Prospective randomized comparison of three endoscopic modalities used in treatment of bladder stones

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1 UJ ISSN Urologia 2016 ; 00 ( 00): 000=000 DOI: /uro Original RESEARCH article Prospective randomized comparison of three endoscopic modalities used in treatment of bladder stones Ankur Bansal, Manoj Kumar, Satyanarayan Sankhwar, Sunny Goel, Madhusudan Patodia, Ruchir Aeron, Ved Bhaskar King George Medical University, Lucknow, Uttar Pradesh - India Abstract Introduction: The aim of this study was to compare three endoscopic modalities used in the treatment of bladder stones: transurethral use of cystoscope or nephroscope and percutaneous cystolithotripsy (PCCL). Methods: This study included 210 patients of bladder stone treated at a tertiary care centre in North India from January 2006 to July 2013 who were randomly assigned into three groups: group 1 (transurethral removal using cystoscope), group 2 (transurethral removal using nephroscope) and group 3 (PCCL). Baseline and perioperative data wererecorded and compared between three groups. Results: Baseline parameters were comparable between the three groups. Operating time in group 2 was significantly less than the other two groups. Complete clearance was achieved in all the patients. Group 2 had maximum number of urethral entries. The incidence of perioperative complications (fever, transient haematuria and persistent leakage from suprapubic site) was comparable between these three groups. Till the last follow-up, 3.2% patients (n = 2) developed urethral stricture in group 1, 7.8% (n = 5) in group 2 and no patient developed urethral stricture in group 3 (p = 0.068). Conclusions: Removal of bladder stones by the transurethral route, using a nephroscope, is the most effective treatment modality in terms of operative time with long-term urethral stricture rate similar to transurethral cystoscope technique. Comparatively, PCCL is a safe procedure with acceptable morbidity. Overall, all three techniques are equally efficacious in treating bladder stones of size 1-4 cm. Keywords: Bladder stones, cystoscope, nephroscope, percutaneous cystolithotripsy, transurethral Introduction Bladder stones account for 5% of all urinary stones in developed countries. The incidence is much higher in developing countries (1). The traditional method of treatment was open suprapubic cystolithotomy, which is still recommended for large stones (2). However, with the advances in endourology, majority of bladder stones are managed by endoscopic transurethral approach using intracorporeal lithotripters such as electrohydraulic lithotripsy, ultrasound lithotripsy, Swiss pneumatic lithoclast and holmium: yttrium-aluminium-garnet laser (Ho: YAG laser). Transurethral removal of bladder stones using a nephroscope has been recently performed and has Accepted: March 8, 2016 Published online: April 9, 2016 Corresponding author: Ankur Bansal, MS Department of Urology King George Medical College Lucknow Uttar Pradesh, India ankurbansaldmc@gmail.com proved to be fast and effective treatment modality as compared withtransurethral cystoscopic approach (3). Principles of percutaneous nephrolithomy (PCNL), that is percutaneous access and tract dilation, can also be applied to bladder stones where rapid and effective removal can be done through suprapubic percutaneous route. This study aimed at comparing three different endoscopic modalities used in the treatment of bladder stones [transurethral removal using cystoscope or nephroscope and percutaneous cystolithotripsy (PCCL)]. Materials and methods This study was conducted at a tertiary care centre in North India from January 2006 to July All patients presenting with bladder calculi who required surgery were enrolled in this study. Informed consent was taken from all the patients. Complete blood count, renal function tests, urine culture and sensitivity, X-ray kidney ureter and bladder (KUB) and ultrasound abdomen were done in all patients. Inclusion criteria were bladder stone of 1-4 cm of size, age 18 years or more and normal renal function. Patients with age less than 18 years, deranged renal function, stone size more than 4 cm, prior history of surgery for bladder stone, pelvic surgery, urinary diversion, bladder tumour or those having urethral stricture were

