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 (Qmax) 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 >100g 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 Qmax 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 Qmax 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 3.2g/dl, 40 vs 148h, 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 Qmax (25.2±7.0ml/s vs 25.7±7.6ml/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.