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While there is no benefit from using tamsulosin (Flomax) versus placebo for the treatment of small ureteral stones, there is a potential upside of increased passage from using the drug to treat 5- to 10-mm stones, according to a study from Australia published online in the Annals of Emergency Medicine (July 13, 2015).
While there is no benefit from using tamsulosin (Flomax) versus placebo for the treatment of small ureteral stones, there is a potential upside of increased passage from using the drug to treat 5- to 10-mm stones, according to a study from Australia published online in the Annals of Emergency Medicine (July 13, 2015).
First author Jeremy Furyk, MBBS, MPH, of Townsville Hospital, Townsville, Queensland, and colleagues studied 403 patients randomized to receive 0.4 mg of tamsulosin or placebo daily, for 28 days. Median stone size was 4.0 mm in the tamsulosin group versus 3.7 mm in the placebo group.
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They found no significant difference between the groups within 28 days of patients’ visits to the emergency department. Eighty-seven percent of those in the tamsulosin group and 81.9% of patients in the placebo group passed their stones. But in a subgroup analysis of large stones-5 to 10 mm-83.3% of tamsulosin participants had stone passage versus 61.0% of those receiving placebo.
Otherwise, the authors found no differences in urologic interventions, time to self-reported stone passage, pain, analgesia needs, or adverse events, according to the study’s abstract.
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Dr. Furyk told Urology Times that the take-home message for urologists is: “Tamsulosin is of no benefit to patients with stones [less than] 5 mm in diameter, but should be considered for distal stones 5 to 10 mm.”
That’s a finding that seems to differ from the interpretation of an article published July 2015 in The Lancet, which suggests “Tamsulosin 400 μg and nifedipine 30 mg are not effective at decreasing the need for further treatment to achieve stone clearance in 4 weeks for patients with expectantly managed ureteric colic.” (For Urology Times’ coverage of that study, click here.)
“I do not think the results are necessarily contradictory,” Dr. Furyk said. “Obviously, there were some differences between study designs, mainly in outcome measured, and Pickard et al included proximal stones. We found benefit in stones 5 to 10 mm only. In the subgroup of 5 to 10 mm stones in the Pickard study also seemed to demonstrate a trend to benefit, although this included the proximal stones (with reported 99% CI crossing the line of no difference).”
Robert Pickard, MD, of the Institute of Cellular Medicine, Newcastle University, United Kingdom, who served as first author of The Lancet study, told Urology Times, “The SUSPEND clinical trial group were very pleased to see that the finding from our trial of over 1,000 patients has been corroborated by the results of Furyk et al, showing no benefit for tamsulosin over placebo for spontaneous passage of symptomatic ureteral stones up to 10 mm. We would urge caution in interpretation of subsidiary subgroup analyses, particularly where sample size is small and the result contradictory to the main analysis.”
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