2 2 Comparison of three modalities used in treatment of bladder stones excluded from the study. Urodynamic study was done when indicated. Patients were randomly allotted into threegroups (using computer-generated simple randomization chart) Group 1: Transurethral removal using cystoscope Group 2: Transurethral removal using nephroscope Group 3: PCCL using nephroscope Surgical technique Prophylactic oral antibiotics were given prior to surgery in all patients. Patients presenting with urinary tract infection were managed with antibiotics preoperatively, and the surgery was postponed till the urine culture became sterile. All patients were operated under spinal anaesthesia by one of the two surgeons (SS or MK). All patients underwent cystoscopy with 19-Fr cystoscope (Karl Storz) to determine the size and number of stones and also to rule out any associated pathology. Group 1 (Transurethral removal using cystoscope) A 22-French (Fr) cystoscope with 30 telescope (KARLZ STORZ Endovision, Inc., Charlton, MA, USA ) was inserted through urethra and fragmentation of stones was done using intracorporeal pneumatic lithotripter (Swiss Lithoclast 2- Richard Wolf, Germany). Evacuation of stone fragments was done by ellik bladder evacuator (BARD, C.R. BARD, INC., New Jersey, US). At the end of procedure, a 16-Fr Foley catheter was inserted perurethrally that was removed on postoperative day 1. Group 2 (Transurethral removal using nephroscope) After inserting adequate 2% lidocaine jelly into the urethra, 22-Fr rigid nephroscope (Richard Wolf) was introduced without sheath into the bladder. The fragmentation of stones was done using intracorporeal pneumatic lithotripter. The nephroscope was then withdrawn followed by reinsertion of 22-Fr cystoscope. Removal of stone fragments was done using ellik evacuator. In case of large fragments thatcould not be evacuated by ellik evacuator, nephroscope was inserted again for further fragmentation and retrieval of fragments was done as described above. At the end of procedure, 16-Fr Foley catheter was inserted perurethrally thatwas removed on postoperative day 1. Group 3 [Percutaneous cystolithotripsy (PCCL) using nephroscope] One centimetre transverse incision was given 2 cm above the pubic symphysis. Through this incision, 18-gauge puncture needle was passed into bladder under transurethral 19-Fr cystoscope guidance. A inch guidewire was then passed through puncture needle following which dilatation of tract was done using telescopic metal dilators and 24-Fr amplatz sheath was placed. A 22-Fr nephroscope was inserted through the amplatz sheath and stone was fragmented with pneumatic lithoclast. Retrieval of fragments was done by stone-grasping forceps. Perurethral and suprapubic catheters were placed at the end of procedure. Suprapubic catheter was removed on postoperative day 1 and urethral catheter was removed on postoperative day 2. Baseline parameters were recorded thatincluded age, gender, mode of presentation, stone size and number of stones. Outcomes The primary outcomes recorded were perioperative complications (fever, transient haematuria and persistent urinary leakage from suprapubic site) and occurrence of urethral stricture. These measures were assessed perioperatively and during follow-up by an independent investigator (NK) blinded to the treatment modality received by each patient. The secondary outcomes recorded were operating time, requirement of additional procedure, type of additional procedure, number of urethral entries, pain score [calculated by visual analogue scale (VAS)], duration of hospital stay and convalescence period. The operative time required for additional procedures was not included in the operative time, which was used for statistical analysis. Pain was assessed at 6 hours postoperatively with VAS measuring 0 to 10 (0 no pain, 10 worst pain). The patients who underwent additional procedures were excluded from further analysis. Stone analysis of all patients wasdone for identification of chemical composition