Benign Prostatic Hyperplasia (BPH) is a common

Transcription

1 Photomedicine and Laser Surgery Volume 35, Number 6, 2017 ª Mary Ann Liebert, Inc. Pp DOI: /pho Photoselective Vaporization of the Prostate Using 120 W High Performance System: A Prospective Evaluation of Results Over 2 Years Alper Eken, 1 Ergun Alma, MD, 2 Durmus Alparslan Demirci, MD, 2 Meltem Açıl, 3 Taner Arpacı, 4 and Bülent Soyupak 5 Abstract Purpose: This study evaluated the safety and efficacy of photoselective vaporization of prostate using the 120 W High Performance System for management of symptomatic benign prostatic hyperplasia (BPH). Methods: We prospectively obtained data from 229 patients between January 2009 and December We evaluated the serum prostate specific antigen level, International Prostate Symptom Score (IPSS), prostate volume; maximum urine flow rate (Q max ); and postvoid residual urine volume (PVR) in the patients at presentation and on followup at 1, 6, 12, and 24 months. The mean duration of the surgery, energy used, hospital stay, and intra- and postoperative complications were assessed. Results: The mean age of the patients was years, and the mean preoperative size of the prostate was ml. The mean duration of the surgery was min, and the mean energy use was kj. The mean time to removal of the urinary catheter was h, while the mean duration of hospital stay was h. The IPSS declined and mean Q max increased by over twofold within the first month. The PVR also declined significantly in all groups up to 6 months after the surgery and increased slightly thereafter. Urinary urgency and incontinence occurred in two patients, while four patients developed urinary strictures. Between 12 and 24 months after the surgery, four patients underwent repeat surgery. Conclusions: Our findings show that photoselective vaporization is safe and effective for the management of BPH and resulted in few complications. It yielded improvements in all parameters that were sustained even up to 2 years after the surgery. Keywords: photoselective vaporization, 120 W HPS laser, benign prostatic hyperplasia, transurethral resection of prostate, GreenLight Introduction Benign Prostatic Hyperplasia (BPH) is a common clinical entity in urological practice. Estimates reveal that BPH affects tens of millions of men worldwide and occurs in about 25% of all men in their fifties, 30% in their sixties, and in 50% of men aged 80 years. 1 BPH causes lower urinary tract symptoms of varying severity and significant deterioration in the quality of life (QoL), similar to that produced by hypertension and cardiac disease. 2 Reports indicate that the annual treatment costs of BPH total around US$ 3.9 million in the United States. 3 With increasing population, especially of the elderly, it is likely that the incidence of BPH and the healthcare costs associated with it will increase in future. Transurethral resection of prostate (TURP), pioneered in the early 1900s, is regarded as the gold standard in the surgical management of BPH. However, this technique can result in a number of acute (such as arterial or venous hemorrhages, urinary tract infection, and TUR syndrome, characterized by dilutional hyponatremia caused by irrigation fluids used in the surgery) or long-term complications (urethral stricture, retrograde ejaculation, and urinary incontinence). 4,5 In view of these, a number of novel techniques have been advanced in the recent years, like the Transurethral Holmium Laser Ablation of the Prostate (HoLAP), Transurethral Holmium Laser Enucleation of the Prostate (HoLEP), Holmium Laser Resection of the Prostate (HoLRP), Transurethral Incision of the Prostate (TUIP), 1 Vocational School of Health Services, Acibadem University, Istanbul, Turkey. 2 Adana Numune Teaching and Research Hospital, Urology, Adana, Turkey. 3 Department of Anesthesiology, Acibadem University, Istanbul, Turkey. 4 Department of Radiology, Acibadem University, Istanbul, Turkey. 5 Acibadem Adana Hospital, Urology, Adana, Turkey. 300

2 PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE 301 Prostate volume Number of patients, n (%) Table 1. Perioperative Parameters Among the Groups Mean lasing time (min) Mean operating time (min) Mean energy use (kj) Mean time to catheter removal (h) Mean duration of hospital stay (h) Less than 80 cc 161 (70.3) cc 49 (21.4) More than 100 cc 19 (8.3) Transurethral Vaporization of the Prostate (TUVP), as well as photoselective vaporization of the prostate (PVP). Comorbidities and concomitant medication use increase the surgical risks in about 10 15% of patients with BPH, in whom minimizing the operative time and blood loss becomes a priority. Techniques as the PVP may offer an effective alternative in this population, as revealed by reports from other regions. 