The investigators hypothesize that Plasmakinetic Enucleation of the Prostate (PkEP) might yield functional results comparable to OP but with lower perioperative morbidity, and have equivalent long-term efficacy with OP for large prostates. The first objective was to demonstrate the non-inferiority of PKEP compared to OP concerning Qmax at one year postoperatively. To explore the long-term efficacy, we compared the efficacy, safety, and morbidity of PkEP with those of OP in BPH patients with prostate glands larger than 100 g over a follow-up period of 6 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Fuzhou General Hospital
Fuzhou, Fujian, China
Qmax at one year postoperatively
Time frame: 1 year postoperatively
Qmax at other time points after surgery
Time frame: 1, 3, 6, 24, 36, 48, 60 and 72 months postoperatively
resected adenoma weight
Time frame: right after the operation
operation time
Time frame: during the operation
blood loss
Time frame: perioperatively and on the first postoperative day
postoperative International Prostate Symptom Score
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively
duration of catheterization
Time frame: after the operation
length of postoperative hospital stay
Time frame: after the operation
QOL
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively
PVR
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively
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