Federal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after. THEM. Sechenov Ministry of Health of Russia (Sechenov University) Research Institute of Uronephrology and Human Reproductive Health Comparison of the effectiveness of thulium laser enucleation of prostate adenoma and retropubic adenomectomy P.V. Glybochko, Yu.G. Alyaev, L.M. Rapoport, D.V. Enikeev, M.E. Enikeev, L.G. Spivak, O.Kh. Khamraev, M.Ya. Gaas, I.Sh. Byadretdinov, Zh.Sh. Inoyatov, M.S. Taratkin Author responsible for contacts with the editors: Taratkin Mark Sergeevich e-mail: marktaratkin@gmail.com [mailto:marktaratkin@gmail.com]; tel.: +7 (967) 089-71-54 work postal address: Russian Federation, Moscow, st. Bolshaya Pirogovskaya 2, building 4, index 119991 Introduction For a long time, open retropubic adenomectomy was considered the main method of treating infravesical obstruction caused by benign prostatic hyperplasia (BPH) with a volume of more than 80 cm3 [1,2,3]. The main advantages of the operation were the absence of the need for expensive equipment and a low rate of false relapses of BPH [4]. The negative aspects of the operation included: a long period of hospitalization, in some cases exceeding two weeks; an increased risk of infectious complications compared to transurethral operations, high morbidity [5]. The introduction of holmium laser enucleation of the prostate (HoLEP) into clinical practice changed the structure of surgical treatment of patients with large and giant BPH, since it allowed the complete removal of adenomas with a volume of more than 80 cm3 [5-7]. In recent years, a significant number of studies have been conducted proving the high efficacy and safety of HoLEP in the treatment of BPH [17,18]. The technique has proven itself to be comparatively safe and as effective as retropubic adenomectomy. The false recurrence rate during its implementation does not exceed 5% [2]. The main disadvantage of HoLEP is the high complexity of mastering and a long learning curve (more than 60 operations) [11,18,19]. In this regard, the search for more advanced laser enucleation techniques continues, as promising for the removal of large BPH [6]. Of certain undoubted interest is the thulium laser. Introduced into clinical practice in 2005, thulium laser enucleation today claims a leading position in the removal of large adenomas [8]. The experience of thulium enucleation accumulated in various centers around the world indicates a relatively short learning curve in contrast to HoLEP [20]. The development and creation of a state-of-the-art thulium laser, superior to its Western counterparts in terms of key technical characteristics, has contributed to the spread of the thulium enucleation technique in Russia. The study was designed to evaluate the efficacy and safety of thulium laser enucleation in comparison with traditional retropubic adenomectomy for BPH removal. Materials and Methods A review of case reports of 98 patients treated at the Urology Clinic of Sechenov University from January 2013 to June 2017 was conducted. The first group of patients (n = 40) underwent retropubic adenomectomy, while the second group (n = 58) underwent thulium laser enucleation of the prostate adenoma. Key inclusion criteria: prostate volume greater than 80 cm3; IPSS (International Prostate Symptom Score) > 20; Qmax (maximum urine flow rate) <12 (Table 1). Patients with cystostomy, bladder stones, and prostate cancer were excluded from the study. Preoperative assessment of patients included assessment of functional parameters—IPSS, QoL (quality of life index), Qmax, and residual urine volume. Hemoglobin levels were assessed preoperatively and three days after surgery. Table 1. Results of preoperative examination of patients Retropubic adenomectomy (n=40) Thulium laser enucleation (n=58) Age, years 68.9 ± 3.1 67.2 ± 7.6 Prostate