of stones. Follow-up of patients in each treatment was done at 6, 12 and 24 months postoperatively, which included uroflowmetry, ultrasound abdomen and metabolic work-up of the patient. Retrograde urethrogram and urethroscopy were done if urethral stricture was suspected. Fever was defined as a temperature of more than 100 F. Haematuria that persisted for more than 6 hours and had resolved spontaneously by 48 hours was defined as transient hematuria. The return back to public life after surgery was considered as duration of convalescence. Sample size The reported cumulative incidence of perioperative and postoperative complications after endoscopic treatment for bladder stones is 7.4% (4). Assuming 80% power, 5% significance level (α = 0.05, β = 0.20), the minimum sample size per treatment arm required was 66 as per Beth and Robert (5). Statistical analysis One-way analysis of variance (ANOVA) was used to compare continuous data and Fischer exact test was used to analyse categorical data. Intergroup comparison was done to find out the groups between which the difference was statistically significant. This was done by applying post hoc comparison test. Statistical analysis was performed using SPSS, version 16 (Chicago, IL, USA). The statistical significance level used was p<0.05. Results A total of 1054 patients presented with lower urinary tract symptoms were screened for this study and 316 patients of bladder stones were enrolled in this study. One hundred six patients were excluded from the study [patients with age

3 Bansal et al 3 Fig. 1 - Flow of patients during the study period. less than 18 years (n = 23), deranged renal function (n = 9), stone size more than 4 cm (n = 29), prior history of surgery for bladder stone (n = 15), pelvic surgery (n = 6), urinary diversion (n = 3), those having urethral stricture (n = 18) or concurrent bladder tumour (n = 3)]. A total of two hundred ten patients met the inclusion criteria during the study period. These patients were randomly assigned into three groups with 70 patients in each group; 86.7% (n = 182) were male and the rest were female. Figure 1 shows the flow of patients during the study period. Baseline parameters such asage, gender, mode of presentation, stone size and number of stones were comparable between the three groups (Tab. I). Significant difference was observed in mean operating times: group 1 (51.2 ± 23.2 min), group 2 (33.6 ± 7.0 min) and group 3 (47.8 ± 17.6 min). Intergroup comparison showed that the mean operating time in group 2 was significantly lower than the other two groups (Tab. II). Complete clearance was achieved in all the patients. Nineteen patients [group 1 (n = 8), group 2 (n = 6), group 3 (n = 5)] required additional procedures,for example, bladder neck incision and transurethral resection of prostate. These patients were excluded from further analysis. When compared withother groups, group 2 had maximum number of urethral entries. VAS score of Group 3 was significantly higher than Group 2, which in turn was significantly higher than Group 1 (p = 0.001). Postoperative hospital stay and duration of convalescence were significantly more in group 3. The incidence of perioperative complications (fever, transient haematuria and persistent leakage from suprapubic site) was comparable between these three groups. Till the last follow-up, 3.2% patients (n = 2) developed urethral stricture in group 1, 7.8% (n = 5) in group 2 and no patient developed urethral stricture in group 3 (p = 0.068). All these patients had short segment, nonobliterative bulbar urethral stricture and were treated successfully with visual internal urethrotomy. Discussion Bladder stones can be classified into either primary or secondary. The stones that fall from kidney and get lodged in bladder are primary in nature, while secondary stones are formed inside the bladder due to bladder outlet obstruction, indwelling prolonged catheterization, bladder diverticulum, neurogenic bladder trauma, foreign body, etc. Struvite, uric acid and calcium stones are most common type of bladder stones in adults and older people. In our study, the most prevalent stone compositions were struvite and uric acid, which were present in 34.7% (n = 73/210) and 24.2% (n = 51/210) patients, respectively (Tab. I). The possible aetiology of bladder stones could be established in 27% (n = 56) of cases,that is prostatic enlargement (n = 19), history of

