Efficacy of silodosin on the outcome of semi-rigid ureteroscopy for the management of large distal ureteric stones: blinded randomised trial

Peer review under responsibility of Arab Association of Urology.

Figures & data

Fig. 1 Flow chart of study inclusion.

Table 1 Patients’ and stone characteristics.

Variable	Silodosin group	Placebo group	P
Number of patients	62	65
Age, years, mean (SD)	38.27 (9.37)	39.67 (9.54)	0.405
Sex, n (%)			0.855
Male	39 (62.9)	39 (60)
Female	23 (37.1)	26 (40)
Stone size, cm, mean (SD)	1.26 (0.125)	1.29 (0.129)	0.196
Stone side, n (%)			0.721
Right	35 (56.5)	39 (60)
Left	27 (43.5)	26 (40)
Stone density, HU, mean (SD)	907.66 (208.52)	898.97 (212.04)	0.887
BMI, kg/m^2, mean (SD)	27.55 (2.28)	27.8 (3.50)	0.634

HU, Hounsfield unit.

Table 2 Operative and postoperative data.

Variable	Silodosin group	Placebo group	P
	(N = 62)	(N = 65)
Ureteric orifice dilatation (overall), n (%)	12 (19.35)	34 (52.3)	<0.001
Balloon dilatation	9 (14.5)	24 (36.9)
Hydrodilatation	3 (4.84)	10 (15.38)
Operative time, min, mean (SD)	41.61 (4.67)	46.85 (4.6)	<0.001
Advancing the ureteroscope to access the stone, n (%)			0.005
Successful	60 (96.8)	52 (80)
Failed	2 (3.2)	13 (20)
Overall complications, n (%)	4 (6.4)	13 (20)	0.036
Stone migration (Clavien–Dindo Grade IIIa)	1 (1.6)	1 (1.5)
Fever (Clavien–Dindo Grade I)	1 (1.6)	3 (4.6)
Mucosal injury (Clavien–Dindo Grade I)	1 (1.6)	4 (6.2)
Haematuria (Clavien–Dindo Grade I)	1 (1.6)	5 (7.7)
Stone-free rate, n/N (%)
At 24–48 h	57/62 (91.94)	48/65 (73.85)	0.009
After 4 weeks	53/56 (94.64)	43/57(75.43)	0.007
Need for analgesia, n (%)	5 (8.1)	17 (26.2)	0.009