Kemal Ener, M.D., Koray Agras, M.D., Mustafa Aldemir, M.D., Emrah Okulu, M.D., and Onder Kayigil, M.D.

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1 JOURNAL OF ENDOUROLOGY Volume 23, Number 7, July 2009 ª Mary Ann Liebert, Inc. Pp DOI: =end The Randomized Comparison of Two Different Endoscopic Techniques in the Management of Large Bladder Stones: Transurethral Use of Nephroscope or Cystoscope? Kemal Ener, M.D., Koray Agras, M.D., Mustafa Aldemir, M.D., Emrah Okulu, M.D., and Onder Kayigil, M.D. Abstract Purpose: Endoscopic treatment of large bladder stones via cystoscope is still bothersome, and open cystolithotomy is the preferred method in many centers. To gain more insight into the endoscopic bladder stone management, we aimed to compare the transurethral use of nephroscope and cystoscope randomly. Patients and Methods: Forty-three male patients with bladder stones were randomized into two groups, to perform nephroscopic (group 1, n ¼ 22) and cystoscopic (group 2, n ¼ 21) stone fragmentation procedures transurethrally. Combined pneumatic=ultrasonic lithotripsy device was used in both groups to fragment the bladder stones. Results: The mean stone size in group 1 and group 2 was cm and cm, respectively ( p > 0.05). Stone fragments were removed completely in all of the patients, and the mean operation time was calculated as minutes in group 1 and minutes in group 2, with no intraoperative complications ( p < 0.01). None of the patients developed urethral stricture disease in the early (postoperative third month) follow-up. Three patients with previously known urethral stricture disease have shown to have the same disease in the late (postoperative months) follow-up. Conclusion: Treatment of large bladder stones by transurethrally placed nephroscope is a fast and effective treatment modality compared to endoscopic treatment via cystoscope. Nephroscope allows for use of larger forceps and facilitates collection of large stone fragments through its 24F sheath. It also prevents multiple entries to the urethra and hence avoids possible urethral injury. Combined pneumatic=ultrasonic lithotripsy device, with its aspiration quality, enables the surgeon to gain a better endoscopic view during both procedures. Introduction Bladder stones generally affect men and correspond to 5% of all urinary system stones. 1 Predisposing factors for bladder stones in adults are the presence of bladder outlet obstruction, neurogenic urinary disorder, urinary infection, and foreign bodies in the bladder. 2,3 Of men operated for benign prostatic hyperplasia (BPH), 1% to 2% have bladder stones. Most bladder stones are of mixed type, and in the presence of infection, the major constituent is struvite stone. However, calcium oxalate and uric acid stones are also common. 4 Various methods are in use today for the treatment of bladder stones. Nevertheless, determining the treatment method is based on factors such as the stone size, location, and constituents as well as patients history of treatment for bladder stones, the age and body structure of the patient, accompanying diseases, treatment cost, and preference of the surgeon. When all of these factors are evaluated, the endoscopic method seems to be the most frequently preferred modality in adults compared to percutaneous and open cystolithotomy, or extracorporeal shock wave lithotripsy (SWL). Differences in the efficiency, cost, and complication rates have been observed to date in the treatment of bladder stones with endoscopic methods. Mechanical, electrohydraulic, pneumatic, ultrasonic, and laser lithotripsy are the endoscopic methods of bladder stone management used in selected patients. 5 7 With recent advances in endourological devices, the success rate of bladder stone treatment has increased significantly; 2nd Urology Clinic, Ataturk Teaching and Research Hospital, Ankara, Turkey. 1151

2 1152 ENER ET AL. however, the rate of complications and hospitalization time vary according to the treatment method used. After a decision is made for the treatment method, bladder is penetrated by transurethral or suprapubic way. 8 Generally, intervention through transurethral way is made using a cystoscope, and after the stones are fragmented, evacuation of the resultant fragments requires a long time, because the lumen of the cystoscope is narrow. In this study, the management of large bladder stones by transurethrally placed nephroscope and that by cystoscope are compared. Patients and Methods The study involved 43 male patients who applied to the urology outpatient clinic of our hospital between March 2006 and July 2008, and were determined to have bladder stones greater than 1 cm by abdominal ultrasonography. The patients were randomly assigned into two groups. In group 1 (n ¼ 22), the procedures were applied with transurethral use of 24F nephroscope (Karl Storz, Tuttlingen, Germany). In group 2 (n ¼ 21), 22F cystoscope (Karl Storz) was placed transurethrally. All procedures were performed by the same surgeon (Agras K) under general anesthesia in lithotomy position. Combined pneumatic=ultrasonic lithotripsy (PUL) device (Lithoclast Master Electro-Medical Systems, Nyon, Switzerland) was used in all patients for stone fragmentation, and the small stone fragments were aspirated using the same device. The large fragments that could not be aspirated were individually removed by means of an alligator forceps without removal of the nephroscope sheath from the urethra in group 1. In group 2, all the stone fragments were broken into very small pieces and then these small stone particles were removed by bladder irrigation through cystoscope lumen. Four patients in group 1 and six patients in group 2 who were found to have urethral stricture were subjected to internal urethrotomy before the stone fragmentation procedure, but the time spent for this urethrotomy was not included in the total operation time. Those 10 patients were all primary cases and they had soft, annular, noncomplicated strictures at the bulbous urethra. Similarly, five patients in group 1 and seven patients in group 2 who were found to have BPH were performed transurethral resection of prostate after the stone fragmentation. The time spent for transurethral resection of prostate was not included in the total operation time. On the postoperative first day, plain graphy or ultrasonography was obtained for all of the patients to evaluate residual stone fragments. The stone analysis was made through X-ray crystallography method. To evaluate the possible presence of postoperative urethral stricture disease, all of the patients were evaluated with retrograde urethrogram or uroflowmetry in the postoperative third month (early intervention). In addition, patients were invited to our outpatient clinic to perform uroflowmetry, as of January 2009 (late intervention), but four patients (three in group 1 and one in group 2) could not be reached and three patients did not accept further intervention because they had no complaints. Statistical comparison of both groups was performed by Mann-Whitney U-test. Statistical analyses were performed using SPSS (Chicago, IL) for Windows software (version 11.5). Differences were accepted to be statistically significant at p Results The mean age of the patients was years in group 1 and years in group 2 ( p ¼ 0.752). The mean stone size of the patients in group 1 was cm (range, cm; median 3.7 cm) and that in group 2 was cm (range, cm; median, 3.5 cm) ( p ¼ 0.789) (Table 1). The predisposing factor for bladder stone formation was urethral stricture in 10 patients, BPH in 16 patients, neurogenic bladder dysfunction in 13 patients, and idiopathic in 4 patients. Stone fragments were removed completely in all of the patients, and the mean operation time was minutes in group 1 and minutes in group 2. The difference between the mean operation time of two groups was statistically significant ( p < 0.01). No intraoperative complications were observed in any of the patients. None of the patients developed urethral stricture disease in the postoperative third month. Only 36 (83.7%) patients could be assessed for the late intervention, and the mean follow-up was months. During the late follow-up, three patients had mild complaints of urination, and uroflowmetry showed decreased flow rates. All of these three patients (one in group 1 and two in group 2) had urethral stricture disease preoperatively. The place and the length of the repeated stricture were almost the same as detected by preoperative urethrogram. There was no stone recurrence in any of the patients. In group 1, only one transurethral access was made throughout the entire procedure via nephroscope in all patients (100%). In group 2, all the stones were removed in only 8 of 21 (38.1%) patients at a single access using a cystoscope. Two transurethral entries were needed in the remaining 13 patients (Table 1). The analysis of stone composition showed that in group 1, 14 patients had whewellite, 6 patients had uric acid, and 2 patients had struvite stones, and in group 2, 12 patients had whewellite, 5 patients had struvite, and 4 patients had uric acid stones. Discussion Evaluation of the treatment modalities to manage bladder stones indicate advantages and drawbacks of each stone fragmentation method. SWL, with its high rate of stone frag- Table 1. Comparison of Both Groups for Age, Stone Size, Operation Time, and the Number of Transurethral Access Group 1 (n ¼ 22) Group 2 (n ¼ 21) p-value Age (years) Stone size (cm) Operation time a (minutes) Transurethral access a (# of accesses) Transurethral access (# of patients) One 22 (100%) 8 (38.1%) Two 0 (0%) 13 (61.9%) a Statistically significant.

