title: 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.
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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  RESULTS
  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.
  
  
  BACKGROUND
  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.
authors: Department of Urology, Fuzhou General Hospital, Xiamen University, Fujian Medical University, Fuzhou, Fujian, China.
authors: Shushang
authors: S
authors: Chen
authors: Department of Urology, Fuzhou General Hospital, Xiamen University, Fujian Medical University, Fuzhou, Fujian, China.
authors: Lingfeng
authors: L
authors: Zhu
authors: Department of Urology, Fuzhou General Hospital, Xiamen University, Fujian Medical University, Fuzhou, Fujian, China.
authors: Jinquan
authors: J
authors: Cai
authors: Department of Oncology, The Second Affiliated Hospital of Fujian Medical University, Quanzhou, Fujian, China.
authors: Zhengrong
authors: Z
authors: Zheng
authors: Department of Gynecology and Obstetrics, Fujian Provincial Hospital, Fuzhou, Fujian, China.
authors: Rong
authors: R
authors: Ge
authors: Department of Health Statistics, Second Military Medical University, Shanghai, China.
authors: Meijing
authors: M
authors: Wu
authors: Department of Urology, Fuzhou General Hospital, Xiamen University, Fujian Medical University, Fuzhou, Fujian, China.
authors: Zhen
authors: Z
authors: Deng
authors: Department of Urology, Fuzhou General Hospital, Xiamen University, Fujian Medical University, Fuzhou, Fujian, China; Department of Urology, People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine (The People's Hospital of Fujian Province), Fuzhou, Fujian, China.
authors: Hao
authors: H
authors: Zhou
authors: Department of Urology, Fuzhou General Hospital, Xiamen University, Fujian Medical University, Fuzhou, Fujian, China.
authors: Shunliang
authors: S
authors: Yang
authors: Department of Urology, Fuzhou General Hospital, Xiamen University, Fujian Medical University, Fuzhou, Fujian, China.
authors: Weizhen
authors: W
authors: Wu
authors: Academy of Integrative Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian, China.
authors: Lianming
authors: L
authors: Liao
authors: Department of Urology, Fuzhou General Hospital, Xiamen University, Fujian Medical University, Fuzhou, Fujian, China. Electronic address: doctortjm@yahoo.com.
authors: Jianming
authors: J
authors: Tan
mesh_terms: D000368:Aged; D005500:Follow-Up Studies; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D057194:Intention to Treat Analysis; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D009929:Organ Size; D011446:Prospective Studies; D011467:Prostate / Q000473:pathology*; D011468:Prostatectomy / Q000009:adverse effects; D011470:Prostatic Hyperplasia / Q000473:pathology* / Q000601:surgery*; D011788:Quality of Life; D013997:Time Factors; D014546:Urinary Catheterization; D014554:Urination / Q000502:physiology*; D014563:Urodynamics
chemical_list: D006454:Hemoglobins
keywords: Benign prostatic hyperplasia; Open prostatectomy; Plasmakinetic enucleation of the prostate