4 4 Comparison of three modalities used in treatment of bladder stones Table I - Comparison of baseline parameters and operative outcomes of three groups Parameters Group 1 Group 2 Group 3 p No. of patients Gender (n) Male Female Age (in years) 46.3 ± ± ± Mean ± SD (Range) (21-70) (19-67) (22-69) Mode of presentation Difficulty in voiding Terminal Hematuria Vague abdominal pain Urinary tract infection Acute urinary retention Incidental finding Stone size (in cm) 2.6 ± ± ± Mean ± SD (Range) ( ) ( ) ( ) Number of stones 1.13 ± ± ± Mean ± SD (Range) (1-3) (1-3) (1-3) Operating time 51.2 ± ± ± Mean ± SD (Range) (30-90) (22-48) (29-77) Additional procedures (n) BNI TURP Total Number of urethral entries 1.13 ± ± ± Mean ± SD (Range) (1-2) (2-5) (1-2) VAS score 3.1 ± ± ± Mean ± SD (Range) (1-5) (2-6) (3-7) Early complications (n) Fever Transient hematuria Persistent urinary leakage from suprapubic site Postoperative hospital stay (in days) 1.15 ± ± ± Mean ± SD (Range) (1-2) (1-2) (1-3) Duration of convalescence (in days) 5.6 ± ± ± Mean ± SD (Range) (2-7) (3-8) (4-10) Stone free rate (%) 100% 100% 100% Late complications (n) Urethral stricture Chemical composition of stone (n) Struvite Uric acid Calcium phosphate Calcium oxalate dihydrate/monohydrate Ammonium acid urate Ammonium acid urate + calcium oxalate Ammonium acid urate + uric acid

5 Bansal et al 5 Table II - Intergroup comparison of parameters (whose p value is significant in Table I) to find out the groups between which the difference was actually significant Parameters p value of intergroup comparison Group 1 vs. 2 Group 2 vs. 3 Group 1 vs. 3 Operating time Number of urethral entries VAS score Postoperative hospital stay Duration of convalescence prolonged catheterisation (n = 20), neurogenic bladder (n = 5) and cystocele in females (n = 12) in this study. Patient with bladder stones usually present with painful and intermittent voiding with or without terminal haematuria. Patient may have dull suprapubic discomfort thatis aggravated by sudden movements (6). In our study, the most common presentation was difficulty in voiding in 58.5% (n = 123) and terminal haematuria in 22.8% (n = 48) of patients, respectively. With the advancement in endourology, the majority of bladder stones are managed with endoscopic transurethral approach using intracorporeal lithotripters such as electrohydraulic lithotripsy, ultrasound lithotripsy, Swiss pneumatic lithoclast and Ho:YAG laser (2-3, 7-10). This study aimed at comparing various endoscopic modalities used in the treatment of bladder stones in our hospital. We currently use the pneumatic Swiss Lithoclast for bladder stone fragmentation, as it rapidly fragments all stones irrespective of their density. Moreover, pneumatic Lithoclast is extremely safe, with no reports of urothelial injury during its clinical use (11). Transurethral endoscopic approach is a familiar technique and favoured by most urologists. Using this technique, stones can be fragmented by either mechanical lithotrite or with one of many intracorporeal lithotripsy devices. The mechanical lithotrite is a less favourable option when the stone is more than 2 cm, hard and bladder is of small capacity. Its complication rate varies from 9 to 25% (12, 13). In our study, in group 1, bladder stones were removed using 22-Fr cystoscope combined with pneumatic lithotrite. During cystoscopic fragmentation, there was a decrease in vision quality thatprolonged the duration of fragmentation and led to longer operating time. We observed that the operative time in group 1 was more than the remaining two groups. This procedure was least painful, as VAS score was significantly low in this group. Recently, nephroscope via transurethral route has been increasingly used for removing bladder stones (3, 14). Sathaye et al (14) described the transurethral use of a nephroscope for the treatment of more than 10 cm bladder stones in four