Shushang Chen1, Lingfeng Zhu1, Jinquan Cai1, Zhengrong Zheng2, Rong Ge3, Meijing Wu4, Zhen Deng1, Hao Zhou5, Shunliang Yang1, Weizhen Wu1, Lianming Liao6, Jianming Tan7. 1. Department of Urology, Fuzhou General Hospital, Xiamen University, Fujian Medical University, Fuzhou, Fujian, China. 2. Department of Oncology, The Second Affiliated Hospital of Fujian Medical University, Quanzhou, Fujian, China. 3. Department of Gynecology and Obstetrics, Fujian Provincial Hospital, Fuzhou, Fujian, China. 4. Department of Health Statistics, Second Military Medical University, Shanghai, China. 5. 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. 6. Academy of Integrative Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian, China. 7. Department of Urology, Fuzhou General Hospital, Xiamen University, Fujian Medical University, Fuzhou, Fujian, China. Electronic address: doctortjm@yahoo.com.
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 >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.
RCT Entities:
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.
Authors: Ahmed M Elshal; Ramy Mekkawy; Mahmoud Laymon; Ahmed El-Assmy; Ahmed R El-Nahas Journal: Can Urol Assoc J Date: 2015-09-09 Impact factor: 1.862
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