volume, cm3 114.1 ± 38.9 121.1 ± 46.5 IPSS index, score 23.1 ± 1.1 23.5 ± 1.7 QoL, score 3.1 ± 0.5 3.0 ± 0.8 Qmax, ml/s 7.1 ± 2.5 7.6 ± 2.9 Residual urine volume, ml 108.2 ± 45.5 106.5 ± 47.9 To perform thulium laser enucleation of the prostate, we used: a resectoscope No. 26 Ch, providing low pressure of irrigation fluid (type Iglesias) with continuous irrigation and a working element equipped with a channel for passing a laser fiber, firms Karl Storz (Germany), Richard Wolf (Germany), ELEPS (Russia); thulium fiber laser "Urolaz" (NTO "IRE-POLUS", Russia) with a power of 120 W and a wavelength of 1940 nm; laser fiber with a light-carrying core diameter of 600 ?m. Operations were performed at an average laser radiation power of 60 W. When working in the area of ????the seminal tubercle, the radiation power was reduced to 30 W (a preventive measure to maintain continence). Removal of adenomatous tissue was performed using a cystoscope with a straight working channel (working channel diameter 5 mm) and morcellators "Piranha" (Richard Wolf, Germany) or ELEPS (Russia). The laser enucleation technique involves sequential enucleation of the lobes of hyperplastic prostate tissue (middle, left lateral, and right lateral, similar to the holmium enucleation technique): an endoscope is inserted into the bladder, followed by passage of a laser fiber through the laserscope channel; incisions are made in the bladder neck area toward the seminal tubercle at the five- and seven-o'clock positions in the folds between the medial and lateral lobes of hyperplasia; the incisions are then combined proximally in front of the seminal tubercle, and the middle lobe is gradually displaced into the bladder; incisions are made through the entire thickness of the hyperplastic tissue to the circular fibers of the prostate capsule. Enucleation of the left lobe of prostatic hyperplasia begins with an incision at the five-o'clock position from the bladder neck to the level of the seminal tubercle, reaching the fibers of the prostate capsule. The incision is widened at the level of the surgical capsule. The incision is performed counterclockwise to the two o'clock position. Next, an incision is made at twelve o'clock along the capsule from the bladder neck to the level of the seminal tubercle, completing the enucleation of the left lobe and then displacing it into the bladder. The right lobe of the gland is enucleated similarly. The endoscope is moved clockwise. In the second stage of the surgery, the hyperplastic tissue is morcellated, then aspirated from the bladder. It is worth noting that the thulium laser effectively separates prostate tissue and, if the enucleation layer is lost, quickly restores it, unlike holmium enucleation, where restoration of the layer takes a significant amount of time. This advantage of the thulium fiber laser is due to two of its main features compared to holmium. Firstly, the radiation of the thulium fiber laser, due to the wavelength of 1.94 ?m, penetrates into tissue only to a small depth (no more than 0.2 mm) [16]. Secondly, the thulium fiber laser has a continuous nature of radiation, while the radiation of the holmium laser is pulsed. Because of this, vapor bubbles are formed at the end of the laser fiber, which rupture the prostate tissue [11]. Therefore, the incision performed with the thulium fiber laser is more precise, which allows for a quick return to the layer. Retropubic adenomectomy is preceded by drainage of the bladder with a Foley urethral catheter. Access to the space of Retzi is achieved through a lower midline incision, separation of the rectus abdominis muscles and dissection of the prevesical fascia. The prevesical tissue together with the bladder is displaced cranially. The anterior surface of the bladder neck and prostate are mobilized. The prostate gland is