Original ContributionTamsulosin does not increase 1-week passage rate of ureteral stones in ED patients☆,☆☆,★,★★
Introduction
Renal colic is a common presenting complaint of patients in an emergency department (ED), and ureterolithiasis is a common diagnosis by emergency physicians. The annual incidence of stones and cost of therapy are increasing, and urolithiasis is reported to create $2.1 billion in health care costs in the United States alone [1]. Prior research demonstrates that most stones will pass spontaneously, and stone passage rates tend to be inversely proportional to stone size. A subset of patients with ureterolithiasis requires operative urologic intervention. This contributes to cost as well as morbidity.
Medical expulsive therapy (MET) has been investigated since the 1960s as an alternative to operative management for ureterolithiasis. Many drugs have been investigated, including steroids, nonsteroidal anti-inflammatory drugs, calcium-channel blockers, and α antagonists. Of these studied MET, α-blocker use is supported by the American Urologic Association for its MET properties in patients with ureteral calculi less than 10 mm [2]. This recommendation is level IV, panel/consensus evidence. The theoretical properties, which may make α-blockers effective for MET, include relaxing ureteral smooth muscle, inhibiting ureteral spasms, and dilating the ureteral lumen, which are postulated to facilitate stone passage [3].
Despite tamsulosin's α-blocking properties, which seem to make it ideal for MET, there are conflicting data in the literature, and only a paucity of studies are prospective or randomized controlled clinical trials. Of the 5 prior studies using α-blocker MET, 1 study that was prospective and randomized, but not double blinded or placebo controlled, did not find any added benefit vs standard analgesics [4]. Al-Ansari et al [5] did find benefit in their prospective, randomized, double-blinded, placebo-controlled investigation of distal-only ureterolithiasis. Further studies also suggest a benefit from tamsulosin, but these studies were not blinded or placebo controlled [6], [7], [8].
These studies are further limited, however, in that 2 [6], [7] used MET in combination with corticosteroids and 1 [8] analyzed only distal ureteral stones. To address this question, the aim of this study is to determine if tamsulosin monotherapy initiated in the ED decreases the time to ureteral stone passage compared to placebo. Our secondary objective was to assess whether tamsulosin decreased patient pain severity or medication use during the study period.
Section snippets
Materials and methods
We performed a prospective, randomized, double-blinded, placebo-controlled trial of tamsulosin vs placebo in ED patients with ureterolithiasis visualized on computed tomography at our tertiary care hospital using a convenience sample. Our tertiary care center has an associated emergency medicine residency program as well as annual ED volume is more than 120 000 patients per year with a 30% admission rate. This was institutional review board approved, and all patients provided informed consent.
Results
Of the 127 patients enrolled during this study, 15 were lost to follow-up, and 12 received surgical intervention before the 7-day mark, leaving 100 patients for analysis. Of the 100 patients, 53 received tamsulosin and 47 received placebo. As seen in the Table, analysis of demographics between the 2 groups revealed similarity in percentage of male, mean age, initial serum creatinine, average stone size, stone location, and history of prior stone.
Discussion
This prospective, randomized, double-blinded, placebo-controlled trial demonstrates no statistical difference in the proportion of stone passage at 7 days between tamsulosin and placebo. We observed a lower 1-week passage rate than previous reports in both the tamsulosin and placebo groups. We did not find a statistical difference in high pain score or Vicodin requirements between the 2 groups either. Of note, we identified no difference in the rate of adverse reactions to study drug vs placebo.
Limitations
Our study has several limitations, the most significant being the small sample size. Our enrollment is nonconsecutive, although no bias was recognized in the patients who were enrolled. Patients in our study had an average stone size of 3.8 mm in the control group and 4.0 mm in the treatment group, which is consistent with prior studies, supporting the lack of bias in recruiting. Our study also did not evaluate the amount of nonsteroidal anti-inflammatory drugs used by both groups, which may or
Conclusion
In this first prospective, randomized, double-blinded, placebo-controlled trial of ED patients with documented ureterolithiasis, we did not demonstrate any benefit in the form of early stone expulsion, decreased pain severity, or decreased pain medication use with the administration of tamsulosin. Reviewing our data and the aforementioned quasiexperimental trials addressing this topic, we conclude that a large multicenter randomized controlled trial would be needed to answer this question
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Cited by (10)
Effect of Tamsulosin on Stone Passage for Ureteral Stones: A Systematic Review and Meta-analysis
2017, Annals of Emergency MedicineCitation Excerpt :Five studies were duplicates, 5 did not contain sufficient data to analyze in a meta-analysis, and 1 reported 1-week outcomes (versus 3- to 4-week outcomes). Authors for 7 studies were contacted for additional information,8,17-22 and complete data were available in only 8 cases. Agreement between study abstractors was excellent (Cohen’s κ=0.94 [95% CI 0.82 to 1.0]).
Medical Expulsive Therapy in Urolithiasis: A Review of the Quality of the Current Evidence
2017, European Urology FocusCitation Excerpt :These trials were parallel in design, whereby each group of participants was exposed to one of the study intreventions (α-blocker vs placebo [22,23,25,52,57] or α-blocker vs calcium channel blocker vs placebo [24]). They conformed to most of the 37 CONSORT criteria (n = 23 [22]; n = 25 [52]; n = 27 [57]; n = 31 [23,25]; n = 36 [24]). Patients with stones located in any part of the ureter [23,24] or with distal ureteral stones [22,25,52,57] were enrolled.
Tamsulosin for urolithiasis: a review of the recent literature and current controversies
2016, American Journal of Emergency MedicineAlpha-blockers: the magic pill for endourology—The great delusion
2024, World Journal of UrologyIs tamsulosin effective for the passage of symptomatic ureteral stones A systematic review and meta-analysis
2019, Medicine (United States)α-blockers as medical expulsive therapy for ureteric stones: a Cochrane systematic review
2018, BJU International
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Meetings: Not presented at any national or international meetings.
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Clinical Trials number NCT00448123; no grant or financial support.
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Conflicts of interest: None for any author.
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Author contribution statement: MR, JH, JZ, RJ, and RS conceived the study and designed the trial. MR, RJ, and RS supervised the conduct of the trial and data collection. RJ and RS managed the data to ensure quality control. RJ and RS provided statistical advice, and the statistical analysis was performed by CC. DB drafted the manuscript, and all authors contributed to its revision. DB, RJ, and RS take responsibility for the article as a whole.