经尿道双极等离子前列腺剜除术与经尿道双极等离子前列腺电切术治疗前列腺增生症的随机对照研究
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摘要
背景
良性前列腺增生症(benign prostatic hyperplasia, BPH)是引起中老年男性排尿障碍最为常见的一种良性疾病,其主要表现为组织学上的前列腺间质和腺体成分的增生、解剖学上的前列腺增大(benign prostatic enlargement, BPE)、尿动力学上的膀胱出口梗阻(bladder outlet obstruction, BOO)和以下尿路症状(lower urinary tract symptom, LUTS)为主的临床症状。BPH具有临床进展性,其发病率随患者年龄增长而增加,相应的,症状亦随年龄的增加而进行性加重。BPH患者疾病进展的最终表现形式是接受外科手术治疗。
随着人类社会经济、科技的不断发展,人类寿命得到较大延长,老年人比例不断增加,人口老龄化将加快到来。尤其在中国,人口老龄化已日趋严峻,截止2013年底,中国老年人口数量已突破2亿人,老龄化水平达到14.8%,远高于国际社会老龄化标准。且未来40年,中国人口老龄化将逐步达到峰值,中国将成为全球老年人口最多的国家,占全球老年人口总量的五分之一,也将是世界上人口老龄化发展速度最快的国家之一。目前我国男性的人均预期寿命延长到72岁,随着我国社会经济和科技的不断发展,今后我国男性的人均预期寿命将进一步得到延长。在未来的数十年内,人口老龄化的加速及男性预期寿命的延长,将会产生更庞大的BPH患者人群,加之人口寿命的延长相应延长了临床治疗的时间,将会产生更加高昂的医疗费用,并占用更多的医疗资源。这使得我国泌尿外科临床工作、医疗卫生事业发展乃至全社会的发展面临一个亟待解决的严峻课题。
目前,手术治疗BPH的“金标准”仍然是经尿道前列腺电切术(TURP)。其具有创伤小、出血少、恢复快、痛苦少、疗效确切,住院时间短等一系列优势,在临床广泛被使用。但其也有不适用于较大体积前列腺(80m1)、切除不彻底、术后残留腺体组织较多(50%)、手术并发症发生率较高等缺点。另外,由于开放手术能够沿着外科包膜彻底摘除前列腺增生组织,远期复发率仅为6%左右,而TURP则必定会有增生的前列腺组织残留,远期复发率达16%～17%(5～8年)。所以泌尿外科医生做了大量的临床研究和探索,希望发明一种同时兼有两者优势,而又消除两者缺点的创伤更小,疗效更好,安全性更高的方法。
经尿道前列腺剜除术(TUERP)是我国学者融合了开放前列腺摘除术与TURP两者的技术优点而独创的手术方式。它从解剖学角度出发,找到增生腺体和外科包膜之间的层面,并沿此包膜平面完整球面剥离增生腺体,然后再切除腺体组织。该术式既具有微创腔内手术创伤小、恢复快的特点,又能达到开放手术的彻底性、不复发的效果,而且安全性高,是BPH手术治疗上革命性的突破。多项研究证实经尿道剜除术安全、有效、可行、术后并发症少,是理想的前列腺增生症的手术治疗方法。
经尿道微创手术治疗前列腺增生症的安全性及有效性会受到手术设备仪器的限制。与传统单极电切系统相比较,双极等离子电切系统不需要专门的负极板,具有以下特点：低温切割、组织热损伤小；采用生理盐水作为冲洗液,极少发生电切综合症(TURS);止血高效、可靠,术中及术后出血少；独特的“被膜保护”作用使包膜穿孔发生率下降；无负极回路板,防止电击和灼伤。双极等离子体电切系统突破了单极电切手术系统的局限性,是经尿道微创手术治疗前列腺增生症的又一大进步。
将等双极离子体的优越性能作为经尿道前列腺剜除术(Transurethral enucleation and resection of the prostate, TUERP)的能量载体,即产生了经尿道双极等离子前列腺腔内剜除术(Transurethral plasmakinetic enucleation of the prostate, TPKEP)。有临床研究显示,经尿道双极等离子前列腺腔内剜除术治疗BPH安全、可行,与经尿道等离子双极电切术(Transurethral plasmakinetic resection of the prostate, TPKRP)相比较,疗效相似,但TPKEP术中切除增生腺体更彻底,手术时间却较短,出血较少,安全性更高。已有学者提出TURP不应该再是手术治疗前列腺增生症的金标准,“经尿道前列腺剜除术(TUERP)"才是未来BPH腔内微创治疗的趋势,不远的未来有可能替代TURP成为BPH外科治疗新的“金标准”。然而也有循证医学meta分析认为,这些临床证据级别较低,仅为谨慎推荐使用。并且目前对于TPKEP术后尿失禁等后术后并发症情况仍存在较多争议,限制了经尿道双极等离子前列腺剜除术的临床推广应用。
目的
本研究通过与经尿道双极等离子体前列腺电切术的对比,评价经尿道双极等离子体前列腺剜除术治疗良性前列腺增生症的安全性、有效性及可行性,为经尿道双极等离子体前列腺剜除术的进一步临床推广应用提供科学依据。
方法
本研究采用随机对照、单盲、单中心、平行组设计,分段均衡随机化分组,以经尿道双极等离子前列腺电切术组为对照组,以经尿道双极等离子前列腺剜除术组为实验组,对比分析两组术前、围手术期及术后随访的观察指标数据。
2012年08月至2013年08月期间,共计136例符合纳入标准的BPH患者被纳入本研究。将这136例病例分段均衡随机化分组,其中68例行经尿道双极等离子前列腺电切术,另外68例行经尿道双极等离子前列腺剜除术。术者均为我院泌尿外科副高以上职称的专家教授,年资及手术例数接近,手术熟练程度接近,均具有丰富的TURP操作经验并熟练掌握“经尿道前列腺剜除术”,本研究开始前,均统一培训并达成手术操作步骤基本共识,以尽量减少因操作者因素所造成的差异。
两组患者术前均测血清前列腺特异性抗原(PSA),以经直肠B超测定前列腺体积(PV),尿动力学检查测定最大尿流率(Qmax)、残余尿量(PVR),问卷调查国际前列腺症状评分(IPSS)、生活质量评分(QOL),血钠离子浓度(Na+)和血红蛋白浓度(Hb),手术开始前和结束后分别测中心静脉压(CVP)。术中详细记录手术时间、术中并发症发生情况、获取标本的重量。另外,术中还记录冲洗液总量并留取样本化验其血红蛋白含量用以计算术中出血量。术后使用国际尿失禁协会(ICS)推荐的1h尿垫试验(pad testing)对术后尿失禁进行判断。于术后拔除导尿管后第24h、术后每周分别行尿垫试验,并记录数据,四周后仍有尿失禁者每月随访观察,直至恢复。于术后第3、6个月时间点随访并记录Qmax.PVR.IPSS.QOL等随访指标数据。
本研究需要收集的研究指标数据包括：术前PSA.PV.Qmax.PVR.IPSS. QOL.Na+、Hb.CVP;术中手术时间、出血量、获取标本的重量及术中并发症发生情况(包膜穿孔、经尿道电切综合征、膀胱损伤、直肠损伤等)；术后膀胱冲洗时间、留置导尿时间、术后住院时间及术后并发症情况(继发性出血、短期尿失禁、膀胱颈挛缩、尿道狭窄、尿道膀胱刺激征、拔除尿管后尿潴留)。术后拔除导尿管后24小时、术后第1、2、4周的尿垫试验结果,术后分别第3、6个月时间点随访指标Qmax.PVR.IPSS.QOL.将这些数据进行统计学分析,对两组手术的术安全性、有效性进行比较分析。
结果
1、剜除组与电切组两组术前一般情况比较：年龄(71.68±6.94岁VS71.76±7.04岁).PV(68.31±22.29ml VS66.99±18.76ml).IPSS(23.51±2.79分VS23.15±3.36分)、QOL(4.50±0.70分VS4.68±0.70分)、PVR(59.82±24.56ml VS62.21±24.96ml).Qmax(6.04±2.08ml/s VS6.32±1.71ml/s). PSA(3.39±0.95ng/ml VS3.35±1.20ng/ml).Na+(141.64±1.78mmol/L VS141.86±1.62mmol/L).Hb(136.04±8.28g/L VS139.18±14.48g/L).CVP(6.76±0.65cmH20VS6.81±0.65cmH20),两组的组间特征比较,无显著统计学差异(P>0.05),两组之间具有可比性。
2、术中剜除组发生2例(2.9%)包膜穿孔,电切组为9例(13.2%),两组间比较,有显著统计差异(P<0.05),说明剜除组术中包膜穿孔发生率小于电切组。两组均无死亡病例发生,均未发生TURS.膀胱损伤、直肠损伤、闭孔神经反射等并发症。两组患者术中、术后均未输血。剜除组与电切组两组手术术中、术后均未发生严重低钠血症；术前、术后血钠比较,差异无统计学意义(P>0.05),提示两组对患者内环境的影响相似。剜除组和电切组两组术后CVP比较(7.58±0.92cmH20VS8.34±0.82cmH20),剜除组CVP低于电切组,差异有显著性(P<0.05)。表明剜除组术中冲洗液吸收进入循环系统的量更少,对循环系统的容量影响更小,手术安全性更高。
3、剜除组与电切组两组围手术期观测指标：手术时间(49.50±16.49min VS61.48±19.68min).术中出血量(61.24±26.30ml VS90.12±33.12ml)、膀胱冲洗时间(12.88±2.52h VS23.40±2.68h)、导尿管留置时间(35.88±6.79h VS79.03±9.54h)、术后住院时间(4.97±0.65d VS6.28±0.64d)、获取标本的重量(39.28±13.57g VS25.69±8.22g)、偶发癌检出剜除组6例(8.8%),电切组未检出,两组间比较,差异均有统计学意义(P<0.05),提示剜除组在这些方面均优于电切组。术后尿道膀胱刺激征剜除组9例(13.3%),电切组19例(27.9%),剜除组尿道膀胱刺激征发生率小于电切组,两组比较,差异有统计学意义(P<0.05)。剜除组术后未发生术后继发性出血和再次留置尿管事件,电切组各发生2例(2.9%),组间比较,差异均无统计学意义(P>0.05)。