sutured and ligated, capturing the prostate vessels above and below the intended transverse incision. The lateral and middle lobes of hyperplasia are enucleated. The sutures are not cut (the future second row of sutures). The prostatic urethra is removed after its transection, along with the hyperplastic tissue of the prostate lobes. Several sutures are placed on the posterior lip of the bladder neck for eversion and hemostasis, and the bladder is drained with a three-way catheter. The prostate gland is closed with a double-layer suture. The space of Retzius is drained through a counter-opening. The wound is sutured layer by layer. Results: The average duration of both surgeries was comparable (p>0.05), and the mass of adenomatous tissue removed during both procedures did not differ statistically (p>0.05). In patients who underwent retropubic adenomectomy, a significant decrease in hemoglobin levels (by 3.2 g/dL) was observed on the third postoperative day compared to thulium fiber laser enucleation (by 1.0 g/dL). The duration of catheterization after retropubic adenomectomy averaged 9.4 days, while in most patients (79%) after thulium laser enucleation, the catheter was removed within the first day. Table 2. Comparison of intra- and postoperative parameters Retropubic adenomectomy (n=40) Thulium laser enucleation (n=58) p Average duration of surgery, min 109.3 ± 8.1 96.3 ± 21.9 p> 0.05 Average weight of removed tissue, (g) 99.1 ± 21.4 98.7 ± 38.2 p> 0.05 Duration of catheterization, (days) 9.4 ± 1.4 1.4 ± 0.8 p<0.01 Duration of hospitalization, (days) 12.1 ± 1.3 2.8 ± 0.6 p<0.01 Decrease in hemoglobin level, g/dl 3.2 ± 1.0 1.4 ± 0.7 p<0.05 A follow-up examination was conducted after 6 months; IPSS, QoL, Qmax, and residual urine volume were assessed. All parameters demonstrated significant improvement in both groups (p<0.05), indicating elimination of infravesical obstruction caused by BPH. No significant differences were found between the groups (p>0.05) (Table 3). Table 3. Comparison of functional parameters of the lower urinary tract 6 months after surgery Retropubic adenomectomy (n=40) Thulium laser enucleation (n=58) p I-PSS, score 8.1 ± 2.4 7.5 ± 2.1 p>0.05 QoL, score 1.9 ± 0.6 1.9 ± 0.3 p>0.05 Qmax, ml/s 16.1 ± 4.1 15.7 ± 3.3 p>0.05 Residual urine volume, ml 11.1 ± 8.3 10.9 ± 6.9 p>0.05 Patients with complaints of stress urinary incontinence underwent a pad test to assess the degree of incontinence. Mild stress urinary incontinence occurred in 2 patients (3.4%) after thulium fiber laser enucleation and in 1 patient (2.5%) after retropubic adenomectomy. Urgent urinary incontinence developed in 4 patients (10.0%) after open adenomectomy, compared with 1 patient (1.7%) after thulium enucleation. Significant complications included an episode of postoperative bleeding that occurred after retropubic adenomectomy and required a blood transfusion. Table 4. Postoperative complications according to the Clavien-Dindo classification Complication Grade Retropubic adenomectomy (n=40) Thulium laser enucleation (n=58) Urinary tract infection, N (%) I 7 (7.5) 2 (3.4) Stress urinary incontinence, N (%) I 1 (2.5) 2 (3.4) Urge urinary incontinence, N (%) I 4 (10.0) 1 (1.7) Postoperative bleeding, N (%) I 1 (2.5) 1 (1.7) Acute urinary retention, N (%) II 1 (2.5) - Bleeding requiring blood transfusion, N (%) II 1 (2.5) - Discussion During the six-month postoperative follow-up, all patients noted a significant improvement in the quality of urination, regardless of the type of surgery, which was confirmed by the improvement in all functional indicators of the lower urinary tract (IPSS, QoL, Qmax, residual urine volume). Compared with retropubic adenomectomy, thulium enucleation leads to a significant decrease in blood loss, both during surgery and in the postoperative period. This is reflected in a