6 No systematic study has investigated the utility of PVP in BPH patients with surgical risks in our region, and our study attempts to fill this gap. In this study, we report the findings on the application of PVP in the management of BPH and long-term follow-up of 229 patients receiving this treatment in our hospital over a 2-year period. Methods Patients A total of 229 patients presenting to the urology clinic of our hospital with a diagnosis of BPH between January 2009 and December 2012 formed the prospective study cohort. Following a detailed history taking, all patients underwent systematic clinical examination. The laboratory investigations included routine urinalysis, ultrasonography, serum prostate specific antigen (PSA), and uroflowmetry to calculate maximal flow rate (Q max ). The severity of urinary symptoms was assessed using the International Prostate Symptom Score (IPSS). Before the surgery, 50 (22%) of the patients were using aspirin, while coumadin and clopidogrel usage percentage were 16 (7%) and 5% of patients, respectively. Patients on anticoagulant medication were suspended from using aspirin 7 days before surgery and allowed to proceed 7 days after the surgery. Warfarin use was suspended for about 5 days and then started again to normalize the international normalized ratio, which was considered normal at <1.3. Surgery was allowed for patients with values near normal (range, ). Patients with a history of prostate cancer, neurological disorders, or spinal cord injury were excluded from the study. Anesthesia All the patients underwent spinal anesthesia with 10 mg bupivacaine and added doses of 10 lg fentanyl and if needed (prolongation of the surgery time and patient s anxiety) sedation was given. Surgical technique All the procedures were done by the same highly trained and experienced urologist. A 120 W High Performance System (HPS) (American Medical System, Incorporation, MN) was used for performing the surgery. The side firing ADD StatÔ laser fiber was placed in the cavity with the double sheath mirror (22.5F, 30 ), and physiological saline was used as the irrigation fluid. The distance between the optical fiber side hole and the prostate tissue was *0.5 mm. The vaporization begins from the median lobe, the ADD optical fiber is continuously swept left and right, vaporization gradually proceeds up to the verumontanum, places the bottom part of the anterior urethra in the same plane as the bladder trigone, and vaporizes the lobes on both sides up to the prostate capsule. The procedure was done as reported earlier by Chen et al. 6 Parameters observed We assessed the surgical operative time, total energy used, duration of indwelling catheter use, duration of hospital stay, and early and delayed postoperative complications. The IPSSs were reassessed during follow-up at 1, 6, 12, and 24 months following the surgery. During the followup, Q max, postvoid residual volume, serum PSA level, occurrence of complications, and requirement for additional medications were evaluated. Statistical analysis Statistical Package for the Social Sciences (SPSS, Inc., Chicago, IL) v.19.0 software package (IBM Corp.) was used to perform statistical tests. Statistical results were presented FIG. 1. Intraoperative view of the prostatic urethra after vaporization.

3 302 EKEN ET AL. Table 2. Comparison of IPSS Among the Patient Groups Before and After Photoselective Vaporization of the Prostate Category of prostate volume Baseline IPSS Postoperative IPSSs Less than 80 cc cc More than 100 cc IPSS, International Prostate Symptom Score. as mean standard deviation along or as a percentage of total patients. Results Preoperative parameters All the data were collected prospectively. A total of 229 patients formed the study cohort. The average age of the patient was years (range, years). The mean PSA level of the patients was ng/ml (range, ng/ml). All the subjects had moderate-to-severe symptoms, as revealed by the IPSSs ranging from 14 to 35 ( ). A total of 72% of patients received alphablockers preoperatively, while 4% received 5-alpha reductase inhibitors and 8% received a combination of these. The preoperative prostate volume ranged from 20 to 160 cc ( cc). A total of 161 (70.3%) patients had a prostate volume <80 cc, while it ranged between 80 and 100 cc for 49 (21.4%) patients, and >100 cc in 19 (8.3%) patients (Table 1). Indications for surgery in patients with small glands were significantly lower than Q max values measured with uroflowmetry with no response to alpha adrenergic blocker treatment. Before surgery, the mean value of the maximal flow rate (Q max ) among the cohort was m/s (range, m/s), while the postvoid residual urine volume (PVR) volumes ranged from 10 to 380 ml ( ml). Intraoperative observations The mean operating time among all patients was min (range, min). The mean lasing time and operating time were lowest in patients with prostate volume <80 cc and highest in those who had prostates sized >100 cc (Table 1). The average energy use during the procedure was kj (range, kj). The mean energy use was kj among patients with prostate volumes <80 cc and increased to and kj, with increases in prostate volumes to and >100 cc, respectively (Table 1). Figure 1 is showing view of the prostatic urethra after vaporization. A total of five patients (2.2%) required conversion of the operative procedure to TURP during the surgery, while one patient had capsular perforation. Postoperative observations The average time to catheter removal was h (range, h), while the mean duration of hospital stay was h (range, h), among all patients. As shown in Table 1, the mean time to catheter removal and duration of hospital stay was lowest among patients with a preoperative prostate volume <80 cc (19.74 and h, respectively). In patients with prostate volumes between 80 and 100 cc, these times were and h, respectively, while the corresponding durations were and h in patients with prostates larger than 100 cc (Table 1). During the period from hospital discharge to 1 month after surgery, 10 (4.4%) patients developed transient urinary retention, while 27 (11.8%) complained of urinary urgency. Urinary infection developed in 14 (6.1%) of the patients during this period, while 3 (1.3%) had urge incontinence. During