4、术后3个月时随访,剜除组患者与电切组Qmax.PVR.IPSS.QOL分别为：(20.99±2.54ml/s VS20.32±1.63ml/s).(4.94±3.11ml VS4.65±3.25ml)、(2.93±0.72分VS2.97±0.75分)、(1.40±0.52分VS1.44±0.58分),6个月时随访,Qmxa.PVR.IPSS.QOL分别为：(21.57±2.55ml/s VS21.65±2.07ml/s)、(3.66±2.40ml VS3.21±2.33ml).(2.24±0.79分VS2.26±0.59分)、(1.12±0.50分VS1.16±0.61分)。两组患者术后3、6个月的Qmax. PVR、IPSS、QOL分别与术前比较,组内比较,差异均有统计学意义(P<0.05),说明患者术后3、6个月Qmax、PVR、IPSS、QOL较术前均有明显改善；两组患者术后3个月与6个月的Qmax、IPSS、QOL情况比较,组内比较,差异有统计学意义(P<0.05),提示Qmax、IPSS、QOL术后3到6个月得到继续改善；两组患者术分别后3个月的PVR情况与6个月时比较,组内比较,差异均无统计学意义(P>0.05)；术后3、6个月Qmax、PVR、IPSS、QOL'情况剜除组与电切组组间比较,差异无统计学著意义(P>0.05),提示两种术式在改善Qmax、PVR、 IPSS、QOL方面效果相似。
5、两组尿失禁发生率比较：两组患者术后尿失禁发生情况为拔除尿管后24小时剜除组10例(14.7%),电切组6例(8.8%)。拔除尿管后1周时剜除组8例(11.1%),电切组3例(4.4%),组间比较,差异均无统计学意义(P>0.05)。拔除尿管后2周时剜除组1例(1.5%),电切组0例。差异无统计学意义(P>0.05),表明两组术后尿失禁发生率及恢复速度相似。术后2周时电切组无尿失禁病例,剜除组仍有1例尿失禁(张力性尿失禁),坚持训练盆底肌,于术后8周恢复。2组均未出现永久性尿失禁。
6、两组尿失禁程度比较：拔除导尿管后24h尿失禁程度为,中度：剜除组9例,漏尿量(6.14±1.62)g/h,电切组6例,漏尿量(3.47±0.84)g/h,两组漏尿量虽有统计学差异(t=3.706,P=0.003<0.05),但均属中度尿失禁范围(1g<1h漏尿<10g)；重度：两组均无发生；极重度：剜除组1例,漏尿量为68.6g/h,电切组无发生,两组比较,尿失禁程度上无差异。术后1周尿失禁程度为,中度：剜除组7例,漏尿量(3.31±0.41)g/h,电切组3例,漏尿量(2.73±0.85)g/h,两组漏尿量无统计学差异(t=1.526,P=0.116>0.05)；重度：两组均无；极重度：剜除组1例,漏尿量为57g/h,电切组无发生。2组比较尿失禁程度上仍无差异。术后2周时仅剜除组有1例极重度尿失禁,坚持训练盆底肌,于术后8周恢复。
结论
1、经尿道双极等离子前列腺剜除术治疗良性前列腺增生症短期手术疗效不差于、甚至超过经尿道双极等离子前列腺电切术。
2、经尿道双极等离子前列腺剜除术手治疗良性前列腺增生症手术安全性高于经尿道双极等离子前列腺电切术。
3、经尿道双极等离子前列腺剜除术更适合用于治疗高龄、高危、大体积的BPH患者。
4、经尿道双极等离子前列腺剜除术术中、术后并发症发生率低,术后恢复时间短,总体上优于经尿道双极等离子前列腺电切术,是治疗BPH比较理想的方法,有可能替代传统的TURP成为前列腺增生症手术治疗新的“金标准”。
5、与经尿道双极等离子前列腺电切术相比,经尿道双极等离子前列腺剜除术治疗前列腺增生症,暂时性尿失禁的发生率相同,程度相同,恢复速度相同,真性尿失禁发生率并不增加。
6、经尿道双极等离子前列腺剜除术对前列腺偶发癌的检出率高于经尿道双极等离子前列腺电切术,有利于前列腺偶发癌早期发现和治疗。
7、本研究显示经尿道双极等离子前列腺剜除术是未来BPH腔内微创治疗的趋势,具有广阔的临床应用前景,但其安全性及有效性仍有待大样本随机对照研究及长期的随访进一步证实。
Background
Benign prostatic hyperplasia (BPH), which is age-related and chronic progressive, is also the most common cause for urination disorder in senile males. BPH is also currently one of the most common diseases in urology department. BPH is mainly embodied in clinical symptoms, including hyperplasia of prostate stromal and glandular components, benign prostatic enlargement(BPE), bladder outlet obstruction(BOO), and lower urinary tract symptom(LUTS). BPH is clinically progressive. Its incidence of a disease and symptoms increase with the progression of age. The final expression form of BPH patients with disease progression is to accept surgical treatment.
With the development of economy, science and technology, the human life has been prolonged greatly, the proportion of older people has been increased, and the population aging will arrive sooner than expected. In China, the population aging has become increasingly serious. By the end of2013, Chinese aging population had exceeded200million, the aging level had reached14.8%, which was far higher than international standards. In the next40years, Chinese aging population will peak gradually, China will become the country that has the most aging population in the world. One fifth of the aging population will be living in China. At the same time, China will become one of the countries with the fastest aging population growth. At present, life expectancy of Chinese males has been increased to72years, and that will be extended further in the future. At this rate, a larger number of patients will be diagnosed with BPH in the next ten years. In addition, the extension of life expectancy will make clinical treatment prolonged, resulting in higher medical spending. This poses a grave problem to the urology clinical work, medical and health undertakings and social development.
At present, the "gold standard" of surgical treatment of BPH was still transurethral resection of the prostate (TURP). It has a series of advantages such as smaller incisions, less bleeding, faster recovery, less pain, more curative effect, and shorter length of stay, etc. At the same time it also has a series of disadvantages such as being not applicable to large volume (80ml) of the prostate, incomplete removal, residual gland tissue (50%), and more complications. In addition, the gland tissue residues cause a long-term recurrence rate of16%～17%(five to eight years), compared with a rate of six percent caused by an open surgery. So urology doctor did a lot of clinical research, trying to invent a kind of method which has advantages from both sides and with minimum disadvantages.
