ESWL is the treatment of choice for upper tract calculi of moderate size. Limitations of ESWL like poor clearance rate and more time to clearance with occasional complaint of steinstrasse are well known [6]. To facilitate fragment passage, a lot of medications have been tried and few have stood the test of the time. The α-blockers can facilitate stone passage by reducing ureteral spasm. They also increase pressure proximal to the calculus and relax the ureter distal to the stone [4, 6]. Deflazacort is a synthetic heterocyclic corticosteroid, oxazoline derivative of Prednisolone with high efficacy, strong anti-inflammatory activity and good tolerability [7]. The average potency ratio of Deflazacort to Prednisolone is 0.69–0.89, and 6 mg of Deflazacort is having equivalent anti-inflammatory potency as 5 mg of Prednisolone [7, 8]. Deflazacort is having small suppressive effect on hypothalamic–pituitary–adrenal axis due to low lipid liposolubility, low risk of sodium retention and hypokalemia due to substantial lack of mineralocorticoid activity and lower interference with carbohydrate and calcium metabolism in comparison with older corticosteroids. Thus, Deflazacort at doses with equivalent anti-inflammatory efficacy to Prednisolone with less severe adverse effects makes it a good choice. Deflazacort shows high dosage flexibility, due to its wide therapeutic index with oral daily dosage ranging from 6 to 90 mg depending on the nature and severity of specific disease [8]. Deflazacort is also used in Duchenne muscular dystrophy at a higher dose of 0.9 mg/kg/day to enhance strength by their effect on myoblast proliferation, myogenic repair, muscle proteolysis and immunosuppression [9]. Deflazacort in combination with Tamsulosin is used at a much lower dose of 30 mg/day in stone disease to reduce inflammation and edema associated with stone with a lower risk of adverse effects. In this study, Tamsulosin with or without Deflazacort was used in post-ESWL period to check whether these expedite the stone expulsion [6, 7].
Various studies have been performed to evaluate the role of alpha blockers and steroid in renal or ureteric stone after ESWL [5, 10, 11]. Our study enrolled a large number of patients compared to previously done studies. We assessed all the relevant parameters including the number of ESWL sessions, stone clearance time, stone clearance rate, complications and analgesic requirement in a large number of population.
A total of 705 patients were enrolled in this study. Kidney stone disease is relatively uncommon before the age of 20, but the incidence rises rapidly and peaks from 40 to 60 years of age and then declines from 65 years of age and beyond [12]. Typically men are approximately two to three times more frequently affected than females [13]. In our study, there was no statistically significant difference between the groups according to age and gender and in terms of side of stone.
In our study, the mean stone size in the patients of Group A was 9.70 ± 1.89 mm, in Group B was 9.22 ± 1.66 mm, and in Group C was 9.79 ± 1.86 mm with no significant difference. In a study by Qadri et al., the mean stone size in the patients of the Tamsulosin group was 1.12 ± 0.31 cm as compared to 1.05 ± 0.26 cm in the control group. The mean stone size was higher in this study as compared to our study because they included up to 20 mm calculus in their study as compared to 15 mm in our study [14].
4.1 Number of ESWL sessions
In our study, difference between Group A and Group C was borderline insignificant in terms of required mean number of ESWL sessions. There was an insignificant difference for required mean ESWL sessions between Groups A and B and between Groups B and C.
Singh et al. studied role of Tamsulosin in clearance of upper ureteral calculi after ESWL and found that the median value of required ESWL sessions is 1 in the Tamsulosin group and 2 in the control group and the difference was significant in two groups (P = 0.031) [15]. In a study done by Naja et al. [4], patients in the Tamsulosin group required the less number of ESWL sessions than the control group (mean 1.66 vs 2.16) and the difference between required ESWL sessions was significant (P = .005) between two groups. So, Tamsulosin with Deflazacort with a higher clearance rate can prevent some patients to undergo further treatment with ESWL.
4.2 Stone clearance rate
In a study conducted on stone size 5–15 mm by Hassan Ismail Mohamed, stone free rate after 3 sessions of ESWL was 89% in the control group and 85% in the Tamsulosin group with no statistically significant difference (P = 0.34). He concluded that the use of Tamsulosin after ESWL did not improve success and stone free rates, but decreased the expulsion time [16]. Qadri et al. analyzed and observed that the overall stone clearance rate in the control and Tamsulosin groups was 80.0% and 96.7% with statistically significant difference (P < 0.004). They stratified the size of stone in three groups and concluded that stone clearance rate was statistically significant in stone group size of 1.1–1.5 cm (P < 0.003) and 1.6–2.0 cm (P < 0.05), but was statistically insignificant in the subgroup of stone size 0.6–1.0 cm (P < 0.21) [14]. We found that though stone clearance was better in Tamsulosin with or without the Deflazacort group, there was no statistically significant difference between the three groups.