significantly smaller decrease in postoperative hemoglobin levels in patients who underwent laser enucleation, compared with patients who underwent retropubic adenomectomy. Moreover, during open surgery, an episode of postoperative bleeding was noted, which required a transfusion of blood components. Similar results were obtained in a number of studies [9-13]. Thus, in the work of Bach et al. it is noted that a lower level of blood loss both during thulium enucleation and in the postoperative period can be associated with the continuously generated wave of the thulium laser, smoothly dissecting and vaporizing tissues, and this, in turn, contributes to a better hemostatic effect [10]. It should be noted that, in addition to good hemostasis, the small penetration depth (no more than 2 ?m) and the continuous nature of the radiation lead to precise and instant tissue excision [11, 12]. This allows for the removal of adenomatous nodes with virtually no damage to the underlying tissues. Our study revealed that postoperative complications were less common with thulium enucleation than with retropubic adenomectomy. Thus, the incidence of postoperative urgent urinary incontinence was significantly lower, and there were no episodes of bladder hemotamponade. The duration of stress urinary incontinence did not exceed 2-3 months. Since thulium enucleation is a minimally invasive endoscopic technique that does not involve opening the urinary tract, the duration of catheterization rarely exceeded 1-2 days, which reduces the risk of infectious catheter-associated complications. A number of studies [13-15] devoted to thulium enucleation confirm our data; Most authors agree that thulium enuleation is an effective and relatively safe method for removing large prostatic hyperplasia [13, 14, 16]. Low morbidity, low incidence of bleeding and postoperative complications makes it accessible to virtually all patient groups. Conclusions: Despite the equally high efficacy of retropubic adenomectomy and ThuLEP in eliminating infravesical obstruction caused by BPH, the number of complications after open surgery is higher than after ThuLEP. Moreover, thulium enucleation allows patients to return to a normal rhythm of life more quickly, does not require (like any endoscopic surgery) the installation of safety drains during surgery, and significantly reduces the duration of hospitalization and rehabilitation. Such circumstances allow us to consider thulium laser enucleation a highly effective minimally invasive technique for the treatment of large benign prostatic hyperplasia (more than 80 cm3). References 1. Herrmann T.R., Bach T., Imkamp F., Georgiou A., Burchardt M., Oekle M., et al. Thulium laser enucleation of the prostate (ThuLEP): transurethral anatomical prostatectomy with laser support. Introduction of a novel technique for the treatment of benign prostatic obstruction. World J Urol. 2010; 28(1): 45-51. 2. Han M., Partin A.W. Retropubic and suprapubic open prostatectomy. In: Kavoussi L.R., Novick A.C., Partin A.W., Peters C.A., eds. Campbell-Walsh Urology, 10th edition, Vol. 4, Chapter 94. Philadelphia: Elsevier, Saunders, 2012; 2696. 3. Galeev R.Kh., Atryaskin S.V., Galeev Sh.R. Modern approaches to the treatment of large prostate adenoma. Bulletin of modern clinical medicine. 2014; 7(1): 13-16. 4. Aslan D., ?m?r G.K., Yakup K., ?smet Y., Ayta? V.B., Hakan V. Open vs Laparoscopic Simple Prostatectomy: A Comparison of Initial Outcomes and Cost. J Endourol. 2016; 30(8): 884-889. 5. Gravas S B. T., Bachmann A, Drake M, Gacci M, Gratzke C, et al. Management of Non-Neurogenic Male Lower Urinary Tract Symptoms (LUTS), incl. Benign Prostatic Obstruction (BPO) // EAU Guidelines on. Eur Assoc Urol. ? 2016. 6. Naspro R., Suardi N., Salonia A., Scattoni V., Guazzoni G., Colombo R., et al. Holmium laser enucleation of the prostate versus open prostatectomy for prostates >70 g: 24-month follow-up. Eur Urol. 2006; 50(3): 563–8. 