Transurethral enucleation and resection of the prostate (TUERP) was created by Chinese researchers. This operation method has both the advantages of open and TURP, with smaller incisions, faster recovery, and safer, more complete resection. Several studies have confirmed that TUERP was safe, effective, feasible, with less postoperative complications. It is ideal for the surgical treatment of BPH.
The efficacy and safety of transurethral minimally invasive surgery in the treatment of BPH was limited by surgical equipment instrument. Compared with the traditional unipolar cutting equipment, plasmakenitic does not need special negative plate, and has the following features:cryogenic cutting, small tissue thermal damage, rare TURS, less intraoperative and postoperative bleeding, less incidence of prostate coated perforation, and few electric burns. Plasmakenitic broke through the limitations of unipolar cutting equipment. It was a big step forward for transurethral minimally invasive surgical treatment of BPH.
Transurethral plasmakinetic enucleation of the prostate was created by the plasmakinetic used as energy carrier for transurethral enucleation of the prostate. Several clinical studies showed that TPKEP treatment of BPH was safe and feasible. The curative effect of TPKEP and TPKRP were similar, but TPKEP has a series of advantages as following:more thorough gland resection, shorter operation time, less bleeding and more security. Academics have proposed that TURP should no longer be the "gold standard" for surgical treatment of BPH, that "transurethral enucleation and resection of the prostate (TUERP)" will become the future trend of intracavitary minimally invasive treatment of BPH, and that in the near future transurethral enucleation of the prostate will be likely to replace TURP as the new "gold standard" surgical treatment of BPH. At the same time, the Meta analysis of evidence-based medicine showed that the level of the clinical evidence was low, thus it can only be recommended to use carefully, and that it is still controversial for the postoperative complications such as recurrence and urinary incontinence.
Objective
We sought to evaluate the safety, effectiveness and feasibility of transurethral plasmakinetic enucleation of the prostate (TPKEP), through comparing with transurethral plasmakinetic resection of the prostate (TPKRP), thus providing clinical evidence for application.
Method
The research is a single blind, single-center randomized trial with parallel and equilibrium designs, which concerns comparative analysis of preoperative general conditions, status of perioperative period, as well as postoperative follow-up. The control group was TPKRP and the experimental group was TPKEP in the study.
136patients with BPH were enrolled randomly from August2013to August2013. Among them,68cases underwent transurethral plasmakinetic resection of the prostate (TPKRP group), while the others underwent transurethral plasmakinetic enucleation of the prostate (TPKEP group). All operations were done by sophisticated surgeons with experience in both TURP and TUERP to attenuate deviations of different operators.
The indicators were measured preoperatively, including PSA, PV, Qmax, PVR, IPSS, QOL, Na+, Hb. Before and after operation respectively to measure central venous pressure (CVP). Intraoperative recorded indicators were as follows:duration of operation, complications during operation, the weight of the obtained organization and the amount of flushing fluid and the hemoglobin in specimen, which can be used to calculate the bleeding. Urinary incontinence was judged after surgery by using pad testing that recommended by the international association of urinary incontinence (ICS), and these data were measured and recorded at the24h after tube drawing and every week after the surgeries. The data of follow-up indicators were recorded in the third and sixth postoperative month respectively.
