific antigen (PSA) level were measured at 6 and 12 months.
RESULTS: The BPEP and OP techniques emphasized similar mean operating durations (91.4 vs 87.5 min) and resected tissue weights (108.3 vs 115.4 g). The postoperative haematuria rate (2.9% vs 12.9%) as well as the mean haemoglobin drop (1.7 vs 3.1 g/dL), catheterization period (1.5 vs 5.8 days) and hospital stay (2.1 vs 6.9 days) were significantly improved for BPEP. Recatheterization for acute urinary retention was more frequent in the OP group (8.6% vs 1.4%), while the rates of early irritative symptoms were similar for BPEP and OP (11.4% vs 7.1%). During the follow-up period, no statistically significant difference was determined in terms of IPSS, Qmax , QoL, PVR, PSA level and postoperative prostate volume between the two series.
CONCLUSIONS: BPEP represents a promising endoscopic approach in large BPH cases, characterized by good surgical efficiency and similar BPH tissue removal capabilities compared with standard transvesical prostatectomy. BPEP patients benefited from significantly reduced complications, shorter convalescence and satisfactory follow-up symptom scores and voiding parameters.

RCT Entities:   Population Interventions Outcomes