3 TWO DIFFERENT TECHNIQUES IN LARGE BLADDER STONES 1153 mentation, seems as an advantageous method; however, the passage of residual fragments is prolonged, and it is not possible to remove especially the large and very hard stones with only one intervention. 9,10 Electrohydraulic lithotripsy (EHL) is highly effective in stone fragmentation, but a better visual control of the bladder is required during the procedure. Otherwise, 1.9% of the patients may suffer bladder rupture. 2 In addition, potential hemorrhage that may occur during EHL renders endoscopic imaging difficult. Ultrasonic lithotripsy is a more reliable method than EHL in stone fragmentation and is advantageous because it enables simultaneous aspiration of the stone fragments. However, the time spent for stone fragmentation with ultrasonic lithotripsy is longer than that with EHL. 11 Pneumatic lithotripsy has been widely used and is an effective method of stone fragmentation; it is also cost effective. Cystolitholapaxy is based on mechanical stone fragmentation with the use of stone fragmentation forceps. It is technically difficult and has a complication rate of 9% to 25%. 8 With the introduction of more effective and safer endourological devices in recent years, this technique has lost popularity. In the management of large bladder stones in particular, holmium: yttrium aluminum-garnet laser technology was reported to have low rates of complications and be a safe and effective method in the recent years. Nevertheless, this method is not yet available in all centers and is an expensive treatment method Despite the advances in endourology, in the case of bladder stones in children and adults with heavy stone burden, open cystolithotomy still remains the main treatment modality in developing countries. 15 As in the case of endoscopic surgery, anesthesia and hospitalization is required for the open surgery. In a retrospective research, Mahran and Dawaba randomized 52 boys with bladder stones into two groups to implement open cystolithotomy and endourological treatment. At the end of the treatment, the stones of all patients have been removed. The hospital stay was significantly less after endourologic procedures than after open surgery, but time of the surgery was similar in both groups. 16 In another study by Bhatia and Biyani, 128 patients with vesical stones were treated with open surgery (5 patients), manual litholopaxy (80 patients), and SWL (43 patients). Open surgery resulted in 100% stone removal at one setting, but required the longest hospital stay (5.2 days). Manual litholopaxy had the biggest complication rate (25%) with a mean hospital stay of 2.4 days. SWL had the shortest hospital stay (20 hours), but additional procedures were needed in four patients. 8 In all endoscopic stone fragmentation methods, the main aim is to achieve a stone-free state with a short operation time and a complication-free procedure. In selected patients, transurethral intervention with nephroscope seems to be the method that widely satisfies these objectives. Nephroscope has a larger lumen than cystoscope, and this specialty enables easy removal of the fragmented stones through its lumen. Use of PUL device to fragment the stones right after and its aspiration quality will facilitate better endoscopic view. To evacuate larger stone fragments that cannot be aspirated, nephroscope sheath could be kept in the urethra, preventing the need for multiple entries to the bladder throughout the entire procedure. However, in the case of cystoscope, the removal of larger stone fragments necessitates pulling the cystoscope out together with the stone at its tip to the urethral meatus. Fragmented stones may damage the urethra during this process, especially when they escape from the grasping forceps, because at this time surgeon would need to make an additional maneuver to grasp or fragment the stone in the urethra. In addition, reinserting the cystoscope after every fragmented stone removal has an additional risk for urethral trauma. For that reason, the surgeon has to fragment the bladder stone as much as possible while using the cystoscope to avoid forceps use and to evacuate small fragments by irrigation and aspiration. This brings up problems of cystoscope use: (1) longer operation time (the need for further stone fragmentation) and (2) worsening visual quality during the procedure parallel to the amount of stone fragmentation. However, as in percutaneous nephrolithotomy (PCNL), nephroscope enables the use of larger and stronger stone retrieval forceps and hence the fragmented stones can be removed more effectively in a shorter time compared to using forceps of cystoscope. The need for further stone fragmentation and the need for bladder irrigation aspiration are less with the use of nephroscope. Maheshwari (1998) reported significantly shorter operation time when Amplatz sheath was placed in the urethra. 