In this study, the data were collected and analyzed as follows:preoperative PSA, PV, Qmax, PVR, IPSS, QOL, Na+, Hb, CVP, duration of operation, intraoperatve blood soss, the weight of the obtained, complications during operation(prostate coated perforation, transurethral resection of syndrome, bladder or rectum injuries, etc.), postoperative bladder irrigation, duration of indwelling catheter, length of stay(LOS), and postoperative complications (including short-term uracratia, secondary bleeding, bladder neck contracture, urethrostenosis, and irritation sign of bladder and urethra, uroschesis), results of pad testing at the24h after tube drawing and every week after surgery in four weeks, and IPSS, QOL, Qmax, PVR in the third and sixth postoperative months respectively.
Results
1. General conditions of two groups:age(71.68±6.94year VS71.76±7.04year), PV(68.31±22.29ml VS66.99±18.76ml), IPSS(23.51±2.79score VS23.15±3.36score), QOL(4.50±0.70score VS4.68±0.70score), PVR(59.82±24.56ml VS62.21±24.96ml). Qmax(6.04±2.08ml/s VS6.32±1.71ml/s), PSA(3.39±0.95ng/ol VS3.35±1.20ng/o), Na+(141.64±1.78mmol/L VS141.86±1.62mmol/L), Hb(136.04±8.28g/L VS139.18±14.48g/L), CVP(6.76±0.65cmH2O VS6.81±0.65cmH2O). These data are comparative without statistical significance.
2. Complications during operation:2cases (2.9%) in TPKEP group suffered from prostate coated perforation compared with9cases (13.2%) in TPKRP group. Comparing the two groups, there were significant statistical difference (P<0.05). All enrolled patients were free of other complications like TURS, bladder or rectum injuries. Patients in both groups were free of severe hyponatremia, and their serum sodium decreases were similar (p>0.05). The postoperative CVP of TPKEP group and TPKRP group:(7.58±0.92cmH20VS8.34±0.82cmH20), there were significant statistical difference (P<0.05).
3. The perioperative indicators in TPKEP group and TPKRP group were respectively duration of operation (49.50±16.49min VS61.48±19.68min), intraoperatve blood soss (61.24±26.30ml VS90.12±33.12ml), time of postoperative bladder irrigation (12.88±2.52h VS23.40±2.68h), duration of indwelling catheter (4.97±0.65d VS6.28±0.64d), the weight of the obtained organization (39.28±13.57g VS25.69±8.22g), the detection rate of incidentally discovered prostatic cancer (IDPC)(6cases VS0case s). There were significant differences in all these indicators between the two groups (P<0.05), but no statistical significance (P>0.05) in irritation sign of bladder and urethra (9cases VS19cases), secondary bleeding and acute urinary retention after operation (0cases VS2cases)respectively,.
4. The postoperative follow-up was carried out in the third and sixth months after the operation. In the third month, the clinical indicators including IPSS, QOL, Qmax and PVR.in the TPKEP and TPKRP groups were(2.93±0.72score VS2.97±0.75score)、(1.40±0.52score VS1.44±0.58score)、(20.99±2.54ml/s VS20.32±1.63ml/s)、(4.94±3.11ml VS4.65±3.25ml) respectively. In the sixth month, they were(2.24±0.79score VS2.26±0.59score)、(1.12±0.50score VS1.16±0.61score)、(21.57±2.55ml/s VS21.65±2.07ml/s)、(3.66±2.40ml VS3.21±2.33ml) respectively. There were significant improvements in these indexes in either the third or the sixth month from the surgeries(p<0.05), and also there were significant improvements in indicators of IPSS、QOL、Qmax from3to6months'time(p<0.05). But there were no significant differences in indicators of PVR between the3and6months'time from surgeries in the two groups respectively(P>0.05). There were no significant differences in indicators of IPSS, QOL, Qmax and PVR between the two groups in either one or three months'time from surgeries(P>0.05), presenting similar effects.
5. The urinary incontinence rate in TPKEP group and TPKRP group respectively were24h after tube drawing (10cases VS6cases), one week after surgery (8cases VS3cases), two weeks after surgery (lcases VS0cases). There were no significant difference between the two groups (P>0.05). In the second postoperative week, there was still one case of urinary incontinence in the PKERP group. Pelvic floor muscle training was implemented by the patient, and the urinary incontinence disappeared in8weeks after the surgery. Both groups did not suffer permanent urinary incontinence.
6. Degree of urinary incontinence at the24h after tube drawing in TPKEP group and TPKRP group are as follows:moderate(6.14±1.62g/h VS3.47±0.84g/h). These data between two groups were statistically significant (t=3.706, P=0.003<0.05), but all of a moderate scope(1g<1h<10g). Both groups did not suffer severe urinary incontinence. For the extreme urinary incontinence, there was one case in TPKEP group, the leakage of this case was68.6g/h, and no case has been found in TPKRP group. There were no significant difference in urinary incontinence between TPKEP group and TPKRP group at the24h after tube drawing. One week after the surgery, moderate(3.31±0.41g/h VS2.73±0.85g/h). These data between the two groups were not statistically significant (t=1.526,P=0.116>0.05). One case with extreme urinary incontinence still has been found in TPKEP group, the leakage of this case was57g/h. there were still no difference at degree of urinary incontinence between TPKEP group and TPKRP group one week after the surgery. Only one case with extreme urinary incontinence in TPKEP group has been found two weeks after the surgery. The degree of the incontinence were of no significant difference between the two groups.
Conclusions
1. The short period efficacy of TPKEP is superior to TPKRP for surgical treatment of symptomatic BPH.
2. The safety of TPKEP is higher than TPKRP for surgical treatment of symptomatic BPH.
3. TPKEP is more suitable for being used to treat senile, high-risk and large volume of BPH.
4. Overall transurethral enucleation of prostate(TPKEP) is superior to TPKRP. It is ideal for the surgical treatment of BPH, and will be likely to replace TURP as a new "gold standard" surgical treatment of BPH.
5. Comparing TPKEP with TPKRP for treatment of BPH, the incidence of temporary incontinence, the degree and the time required for recovery are the same, and the incidence of true urinary incontinence is not increased.
6. The detection rate of incidentally discovered prostatic cancer (IDPC) of TPKEP is higher than TPKRP, and it is good for early detection and treatment of IDPC.
7. TPKEP is the future trend of intracavitary minimally invasive treatment of BPH. It has an excellent clinical application prospect, while its safety and effectiveness are yet to be proved by larger scales of randomized and controlled studies.
