Efficacy and Safety of Tamsulosin in Medical Expulsive Therapy for Distal Ureteral Stones with Renal Colic: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial.

Abstract

BACKGROUND:

Recent large high-quality trials have questioned the clinical effectiveness of medical expulsive therapy using tamsulosin for ureteral stones.

OBJECTIVE:

To evaluate the efficacy and safety of tamsulosin for distal ureteral stones compared with placebo.

DESIGN, SETTING, AND PARTICIPANTS:

We conducted a double-blind, placebo-controlled study of 3296 patients with distal ureteral stones, across 30 centers, to evaluate the efficacy and safety of tamsulosin.

INTERVENTION:

Participants were randomly assigned (1:1) into tamsulosin (0.4mg) or placebo groups for 4 wk.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:

The primary end point of analysis was the overall stone expulsion rate, defined as stone expulsion, confirmed by negative findings on computed tomography, over a 28-d surveillance period. Secondary end points included time to stone expulsion, use of analgesics, and incidence of adverse events.

RESULTS AND LIMITATIONS:

Among 3450 patients randomized between September 1, 2011, and August 31, 2013, 3296 (96%) were included in the primary analysis. Tamsulosin benefits from a higher stone expulsion rate than the placebo (86% vs 79%; p<0.001) for distal ureteral stones. Subgroup analysis identified a specific benefit of tamsulosin for the treatment of large distal ureteral stones (>5mm). Considering the secondary end points, tamsulosin-treated patients reported a shorter time to expulsion (p<0.001), required lower use of analgesics compared with placebo (p<0.001), and significantly relieved renal colic (p<0.001). No differences in the incidence of adverse events were identified between the two groups.

CONCLUSIONS:

Our data suggest that tamsulosin use benefits distal ureteral stones in facilitating stone passage and relieving renal colic. Subgroup analyses find that tamsulosin provides a superior expulsion rate for stones >5mm, but no effect for stones ≤5mm.

PATIENT SUMMARY:

In this report, we looked at the efficacy and safety of tamsulosin for the treatment of distal ureteral stones. We find that tamsulosin significantly facilitates the passage of distal ureteral stones and relieves renal colic.

• Authors: Zhangqun Ye, Guohua Zeng, Huan Yang, Kun Tang, Xiaochun Zhang, Hong Li, Weibing Li, Zhong Wu, Lingwu Chen, Xingfa Chen, Xiankui Liu, Yaoliang Deng, Tiejun Pan, Jinchun Xing, Shusheng Wang, Yue Cheng, Xiaojian Gu, Wenxi Gao, Jianggen Yang, Yonghai Zhang, Qiwu Mi, Lin Qi, Jiongming Li, Weilie Hu, Peiyu Liang, Zhaolin Sun, Changbao Xu, Yongfu Long, Yongbin Liao, Siping Liu, Guoqing Liu, Xun Xu, Wei He, Zhiqiang Chen, Hua Xu
• Journal: European urology (Eur Urol) Vol. 73 Issue 3 Pg. 385-391 (Mar 2018) ISSN: 1873-7560 [Electronic] Switzerland
• PMID: 29137830 (Publication Type: Journal Article)
• Copyright: Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.