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Summary

Aim

Medical expulsive therapy (MET) using alpha-blockers is effective for distal ureteral calculi (UC). We aimed to evaluate the efficacy of tamsulosin for proximal UC expulsion.

Materials and methods

An open-label randomized controlled trial was conducted with 108 patients who agreed to conservative management for single, radiopaque, proximal UC ≤ 6 mm and were randomized into group A (n = 54, conservative managements only) or B (n = 54, 0.2 mg tamsulosin once a day). The primary end-point was stone passage rates (SPR) in the intention-to-treat population in 4 treatment weeks. The secondary end-points were estimated in per-protocol population and were time to stone passage, post-trial Euro-quality-of-life (EuroQOL) score, oral analgesic requirements, and willingness to undergo conservative treatment again.

Results

The two groups were well balanced in terms of baseline patient and stone characteristics. Seventy nine patients (73.2%; 35 of group A and 44 of group B) completed the study protocol. The overall SPR was 60.2% (65/108). Group B had a higher SPR (74.1%; 40/54) than group A (46.3%; 25/54; p = 0.003) and a significantly shorter time to stone passage (mean days, A: 19.6 vs. B: 14.3, p = 0.005). The groups did not differ in post-trial EuroQOL score or oral analgesic requirements, whereas 74.3% (26/35) of group A and 90.9% (40/44) of group B were willing to undergo conservative treatment again (p = 0.048). Univariate logistic regression analysis showed that stone size (OR = 1.447, p = 0.045) and tamsulosin treatment (OR = 3.314, p = 0.004) significantly predicted stone expulsion. On multivariate analysis, only tamsulosin was statistically significant (OR=3.198, p = 0.021).

Conclusions

Tamsulosin was associated with significantly higher stone expulsion rate and shorter expulsion time in proximal UC ≤ 6 mm compared with conservative managements only. Our results indicate that similar to patients with distal UC, MET using tamsulosin is a reasonable treatment option for patients with proximal UC.