The effect of Tamsulosin on the quality and complications of Ureteroscopy: A double blind clinical trial

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1 RESEARCH 22(91), May - June, 2018 ISSN EISSN Medical Science The effect of Tamsulosin on the quality and complications of Ureteroscopy: A double blind clinical trial Nader Rashahmadi 1, Heshmatollah Sofimajidpour 2, Ali Saedi 3, Ghobad Moradi 4 1. Urologist, Department of Urology, Faculty of Medicine, Kurdistan University of Medical Sciences, Sanandaj, Iran 2. Associate Professor, Department of Urology, Faculty of Medicine, Kurdistan University of Medical Sciences, Sanandaj, Iran 3. General Practitioner, Faculty of Medicine, Kurdistan University of Medical Sciences, Sanandaj, Iran 4. Associate Professor, Social Determinants of Health Research Center, Kurdistan University of Medical Sciences, Sanandaj, Iran Corresponding Author: Heshmatollah Sofimajidpour, Associate Professor, Department of Urology, Faculty of Medicine, Kurdistan University of Medical Sciences, Sanandaj, Iran. hsmajidpour@gmail.com, Tel: Article History Received: 10 January 2018 Accepted: 27 February 2018 Published: May-June 2018 Citation Nader Rashahmadi, Heshmatollah Sofimajidpour, Ali Saedi, Ghobad Moradi. The effect of Tamsulosin on the quality and complications of Ureteroscopy: A double blind clinical trial. Medical Science, 2018, 22(91), Publication License General Note This work is licensed under a Creative Commons Attribution 4.0 International License. Article is recommended to print as color digital version in recycled paper. Page272

2 ABSTRACT Objective: Ureteroscopy is a common diagnostic and therapeutic approach frequently used in urology. There is an increasing interest in finding methods to improve the quality of ureteroscopy process, reduce its time, and decrease its complications. The aim of this study was to evaluate the effect of tamsulosin on the quality, time, and complications of ureteroscopy. Materials and Methods: This double blind clinical trial study which was conducted on 120 patients who referred to Tohid Hospital in Sanandaj for ureteroscopy from 2013 to Using randomization method, 58 and 62 patients were randomly assigned to the intervention and control groups respectively. The samples were selected through block randomization. Two doses of tamsulosin were given to the intervention group while two doses of the placebo were given to the control group. The success rate, facilitation of ureteroscopy, and ureteral injury, as the outcomes, were studied in the two groups. Data analysis was performed through logistic regression test using Stata 12 software. Results: The mean age of the patients in the intervention group and the control group were 37.7 and 41.5 years, respectively. The odds ratio of successful ureteroscopy in the intervention group was 8.44 times more than that in the control group [OR: 8.44, 95% CI ( ), P=0.048], while, the odds ratio of problematic ureteroscopy in the intervention group was 0.25 times more than that in the control group [OR: 0.25; 95% CI ( ); P=0.013]. The odds ratio of injury to the ureter when performing ureteroscopy in the intervention group was 0.30 times more than that in the control group [OR: 0.30, 95% CI ( ), P=0.054]. Conclusion: Based on the findings of this study, the administration of tamsulosin increases the success of ureteroscopy and facilitates this process. Thus, it is recommended to administer tamsulosin before performing ureteroscopy. Keywords: Ureteroscopy, Tamsulosin, Clinical Trial, Ureteral Diseases, Complications 1. INTRODUCTION For a long time there was a debate and controversy among renal surgeons over the best treatment of kidney stones to be administered for the patients, and complicated and difficult stones were treated through performing a surgery (1). Since the beginning of the third millennium, less invasive surgeries have become more popular because they provide an opportunity for increasing the quality of life and reducing postoperative complications. Urology patients, like many other types of patients who are in need of the surgery, have benefited from recent technological advances in the treatment of urinary tract stones, so that most of the lower ureteral stones can be treated today through performing ureteroscopy (2, 3). Ureteroscopy is widely used for observing the inner parts of the kidney and facilitates diagnostic and therapeutic interventions which are performed for treating kidney stone (4). Diagnostic and therapeutic ureteroscopy can lead to various complications, including ureteral membrane injury, perforation, and bleeding of the ureter. However, in some cases, it is not possible to enter the ureter and performing ureteroscopy for various reasons, such as spasm and uterine stenosis (5, 6). The effect of tamsulosin on ureter, as an alpha blocker agent, is known. Tamsulosin can result in loosening of the muscles of prostate, bladder neck, and ureter, and inhabit the peristaltic movements of these muscles (7). Some studies have investigated and compared the effects of tamsulosin on acceleration of the automatic excretion of lower ureteric stones (8). The administration of tamsulosin after Extracorporeal Shock Wave Lithotripsy (ESWL) accelerates the removal of stones and reduces colic pain, the recurrence of stone-induced colic pains, the amount of sedative medications used, and the number of hospital readmissions (9, 10).As nowadays ureteroscopy is a commonly used diagnostic and therapeutic approach in urology, it is of great importance to find methods to improve the quality of performing ureteroscopy, reduce its duration, and decrease its complications (4, 5). Given the lack of enough evidences regarding the effect of tamsulosin on ureteroscopy, the aim of this study was to investigate the effect of tamsulosin on the quality, convenience, and complications of ureteroscopy. 2. MATERIALS AND METHODS Patients This double blind clinical trial study was conducted on 120 patients who referred to Tohid Hospital in Sanandaj during For randomization of patients, random block method was used. Using randomization method, 58 and 62 patients were randomly Page273