17 In that study, bladder stones of female patients were fragmented through transurethral method after urethral dilatation, and keeping the Amplatz sheath in the urethra was reported to be an effective and safe method. The female urethra is shorter than the male urethra, and it has a larger lumen. Thus, it is easier to use endoscopic techniques in women. The same method was also successfully used in men with bladder stones. Okeke and coworkers have presented transurethral penetration with a nephroscope using an Amplatz sheath in the urethra as a novel minimally invasive technique in the management of large bladder stones without a need for open or percutaneous cystolithotomy. They achieved urethral dilatation up to 30F using Amplatz dilatator or balloon dilatation in five patients with high load of stones who were at risk for surgical complications. 18 After leaving the Amplatz sheath in the urethra and using 26F nephroscope, they applied transurethral penetration through this sheath and performed ultrasonic stone fragmentation. They have concluded that stone remnants are easily irrigated through nephroscope and Amplatz sheath and that larger fragments that cannot be evacuated can easily be collected with grasping forceps. No intraoperative or postoperative complications were noted in their study on this group of patients with high risk of surgery. The method used in this study was not evaluated for operation time; however, when used in patients with stones of a mean size of 6.7 cm, the method has provided successful outcomes. Recently, there is an increase in the number of publications that deal with the mini PCNL technique, which is considered to decrease the kidney and body wall trauma, in the treatment of kidney stones. Mini PCNL was first developed for children and reported in ,20 The technique is achieved with a miniaturized instrument through a smaller sheath for patients with stones measuring 2 cm. However, the use of mini PCNL is restricted when stones larger than 2 cm need to be extracted. 21 For stones larger than 2 cm, it was not able to replace the standard PCNL, in which larger access sheath and instruments are used. It is also possible to observe a similar relationship for large bladder stones. With its positive contribution to the duration of the surgery, using larger sheaths and endoscopes in bladder is our preferred treatment modality,

4 1154 ENER ET AL. which provides a better irrigation flow and vision, and allows the use of larger forceps to gather large fragmentations. As in all of the endoscopic interventions, a potential complication of transurethral method in the treatment of bladder stones is the traumatic injury of the urethral lumen. This complication may develop depending on the device used and the size of the stone. In our study, no such complications were noted in the early follow-up period. In the late follow-up, in 10 patients with previously known urethral stricture disease, only 3 (30%) developed recurrence. Our high success rate of 70% after internal urethrotomy may be contributed to the soft, annular, and noncomplicated structure of these strictures in our study population. The knowledge that the strictures at the bulbous urethra that are less than 1.5 cm in length and not associated with dense, deep spongiofibrosis (i.e., straddle injuries) can be managed with internal urethrotomy with a 74% and moderately long-term success rate is consistent with our findings. 22 In addition, neither the cystoscope nor the nephroscope caused the development of new urethral stricture disease in the late follow-up in patients with no urethral stricture preoperatively. Although we did not observe any difference between group 1 and group 2 in terms of postoperative incidence of urethral stricture, studies designed with higher number of patients may reveal different results in the future. We believe that because cystoscope use necessitates more transurethral entries, as in our study, than nephroscope use does, the development of urethral stricture disease with cystoscope may be more likely. However, the use of larger nephroscope sheath may cause the same result. We had no difficulty in assessing the stone by nephroscope in patients with BPH. However, this procedure may be difficult in some patients with a higher bladder neck. For that reason, a new instrument with a softer tip and longer body, similar to a nephroscope, should be developed for the management of bladder stones through urethral access. Conclusions Evacuation of large bladder stones by the transurethral method, using a nephroscope, combined