7. Kuntz R.M., Lehrich K., Ahyai S.A. Holmium laser enucleation of the prostate versus open prostatectomy for prostates greater than 100 grams: 5-year follow-up results of a randomized clinical trial. Euro Urol 2008; 53(1): 160–8. 8. Fried N.M., Murray K.E. High-power thulium fiber laser ablation of urinary tissues at 1.94 microm. J Endourol. 2005; 19(1): 25– 31. 9. Ketan PV, Prashant HS. Thulium laser enucleation of the prostate is a safe and a highly effective modality for the treatment of benign prostatic hyperplasia - Our experience of 236 patients. Urol Ann. 2016 Jan-Mar; 8(1): 76–80. 10. Bach T., Wezel F., Haecker A., ??Gross A.J., Michel M.S. 70 vs 120 W thulium:yttrium-aluminum-garnet 2 microm continuous-wave laser for the treatment of benign prostatic hyperplasia: a systematic ex-vivo evaluation. BJU Int. 2010; 106(3): 368-72. 11. Teichmann H. O., Herrmann T. R., Bach T. Technical aspects of lasers in urology. World J Urol. 2007; 25(3): 221-5. 12. Wei H. B., Zhuo J., Sun X. W., Pang K., Shao Y., Liang S. J., et al. Safety and efficacy of thulium laser prostate resection for the treatment of benign prostatic hyperplasia in large prostates. Lasers Med Sci. 2014; 29(3): 957-63. 13. Enikeev D. V., Glybochko P. V., Alyaev Yu. G., Rapoport L. M., Sorokin N. I., Enikeev M. E., et al. Laser enucleation of prostatic hyperplasia (HoLEP and ThuLEP): comparative analysis of efficacy in the treatment of recurrent prostatic hyperplasia. Urology. 2017; 4: 50-54. 14. Kyriazis I., ?winiarski P.P., Jutzi S., Wolters M., Netsch C., Burchardt M., et al. Transurethral anatomical enucleation of the prostate with Tm:YAG support (ThuLEP): review of the literature on a novel surgical approach in the management of benign prostatic enlargement. World J Urol. 2015; 33(4): 525-30. 15. Enikeev D.V., Glybochko P.V., Alyaev Yu.G., Rapoport L.M., Enikeev M.E., Spivak L.G., Tsarichenko D.G., Sorokin N.I., Sukhanov R.B., Dymov A.M., Khamraev O.Kh., Gaas M.Ya., Taratkin M.S. Endoscopic enucleation of the prostate gland is a new standard for surgical treatment of prostatic hyperplasia. Andrology and genital surgery. 2017;18(3):83-88. DOI:10.17650/2070-9781-2017-18-3-83-88. 16. Enikeev D.V., Glybochko P.V., Alyaev Yu.G., Rapoport L.M., Vinarov A.Z., Enikeev M.E., Sorokin N.I., Spivak L.G., Sukhanov R.B., Dymov A.M., Khamraev O.Kh., Taratkin M.S., Vinnichenko V.A. Modern laser technologies in the surgical treatment of prostate hyperplasia. Urology. 2017. No. 1. P. 108-113 17. Enikeev D.V., Glybochko P.V., Alyaev Yu.G., Rapoport L.M., Enikeev M.E., Tsarichenko D.G., Sorokin N.I., Sukhanov R.B., Dymov A.M., Khamraev O.Kh., Davydov D.S., Taratkin M.S., Simberdeev R.R. Holmium laser enucleation (HOLEP) for prostate hyperplasia of small, large and giant sizes. Practical recommendations. Experience of more than 450 operations. Urology. 2016. No. 4. P. 63-69. 18. Krambeck AE, Handa SE, Lingeman JE. Holmium laser enucleation of the prostate for prostates larger than 175 grams. J Endourol. 2010 Mar;24(3):433-7. doi:10.1089/end.2009.0147 19. Brunckhorst O, Ahmed K, Nehikhare O, Marra G, Challacombe B, Popert R. Evaluation of the Learning Curve for Holmium Laser Enucleation of the Prostate Using Multiple Outcome Measures. Urology. 2015 Oct;86(4):824-9. doi: 10.1016/j.urology.2015.07.021. Epub 2015 Aug 4. 20. Saredi G, Pirola GM, Pacchetti A, Lovisolo JA, Borroni G, Sembenini F, Marconi AM. Evaluation of the learning curve for thulium laser enucleation of the prostate with the aid of a simulator tool but without tutoring: comparison of two surgeons with different levels of endoscopic experience. BMC Urol. 2015 Jun 9;15:49. doi: 10.1186/s12894-015-0045-2. Научно-практический журнал "Вопросы урологии и андрологии", 2017, том 5, №4