3 assigned to the intervention and control groups respectively (Figure 1). The exclusion criteria in this study included: patients with a history of ureteroscopy or a history of urinary system surgery or ureteral anomalies, being under 18 years of age, patients with a contraindication preventing the use of tamsulosin, a history or presence of urinary tract tumors, urinary system tuberculosis, and a history of abdominal and pelvic radiotherapy. The data about each patient including age, sex, height, weight, cause of ureteroscopy, location of stone, ureteral stenosis, and type of stone were recorded only by a surgeon and were registered in a checklist designed for checking the related outcomes. Two doses of tamsulosin (0.4 mg capsule) were given to the intervention group and two doses of placebo (with a similar shape) were given to the control group prior to the surgery (at 12 am and 6 am). The medications were delivered to the patients by a predetermined person who had previously recorded the patient's demographic data. He also recorded the information about the type of drug administered for each patient, without informing the surgeon. Taking into consideration the patient's condition, an anesthesiologist selected one of the two anesthesia options (general anesthesia and spinal anesthesia) for each patient which was candidate for ureteroscopy. The data on the outcomes of the ureteroscopy for each patient were recorded by a surgeon. The success of each procedure of ureteroscopy was determined based on the two states i.e. performing or non-performing the operation. The ease of ureteroscopy (easy, moderate, and difficult) was determined based on the judgment of the surgeon during the procedure, based on the factors such as the duration of the procedure and its ease or difficulty. Moreover, the possibility of ureteral injury during ureteroscopy (no injury, minor injury, moderate injury, and severe injury) was determined based on patient Page274

4 follow-up and intra-operational events including mucosal rupture, perforation, and urethral laceration. The ureteroscope No. 8 was used. Data Analysis The collected data were entered into Stata 12 software. The quantitative descriptive objectives were measured by calculating means and standard deviations and qualitative descriptive objectives were assessed by calculating the ratios along with the confidence intervals. In univariate analysis, Chi-square and Fisher test were used for the analysis of qualitative objectives. Logistic regression analysis was used to calculate odds ratios between the two groups. The significance level in this study was set at P <0.05. Ethics Before enrolling the patients into the study, informed consent was obtained from all patients. This study was approved by Ethics Committee of Kurdistan University of Medical Sciences under following registration code; IR.MUK.REC RESULTS The results of this study showed that 74.1% and 71% of the patients in the intervention and control group respectively were male. The mean age of the patients in the intervention and control groups were 37.7 ± 11.8 years and 41.5 ± 14 years, respectively and there was no significant difference between them. The most common cause of ureteroscopy in the two groups was stones, and the most cases of stones were observed in lower ureter. In addition, the most common stone sizes were in the two groups of 6 mm and 10 mm. There was no significant difference between the two groups in terms of ureteral stenosis (Table 1). The results of regression analysis showed that the odds ratio of success of each procedure of ureteroscopy in the intervention group was 8.44 times more than that in the control group and the difference was statistically significant [OR: % CI ( ); P=0.048]. The odds ratio of ureteral injury during ureteroscopy in the patients receiving tamsulosin was 0.3 times more than that in the patients in the control group and the difference was statistically significant [OR: 0.30, 95% CI ( ); P=0.054]. Concerning the ease of ureteroscopy, the odds ratio of difficult ureteroscopy in the patients receiving tamsulosin was 0.25 times more than that in the control group and the difference was statistically significant [OR: 0.25; 95% CI ( ); P=0.013]. However, the odds ratio of moderate ureteroscopy in the patients receiving tamsulosin was 0.60 times more than that in the control group and the difference was not statistically significant[or: 0.60, 95% CI ( ), P=0.418] (Table 2). The results also showed that ureteral injury (moderate and minor) was more frequent in the control group than the intervention group. Table 1 Demographic and clinical characteristics of patients in the two groups Variables Intervention group Control group (N: 58) (N: 62) P-value Gender (%) Male 43 (74.1) 44 (71) Female 15 (25.9) 18 (29) Age (± standard deviation) 37.7 ± ± Weight (± standard deviation) ± ± Height (± standard deviation) 66.1 ± ± BMI (± standard deviation) 23.4 ± ± stone 49 (84.5) 51 (82) Reason for ureteroscopy Hydronephrosis 4 (7) 5 (8) Diagnostic evaluation 2 (3.5) 4 (6.5) Others 3 (5) 2 (3.5) Upper ureter 3 (6) 9 (17) Place of the stone Type of anesthesia Middle ureter 12 (24) 8 (15.1) Lower ureter 23 (46) 23 (43.4) Multiple stones 12 (24) 13 (24.5) General anesthesia 26 (44.8) 28 (45.1) Spinal anesthesia 32 (55.2) 34 (54.9) Page275