the period from 1 to 6 month after the surgery, two (0.9%) patients each developed urinary urgency and urinary tract infection (UTI). Between 6 and 12 months postsurgery, four (1.8%) patients developed urinary stricture. Repeat surgery was required in four (1.8%) patients between 12 and 24 months after the initial operation. The incontinences were urge incontinence, and all were pad free with anticholinergic treatment. Two of the urethral stenosis were meatal stenosis in which during cystoscopy sheath was hardly inserted with the narrowing of external meatus. As shown in Table 2, all patient groups showed significant reduction in the IPSS from preoperative levels, as early as 1 month after the surgery. The low IPSS continued up to 24 months after the surgery, which was the last point of follow-up. Table 3. Comparison of Q max Measurements Among the Patient Groups Before and After Photoselective Vaporization of the Prostate Category of prostate size Baseline Q max Postoperative Q max scores Less than 80 cc cc More than 100 cc Q max, maximum urine flow rate.

4 PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE 303 Category of prostate volume Table 4. Comparison of PVR Measurements Among the Patient Groups Before and After Photoselective Vaporization of the Prostate Baseline PVR Postoperative measurement of PVR Less than 80 cc cc More than 100 cc PVR, postvoid residual urine volume. The mean value of Q max increased to 15 ml/s in all age groups from the first month after surgery. The measurements increased by over twofold from the baseline scores and were comparable across the patient groups. The increase was sustained even at the follow-up after 24 months (Table 3). Similarly, the mean values of PVR also reduced over 33% by 1 month after PVP, across all patient groups. The values decreased even further by the 6th month after surgery, but showed an increase in all groups during the follow-up at 12th and 24th months (although remaining well below the baseline) (Table 4). When evaluated at 12 months after PVP, the mean serum PSA level decreased from to ng/ml in the group with prostate volumes >100 cc. The group with prostate sizes between 80 and 100 cc showed a reduction from 5.16 to 2.56 ng/ml, while the mean value decreased from 2.74 to 1.48 in the group with smaller prostates at this time point. Discussion PVP is fast emerging as an alternative to TURP for surgical management of BPH. Many reports have earlier reported on its safety and efficacy. 6 9 The present study summarizes observations on the safety and efficacy of PVP using 120 W HPS laser in 229 patients attending our tertiary care hospital and the results of the follow-up over 24 months. Computed tomography showing prostatic urethra 2 years after vaporization is shown in Fig. 2. The study cohort included patients in the age range years and with prostate volumes ranging from 20 to 160 cc. Despite concomitant use of medications, including alphablockers, 5a-reductase inhibitor (ARI), or combinations thereof, PVP was completed successfully in all patients except five whose disease necessitated TURP. The average operating time in this study was min, which seems to be greater than that reported earlier by Choi et al. 10 who used 120 W HPS laser for BPH surgery. However, the mean energy use and duration of catheterization in the present study were comparable to his findings. Mosli et al. 11 had reported lesser durations of operative time, as well as hospital stay, earlier. Dyachuk 12 recently reported comparable clinical efficacy of PVP with TURP, when prostate volume was 80 ml, and superior clinical efficacy of the former in patients with larger prostates. Batura et al. 13 in a study comparing both methods observed that complication rates (15.4%) were comparable among patients who underwent PVP with 120 W HPS and TURP. Among the patients who underwent PVP, 4.3% required repeat surgery, while urethral stricture developed in 3.4%. In the present study, complications mostly occurred in the first month after the surgery, included transient urinary retention, urinary infection, urgency, and urge incontinence, and resolved eventually. Our findings appear to be in consonance with the observations of Teng et al. 14 of low occurrence of complications following PVP. Four patients in the present series required repeat surgery between 12 and 24 months after PVP. This seems to agree with the observations by Teng et al. 14 on re-interventions following PVP. In a meta-analysis of six randomized control trials and five case control studies, Ding et al. 15 observed no significant differences in IPSS, Q max, QoL, and PVR between patients who underwent TURP and PVP. Teng et al., 14 in a metaanalysis, reported no significant difference among Q max,pvr, and IPSS between TURP and PVP at 1 month after the procedures, which was also maintained at 6 months of followup. Zang et al., 16 in a recent meta-analysis, observed no significant differences between PVP and TURP in terms of QoL, Q max, IPSS, and PVR among the recipients of both methods, when followed up at 1, 3, 6, 12, and 24 months later. In the present study, PVP using 120 W HPS effectively reduced the IPSS within 1 month in the group of patients with prostate volume <80 cc, while reductions occurred in patients with larger prostates (Table 2). This is greater than that reported in a study by Capitán et al. 17 who undertook a randomized controlled trial comparing PVP and TURP. FIG. 2. Computed tomography showing prostatic urethra 2 years after vaporization.

