2010 等离子电切治疗前列腺增生

E U RO P E AN URO LOG Y 5 8 ( 2 0 1 0 ) 7 5 2 – 7 5 8 avai lable at www.sciencedirect .com journal homepage: www.europeanurology.com Benign Prostatic Hyperplasia A Prospective, Randomised Trial Comparing Plasmakinetic Enucleation to Standard Transurethral Resection of the Prostate for Symptomatic Benign Prostatic Hyperplasia: Three-year Follow-up Results Zhigang Zhao, Guohua Zeng *, Wen Zhong, Zanlin Mai, Shaohua Zeng, Xueting Tao Department of Urology, Minimally Invasive Surgery Centre, The First Affiliated Hospital of Guangzhou Medical College, Guangzhou, Guangdong Province, China Article info Article history: Accepted August 12, 2010 Published online ahead of print on August 20, 2010 Keywords: Benign prostatic hyperplasia (BPH) Plasmakinetic prostatectomy Transurethral enucleation of the prostate Transurethral resection of the prostate (TURP) Abstract Background: Plasmakinetic enucleation of the prostate (PKEP) has recently been proved a safe and technically feasible procedure for benign prostatic hyperplasia (BPH). However, its long-term safety, efficacy, and durability in comparison with the gold-standard transurethral resection of the prostate (TURP) have not yet been reported. Objective: To report the 3-yr follow-up results of a prospective, randomised clinical trial comparing PKEP with standard TURP for symptomatic BPH. Design, setting, and participants: A total of 204 patients with bladder outflow obstruction (BOO) secondary to BPH were prospectively randomised 1:1 into either the PKEP group or the TURP group. Intervention: The patients in each group underwent the procedure accordingly. Measurements: All patientswere assessedperioperatively and followedat 1, 3, 6, 12, 18, 24, and36mo postoperatively. The preoperative and postoperative parameters included International Prostate Symptom Score (IPSS), quality of life (QoL) scores, the International Index of Erectile Function (IIEF) questionnaire, maximum urinary flow rates (Qmax), transrectal ultrasound (TRUS)–assessed prostate volume, postvoid residual urine (PVRU) volume, and serum prostate-specific antigen (PSA) level. Patient baseline characteristics, perioperative data, and postoperative outcomes were compared. All complications were recorded. Results and limitations: PKEPwas significantly superior to TURP in terms of the drop in haemoglobin (0.74 � 0.33 g/dl vs 1.88 � 1.06 g/dl; p < 0.001), intraoperative irrigation volume (11.7 � 4.5 l vs 15.4 � 6.2 l; p < 0.001), postoperative irrigation volume and time (18.5 � 7.6 l vs. 30.0 � 11.4 l and 16.6 � 5.2 h vs 25.3 � 8.5 h; all p < 0.001), recovery room stay (67.3 � 11.1 min vs 82.0 � 16.4 min; p < 0.001), catheterisation time (51.7 � 26.3 h vs 80.5 � 31.6 h; p < 0.001), hospital stay (98.4 � 20.4 h vs 134.2 � 31.5 h; p < 0.001), and resected tissue (56.4 � 12.8 g vs 43.8 � 15.5 g; p < 0.001). There were no statistical differences in operation time and sexual function between the two groups. At 36 mo postoperatively, the PKEP group had a maintained and statistically significant improvement in IPSS (2.4 � 2.2 vs 4.3 � 2.9; p < 0.001), QoL (0.6 � 0.5 vs 1.6 � 1.4; p < 0.001), Qmax (28.8 � 10.1 ml/s vs 25.1 � 8.0 ml/s; p = 0.017), and TRUS volume (21.0 � 7.3 ml vs 26.4 � 6.8 ml; p < 0.001), with urody- namically proven deobstruction (Scha¨fer grade 0.2 � 0.02 vs 0.8 � 0.1; p < 0.001). More extensive clinical trials are required to validate these results. Conclusions: PKEP is a safe and highly effective technique for relieving BOO. At 3-yr follow-up, the clinical efficacy of PKEP is durable and compares favourably with TURP. # 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved. * Corresponding author. Department of Urology, Minimally Invasive Surgery Centre, The First Affiliated Hospital of Guangzhou Medical College, No.1-3, Kangda Road, Guangzhou 510230, Guangdong Province, China. Tel. +86 20 34294184. E-mail address: zgzhaodr@yahoo.com.cn, gzgyzgh@vip.tom.com (G. Zeng). 