良性前列腺增生症(benign prostatic hyperplasia, BPH)是引起中老年男性排尿障碍最为常见的一种良性疾病,其主要表现为组织学上的前列腺间质和腺体成分的增生、解剖学上的前列腺增大(benign prostatic enlargement, BPE)、尿动力学上的膀胱出口梗阻(bladder outlet obstruction, BOO)和以下尿路症状(lower urinary tract symptom, LUTS)为主的临床症状。BPH具有临床进展性,其发病率随患者年龄增长而增加,相应的,症状亦随年龄的增加而进行性加重。BPH患者疾病进展的最终表现形式是接受外科手术治疗。
随着人类社会经济、科技的不断发展,人类寿命得到较大延长,老年人比例不断增加,人口老龄化将加快到来。尤其在中国,人口老龄化已日趋严峻,截止2013年底,中国老年人口数量已突破2亿人,老龄化水平达到14.8%,远高于国际社会老龄化标准。且未来40年,中国人口老龄化将逐步达到峰值,中国将成为全球老年人口最多的国家,占全球老年人口总量的五分之一,也将是世界上人口老龄化发展速度最快的国家之一。目前我国男性的人均预期寿命延长到72岁,随着我国社会经济和科技的不断发展,今后我国男性的人均预期寿命将进一步得到延长。在未来的数十年内,人口老龄化的加速及男性预期寿命的延长,将会产生更庞大的BPH患者人群,加之人口寿命的延长相应延长了临床治疗的时间,将会产生更加高昂的医疗费用,并占用更多的医疗资源。这使得我国泌尿外科临床工作、医疗卫生事业发展乃至全社会的发展面临一个亟待解决的严峻课题。
目前,手术治疗BPH的“金标准”仍然是经尿道前列腺电切术(TURP)。其具有创伤小、出血少、恢复快、痛苦少、疗效确切,住院时间短等一系列优势,在临床广泛被使用。但其也有不适用于较大体积前列腺(80m1)、切除不彻底、术后残留腺体组织较多(50%)、手术并发症发生率较高等缺点。另外,由于开放手术能够沿着外科包膜彻底摘除前列腺增生组织,远期复发率仅为6%左右,而TURP则必定会有增生的前列腺组织残留,远期复发率达16%～17%(5～8年)。所以泌尿外科医生做了大量的临床研究和探索,希望发明一种同时兼有两者优势,而又消除两者缺点的创伤更小,疗效更好,安全性更高的方法。
经尿道前列腺剜除术(TUERP)是我国学者融合了开放前列腺摘除术与TURP两者的技术优点而独创的手术方式。它从解剖学角度出发,找到增生腺体和外科包膜之间的层面,并沿此包膜平面完整球面剥离增生腺体,然后再切除腺体组织。该术式既具有微创腔内手术创伤小、恢复快的特点,又能达到开放手术的彻底性、不复发的效果,而且安全性高,是BPH手术治疗上革命性的突破。多项研究证实经尿道剜除术安全、有效、可行、术后并发症少,是理想的前列腺增生症的手术治疗方法。
经尿道微创手术治疗前列腺增生症的安全性及有效性会受到手术设备仪器的限制。与传统单极电切系统相比较,双极等离子电切系统不需要专门的负极板,具有以下特点：低温切割、组织热损伤小；采用生理盐水作为冲洗液,极少发生电切综合症(TURS);止血高效、可靠,术中及术后出血少；独特的“被膜保护”作用使包膜穿孔发生率下降；无负极回路板,防止电击和灼伤。双极等离子体电切系统突破了单极电切手术系统的局限性,是经尿道微创手术治疗前列腺增生症的又一大进步。
将等双极离子体的优越性能作为经尿道前列腺剜除术(Transurethral enucleation and resection of the prostate, TUERP)的能量载体,即产生了经尿道双极等离子前列腺腔内剜除术(Transurethral plasmakinetic enucleation of the prostate, TPKEP)。有临床研究显示,经尿道双极等离子前列腺腔内剜除术治疗BPH安全、可行,与经尿道等离子双极电切术(Transurethral plasmakinetic resection of the prostate, TPKRP)相比较,疗效相似,但TPKEP术中切除增生腺体更彻底,手术时间却较短,出血较少,安全性更高。已有学者提出TURP不应该再是手术治疗前列腺增生症的金标准,“经尿道前列腺剜除术(TUERP)"才是未来BPH腔内微创治疗的趋势,不远的未来有可能替代TURP成为BPH外科治疗新的“金标准”。然而也有循证医学meta分析认为,这些临床证据级别较低,仅为谨慎推荐使用。并且目前对于TPKEP术后尿失禁等后术后并发症情况仍存在较多争议,限制了经尿道双极等离子前列腺剜除术的临床推广应用。
目的
本研究通过与经尿道双极等离子体前列腺电切术的对比,评价经尿道双极等离子体前列腺剜除术治疗良性前列腺增生症的安全性、有效性及可行性,为经尿道双极等离子体前列腺剜除术的进一步临床推广应用提供科学依据。
方法
本研究采用随机对照、单盲、单中心、平行组设计,分段均衡随机化分组,以经尿道双极等离子前列腺电切术组为对照组,以经尿道双极等离子前列腺剜除术组为实验组,对比分析两组术前、围手术期及术后随访的观察指标数据。
2012年08月至2013年08月期间,共计136例符合纳入标准的BPH患者被纳入本研究。将这136例病例分段均衡随机化分组,其中68例行经尿道双极等离子前列腺电切术,另外68例行经尿道双极等离子前列腺剜除术。术者均为我院泌尿外科副高以上职称的专家教授,年资及手术例数接近,手术熟练程度接近,均具有丰富的TURP操作经验并熟练掌握“经尿道前列腺剜除术”,本研究开始前,均统一培训并达成手术操作步骤基本共识,以尽量减少因操作者因素所造成的差异。
两组患者术前均测血清前列腺特异性抗原(PSA),以经直肠B超测定前列腺体积(PV),尿动力学检查测定最大尿流率(Qmax)、残余尿量(PVR),问卷调查国际前列腺症状评分(IPSS)、生活质量评分(QOL),血钠离子浓度(Na+)和血红蛋白浓度(Hb),手术开始前和结束后分别测中心静脉压(CVP)。术中详细记录手术时间、术中并发症发生情况、获取标本的重量。另外,术中还记录冲洗液总量并留取样本化验其血红蛋白含量用以计算术中出血量。术后使用国际尿失禁协会(ICS)推荐的1h尿垫试验(pad testing)对术后尿失禁进行判断。于术后拔除导尿管后第24h、术后每周分别行尿垫试验,并记录数据,四周后仍有尿失禁者每月随访观察,直至恢复。于术后第3、6个月时间点随访并记录Qmax.PVR.IPSS.QOL等随访指标数据。
本研究需要收集的研究指标数据包括：术前PSA.PV.Qmax.PVR.IPSS. QOL.Na+、Hb.CVP;术中手术时间、出血量、获取标本的重量及术中并发症发生情况(包膜穿孔、经尿道电切综合征、膀胱损伤、直肠损伤等)；术后膀胱冲洗时间、留置导尿时间、术后住院时间及术后并发症情况(继发性出血、短期尿失禁、膀胱颈挛缩、尿道狭窄、尿道膀胱刺激征、拔除尿管后尿潴留)。术后拔除导尿管后24小时、术后第1、2、4周的尿垫试验结果,术后分别第3、6个月时间点随访指标Qmax.PVR.IPSS.QOL.将这些数据进行统计学分析,对两组手术的术安全性、有效性进行比较分析。
结果
1、剜除组与电切组两组术前一般情况比较：年龄(71.68±6.94岁VS71.76±7.04岁).PV(68.31±22.29ml VS66.99±18.76ml).IPSS(23.51±2.79分VS23.15±3.36分)、QOL(4.50±0.70分VS4.68±0.70分)、PVR(59.82±24.56ml VS62.21±24.96ml).Qmax(6.04±2.08ml/s VS6.32±1.71ml/s). PSA(3.39±0.95ng/ml VS3.35±1.20ng/ml).Na+(141.64±1.78mmol/L VS141.86±1.62mmol/L).Hb(136.04±8.28g/L VS139.18±14.48g/L).CVP(6.76±0.65cmH20VS6.81±0.65cmH20),两组的组间特征比较,无显著统计学差异(P>0.05),两组之间具有可比性。
2、术中剜除组发生2例(2.9%)包膜穿孔,电切组为9例(13.2%),两组间比较,有显著统计差异(P<0.05),说明剜除组术中包膜穿孔发生率小于电切组。两组均无死亡病例发生,均未发生TURS.膀胱损伤、直肠损伤、闭孔神经反射等并发症。两组患者术中、术后均未输血。剜除组与电切组两组手术术中、术后均未发生严重低钠血症；术前、术后血钠比较,差异无统计学意义(P>0.05),提示两组对患者内环境的影响相似。剜除组和电切组两组术后CVP比较(7.58±0.92cmH20VS8.34±0.82cmH20),剜除组CVP低于电切组,差异有显著性(P<0.05)。表明剜除组术中冲洗液吸收进入循环系统的量更少,对循环系统的容量影响更小,手术安全性更高。
3、剜除组与电切组两组围手术期观测指标：手术时间(49.50±16.49min VS61.48±19.68min).术中出血量(61.24±26.30ml VS90.12±33.12ml)、膀胱冲洗时间(12.88±2.52h VS23.40±2.68h)、导尿管留置时间(35.88±6.79h VS79.03±9.54h)、术后住院时间(4.97±0.65d VS6.28±0.64d)、获取标本的重量(39.28±13.57g VS25.69±8.22g)、偶发癌检出剜除组6例(8.8%),电切组未检出,两组间比较,差异均有统计学意义(P<0.05),提示剜除组在这些方面均优于电切组。术后尿道膀胱刺激征剜除组9例(13.3%),电切组19例(27.9%),剜除组尿道膀胱刺激征发生率小于电切组,两组比较,差异有统计学意义(P<0.05)。剜除组术后未发生术后继发性出血和再次留置尿管事件,电切组各发生2例(2.9%),组间比较,差异均无统计学意义(P>0.05)。