5 304 EKEN ET AL. In the present study, Q max values increased by over 2.2-fold compared to the preoperative measurements in all groups. The change was comparable across all patient groups, and the enhancement was maintained at all points of follow-up. This appears to agree with earlier reports by Capitánetal. 17 A comparable reduction of over 1.8-fold in mean serum PSA level also occurred from the preoperative levels, across all patient groups, when evaluated at 12 months after PVP. The present study revealed a short duration of catheterization and time to discharge from hospital in patients treated by PVP. This is in consonance with similar observations by Capitán et al., 17 Lukacs et al., 18 Pereira-Correia et al., 19 Ding et al., 15 Tasci et al., 20 and Zang et al. 16 Conclusions Findings from our study reveal that PVP using 120 W HPS laser is a safe and effective option in patients on anticoagulant medications and is associated with a lower incidence of complications. This technique induced sustained improvements in subjective and objective parameters associated with BPH and had a shorter time to removal of urinary catheter and overall hospital stay. However, we believe that it is essential to confirm the novelty of this procedure with more prospective studies, such as ours. Author Disclosure Statement No competing financial interests exist. References 1. Kramer G, Mitteregger D, Marberger M. Is benign prostatic hyperplasia (BPH) an immune inflammatory disease? Eur Urol 2007;51: Srivastava A, Gupta VB. Various treatment options for benign prostatic hyperplasia: a current update. J Midlife Health 2012;3: Wei JT, Calhoun E, Jacobsen SJ. Urologic diseases in America project: benign prostatic hyperplasia. J Urol 2005;173: Mayer EK, Kroeze SG, et al. Examining the gold standard : a comparative critical analysis of three consecutive decades of monopolar transurethral resection of the prostate (TURP) outcomes. 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Photoselective vaporization with the green light laser vs transurethral resection of the prostate for treating benign prostate hyperplasia: a systematic review and meta-analysis. BJU Int 2013;111: Ding H, Du W, Lu ZP, Zhai ZX, Wang HZ, Wang ZP. Photoselective green-light laser vaporization vs. TURP for BPH: meta-analysis. Asian J Androl 2012;14: Zang YC, Deng XX, Yang DR, et al. Photoselective vaporization of the prostate with GreenLight 120-W laser versus transurethral resection of the prostate for benign prostatic hyperplasia: a systematic review with meta-analysis of randomized controlled trials. Lasers Med Sci 2016;31: Capitán C, Blazquez C, Martin MD, Hernandez V, de la Pena E, Llorente C. GreenLight HPS 120-W laser vaporization versus transurethral resection of the prostate for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia: a randomized clinical trial with 2-year follow-up. Eur Urol 2011;60: Lukacs B, Loeffler J, Bruyère F, et al. Photoselective vaporization of the prostate with GreenLight 120-W laser compared with monopolar transurethral resection of the prostate: a multicenter randomized controlled trial. Eur Urol 2012;61: Pereira-Correia JA, de Moraes Sousa KD, Santos JB, et al. GreenLight HPSÔ 120-W laser vaporization vs transurethral resection of the prostate (<60 ml): a 2-year randomized double-blind prospective urodynamic investigation. BJU Int 2012;110: Tasci AI, Tugcu V, Sahin S, Zorluoglu F. Rapid communication: photoselective vaporization of the prostate versus transurethral resection of the prostate for the large prostate: a prospective nonrandomized bicenter trial with 2-year follow-up. J Endourol 2008;22: Address correspondence to: Alper Eken Department of Urology Acıbadem Adana Hospital Cumhuriyet Cad. No. 66 Adana Turkey alpereken@yahoo.com Received: October 14, Accepted after revision: November 26, Published online: May 25, 2017.