Plasmakinetic enucleation of the prostate compared with open prostatectomy for prostates larger than 100 grams: A randomized noninferiority controlled trial with long-term results at 6 years

Background Studies have demonstrated that plasmakinetic enucleation of the prostate (PKEP) and open prostatectomy (OP) have equivalent short-term efficacy for large prostates, but no comparison concerning their long-term results was reported. Objective To demonstrate the noninferiority of PKEP to OP concerning maximum urinary flow rate (Q_max) at 1 yr postoperatively and to compare the long-term results of both procedures. Design, setting, and participants From 2004 to 2007, 160 patients with prostates >100 g were randomized to receive PKEP or OP. A total of 153 patients (95.6%) completed the noninferiority study, and 123 patients (76.9%) finished a 6-yr follow-up assessment. Intervention The PKEP procedures were performed with 27F Karl Storz continuous flow resectoscopy and the Gyrus PlasmaKinetic device. OP was performed by a suprapubic transvesical approach. Outcome measurements and statistical analysis The primary end point was Q_max at 1 yr postoperatively. Secondary end points included other perioperative parameters and postoperative micturition variables. The student t test, Mann-Whitney U test, chi-square test, or Fisher exact probability test was used as appropriate. Results and limitations PKEP was noninferior to OP regarding Q_max at 1 yr postoperatively. Compared with OP, PKEP was associated with less perioperative hemoglobin decrease, shorter catheterization time, and shorter postoperative hospital stay (1.0 vs 3.2 g/dl, 40 vs 148 h, and 3 vs 8 d, respectively; p < 0.001 for all), as well as fewer short-term complications (22.5% vs 42.5%, p = 0.031). On intention-to-treat analysis, both the PKEP and OP groups had equivalent Q_max (25.2 ± 7.0 ml/s vs 25.7 ± 7.6 ml/s, respectively; p = 0.688), International Prostate Symptom Score (3.5 [2-5] vs 3 [2-5], respectively p = 0.755), quality of life (2 [1-3] vs 2 [1-3], respectively; p = 0.950), and postvoid residual urine (20 [9-33.5] vs 16.5 [7-31] ml, respectively; p = 0.469) at 72 mo postoperatively. No patients required reoperation because of recurrence of BPH. The relatively small sample size is the limitation. Conclusions PKEP is a durable procedure with short- to long-term micturition improvement equivalent to OP and significantly lower perioperative morbidity. Patient summary We compared PKEP with OP for large prostates and found that PKEP is less invasive, with short- to long-term micturition improvement equivalent to OP. Trial registration Plasmakinetic Enucleation of the Prostate and Open Prostatectomy to Treat Large Prostates. ClinicalTrials.gov identifier NCT01952912. http://www.clinicaltrials.gov/ct2/ show/NCT01952912?term=NCT016301952912&rank=1.