4、术后3个月时随访,剜除组患者与电切组Qmax.PVR.IPSS.QOL分别为：(20.99±2.54ml/s VS20.32±1.63ml/s).(4.94±3.11ml VS4.65±3.25ml)、(2.93±0.72分VS2.97±0.75分)、(1.40±0.52分VS1.44±0.58分),6个月时随访,Qmxa.PVR.IPSS.QOL分别为：(21.57±2.55ml/s VS21.65±2.07ml/s)、(3.66±2.40ml VS3.21±2.33ml).(2.24±0.79分VS2.26±0.59分)、(1.12±0.50分VS1.16±0.61分)。两组患者术后3、6个月的Qmax. PVR、IPSS、QOL分别与术前比较,组内比较,差异均有统计学意义(P<0.05),说明患者术后3、6个月Qmax、PVR、IPSS、QOL较术前均有明显改善；两组患者术后3个月与6个月的Qmax、IPSS、QOL情况比较,组内比较,差异有统计学意义(P<0.05),提示Qmax、IPSS、QOL术后3到6个月得到继续改善；两组患者术分别后3个月的PVR情况与6个月时比较,组内比较,差异均无统计学意义(P>0.05)；术后3、6个月Qmax、PVR、IPSS、QOL'情况剜除组与电切组组间比较,差异无统计学著意义(P>0.05),提示两种术式在改善Qmax、PVR、 IPSS、QOL方面效果相似。
5、两组尿失禁发生率比较：两组患者术后尿失禁发生情况为拔除尿管后24小时剜除组10例(14.7%),电切组6例(8.8%)。拔除尿管后1周时剜除组8例(11.1%),电切组3例(4.4%),组间比较,差异均无统计学意义(P>0.05)。拔除尿管后2周时剜除组1例(1.5%),电切组0例。差异无统计学意义(P>0.05),表明两组术后尿失禁发生率及恢复速度相似。术后2周时电切组无尿失禁病例,剜除组仍有1例尿失禁(张力性尿失禁),坚持训练盆底肌,于术后8周恢复。2组均未出现永久性尿失禁。
6、两组尿失禁程度比较：拔除导尿管后24h尿失禁程度为,中度：剜除组9例,漏尿量(6.14±1.62)g/h,电切组6例,漏尿量(3.47±0.84)g/h,两组漏尿量虽有统计学差异(t=3.706,P=0.003<0.05),但均属中度尿失禁范围(1g<1h漏尿<10g)；重度：两组均无发生；极重度：剜除组1例,漏尿量为68.6g/h,电切组无发生,两组比较,尿失禁程度上无差异。术后1周尿失禁程度为,中度：剜除组7例,漏尿量(3.31±0.41)g/h,电切组3例,漏尿量(2.73±0.85)g/h,两组漏尿量无统计学差异(t=1.526,P=0.116>0.05)；重度：两组均无；极重度：剜除组1例,漏尿量为57g/h,电切组无发生。2组比较尿失禁程度上仍无差异。术后2周时仅剜除组有1例极重度尿失禁,坚持训练盆底肌,于术后8周恢复。
结论
1、经尿道双极等离子前列腺剜除术治疗良性前列腺增生症短期手术疗效不差于、甚至超过经尿道双极等离子前列腺电切术。
2、经尿道双极等离子前列腺剜除术手治疗良性前列腺增生症手术安全性高于经尿道双极等离子前列腺电切术。
3、经尿道双极等离子前列腺剜除术更适合用于治疗高龄、高危、大体积的BPH患者。
4、经尿道双极等离子前列腺剜除术术中、术后并发症发生率低,术后恢复时间短,总体上优于经尿道双极等离子前列腺电切术,是治疗BPH比较理想的方法,有可能替代传统的TURP成为前列腺增生症手术治疗新的“金标准”。
5、与经尿道双极等离子前列腺电切术相比,经尿道双极等离子前列腺剜除术治疗前列腺增生症,暂时性尿失禁的发生率相同,程度相同,恢复速度相同,真性尿失禁发生率并不增加。
6、经尿道双极等离子前列腺剜除术对前列腺偶发癌的检出率高于经尿道双极等离子前列腺电切术,有利于前列腺偶发癌早期发现和治疗。
7、本研究显示经尿道双极等离子前列腺剜除术是未来BPH腔内微创治疗的趋势,具有广阔的临床应用前景,但其安全性及有效性仍有待大样本随机对照研究及长期的随访进一步证实。
Background
Benign prostatic hyperplasia (BPH), which is age-related and chronic progressive, is also the most common cause for urination disorder in senile males. BPH is also currently one of the most common diseases in urology department. BPH is mainly embodied in clinical symptoms, including hyperplasia of prostate stromal and glandular components, benign prostatic enlargement(BPE), bladder outlet obstruction(BOO), and lower urinary tract symptom(LUTS). BPH is clinically progressive. Its incidence of a disease and symptoms increase with the progression of age. The final expression form of BPH patients with disease progression is to accept surgical treatment.
With the development of economy, science and technology, the human life has been prolonged greatly, the proportion of older people has been increased, and the population aging will arrive sooner than expected. In China, the population aging has become increasingly serious. By the end of2013, Chinese aging population had exceeded200million, the aging level had reached14.8%, which was far higher than international standards. In the next40years, Chinese aging population will peak gradually, China will become the country that has the most aging population in the world. One fifth of the aging population will be living in China. At the same time, China will become one of the countries with the fastest aging population growth. At present, life expectancy of Chinese males has been increased to72years, and that will be extended further in the future. At this rate, a larger number of patients will be diagnosed with BPH in the next ten years. In addition, the extension of life expectancy will make clinical treatment prolonged, resulting in higher medical spending. This poses a grave problem to the urology clinical work, medical and health undertakings and social development.
At present, the "gold standard" of surgical treatment of BPH was still transurethral resection of the prostate (TURP). It has a series of advantages such as smaller incisions, less bleeding, faster recovery, less pain, more curative effect, and shorter length of stay, etc. At the same time it also has a series of disadvantages such as being not applicable to large volume (80ml) of the prostate, incomplete removal, residual gland tissue (50%), and more complications. In addition, the gland tissue residues cause a long-term recurrence rate of16%～17%(five to eight years), compared with a rate of six percent caused by an open surgery. So urology doctor did a lot of clinical research, trying to invent a kind of method which has advantages from both sides and with minimum disadvantages.