0302-2838/$ – see back matter# 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved. doi:10.1016/j.eururo.2010.08.026 E U RO P E AN URO LOG Y 5 8 ( 2 0 1 0 ) 7 5 2 – 7 5 8 753 1. Introduction Benign prostatic hyperplasia (BPH) is a frequent disease in ageing men and is associated with bladder outlet obstruc- tion (BOO). Despite the gold-standard surgical treatment of BOO [1,2], transurethral resection of the prostate (TURP) is limited to prostates weighing<100 g and is associated with significant complications and morbidity [3,4]. Therefore, a demand for technologic alternatives that can minimise the risks of TURP exists. Recently, a plasmakinetic system was developed that enables anatomic enucleation of the entire lobes of the prostate, as described by Neill and co-workers [5]. The 1-yr follow-up results of their prospective, randomised trial (PRT) comparing holmium laser enucleation of the prostate (HoLEP) to plasmakinetic enucleation of the prostate (PKEP) in 20 BPH patients assigned to each procedure demonstrat- ed that PKEP is a safe and technically feasible procedure for the enucleation of prostatic adenomata of 20–200 cm3 on transrectal ultrasound (TRUS). However, data on the efficacy, safety, and durability of PKEP after follow-up periods >1 yr postoperatively in a relatively large sample size have not yet been published. To address these issues, we report the 3-yr follow-up results of a PRT that compared PKEP with gold-standard TURP in 204 patients with BPH- induced symptomatic outflow tract obstruction. This study is, to the best of our knowledge, the first PRT comparing PKEP with TURP. 2. Patients and methods 2.1. Patients From January 2004 to December 2006, men with BOO resulting from clinically diagnosed BPH in our Department of Urology who desired endosurgical treatment were invited to participate in the trial. Inclusion criteria were age >45 yr, maximal urinary flow rate (Qmax) <15 ml/s, International Prostate Symptom Score (IPSS) >12, medication failure, prostate volume on TRUS>20 gwith no upper limit, and urodynamically proven obstruction (Scha¨fer grade �2). Medications such as 5a- reductase inhibitors and/or a-blockers, if any, were stopped before urodynamics and surgery. Any patients with neurovesical dysfunction, a diagnosis of prostate carcinoma, and a previous history of prostatic or urethral surgery were excluded. A total of 204 cases were enrolled in the study. These patients were randomised in a 1:1 ratio to undergo either PKEP or TURPbyusing a sealed envelope sequence after ethical approval from the institutional review board at our institution, andwritten informed consentwas obtained from all subjects. No crossovers occurred between the treatment groups after allocation.Neither thepatientnor thesurgeonwasblindedas to the typeof the procedure performed, but two independent investigators, who did not knowwhich treatment the patients had undergone, performed the 1-, 3-, 6-, 12-, 18-, 24-, and 36-mo follow-up. Perioperative outcome measures included operation time; changes in serum sodium, haemoglobin, and haematocrit levels; the need for blood transfusion; resected tissueweight; transurethral resection(TUR) syndrome; intraoperativeandpostoperative irrigation; recovery room stay; and the duration of catheterisation and hospitalisation. Postoperative outcome measures included IPSS with quality of life (QoL) scores, the International Index of Erectile Function (IIEF)-5 questionnaire, Qmax, postvoid residual urine (PVRU) volume, prostate-specific antigen (PSA) level, and sexual function at each visit on follow-up. Postoperative urodynamic pressure flow assessments, digital rectal examination, and TRUSmeasurementsof prostatevolumewere also performed at 6-, 12-, 18-, 24-, and 36-mo follow-up. Operative time was calculated as the time during which the resectoscope sheath was within the urethra. All perioperative and postoperative adverse events were recorded, and all parameters were compared at baseline and each postoperative visit between the two groups. 