with a PUL fragmentation device, is a fast and effective treatment modality. Nephroscope allows the use of larger forceps such as alligator forceps and facilitates collection of large stone fragments. In addition, a combined PUL device prevents the blurry vision with its aspiration quality, and enables the surgeon to gain a better endoscopic view, which facilitates stone fragmentation. Thereby, the use of this device has positive contributions to the efficiency of the method and operation time. In the group that was intervened with a nephroscope, the total number of transurethral entries was smaller than that of the group intervened with a cystoscope, which suggests that potential long-term urethral stricture complications may be reduced by the use of this method. Disclosure Statement No competing financial interests exist. References 1. Schwartz BF, Stoller ML. The vesical calculus. Urol Clin North Am 2000;27: Bulow H, Frohmuller HGW. Electrohydraulic lithotripsy with aspiration of fragments under vision-304 consecutive cases. J Urol 1981;126: Teichman JM, Rogenes VJ, McIver BJ, Haris JM. Holmium: yttrium-aluminum-garnet laser cystolithotripsy of large bladder calculi. Urology 1997;50: Grenabo L, Hedelin H, Petterson S. Adherence of urease induced crystals to rat bladder epithelium. Urol Res 1988; 16: Menon M, Resnick MI. Urinary lithiasis: Etiology, diagnosis, and medical management. In: Walsh PC, Retik AB, Vaughan ED, Wein AJ (eds). Campbell s Urology, 8th edition. Philadelphia: W.B. Saunders, 2002, pp Drach GW. Urinary lithiasis: Etiology, diagnosis, and medical management. In: Walsh PC, Retik AB, Stamey TA, Vaughan ED (eds). Campbell s Urology, 6th edition. Philadelphia: W.B. Saunders Co, 1992, pp Ebert A, Stangl J, Kuhn R, et al. The frequency-doubled double-pulse Neodym:YAG laser lithotripter (FREDDY) in lithotripsy of urinary stones. First clinical experience. Urologe A 2003;42: Bhatia V, Biyani CS. A comparative study of cystolithotripsy and extracorporeal shock wave therapy for bladder stones. Int Urol Nephrol 1994;26: Vandeusen H, Baert L. Extracorporeal shock wave lithotripsy monotherapy for bladder stones with the second generation lithotriptors. J Urol 1990;143: Hausmann R, Klein-Fischer C, Sommerer E, Raucenwald M. ESWL of bladder stones: Hobby or alternative option? J Endourol 1996;10:S Stone NN. Bladder calculi. In: Seidmon EJ, Hanno PM (eds). Current Urologic Therapy, 3rd edition. Philadelphia: W.B. Saunders, 1994, pp Matsuoka K, Iida S, Nakanami M, Koga H, Shimada A, Mikangi T, Noda S. Holmium:ytrrium-aluminium garnet laser for endoscopic lithotripsy. Urology 1995;45: Yang SS, Hong J. Electrohydraulic lithotripsy of upper ureteral calculi with semirigid ureteroscope. J Endourol 1996; 10: Loisides P, Grasso M, Bagley DH. Mechanical impactor employing nitinol probes to fragment human calculi: Fragmentation efficiency with flexible endoscope deflection. J Endourol 1995;9: Papatsoris AG, Varkarakis I, Dellis A, Deliveliotis C. Bladder lithiasis: From open surgery to lithotripsy. Urol Res 2006;34: Mahran MR, Dawaba MS. Cystolitholapaxy versus cystolithotomy in children. J Endourol 2000;14: Maheshwari PN. The Amplatz sheath in the female urethra: A safe and effective approach for cystolitholapaxy. Br J Urol 1998;82: Okeke Z, Shabsigh A, Gupta M. Use of Amplatz sheath in male urethra during cystolitholapaxy of large bladder calculi. Urology 2004;64: Jackman SV, Hedican SP, Docimo SG, Peters CA. Miniaturized access for pediatric percutaneous nephrolithotomy. J Endourol 1997;11: Helal M, Black T, Lockhart J, Figueroa TE. The Hickman peel-away sheath: Alternative for pediatric percutaneous nephrolithotomy. J Endourol 1997;11: Lahme S, Bichler KH, Strohmaier WL, Götz T. Minimally invasive PCNL in patients with renal pelvic and calyceal stones. Eur Urol 2001;40:

5 TWO DIFFERENT TECHNIQUES IN LARGE BLADDER STONES Jordan GH, Schlossberg SM. Surgery of the penis and urethra: Urethral stricture disease. In: Walsh PC, Retik AB, Vaughan ED, Wein AJ (eds). Campbell s Urology, 9th edition. Philadelphia: W.B. Saunders Co, 2007, vol. 1, pp Address correspondence to: Kemal Ener, M.D. 2nd Urology Clinic Ataturk Teaching and Research Hospital Ankara Turkey Abbreviations Used BPH ¼ benign prostatic hyperplasia EHL ¼ electrohydraulic lithotripsy PCNL ¼ percutaneous nephrolithotomy PUL ¼ pneumatic=ultrasonic lithotripsy SWL ¼ extracorporeal shock wave lithotripsy kemalener75@yahoo.com kemalener75@hotmail.com

JMSCR Vol 04 Issue 10 Page October 2016

JMSCR Vol 04 Issue 10 Page October 2016 www.jmscr.igmpublication.org Impact Factor 5.244 Index Copernicus Value: 83.27 ISSN (e)-2347-176x ISSN (p) 2455-0450 DOI: https://dx.doi.org/10.18535/jmscr/v4i10.40 Combined Bladder Stones Removal: In