Transurethral enucleation and resection of the prostate (TUERP) was created by Chinese researchers. This operation method has both the advantages of open and TURP, with smaller incisions, faster recovery, and safer, more complete resection. Several studies have confirmed that TUERP was safe, effective, feasible, with less postoperative complications. It is ideal for the surgical treatment of BPH.
The efficacy and safety of transurethral minimally invasive surgery in the treatment of BPH was limited by surgical equipment instrument. Compared with the traditional unipolar cutting equipment, plasmakenitic does not need special negative plate, and has the following features:cryogenic cutting, small tissue thermal damage, rare TURS, less intraoperative and postoperative bleeding, less incidence of prostate coated perforation, and few electric burns. Plasmakenitic broke through the limitations of unipolar cutting equipment. It was a big step forward for transurethral minimally invasive surgical treatment of BPH.
Transurethral plasmakinetic enucleation of the prostate was created by the plasmakinetic used as energy carrier for transurethral enucleation of the prostate. Several clinical studies showed that TPKEP treatment of BPH was safe and feasible. The curative effect of TPKEP and TPKRP were similar, but TPKEP has a series of advantages as following:more thorough gland resection, shorter operation time, less bleeding and more security. Academics have proposed that TURP should no longer be the "gold standard" for surgical treatment of BPH, that "transurethral enucleation and resection of the prostate (TUERP)" will become the future trend of intracavitary minimally invasive treatment of BPH, and that in the near future transurethral enucleation of the prostate will be likely to replace TURP as the new "gold standard" surgical treatment of BPH. At the same time, the Meta analysis of evidence-based medicine showed that the level of the clinical evidence was low, thus it can only be recommended to use carefully, and that it is still controversial for the postoperative complications such as recurrence and urinary incontinence.
Objective
We sought to evaluate the safety, effectiveness and feasibility of transurethral plasmakinetic enucleation of the prostate (TPKEP), through comparing with transurethral plasmakinetic resection of the prostate (TPKRP), thus providing clinical evidence for application.
Method
The research is a single blind, single-center randomized trial with parallel and equilibrium designs, which concerns comparative analysis of preoperative general conditions, status of perioperative period, as well as postoperative follow-up. The control group was TPKRP and the experimental group was TPKEP in the study.
136patients with BPH were enrolled randomly from August2013to August2013. Among them,68cases underwent transurethral plasmakinetic resection of the prostate (TPKRP group), while the others underwent transurethral plasmakinetic enucleation of the prostate (TPKEP group). All operations were done by sophisticated surgeons with experience in both TURP and TUERP to attenuate deviations of different operators.
The indicators were measured preoperatively, including PSA, PV, Qmax, PVR, IPSS, QOL, Na+, Hb. Before and after operation respectively to measure central venous pressure (CVP). Intraoperative recorded indicators were as follows:duration of operation, complications during operation, the weight of the obtained organization and the amount of flushing fluid and the hemoglobin in specimen, which can be used to calculate the bleeding. Urinary incontinence was judged after surgery by using pad testing that recommended by the international association of urinary incontinence (ICS), and these data were measured and recorded at the24h after tube drawing and every week after the surgeries. The data of follow-up indicators were recorded in the third and sixth postoperative month respectively.