4.3 Stone clearance time
Singh et al. [15] found that the mean expulsion time of stone was 26.78 ± 11.96 in the Tamsulosin group and 31.28 ± 18.31 days in the control group, but the difference was statistically insignificant (P = 0.138). Qadri et al. found the mean stone clearance time for 0.6–1.0 cm stone size was 2.16 ± 0.96 weeks in the Tamsulosin group and 2.82 ± 1.16 weeks in the control group (P < 0.0001). For stone size 1.1–1.5 cm, mean stone clearance time was 4.39 ± 0.98 weeks in the Tamsulosin group and 5.75 ± 1.16 weeks in the control group (P < 0.002). In stone size 1.6–2.0 cm, the mean stone clearance time was 6.25 ± 0.95 weeks and 8 weeks in the study and control group, respectively (P < 0.172) [14].
In our study, there was an early clearance of stone fragments in Group A than in Groups B and C, and it was statistically significant between Group A and Group C, specifically in the subgroup of stone size 10.1–15 mm. So, Tamsulosin with Deflazacort can help by facilitating early clearance with decreased ESWL session.
4.4 Complications
In the study of Naja et al. [4], overall 11 patients developed steinstrasse, 2 in the Tamsulosin group and 9 in the control group. One patient in each group was successfully treated with conservative management. Similarly in the study of Singh et al., 8 patients in the Tamsulosin group and 13 patients in the control group developed steinstrasse, but the difference was insignificant (P = 0.167). All these patients had stones in the size of 11–15 mm. In the Tamsulosin group, 6 patients were treated conservatively and 2 patients required ureteroscopic removal of stone (URS). Of 13 patients in the control group, 5 required auxiliary procedure (URS) [15].
Hassan Ismail Mohamed used the modified Clavien–Dindo system to classify the post-ESWL complications. Overall, there were 4 (3%) grade 1 complications and 8 (6%) grade 2 complications. In the control group, there were 8 (12%) complications, 4 with severe ureteric colic with the requirement of hospitalization and auxiliary procedure and another 4 with progressive hydronephrosis with fever. In the Tamsulosin group, 4 (6%) patients had fever with progressive hydronephrosis [16]. Bhagat et al. [11] concluded that Tamsulosin improved the outcome of steinstrasse.
In our study, the difference in complication rates and steinstrasse is clinically insignificant between groups. Overall, a total of 35 (5.0%) patients developed steinstrasse and in all patients ureteroscopic removal of stones (URS) was done as an auxiliary procedure.
4.5 Requirement of analgesics
In a study by Singh et al. [15], Visual Analogue Scale pain score in the Tamsulosin group was 24.92 ± 7.57 and in the control group was 41.81 ± 17.24, and the difference was statistically significant (P = 0.00). Hassan Ismail Mohamed showed that the mean cumulative Diclofenac dose was 380 mg/patient in the Tamsulosin group and 750 mg/patient in the control group and the difference was statistically significant (P = 0.004) [16]. We compared the requirement of the mean number of analgesic tablets in our study and found that the difference was significant between Groups A and C. We conclude that the use of Tamsulosin with Deflazacort can reduce most distressing symptoms of colic and associated with the decrease in requirement of analgesics.
In a meta-analysis by Skolarikos et al. [17], the stone clearance time, pain score, steinstrasse formation and the need for auxiliary procedures were decreased with alpha blockers.
We conclude that Tamsulosin with Deflazacort decreases the number of required ESWL sessions and also improves complete stone clearance after ESWL. Tamsulosin with Deflazacort also facilitates early stone clearance after ESWL and also decreases stone clearance time. Steinstrasse formation incidence is less with both Tamsulosin with Deflazacort and Tamsulosin alone. Requirement of mean analgesic tablets after ESWL is also decreased by Tamsulosin with Deflazacort compared to no treatment group. Thus, Tamsulosin with Deflazacort can be used safely to facilitate stone clearance without increased complication rate.