patients. All patients were stone free with no complications, concluding that this is an effective method with low morbidity. In group 2, 22-F nephroscope (without sheath) with pneumatic lithotrite was used to fragment the stone. Group 2 had significantly shorter operating time than the other two groups. This can be attributed partly to the better vision provided by the nephroscope and partly to the fact that this method does not require a percutaneous access. Intraoperatively, we kept a slow inflow of saline and stopped intermittently to avoid over distension of bladder. However, when bladder got distended, the bladder was emptied by removing rubber covering over the port inlet of nephroscope. Group 2 had maximum number of mean urethral entries, as 22-Fr cystoscope was inserted for the removal of fragments after removing nephroscope. In case of large fragments thatcould not be evacuated by ellik evacuator, nephroscope was inserted again for further fragmentation and retrieval of fragments. The number of entries into the urethra weremore in earlier phase of study, but as the study progressed, the number of entries were decreased,asthe fragmentation was done at the first occasion before withdrawing the nephroscope. Similar results were seen by Ener et al (3) who compared transurethrally placed nephroscope with transurethral cystoscope for the removal of large bladder stones and demonstrated that the former is a fast and effective treatment modality. PCCL is another treatment option for the removal of bladder stones. It is particularly useful in hard and large stones where transurethral route can lengthen the procedure or can lead to urethral injury. It is an effective and safe procedure in patients with artificially created urinary bladder or anatomical abnormalities of bladder (15-18). PCCL is also a better option than transurethral endoscopic approach in male children, as their urethral calibre is small (19). Recently, Salah et al (20) performed PCCL in 155 children with endemic bladder stones and concluded that it is an effective and safe procedure. Demeriel et al (21) reported the results in PCCL in 72 patients (30 children and 42 adults). The average size of stone was 3.2 cm in children and 5.5 cm in adults. All patients were stone free with no major intra or postoperative complications. In group 3, PCCL was done using 22-Fr nephroscope. Suprapubic percutaneous insertion of amplatz sheath provides excellent view and aids in better fragmentation of the stone. This also decreases prolonged urethral instrumentation. Patients in group 3 experienced more pain in postoperative period than the other two groups probably due to placement of suprapubic catheter, which increases the morbidity as well as the hospital stay of the patient. Hence, group 3 had significantly longer postoperative hospital stay and duration of convalescence. One patient had persistent urinary leakage from suprapubic site thathealed spontaneously after 1 week of catheterisation. A similar study by Kamaljeet et al (22) who also compared these three routes for removal of bladder stone in 67 patients and reported that use of nephroscope via transurethral route is an efficacious and safe method to removal for bladder stones without increase in morbidity. A potential complication of transurethral method in the treatment of bladder stones is the iatrogenic traumatic injury of the urethral lumen. Till the last follow-up, 3.2% patients (n = 2) developed urethral stricture in group 1, 7.8% (n = 5) in group 2 and none in group 3, which was statistically not significant. All these patients had short segment, nonobliterative bulbar urethral stricture and were treated with visual internal urethrotomy. The probable reason of urethral stricture was

