Transurethral Plasmakinetics Anatomical Enucleation Of The Prostate Compared With Transurethral Plasmakinetics Resection Of The Prostate For Benign Prostatic Hyperplasia:a Randomized Controlled Trial

BackgroundBenign prostatic hyperplasia(BPH)is one of the most common cause for lower urinary tract symptoms in elderly males,which is clinically progressive,and its morbidity and symptoms increase with the progression of age.About 50%males over 50 years old may develop,from moderate to severe,lower urinary tract symptoms,and about 25%of those eventually need to receive surgical treatments.As a classic minimally invasive surgery,transurethral resection of the prostate(TURP)has taken the place of traditional open siirgery since the 1930s,and has been written into the guidelines of CUA,AUA and EUA,which still represents the"golden standard"in the treatment of benign prostatic hyperplasia.However,researchers have found some defects of TURP as follows:1· Incomplete glandular resection results in the residual of glandular tissue(50%),which can potentially lead to a high retreatment rate at about 17%when 5-8 years after surgery,compared with a rate at 6%of open surgery.2.Its inability to effectively control intraoperative glandular bleeding,and the long operation time may cause the excessive blood volume,massive bleeding and other perioperative complications.3.Being not applicable for large volume prostate over 80ml.Transurethral plasmakinetics anatomical enucleation of the prostate use plasmakinetics as its energy carrier,it compares the outer sheath to the finger in open surgery,TUKEP enucleates the hyperplastic glandular tissue from the surgical capsule integrally by means of retrograde bunt dissection.It solves the defects that high residual rate of adenoma and high secondary surgery rate in TURP.However,its long-term safety,efficacy,and durability in comparison with the gold-standard TURP have not yet been reported,and it is still controversial for the postoperative complications such as incontinence.Therefore,a larger sample,multi-centered,prospective randomized controlled clinical trial is urgently needed.ObjectiveThis study use the bipolar transurethral plasmakinetic prostatectomy(TUPKP)for comparison,by means of randomized controlled clinical trial,to evaluate the effectiveness,safety and efficacy of TUKEP in the treatment of benign prostatic hyperplasia.We wish to provide high-level evidence-based medical evidence to rewrite or consummate the guidelines of surgical treatment of BPH,and further promote the method around the world.Design,setting,and participants:This is a multi-center,randomized,open Label,clinical trial with parallel assignment and equivalence validation designs,and was approved by the institutional ethics committee of Zhujiang Hospital of Southern Medical University.Both the surgeons and the patients were aware of the treatments.The control group was TUPKP while the experimental group was TUKEP,a total of 73 participants with bladder outflow obstruction(BOO)secondary to BPH was allocated equally into either group underwent the central randomization system of Southern Medical University,with a total follow-up period for 4 years.All patients were evaluated preoperatively,perioperatively,and followed at followed at 1,3,6,12,24,36 and 48 months postoperatively,to compare the baseline characteristics,perioperative data,and postoperative outcomes.ResultA total of 69 patients was enrolled randomly from October 2017 to February 201933 cases underwent transurethral plasmakinetics resection of the prostate(TUPKP group)and 36 cases underwent transurethral plasmakinetics enucleation of the prostate(TUKEP group).There was no statistical difference in the preoperative observation indexes between the two groups,and the postoperative urination of patients in the two groups was improved.Compared with TUPKP,TUKEP has higher tissue excision weight,shorter total operation time,less intraoperative blood loss and faster postoperative recovery.There was no significant difference in the incidence of complications between the two groups,but the TUKEP group has lower complication severity than the TUPKP group.There was no significant difference between TUKEP and TUPKP in IPSS score,QoL score and Qmax at 1 month and 3 months after surgery,but the Qmax in TUKEP group was better than that in TUPKP group 1 year after surgery.ConclusionTUKEP is a safe and effective surgical method for the treatment of BPH,which has the advantages of less intraoperative bleeding and fewer complications.The treatment of large prostate may be a unique advantage of TUKEP.The short-term effects and complications were similar to those of TUPKP.TUKEP showed superior efficacy in the 1-year mid-term follow-up,but the medium-and long-term efficacy still needs to be further studied.TUKEP is a minimally invasive treatment in line with the current national conditions of developing countries in China.It has broad application prospects and may replace TURP as the gold standard in the future.