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

• Published in: European urology Vol. 66; no. 2; pp. 284 - 291
• Main Authors: Chen, Shushang, Zhu, Lingfeng, Cai, Jinquan, Zheng, Zhengrong, Ge, Rong, Wu, Meijing, Deng, Zhen, Zhou, Hao, Yang, Shunliang, Wu, Weizhen, Liao, Lianming, Tan, Jianming
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier B.V 01-08-2014; Elsevier
• Subjects: Aged; Benign prostatic hyperplasia; Biological and medical sciences; Follow-Up Studies; Gynecology. Andrology. Obstetrics; Hemoglobins - metabolism; Humans; Intention to Treat Analysis; Length of Stay; Male; Male genital diseases; Medical sciences; Middle Aged; Nephrology. Urinary tract diseases; Open prostatectomy; Operative Time; Organ Size; Plasmakinetic enucleation of the prostate; Prospective Studies; Prostate - pathology; Prostatectomy - adverse effects; Prostatic Hyperplasia - pathology; Prostatic Hyperplasia - surgery; Quality of Life; Time Factors; Tumors; Tumors of the urinary system; Urinary Catheterization; Urinary tract. Prostate gland; Urination - physiology; Urodynamics; Urology; Benign prostatic hyperplasia; Plasmakinetic enucleation of the prostate; Open prostatectomy; Nephrology; Urinary system disease; Prostate disease; Long term; Randomized controlled trial; Urology; Enucleation; Treatment; Surgery; Prostatectomy; Benign neoplasm; Urogenital system; Male genital diseases; Prostate; Comparative study
• ISSN: 0302-2838; 1873-7560
• DOI: 10.1016/j.eururo.2014.01.010

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.