5 Stone size Ureteral stenosis (pyelonephritis) less than 5 mm 3 (6) 1 (2) mm 31 (62) 23 (46) 11 to 15 mm 10 (20) 12 (24) More than 16 mm 5 (10) 5 (10) Yes 6 (10.3) 4 (6.4) No 52 (89.7) 58 (93.6) Table 2 Studied outcomes of the effects of tamsulosin and placebo in the two groups success rate Facilitating ureteroscopy Ureteral injury Variables Intervention group (N: 58) Control group (N: 62) Odds ratio (95% confidence interval) P-value Unsuccessful 1 (2) 8 (13) - Successful 57 (98) 54 (87) 8.44 ( ) Easy 39 (67.2) 23 (37.1) - - Moderate 12 (20.7) 17 (27.4) 0.60 ( ) Difficult 6 (10.3) 14 (22.6) 0.25 ( ) Yes 4 (6.9) 12 (19.3) - No 54 (93.1) 50 (80.7) 0.30 ( ) DISCUSSION After diagnosis of urinary stones, it is of great importance to choose the appropriate treatment for the patients. Anatomical malignancies of the kidney, chronic infections of the urethra, reduced pulmonary capacity, and complications due to reduced movement must be considered when choosing the appropriate therapeutic treatment (3). This study examined the effect of tamsulosin on quality and complications of ureteroscopy. The results of this study showed that the success rate of ureteroscopy was higher in the intervention group. In addition, difficult ureteroscopy was less frequent in patients who received tamsulosin. Although ureteral injury was less frequent in the intervention group, there was no significant difference between the two groups. In this study, there was no significant difference between the intervention and control groups in terms of demographic characteristics; these findings are consistent with the findings of previous studies (11, 12). Based on the findings of this study, the most common cause of ureteroscopy was ureteral stone (84.5%) and most of the stones were found in the lower urethra (46%) while the least number of stones were in the upper urethra (6%). In a study by Al Badran et al., which compared the effect of tamsulosin and alfuzosin on the removal of urinary stones, it was found that ureteral stones accounted for 46% of all the stones (13).In Hermans et al. s study, which investigated the effect of tamsulosin on the treatment of ureter stones, 40% of stones were found in the lower urethra (14). In this study, the most frequent stone sizes were 6 mm and 10mm stones and there was no significant difference between the two groups in terms of ureteral stenosis. In Al Badran et al. s study, stone with a size more than 10 mm were more frequent than stones less than 10 mm, but there were no statistically significant differences between the groups (13). The results of our study showed that ureteral injury in patients with 5-10 mm and mm stones was less frequent in the intervention group than in the placebo group. Bhaghat et al. studied the effect of tamsulosin and Extracorporeal shock wave lithotripsy (ESWL) to treat ureteral and kidney stones; their study was conducted on 64 patients with lower urethra stones. Based on the results of the mentioned study, the use of tamsulosin did not have a significant effect on treating patients and the elimination of stones in the intervention and placebo groups (15). In a study by Kirac et al., the effect of tamsulosin on the removal of stones was investigated. The results showed that the success rate in patients who had stones with a size of 4 to 7 mm was 93% in the intervention group and 90% in the placebo group which was not statistically significant, but the success rate in patients who had stones with a size of 8 to 12 mm was 80% in the intervention group and 52% in the placebo group which was statistically significant (16). The results of this study showed that the odds ratio of success in each intervention was 8.44 times higher in the intervention group than in the control group and the difference was statistically significant. In studies by Hollingsworth and Singh, the Page276