6 6 Comparison of three modalities used in treatment of bladder stones prolonged operating time in group 1 and the more number of urethral entries in group 2 that may cause the similar insult as scope size was same in both groups. To conclude, removal of bladder stones by the transurethral route, using a nephroscope, is the most effective treatment modality in terms of operative time with long-term urethral stricture rates similar to transurethral cystoscope technique. Comparatively, PCCL is a safe procedure with acceptable morbidity. Overall, all three techniques are equally efficacious in treating bladder stones of size 1-4 cm. Acknowledgement The authors acknowledge the cooperation of residents of Urology department of King George medical university who participated in appointing the patient and following up. We also appreciate the commitment and compliance of the patient who reported the required data and attended for the regular follow-up. Disclosures Financial support: The authors declared that this study has received no financial support. Conflict of interests: No conflict of interest was declared by the authors. References 1. Zhao J, Shi L, Gao Z, Liu Q, Wang K, Zhang P. Minimally invasive surgery for patients with bulky bladder stones and large benign prostatic hyperplasia simultaneously: a novel design. Urol Int. 2013;91(1): Maheshwari PN, Oswal AT, Bansal M. Percutaneous cystolithotomy for vesical calculi: a better approach. Tech Urol. 1999;5(1): Ener K, Agras K, Aldemir M, Okulu E, Kayigil O. The randomized comparison of two different endoscopic techniques in the management of large bladder stones: transurethral use of nephroscope or cystoscope? J Endourol. 2009;23(7): Al-Marhoon MS, Sarhan OM, Awad BA, Helmy T, Ghali A, Dawaba MS. Comparison of endourological and open cystolithotomy in the management of bladder stones in children. J Urol. 2009;181(6): , discussion Dawson B, Trapp RG. Basic & clinical biostatistics. International edition, 4 th ed. New York: Mc-Graw-Hill;2004. p Papatsoris AG, Varkarakis I, Dellis A, Deliveliotis C. Bladder lithiasis: from open surgery to lithotripsy. Urol Res. 2006;34(3): Schwartz BF, Stoller ML. The vesical calculus. Urol Clin North Am. 2000;27(2): Asci R, Aybek Z, Sarikaya S. Buyukalpelli, Yilmaz A F. The management of vesical calculi with optical mechanical cystolithotripsy and transurethral prostatectomy is it safe and effective? BJU Int. 1999;84: Zhaowu Z, Xiwen W, Fenling Z. Experience with electrohydraulic shockwave lithotripsy in the treatment of vesical calculi. Br J Urol. 1988;61(6): Aron M, Goel R, Gautam G, Seth A, Gupta NP. Percutaneous versus transurethral cystolithotripsy and TURP for large prostates and large vesical calculi: refinement of technique and updated data. Int Urol Nephrol. 2007;39(1): Schulze H, Haupt G, Piergiovanni M, Wisard M, von Niederhausern W, Senge T. The Swiss Lithoclast: a new device for endoscopic stone disintegration. J Urol. 1993;149(1): Bhatia V, Biyani CS. Vesical lithiasis: open surgery versus cystolithotripsy versus extracorporeal shock wave therapy. J Urol. 1994;151(3): Razvi HA, Song TY, Denstedt JD. Management of vesical calculi: comparison of lithotripsy devices. J Endourol. 1996;10(6): Sathaye UV. Per-urethral endoscopic management of bladder stones: does size matter? J Endourol. 2003;17(7): , discussion Cain MP, Casale AJ, Kaefer M, Yerkes E, Rink RC. Percutaneous cystolithotomy in the pediatric augmented bladder. J Urol. 2002;168(4 Pt 2): Lam PN, Te CC, Wong C, Kropp BP. Percutaneous cystolithotomy of large urinary-diversion calculi using a combination of laparoscopic and endourologic techniques. J Endourol. 2007;21(2): Ikari O, Nettó NR Jr, D Ancona CA, Palma PC. Percutaneous treatment of bladder stones. J Urol. 1993;149(6): Wollin TA, Singal RK, Whelan T, Dicecco R, Razvi HA, Denstedt JD. Percutaneous suprapubic cystolithotripsy for treatment of large bladder calculi. J Endourol. 1999;13(10): Ahmadnia H, Younesi Rostami M, Yarmohammadi AA, Parizadeh SM, Esmaeili M, Movarekh M. Percutaneous treatment of bladder calculi in children: 5 years experience. Urol J. 2006; 3(1): Salah MA, Holman E, Khan AM, Toth C. Percutaneous cystolithotomy for pediatric endemic bladder stone: experience with 155 cases from 2 developing countries. J Pediatr Surg. 2005; 40(10): Demirel F, Cakan M, Yalçinkaya F, Demirel AC, Aygün A, Altuğ UU. Percutaneous suprapubic cystolithotripsy approach: for whom? Why? J Endourol. 2006;20(6): Singh KJ, Kaur J. Comparison of three different endoscopic techniques in management of bladder calculi. Indian J Urol. 2011;27(1):10-13.