2.2. Surgical procedures Each procedure was performed by one of three experienced surgeons (ZZ, GZ, or WZ) in our Department of Urology. Each of the surgeons was skilled in transurethral plasmakinetic resection of the prostate and standard TURP. All the procedureswere performed using a Karl Storz 26F continuous-flow resectoscope (Karl Storz, Tuttlingen, Germany), and the patients were under epidural anaesthesia and placed in a lithotomy position. The PKEP procedure was performed using the Gyrus Plasmakinetic SuperPulse System (Gyrus Medical, Cardiff, UK) with PlasmaSect electrodes and operated with a cutting power of 160 W and a coagulating power of 80 W. We used a technique similar to HoLEP, which was previously designed by Hochreiter et al [6]. In essence, the enucleation was begun bymaking marks with a cutting loop at the distal edge of the prostate lobes and the proximal edge of the external sphincter muscle. A circular incision on the urethral mucosa was made along the marks and deep into the surgical capsule until clear transverse fibres were seen. The tip of resectoscope sheath was then inserted from the circular incision line at the 5 o’clock and 7 o’clock positions tomake a cleavage plane between the detached lobe and the capsule. The resectoscope sheath moved in the cleavage plane just as the surgeon’s index finger does when performing open prostatectomy, and the detachment area was extended to the lateral and forward sides. Meanwhile, themedian and the lateral prostatic lobeswere dissected away from the surgical capsule in a retrograde fashion from the prostate apex towards the bladder. During these steps, haemostasis can be achieved with coagulation if bleeding on the established plane occurs. Thus, the prostatic lobes were subtotally enucleated and devascularised but still connected to the bladder neck by a narrow pedicle. Finally, these devascularised lobes were fast-fragmented with the plasmakinetic cutting loop into pieces small enough to be evacuated through the resectoscope sheath (ie, the ‘‘mushroom’’ technique [6]). During PKEP, 0.9% saline solution was used as irrigation fluid in all cases. The TURP procedure was performed with 27040 electrodes and a standard tungsten cutting wire loop at a setting of 160-W cutting and 80-W coagulating current. The resection was started at the bladder neck at the 6 o’clock position, extending to the verumontanum, and carried down to the surgical capsule, with complete removal of the prostatic stroma. At the end of both procedures, a 22F three-way Foley catheter was inserted into the bladder with a closed drainage system. All retrieved tissue was collected and examined histopathologically. All patients had full blood count, serum electrolytes, and haemoglobin and haematocrit levels measured immediately after the procedure. Postoperative bladder irrigation with physiologic saline solution was applied as necessary until the efflux was sufficiently clear. A single experienced urologist at our institution, who had no knowledge of the treatments the patients had received, decided catheter removal for all cases. It is our institution’s policy that the catheters be removed within 24 h after irrigation was stopped, and the patients were then discharged from the hospital within 24 h after decatheterisation and passing clear urine. No patients were discharged after 6:00 PM. Within those 24 h, we routinely observe the colour of the urine drained from the catheters to ensure completely clear urine after stopping the irrigation and to assess the frequency and volume of micturition after removing the catheter, respectively. Table 1 – Baseline characteristics of eligible patients Parameters All patients (n = 204), mean � SD (range) PKEP group (n = 102), mean � SD (range) TURP group (n = 102), mean � SD (range) p value Age, yr 67.7 � 6.4 (49–86) 67.3 � 6.6 (49–86) 67.8 � 6.4 (51–84) 0.54 TRUS prostate volume, ml 68.4 � 12.2 (30–158) 69.2 � 13.5 (35–158) 67.5 � 11.8 (30–150) 0.32 Serum PSA, mg/ml 2.26 � 1.2 (0.13–4.07) 2.20 � 1.1 (0.19–4.0) 2.28 � 1.13 (0.13–4.07) 0.36 IPSS 22.8 � 4.3 (13–35) 23.2 � 4.7 (15–35) 22.4 � 4.3 (13–35) 0.10 QoL score 4.6 � 0.7 (3–6) 4.5 � 0.7 (3–6) 4.8 � 0.8 (3–6) 0.21 IIEF score 19.4 � 5.1 (7–25) 19.3 � 4.6 (7–25) 19.6 � 4.8 (7–25) 0.64 Haemoglobin, g/dl 15.6 � 1.3 (10.2–18.4) 15.5 � 1.7 (10.8–18.4) 15.8 � 1.8 (10.2–18.4) 0.30 Serum sodium, mmol/l 143.1 � 1.2 (141.7–146.2) 143.6 � 1.5 (141.7–146.2) 142.7 � 1.8 (141.9–145.3) 0.55 Qmax, ml/s 8.2 � 1.8 (2–14) 8.3 � 2.0 (2–4) 8.0 � 1.6 (2–14) 0.43 PVRU volume, ml 94 � 32 (42–186) 92 � 33 (45–180) 97 � 36 (42–186) 0.08 PdetQmax, cm H2O 86.4 � 11.3 (45–138) 88.2 � 12.7 (43–138) 84.5 � 11.2 (45–136) 0.38 Sha¨fer grade 3.9 � 1.2 (2–6) 3.8 � 1.3 (2–6) 4.0 � 1.2 (2–6) 0.11 PKEP = plasmakinetic enucleation of the prostate; TURP = transurethral resection of the prostate; SD = standard deviation; TRUS = transrectal ultrasound; PSA = prostate-specific antigen; IPSS = International Prostate Symptom Score; QoL = quality of life; IIEF = International Index of Erectile Function; = d E U RO P E AN URO LOGY 5 8 ( 2 0 1 0 ) 7 5 2 – 7 5 8754 2.3. Statistical analysis Assuming a two-sided significance test with significance level a = 0.05 for the current study, with our sample size of 102 cases per group, the estimated power was 90%. Baseline characteristics and perioperative data between the two groups were compared by means of the Mann- Whitney test. Postoperative adverse events were compared by means of the two-tailed x2 test. The Friedman test was used to compare preoperative and postoperative parameters within each group. Statisti- cal significance was considered at p < 0.05 for all analyses. 3. Results The histologic finding was BPH in all PKEP and TURP cases. There was no statistically significant difference in any preoperative parameters between the two arms (Table 1). Table 2 shows that significant differences favouring PKEP were seen in the resected tissue weight, perioperative irrigation, haemoglobin loss and haematocrit decrease, recovery room stay, catheter duration, and hospital stay. Treatment efficacy is detailed in Table 3. There were significant improvements of IPSS, QoL, Qmax, and PVRU by Qmax = maximum urinary flow rate; PVRU = postvoid residual urine; PdetQmax both modalities at each postoperative assessment com- pared with baseline. However, no statistically significant Table 2 – Perioperative data of the patients in the two groups Parameters PKEP group, mean � SD (ran Operative time, min 62.8 � 18.6 (35–120) Intraoperative irrigation volume, l 11.7 � 4.5 (9–18) Resected tissue weight, g 56.4 � 12.8 (32–102) Decrease in haemoglobin, g/dl 0.74 � 0.33 (0–1.88) Decrease in haematocrit, g/dl 0.03 � 0.01 (0.004–0.08) Decrease in sodium, mmol/l 1.36 � 0.83 (0.57–3.77) Recovery room stay, min 67.3 � 11.1 (25–125) Catheter duration, h 51.7 � 26.3 (26–156) Hospital stay, h 98.4 � 20.4 (60–168) Postoperative irrigation volume, l 18.5 � 7.6 (0–41) Postoperative irrigation time, h 16.6 � 5.2 (0–32) PKEP = plasmakinetic enucleation of the prostate; TURP = transurethral resection * The postoperative sodium level was the value that was measured immediately surgery, with serum sodium levels of 119 mmol/l and 122 mmol/l, respectively. disparities were identified in postoperative IPSS, QoL, Qmax, or PVRU between the two groups at 1, 3, and 6 mo. Table 3 also reveals that there were statistically significant differ- ences in favour of PKEP with regard to improvements in postoperative mean PSA reduction at 6 mo, TRUS volume and Scha¨fer grade decreases after 6 mo, and detrusor pressure at Qmax (PdetQmax) reduction after 12mo of follow- up, respectively. Preoperatively, 39 (38.2%) PKEP and 43 (42.2%) TURP patients had