In this study, the data were collected and analyzed as follows:preoperative PSA, PV, Qmax, PVR, IPSS, QOL, Na+, Hb, CVP, duration of operation, intraoperatve blood soss, the weight of the obtained, complications during operation(prostate coated perforation, transurethral resection of syndrome, bladder or rectum injuries, etc.), postoperative bladder irrigation, duration of indwelling catheter, length of stay(LOS), and postoperative complications (including short-term uracratia, secondary bleeding, bladder neck contracture, urethrostenosis, and irritation sign of bladder and urethra, uroschesis), results of pad testing at the24h after tube drawing and every week after surgery in four weeks, and IPSS, QOL, Qmax, PVR in the third and sixth postoperative months respectively.
Results
1. General conditions of two groups:age(71.68±6.94year VS71.76±7.04year), PV(68.31±22.29ml VS66.99±18.76ml), IPSS(23.51±2.79score VS23.15±3.36score), QOL(4.50±0.70score VS4.68±0.70score), PVR(59.82±24.56ml VS62.21±24.96ml). Qmax(6.04±2.08ml/s VS6.32±1.71ml/s), PSA(3.39±0.95ng/ol VS3.35±1.20ng/o), Na+(141.64±1.78mmol/L VS141.86±1.62mmol/L), Hb(136.04±8.28g/L VS139.18±14.48g/L), CVP(6.76±0.65cmH2O VS6.81±0.65cmH2O). These data are comparative without statistical significance.
2. Complications during operation:2cases (2.9%) in TPKEP group suffered from prostate coated perforation compared with9cases (13.2%) in TPKRP group. Comparing the two groups, there were significant statistical difference (P<0.05). All enrolled patients were free of other complications like TURS, bladder or rectum injuries. Patients in both groups were free of severe hyponatremia, and their serum sodium decreases were similar (p>0.05). The postoperative CVP of TPKEP group and TPKRP group:(7.58±0.92cmH20VS8.34±0.82cmH20), there were significant statistical difference (P<0.05).
3. The perioperative indicators in TPKEP group and TPKRP group were respectively duration of operation (49.50±16.49min VS61.48±19.68min), intraoperatve blood soss (61.24±26.30ml VS90.12±33.12ml), time of postoperative bladder irrigation (12.88±2.52h VS23.40±2.68h), duration of indwelling catheter (4.97±0.65d VS6.28±0.64d), the weight of the obtained organization (39.28±13.57g VS25.69±8.22g), the detection rate of incidentally discovered prostatic cancer (IDPC)(6cases VS0case s). There were significant differences in all these indicators between the two groups (P<0.05), but no statistical significance (P>0.05) in irritation sign of bladder and urethra (9cases VS19cases), secondary bleeding and acute urinary retention after operation (0cases VS2cases)respectively,.
4. The postoperative follow-up was carried out in the third and sixth months after the operation. In the third month, the clinical indicators including IPSS, QOL, Qmax and PVR.in the TPKEP and TPKRP groups were(2.93±0.72score VS2.97±0.75score)、(1.40±0.52score VS1.44±0.58score)、(20.99±2.54ml/s VS20.32±1.63ml/s)、(4.94±3.11ml VS4.65±3.25ml) respectively. In the sixth month, they were(2.24±0.79score VS2.26±0.59score)、(1.12±0.50score VS1.16±0.61score)、(21.57±2.55ml/s VS21.65±2.07ml/s)、(3.66±2.40ml VS3.21±2.33ml) respectively. There were significant improvements in these indexes in either the third or the sixth month from the surgeries(p<0.05), and also there were significant improvements in indicators of IPSS、QOL、Qmax from3to6months'time(p<0.05). But there were no significant differences in indicators of PVR between the3and6months'time from surgeries in the two groups respectively(P>0.05). There were no significant differences in indicators of IPSS, QOL, Qmax and PVR between the two groups in either one or three months'time from surgeries(P>0.05), presenting similar effects.
5. The urinary incontinence rate in TPKEP group and TPKRP group respectively were24h after tube drawing (10cases VS6cases), one week after surgery (8cases VS3cases), two weeks after surgery (lcases VS0cases). There were no significant difference between the two groups (P>0.05). In the second postoperative week, there was still one case of urinary incontinence in the PKERP group. Pelvic floor muscle training was implemented by the patient, and the urinary incontinence disappeared in8weeks after the surgery. Both groups did not suffer permanent urinary incontinence.
6. Degree of urinary incontinence at the24h after tube drawing in TPKEP group and TPKRP group are as follows:moderate(6.14±1.62g/h VS3.47±0.84g/h). These data between two groups were statistically significant (t=3.706, P=0.003<0.05), but all of a moderate scope(1g<1h<10g). Both groups did not suffer severe urinary incontinence. For the extreme urinary incontinence, there was one case in TPKEP group, the leakage of this case was68.6g/h, and no case has been found in TPKRP group. There were no significant difference in urinary incontinence between TPKEP group and TPKRP group at the24h after tube drawing. One week after the surgery, moderate(3.31±0.41g/h VS2.73±0.85g/h). These data between the two groups were not statistically significant (t=1.526,P=0.116>0.05). One case with extreme urinary incontinence still has been found in TPKEP group, the leakage of this case was57g/h. there were still no difference at degree of urinary incontinence between TPKEP group and TPKRP group one week after the surgery. Only one case with extreme urinary incontinence in TPKEP group has been found two weeks after the surgery. The degree of the incontinence were of no significant difference between the two groups.
Conclusions
1. The short period efficacy of TPKEP is superior to TPKRP for surgical treatment of symptomatic BPH.
2. The safety of TPKEP is higher than TPKRP for surgical treatment of symptomatic BPH.
3. TPKEP is more suitable for being used to treat senile, high-risk and large volume of BPH.
4. Overall transurethral enucleation of prostate(TPKEP) is superior to TPKRP. It is ideal for the surgical treatment of BPH, and will be likely to replace TURP as a new "gold standard" surgical treatment of BPH.
5. Comparing TPKEP with TPKRP for treatment of BPH, the incidence of temporary incontinence, the degree and the time required for recovery are the same, and the incidence of true urinary incontinence is not increased.
6. The detection rate of incidentally discovered prostatic cancer (IDPC) of TPKEP is higher than TPKRP, and it is good for early detection and treatment of IDPC.
7. TPKEP is the future trend of intracavitary minimally invasive treatment of BPH. It has an excellent clinical application prospect, while its safety and effectiveness are yet to be proved by larger scales of randomized and controlled studies.
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