Safety and efficacy of silodosin and tadalafil in ease of negotiation of large ureteroscope in the management of ureteral stone: A prosective randomized trial
Abstract
OBJECTIVE: To evaluate the safety and efficacy of silodosin and tadalafil in ease of negotiation of large size ureteroscope (8/9.8 Fr) in the management of ureteral stone.
MATERIAL AND METHODS: Between June 2015 and May 2016, 86 patients presented with ureteral stone of size 6-15 mm were on consent randomly assigned to 1 of 3 outpatient treatment arms: silodosin (Group A), tadalafil (Group B), and placebo (Group C). After two weeks of therapy 67 patients underwent ureteroscopy, and ureteral orifice configuration, ureteroscopic negotiation, ureteral dilatation, operating time, procedural complication and drug related side effects were noted in each group.
RESULTS: Ureteral negotiation was significantly better in Groups A (73.9%) and B (69.6%) as compared to Group C (38.1%) (p<0.01). Statistically significant difference was noted in the requirement for dilatation in Group C (71.4%) as compared to Groups A (26.1%) and B (39.1%) (p<0.01). Ureteral orifice was found to be more dilated in Groups A (69.6%) and B (60.9%) as compared to Group C (28.6%). Mean operating time was statistically lower in Groups A (35.2 min) and B (34.91 min) as compared to Group C (41.14 min) (p<0.01).
CONCLUSION: Both silodosin and tadalafil not only relax ureteral smooth muscle but also help in forward propagation of large size ureteroscope (8/9.8 Fr) without any significant risk of adverse events.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 67 participants or records.
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