Effect of tamsulosin on stone expulsion in proximal ureteral calculi: an open-label randomized controlled trial
Article first published online: 22 DEC 2013
© 2013 John Wiley & Sons Ltd
International Journal of Clinical Practice
Volume 68, Issue 2, pages 216–221, February 2014
How to Cite
Lee, S. W., Woo, S. H., Yoo, D.-S. and Park, J. (2014), Effect of tamsulosin on stone expulsion in proximal ureteral calculi: an open-label randomized controlled trial. International Journal of Clinical Practice, 68: 216–221. doi: 10.1111/ijcp.12271
All authors declare no competing financial interests. All authors declare no conflict of interests.
- Issue published online: 26 JAN 2014
- Article first published online: 22 DEC 2013
- Manuscript Accepted: 29 JUL 2013
- Manuscript Received: 2 JUN 2013
- Korean Astellas Pharm, Co
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.
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).
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.