Elsevier

European Urology

Volume 66, Issue 2, August 2014, Pages 284-291
European Urology

Platinum Priority – Benign Prostatic Hyperplasia
Editorial by Malte Rieken and Christian Gratzke on pp. 292–293 of this issue
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

https://doi.org/10.1016/j.eururo.2014.01.010Get rights and content

Abstract

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 >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 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 3.2 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 Qmax (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.

Introduction

Transurethral resection of the prostate (TURP) remains the standard surgical therapy for lower urinary tract symptoms secondary to bladder outlet obstruction (BOO) due to benign prostatic hyperplasia (BPH) with prostate sizes of 30–80 g [1]. In cases with large prostate adenomas (>80 g), the resection time required by TURP is associated with increased risk of transurethral resection syndrome, blood loss, and other complications [1], [2]. Open prostatectomy (OP) is therefore still considered a valid option for patients with prostates >100 g [1], [3].

Despite the low failure rate and reoperation rate, OP is an invasive procedure, associated with more intraoperative bleeding, longer catheterization time, and longer hospital stay [4]. The high incidence of perioperative morbidity of OP has prompted urologists to find less invasive treatment options that can reproduce the same functional results. Several studies have demonstrated that holmium laser enucleation of the prostate (HoLEP) is a highly effective treatment for large prostates, with efficacy equivalent to that of OP and significantly lower perioperative morbidity; HoLEP is considered an alternative to OP. The long learning curve and initial cost of holmium laser equipment are the main limitations of HoLEP.

Plasmakinetic enucleation of the prostate (PKEP) has been developed to treat BOO due to BPH [5], [6], [7], [8], [9]. By dissecting along the surgical capsule using the tip and loop of the resectoscope in the same way a surgeon's finger does during OP, this technique enables anatomic enucleation of the entire lobes of the prostate. PKEP has been acknowledged to be a safe and technically feasible procedure for managing prostatic adenomas of any size with few complications, requiring no additional devices. It was not until recently that two randomized controlled trials (RCTs) compared plasmakinetic (or plasma) enucleation with standard OP [10], [11]. Both studies demonstrated that plasmakinetic (or plasma) enucleation and OP had equivalent short- to medium-term efficacy.

Since the proven durability is one of the main advantages of OP, a comparison of PKEP and OP in terms of long-term outcomes is of great significance. Nevertheless, there has been no RCT comparing PKEP with OP with a follow-up >1 yr [10], [11]. In the present study, we compared the efficacy, safety, and morbidity of PKEP with those of OP in patients with prostate glands >100 g. Our first objective was to demonstrate the noninferiority of PKEP compared with OP concerning the voiding parameter at 1 yr postoperatively. More important, the long-term results over a follow-up period of 6 yr for both procedures were compared. We hypothesized that PKEP might yield functional results comparable with OP but with lower perioperative morbidity.

Section snippets

Patients

This single-center, prospective, randomized, open-label study was approved by the institutional ethics committee. Consecutive patients with large-volume BPH were assessed by Zhu for eligibility and assigned to undergo PKEP or OP with computer-generated numbers after the written informed consents were obtained. The randomized treatment assignments were sealed in opaque envelopes and were opened individually for each patient. Inclusion criteria were age between 50 and 70 yr, urodynamic

Patient characteristics

From January 2004 to June 2007, 241 patients were assessed for eligibility, and 160 eligible patients were randomly assigned in equal numbers to either PKEP or OP. One patient in the PKEP group had prostate cancer on postoperative pathologic examination and was excluded. A total of 153 patients completed the noninferiority study at the postoperative 1-yr point. The reasons for exclusion from final analysis in the other six patients were urethral stricture, receiving surgery for rectal cancer,

Discussion

Our study showed the noninferiority of PKEP to OP in regard to Qmax at the postoperative 1-yr point. PKEP was associated with fewer perioperative complications and shorter hospital stay. The 6-yr follow-up showed that both procedures had equivalent micturition improvement, PSA decrease, and long-term complications. The relatively small sample size and the single-center setting are the limitations.

OP is still considered as an option for patients with prostates >100 g [4]. OP has been demonstrated

Conclusions

This RCT confirms that PKEP is a durable procedure with equivalent short- to long-term micturition improvement compared with OP. In addition, PKEP is associated with significantly lower perioperative morbidity. Thus, PKEP seems to be a safe and highly effective technique for the treatment of large prostates.

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