6 spontaneous removals of stones in the intervention group were higher than that in the placebo group (8, 12, 17, 18). A clinical trial study found a significant relationship between the rate of stone removal and the time of stone exit (19). In a meta-analysis by Parsons et al., there was a significant relationship between different treatment groups in terms of stone excretion after taking alpha blockers (20). In a double-blind clinical trial by Bensalah et al., which evaluated the efficacy of tamsulosin versus placebo in patients with vaginal colic due to distal urinary stones, after 42 days of treatment for 129 patients, no significant difference was observed between the placebo and intervention groups in terms of the excretion of stones on the final day. Spontaneous rocks were not observed between the placebo group and the intervention (21). In a study by Ketabchi et al., although the success rate of stone removal in both intervention and control groups were satisfactory, the difference was not significant (11). Tamsulosin relaxes the intestinal muscles and facilitates the removal of small stones which in turn leads to the successful removal of stones at the time of ureteroscopy (11). Other studies have shown that alpha-blockers are more effective than MET (Medical Expulsion Therapy) in the process of ESWL performed for stone removal. They suggest that alpha-blockers, and especially tamsulosin as a selective sympatholytic agent, reduce the complications after stone breakdown and stone removal and facilitate the removal of small stones in all lipotropic processes (19, 22-24). In the present study, the odds ratio of ureteral injury in patients taking tamsulosin was 0.3 times more than that in the control group. Moreover, concerning the ease of ureteroscopy, the odds ratio of difficult ureteroscopy in patients taking tamsulosin was 0.25 times more than that in the control group, which showed a significant difference. Abdelaziz et al. showed that endoscopic interventions without tamsulosin injections are associated with increased complications or failure; they observed minor and moderate complications (grades 1, 2, and 3) in 13% of patients, which significantly decreased after the administration of tamsulosin in the intervention group. The results of their study showed that the administration of tamsulosin was more convenient and safer and significantly increased stone removal and decreased the related complications after ureteroscopy (12). Considering the results of various studies, it can be concluded that tamsulosin can increase the rate of stone removal and reduce the incidence of colic in patients. In other words, there are some common alpha-blockers which are commonly administered in most hospitals for the treatment of colic (8, 25). 5. CONCLUSION Based on the findings of this study, it could be said that the administration of tamsulosin increases the success of ureteroscopy and facilitates it. CONFLICT OF INTERESTS The authors declare that they have no conflict of interests. FINANCIAL SUPPORT This work was supported by Vice Chancellor for Research of Kurdistan University of Medical Sciences. ACKNOWLEDGMENT Authors would like to thank Vice Chancellor for Research of Kurdistan University of Medical Sciences to support this study financially. REFERENCE 1. Sofimajidpour H, Rasti M, Gharibi F. The Effect of a Double-J Stent in the Treatment of Kidney Stones Larger Than 10 mm in Children Under 13 Years, Using Extracorporeal Shock Wave Lithotripsy (ESWL). Scientific Journal of Kurdistan University of Medical Sciences.2016; 21(1): Nikoobakht. Urethroscopic Management Of Iatrogenic Urethral Injuries. Tehran University Medical Journal. 2005;63(2): Sofimajidpour H, Kolahghoci P, Gharibi F. Outcome of Percutaneous Nephrolithotomy in Patients with Spinal Cord Neuropathy. Urol J. 2016;13(3): Khoury A, Bägli D, Mc-Dougal W, Wein A, Kavoussi L, Novick A, et al. Campbell-Walsh urology tenth edition review Geavlete P, Georgescu D, NiţĂ G, Mirciulescu V, Cauni V. Complications of 2735 retrograde semirigid ureteroscopy procedures: a single-center experience. Journal of Endourology. 2006;20(3): Abdelrahim AF, Abdelmaguid A, Abuzeid H, Amin M, Mousa E-S, Abdelrahim F. Rigid ureteroscopy for ureteral stones: factors associated with intraoperative adverse events. Journal of endourology. 2008;22(2): Page277

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