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.Keywords: Silodosin; tadalafil; ureteral stone; ureteroscope; ureteral orifice.Cite this article as: Bhattar R, Jain V, Tomar V, Yadav SS. Safety and efficacy of silodosin and tadalafil in ease of negotiation of large ureteroscope in management of ureteral stone: A prosective randomized trial. Turk J Urol 2017; 43(4): 484-9

Pooled analysis of the efficacy and safety of adjunctive alpha-blocker therapy before ureteroscopy in the management of ureteral stones

“…All five studies (n ¼ 557; 274 in the alphablockers group and 283 in the placebo group) were used in the analysis of operation time. [13][14][15][16][17] Heterogeneity was found among the trials (I 2 ¼ 82%; P ¼ 0.0002), so a random-effects model was chosen for the analysis. There was no significant difference in operation time between the adjunctive alpha-blockers and placebo groups (MD: -3.33; 95% CI -7.03, 0.37; P ¼ 0.08) (Figure 5).…”

“…24 Although ureteroscopy has yielded high success rates in the treatment of ureteral stones, the Successful access to the ureteral stone during ureteroscopy in groups treated with either adjunctive alpha-blocker therapy or placebo therapy before ureteroscopy. [13][14][15][16][17] Figure 3. Stone-free rate at the end of week 4 in groups treated with either adjunctive alpha-blocker therapy or placebo therapy before ureteroscopy.…”

“…25,26 Several RCTs have reported the promising results of adjunctive alphablocker therapy before ureteroscopy. [13][14][15][16][17] A previous RCT that included 1136 analysed patients reported that tamsulosin was not effective in terms of stone-free status at Requirement for balloon dilatation during ureteroscopy in groups treated with either adjunctive alpha-blocker therapy or placebo therapy before ureteroscopy. [14][15][16][17] Figure 5.…”

“…27 The current metaanalysis results were different to those of the previous study, 27 which suggests that caution is required when considering the results of the current meta-analysis of five relatively small RCTs. [13][14][15][16][17] A network meta-analysis showed a significant increase in stone expulsion rate and a reduction in stone expulsion time with alpha-blockers compared with placebo or phosphodiesterase inhibitors. 28 In terms of the stone expulsion rate, alpha-blockers were very likely to be the 'best' interventions.…”

“…13 Subsequent publications demonstrated that alphablockers (tamsulosin and silodosin) increased access to stones and contributed to stone-free rates. [13][14][15][16][17] To date, there has not been a systematic meta-analysis to assess the efficacy and safety of adjunctive alpha-blockers versus placebo before ureteroscopy in the treatment of ureteral stones. Therefore, this current metaanalysis evaluated the effects of adjunctive alpha-blocker therapy prior to ureteroscopy in patients with ureteral stones.…”