Effect of Tamsulosin on Passage of Symptomatic Ureteral Stones

Abstract

stone disease is a common presentation in the emergency department, and α-adrenergic receptor blockers, such as tamsulosin, are commonly used to facilitate stone passage.OBJECTIVE To determine if tamsulosin promotes the passage of urinary stones within 28 days among emergency department patients. DESIGN, SETTING, AND PARTICIPANTSWe conducted a double-blind, placebo-controlled clinical trial from 2008 to 2009 (first phase) and then from 2012 to 2016 (second phase). Participants were followed for 90 days. The first phase was conducted at a single US emergency department; the second phase was conducted at 6 US emergency departments. Adult patients were eligible to participate if they presented with a symptomatic urinary stone in the ureter less than 9 mm in diameter, as demonstrated on computed tomography.INTERVENTIONS Participants were randomized to treatment with either tamsulosin, 0.4 mg, or matching placebo daily for 28 days. MAIN OUTCOMES AND MEASURESThe primary outcome was stone passage based on visualization or capture by the study participant by day 28. Secondary outcomes included crossover to open-label tamsulosin, time to stone passage, return to work, use of analgesic medication, hospitalization, surgical intervention, and repeated emergency department visit for urinary stones. RESULTSThe mean age of 512 participants randomized to tamsulosin or placebo was 40.6 years (range, 18-74 years), 139 (27.1%) were female, and 110 (22.8%) were nonwhite. The mean (SD) diameter of the urinary stones was 3.8 (1.4) mm. Four hundred ninety-seven patients were evaluated for the primary outcome. Stone passage rates were 50% in the tamsulosin group and 47% in the placebo group (relative risk, 1.05; 95.8% CI, 0.87-1.27; P = .60), a nonsignificant difference. None of the secondary outcomes were significantly different. All analyses were performed according to the intention-to-treat principle, although patients lost to follow-up before stone passage were excluded from the analysis of final outcome. CONCLUSIONS AND RELEVANCETamsulosin did not significantly increase the stone passage rate compared with placebo. Our findings do not support the use of tamsulosin for symptomatic urinary stones smaller than 9 mm. Guidelines for medical expulsive therapy for urinary stones may need to be revised.

The Urological Association of Asia clinical guideline for urinary stone disease

“…Tamsulosin significantly facilitated the passage of distal ureteral stones in patients with well‐controlled pain, no infections, abnormal anatomy, renal insufficiency or high‐grade obstruction No improvement in stone passage rates was observed in patients with ≤5‐mm distal ureteral stones treated with tamsulosin While one RCT does not recommend the use of tamsulosin for symptomatic stones <9 mm, a similar result was shown by another RCT trial . However, several well‐designed, randomized, double‐blind, placebo‐controlled studies have recently produced contradictory results, showing no overall benefit of MET .…”

The evaluation of the effectiveness of Gilaburu (Viburnum opulus L.) extract in the medical expulsive treatment of distal ureteral stones

“…In this study, 512 patients were randomized to tamsulosin and placebo arms, and no significant difference was observed between the two groups with regard to stone passage rates. [23] PDE5Is sildenafil and tadalafil cause cyclic guanosine monophosphate (cGMP) increase and ureteric muscle relaxation by the nitric oxide/cGMP signaling pathway. Thus, it facilitates the passage of stones with a similar effect to alpha-blockers.…”

Rückblick auf 50 Jahre Steintherapie

“…Hierfür spricht eine ebenfalls prospektiv-randomisierte und Placebo-kontrollierte Studie aus China, welche genau dies zeigen konnte [56]. Eine negativere Interpretation zeigte eine weitere aktuelle Studie aus den USA, welche analog zur britischen Studie keinen Benefit, allerdings bei ebenfalls größtenteils kleinen Harnleitersteinen zeigen konnte [57]. Die aktuellen EAU-Leitlinien sprechen hinsichtlich der Gabe von Tamsulosin aktuell nur noch von einer "Kann"-Empfehlung bei distalen Harnleitersteinen > 5 mm.…”