potency sufficient for intercourse. Neither PKEP nor TURP caused significant changes in erectile potency postoperatively (Table 4). In the study, 10 patients (9.8%) in the PKEP group and 12 patients (11.8%) in the TURP group experienced a self-limiting urinary irritation postop- eratively. Two patients in the PKEP arm and three patients in the TURP armwere diagnosedwith urinary tract infection (UTI). Urine cultures in these patients were positive, and the irritative symptoms eased after the sensitive antibiotics were used for 3–7 d. Urethral strictures occurred in three patients in the TURP arm, but there was no such occurrence in the PKEP arm. All these strictures required dilatation in the office without internal urethrotomies. Two patients in etrusor pressure at Qmax. each group developed transient incontinence without intrinsic sphincter deficiency by urodynamic evaluation, ge) TURP group, mean � SD (range) p value 55.3 � 21.2 (27–110) 0.13 15.4 � 6.2 (11–24) 0.017 43.8 � 15.5 (24–83) <0.001 1.88 � 1.06 (0.84–3.73) <0.001 0.07 � 0.03 (0.02–1.24) <0.001 1.67 � 1.0* (0.49–4.3) 0.12 82.0 � 16.4 (20–140) <0.001 80.5 � 31.6 (48–164) <0.001 134.2 � 31.5 (84–136) <0.001 30.0 � 11.4 (13–70) <0.001 25.3 � 8.5 (10–62) <0.001 of the prostate; SD = standard deviation. after the surgery. Two patients developed hyponatraemia at 8 h and 13 h after The sodium decreases in these patients were not included. Table 3 – Follow-up data stratified by treatment Parameters PKEP TURP p value Patients, no. Mean � SD (range) Change, % Patients, no. Mean � SD (range) Change, % IPSS Preoperative 102 23.2 � 4.7 (15–35) – 102 22.4 � 4.3 (13–35) – 0.12 1 mo 102 6.9 � 4.2 (0–16) �70.3 102 6.7 � 3.7 (1–15) �70.1 0.56 3 mo 102 5.5 � 4.8 (1–14) �76.3 102 5.3 � 4.1 (0–14) �76.3 0.86 6 mo 102 4.8 � 3.7 (0–12) �79.3 102 5.0 � 4.1 (1–14) �77.7 0.55 12 mo 102 3.4 � 2.4 (0–13) �85.3 102 5.1 � 4.4 (1–14) �77.2 0.004 18 mo 95 2.8 � 2.1 (0–11) �87.9 97 4.6 � 3.6 (1–13) �79.5 <0.001 24 mo 91 2.3 � 1.8 (0–9) �90.1 89 4.5 � 2.8 (1–12) �79.9 <0.001 36 mo 87 2.4 � 2.2 (0–9) �89.7 83 4.3 � 2.9 (1–10) �80.8 <0.001 QoL score Preoperative 102 4.5 � 0.7 (3–6) – 102 4.8 � 0.8 (3–6) – 0.18 1 mo 102 2.4 � 1.5 (1–6) �46.7 102 2.8 � 2.3 (0–6) �41.7 0.25 3 mo 102 1.8 � 1.8 (0–6) �60 102 2.0 � 1.6 (0–5) �58.3 0.32 6 mo 102 1.2 � 1.1 (0–5) �73.3 102 2.2 � 1.6 (1–6) �54.2 <0.001 12 mo 102 1.0 � 0.8 (0–4) �77.8 102 1.6 � 1.6 (0–5) �66.7 <0.001 18 mo 95 0.6 � 0.4 (0–3) �86.7 97 1.8 � 1.5 (0–5) �62.5 <0.001 24 mo 91 0.8 � 0.6 (0–3) �82.2 89 1.5 � 1.4 (0–4) �68.8 <0.001 36 mo 87 0.6 � 0.5 (0–3) �86.7 83 1.6 � 1.4 (0–4) �66.7 <0.001 Qmax, ml/s Preoperative 102 8.3 � 2.0 (2–14) � 102 8.0 � 1.6 (2–14) – 0.37 1 mo 102 22. 6 �7.3 (7–41) +172.3 102 23.5 � 7.2 (6–39) +173.3 0.60 3 mo 102 23.8 � 7.5 (8–43) +186.7 102 23.5 � 7.6 (7–39) +173.3 0.83 6 mo 102 25.5 � 7.9 (9–49) +207.2 102 20.8 � 6.5 (6–37) +141.9 <0.001 12 mo 102 28.1 � 9.4 (10–50) +238.6 102 26.7 � 7.6 (9–49) +210.5 0.27 18 mo 95 27.4 � 8.4 (10–49) +230.1 97 27.3 � 9.1 (10–50) +217.4 0.29 24 mo 91 29.0 � 10.2 (12–52) +249.4 89 24.6 � 7.7 (11–49) +186.1 <0.001 36 mo 87 28.8 � 10.1 (12–52) +247 83 25.1 � 8.0 (10–50) +191.9 0.017 PVRU volume, m Preoperative 102 92 � 33 (45–180) – 102 97 � 36 (42–186) – 0.06 1 mo 102 10.3 � 9.5 (4–38) �88.8 102 12.4 � 10.2 (2–53) �87.2 0.07 3 month 102 8.7 � 8.3 (3–36) �90.5 102 11.1 � 8.8 (0–50) �88.6 0.08 6 mo 102 6.4 � 6.7 (2–35) �93 102 8.8 � 8.0 (2–50) �91 0.12 12 mo 102 5.0 � 5.6 (0–40) �94.6 102 9.0 � 8.4 (0–48) �90.7 0.014 18 mo 95 5.3 � 5.8 (0–38) �94.2 97 8.2 � 7.9 (3–52) �91.5 0.052 24 mo 91 5.8 � 6.1 (0–35) �93.7 89 6.3 � 5.6 (0–45) �93.5 0.17 36 mo 87 5.0 � 5.7 (0–36) �94.6 83 5.4 � 5.1 (0–41) �94.4 0.39 Serum PSA, ng/ml Preoperative 102 2.20 � 1.1 (0.19–4.0) – 102 2.28 � 1.13 (0.13–4.07) – 0.33 1 mo 102 1.03 � 0.79 (0.04–2.16) �53.2 102 1.17 � 0.11 (0.08–2.39) �48.7 0.10 3 mo 102 0.96 � 0.52 (0.02–1.67) �56.4 102 1.04 � 0.83 (0.08–1.66) �54.4 0