Efficacy and Safety of Tamsulosin in Medical Expulsive Therapy for Distal Ureteral Stones with Renal Colic: A Multicenter,Randomized, Double-blind,Placebo-controlled Trial |
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| 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 Hua Xu |
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| Institution: | 1. Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China;2. Hubei Institute of Urology, Wuhan, China;3. The Center of Minimally-invasive Surgery, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China;4. The Institute of Urology, Peking University, Beijing, China;5. Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu, China;6. Department of Urology and Nephrology, The Third Affiliated Hospital of Chongqing Medical University, Chongqing, China;g. Department of Urology, Huashan Hospital of Fudan University, Shanghai, China;h. Department of Urology, the First Affiliated Hospital of Zhongshan University, Guangzhou, China;i. Department of Urology, the First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China;j. Department of Urology, the First Affiliated Hospital of Chinese Medical University, Shenyang, China;k. Department of Urology, the First Affiliated Hospital of Guangxi Medical University, Nanning, China;l. Department of Urology, Wuhan General Hospital of Guangzhou Military Region, Wuhan, China;m. Department of Urology, the First Affiliated Hospital of Xiamen University, Xiamen, China;n. Department of Urology, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China;o. Department of Urology, the First People''s Hospital of Ningbo City, Ningbo University Medical School, Ningbo, China;p. Department of Urology, JiangSu Province Hospital of Traditional Chinese Medicine, Nanjing, China;q. Department of Urology, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China;r. Department of Urology, the People''s Hospital of Shenzhen, Shenzhen, China;s. Department of Urology, Shantou Central Hospital, Shantou, China;t. Department of Urology, the People''s Hospital of Dongguan, Dongguan, China;u. Department of Urology, Xiangya Hospital of Centra South University, Changsha, China;v. Department of Urology, the Second Affiliated Hospital of Kunming Medical University, Kunming, China;w. Department of Urology, Guangzhou General Hospital of Guangzhou Military Region, Guangzhou, China;x. Department of Urology, the Affiliated Hospital of Hainan Medical College, Haikou, China;y. Department of Urology, the People''s Hospital of Guizhou Province, Guiyang, China;z. Department of Urology, the Second Affiliated Hospital of Zhengzhou University Medical School, Zhengzhou, China;11. Department of Urology, Shaoyang Central Hospital, Shaoyang, China;22. Department of Urology, Jiangmen Hospital of Zhongshan University, Jiangmen, China;33. Department of Urology, Meizhou Hospital of Zhongshan University, Meizhou, China;44. Department of Urology, Foshan Maternal and Child Health Care Hospital of Nanfang Medical University, Foshan, China;55. Department of Urology, Nanhai Hospital of Nanfang Medical University |
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| Abstract: | BackgroundRecent large high-quality trials have questioned the clinical effectiveness of medical expulsive therapy using tamsulosin for ureteral stones.ObjectiveTo evaluate the efficacy and safety of tamsulosin for distal ureteral stones compared with placebo.Design, setting, and participantsWe 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.InterventionParticipants were randomly assigned (1:1) into tamsulosin (0.4 mg) or placebo groups for 4 wk.Outcome measurements and statistical analysisThe 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 limitationsAmong 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 (>5 mm). 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.ConclusionsOur 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 >5 mm, but no effect for stones ≤5 mm.Patient summaryIn 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. |
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| Keywords: | Adrenergic alpha blockers Medical expulsive therapy Tamsulosin Distal ureteral stones Renal colic |
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